Search Results

Restoration ADM and MDM Systems (ADM/MDM X3 Inserts, MDM Acetabular Inserts, MDM Acetabular Liners)

Indications for Use:
The indications for use for total hip arthroplasty include:

1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
2. Rheumatoid arthritis;
3. Correction of functional deformity;
4. Revision procedures where other treatments or devices have failed; and,
5. Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
6. Dislocation risks

MDM Liners are intended for cementless use only.

Trident II Acetabular System (Trident II Cups (Clusterhole HA, PLS Clusterhold HA, Tritanium Clusterhole, Tritanium Multihole, Tritanium Solidback))

Indications for Use:

• Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
• Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
• Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
• Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.

When used with MDM Liners

• Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
• Dislocation risks

When used with Constrained Liner:

• The Trident Constrained Acetabular Insert is indicated for use in primary and revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability.

The Trident II Acetabular Shells are indicated for cementless use only.

Restoration® Modular Hip System

The Restoration® Modular Hip System is indicated for use in:

• Noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
• Rheumatoid arthritis;
• Correction of functional deformity;
• Revision procedures where other treatments or devices have failed; and,
• Nonunions, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

Additional indications specific to the Restoration Modular Hip System

The Restoration® Modular Hip System is intended to be used for primary and revision total hip arthroplasty, as well as in the presence of severe proximal bone loss. These femoral stems are designed to be press fit into the proximal femur.

Secur-Fit Advanced

The indications for use for total hip arthroplasty with stems include:

• noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
• rheumatoid arthritis;
• correction of functional deformity;
• revision procedures where other treatments or devices have failed; and,
• nonunions, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

Additional indication specific to use of the Femoral Stem with compatible Howmedica Osteonics Constrained Liners:

• When the stem is to be used with compatible Howmedica Osteonics Constrained Liners, the device is intended for use in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability.

The Stems are intended for cementless use only and are intended for total and hemiarthroplasty procedures.

Accolade II Femoral Stems

The indications for use of the total hip replacement prostheses include:

• noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
• rheumatoid arthritis;
• correction of functional deformity;
• revision procedures where other treatments or devices have failed; and,
• nonunions, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

Additional indication specific to use of the Femoral Stems with compatible Howmedica Osteonics Constrained Liners:

• When the stem is to be used with compatible Howmedica Osteonics Constrained Liners, the device is intended for use in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra- operative instability.

The Stems are intended for cementless use only and are intended for total and hemiarthroplasty.

TRIDENT AND TRITANIUM ACETABULAR COMPONENTS

• Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
• Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
• Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
• Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.

The HOWMEDICA OSTEONICS TRIDENT and TRITANIUM Acetabular Shells are intended for cementless use only.

Dome hole plug is indicated for cemented or cementless hip arthroplasty, when an acetabular shell plug is thought to be advantageous

V40 COBALT-CHROME (COCR) FEMORAL HEADS (LFIT V40™ Femoral Heads)

• Painful disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
• Revision of previous cup arthroplasty or other procedures
• Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
• Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies in the acetabulum.

Insignia Hip Stem

Hip Arthroplasty Indications:

• Painful, disabling joint disease of the hip resulting from: noninflammatory degenerative joint disease (including osteoarthritis or avascular necrosis), rheumatoid arthritis or post-traumatic arthritis.
• Revision of previous unsuccessful femoral head replacement, hip arthroplasty or other procedure.
• Correction of functional deformity
• Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

Additional indication specific to use of lnsignia Hip Stems with compatible Howmedica Osteonics Constrained Liners:

• When the stem is to be used with compatible Howmedica Osteonics Constrained Liners, the device is intended for use in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability.

Additional indication specific to use of lnsignia Hip Stems with compatible ADM and MDM Acetabular Components:

• When the stem is to be used with compatible Howmedica Osteonics ADM and MDM Acetabular Components, the device is indicated for Dislocation risks

Insignia Femoral Stems are intended for cementless use only and are intended for total and hemiarthroplasty procedures.

Restoration Anatomic Shells

Indications for Use

• Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, posttraumatic arthritis or late stage avascular necrosis.
• Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
• Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
• Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.

When used with MDM Liners

• Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
• Dislocation risks

When used with Constrained Liner:

• The Trident Constrained Acetabular Insert is indicated for use in primary and revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability.

The Restoration® Anatomic Shell is indicated for cementless use only.

Trident X3, Trident X3 Elevated Rim, Trident X3 Eccentric Inserts)

Indications for Use:

• Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
• Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
• Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
• Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.

BIOLOX Delta Ceramic V40 Femoral Heads (V40)

The femoral heads are intended for mechanical fixation to their mating hip stems, and can be used in cemented or cementless hip arthroplasty procedures.

For Use as a Total Hip Replacement:

• Painful disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
• Revision of previous cup arthroplasty or other procedures.
• Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
• Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies in the acetabulum.

For Use as a Bipolar Hip Replacement

• Femoral head/neck fractures or non-unions.
• Aseptic necrosis of the femoral head.
• Osteo-, rheumatoid, and post traumatic arthritis of the hip with minimal acetabular involvement or distortion.
• Pathological considerations or age considerations which indicate a more conservative acetabular procedure and an avoidance of the use of bone cement in the acetabulum.
• Salvage of failed total hip arthroplasty

"D" femoral heads

The Novae® Dual Mobility and Hype® hip Systems are indicated for total hip replacement, which includes:

• osteoarthritis,
• femoral neck fracture,
• dislocation risk,
• osteonecrosis of the femoral head,
• revision procedures where other treatments or devices have failed and if bone reconstruction so permits.
• Sunfit TH, Novae® E TH, and Coptos TH acetabular cups are intended for press-fit use and Novae® Stick acetabular cup is indicated for cemented use.
• Hype® SCS, SCC, SCL, SCV, SCC Mini, and SCLA Mini hip stems are intended for press-fit use.

"C" femoral heads

The Novae® Dual Mobility and Hype® hip Systems are indicated for total hip replacement, which includes:

• osteoarthritis,
• femoral neck fracture,
• dislocation risk,
• osteonecrosis of the femoral head,
• revision procedures where other treatments or devices have failed and if bone reconstruction so permits.
• Sunfit TH, Novae® E TH, and Coptos TH acetabular cups are intended for press-fit use and Novae® Stick acetabular cup is indicated for cemented use.
• Hype® SCS, SCC, SCL, SCV, SCC Mini, and SCLA Mini hip stems are intended for press-fit use.

Hype® SC cementless hip stems

The Novae® Dual Mobility and Hype® hip Systems are indicated for total hip replacement, which includes:

• osteoarthritis,
• femoral neck fracture,
• dislocation risk,
• osteonecrosis of the femoral head,
• revision procedures where other treatments or devices have failed and if bone reconstruction so permits.
• Sunfit TH, Novae® E TH, and Coptos TH acetabular cups are intended for press-fit use and Novae® Stick acetabular cup is indicated for cemented use.
• Hype® SCS, SCC, SCL, SCV, SCC Mini, and SCLA Mini hip stems are intended for press-fit use.

Novae® dual mobility acetabular cup range including Novae® cementless or cemented metal‑backs, CI E and XPEO‑E liners, pegs and VCI screws

• Novae® dual mobility acetabular cups are indicated for total hip replacement, which includes:
  • osteoarthritis,
  • femoral neck fracture,
  • dislocation risk,
  • osteonecrosis of the femoral head,
  • revision procedures where other treatments or devices have failed and if bone reconstruction so permits.
• "Sunfit TH", "Novae E TH" and "Coptos TH" acetabular cups are intended for press-fit use.
• Novae® Stick acetabular cup is intended for cemented use.

The devices covered by this submission are Stryker and Serf femoral stems, femoral heads, acetabular shells and liner, and Serf acetabular bone screw, to form traditional hip or dual mobility (DM) hip systems. All devices are commercially available and have been cleared in prior 510(k) submissions.

This FDA 510(k) clearance letter details the clearance of Stryker and Serf hip devices. It's important to note that this document is for traditional medical devices (implants) and NOT for a medical device (AI/ML) software. Therefore, many of the requested categories related to AI/ML software performance (like accuracy, F1 score, sample sizes for test/training sets, expert ground truth, MRMC studies) are not applicable to this submission.

The "device" in this context refers to the physical hip implant components. The submission (K250989) is primarily for updating labeling to inform users of compatibility between components from Stryker and Serf, and for adding MR safety information to Serf products.

Here's an analysis of the provided text based on the requested information categories, indicating when a category is not applicable:

1. Table of acceptance criteria and the reported device performance

Since this is for physical hip implant components and primarily a labeling update for compatibility, the "acceptance criteria" and "reported device performance" are based on engineering analyses verifying the physical and functional compatibility and MR safety of the combined components, rather than typical performance metrics for AI/ML software.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not applicable in the context of clinical images or AI/ML data. The "test set" here refers to the physical samples of the hip implant components and their combinations. The document does not specify the exact number of physical samples tested for each engineering analysis (wear, impingement, etc.).
• Data Provenance: Not applicable in the context of clinical images. The data provenance would be internal laboratory testing results performed by the manufacturer. No country of origin for clinical data is relevant here. The studies were non-clinical (engineering analyses).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. For physical device compatibility and MR safety, ground truth is established through engineering principles, mechanical testing, and standardized MR safety protocols, not by expert consensus on clinical data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No clinical adjudication of results from image analysis is relevant for this type of device submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI/ML software device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI/ML software device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Given the nature of the device (physical hip implants), the "ground truth" for the engineering analyses would be:

• Established engineering standards and specifications: For wear, impingement, range of motion, and femoral head disassembly.
• International standards for MR safety: Such as ASTM standards for MR compatibility testing (e.g., heating, displacement, induced torque, image artifact).

8. The sample size for the training set

Not applicable. This is not an AI/ML software device.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/ML software device.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study that proves the device meets the (implied) acceptance criteria is a series of non-clinical engineering analyses. The submission states:

• Non-Clinical Testing: "Performance of the subject combinations of Stryker and Serf hip devices were evaluated in a series of engineering analyses. These included wear and articular surface tolerances, impingement, range of motion, femoral head disassembly, and MR safety (including heating, displacement, induced torque, and image artifact)."
• Clinical Testing: "Clinical testing was not required as a basis for substantial equivalence."
• Conclusion on Equivalence: "Based upon a comparison of the intended use, indications for use, design, material, sterilization method, technical and performance characteristics, and operational principles, the Stryker and Serf subject hip devices, when used in the proposed compatible combinations with each other, are substantially equivalent to the predicate devices identified in this premarket notification."

The FDA's clearance is based on the determination that these engineering analyses confirm the safety and effectiveness of the proposed compatible combinations and MR safety, demonstrating substantial equivalence to previously cleared predicate devices. The acceptance criteria are implicit in the successful completion of these standard engineering tests for orthopedic implants.

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Triathlon® Hinge Knee System is intended to be implanted with bone cement for the following condition(s):

• There is destruction of the joint surfaces, with or without significant bone deformity.
• The cruciate and/or collateral ligaments do not stabilize the knee joint.
• The ligaments are inadequate and/or the musculature is weak. And/or
• Revision is required of a failed prosthesis where there has been gross instability, with or without bone loss or inadequate soft tissue.

When used with MRH femur and/or MRH tibial baseplate replacement indicated in revision of an existing prosthesis:

• Revision is required of a failed prosthesis where there has been gross instability, with or without bone loss or inadequate soft tissue.

When used with compatible GMRS components:

• Where segmental resection and/or replacement of femur and/or proximal tibia is required

The subject THK components are a line extension of the previously cleared Triathlon® Hinge Knee System (K223528, K230416). The THK System (K223528, K230416) is a tricompartmental knee system consisting of a stemmed femoral component and a stemmed tibial bearing component connected by a set of previously cleared MRH or THK Bushings and an MRH or THK Axle (K994207, K002552, K223528, K230416). A bumper locks this assembly. This assembly provides motion through the MRH or THK Axle/Bushings combination in the flexion/extension plane. The articulation between the bearing surfaces on the underside of a tibial bearing component and a tibial insert provides motion in the rotating plane. A hinge tibial insert is assembled to a Triathlon® Hinge Revision Tibial Baseplate that incorporates a longitudinal bore to accept a previously cleared MRH Tibial Sleeve (K994207, K002552) or Triathlon Tibial Sleeve (K223528, K230416). Optional distal femoral and tibial augments are available to fill bone defects.

The subject Triathlon® Hinge Small Proximal Tibial Bearing Component and Triathlon® End Cap are sterile, single use devices intended for cemented use only and are being added to the previously cleared THK system (K223528, K230416) as an extension. They can be used with previously cleared MRH Knee components (K994207, K002552), GMRS (K023087, K222056), and Triathlon® Knee System components (K172634, K172326, K190991, K143393, K141056, K132624, K070095, K061521, K053514, K052917, K051948, K051146, K040267).

This FDA 510(k) clearance letter is for a mechanical medical device (a knee implant system), not an AI/software as a medical device. Therefore, the request for "acceptance criteria and the study that proves the device meets the acceptance criteria" using metrics relevant to AI/software (like sensitivity, specificity, MRMC studies, ground truth for training/test sets, etc.) is not applicable here.

The document provided details about the substantial equivalence of the "Triathlon® Hinge Knee System" to previously cleared predicate devices. The "study" proving the device meets acceptance criteria for a mechanical implant typically involves non-clinical (benchtop) testing and engineering analyses to demonstrate performance, material compatibility, and safety, rather than clinical trials or AI performance evaluations with ground truth.

Here's how the provided information relates to the typical evaluation of such a device, addressing the closest analogues to your requested points:

Acceptance Criteria and Device Performance for a Mechanical Implant:

For mechanical implants like the Triathlon® Hinge Knee System, "acceptance criteria" are generally tied to the successful completion of various non-clinical (benchtop) tests and analyses. These tests simulate the physical stresses and conditions the implant will experience in the human body. The "study" proving the device meets these criteria is the execution and successful outcome of these non-clinical tests.

No direct table of "acceptance criteria" vs. "reported device performance" in the AI sense is provided in this 510(k) summary. Instead, the summary lists the types of non-clinical tests performed to demonstrate performance and substantial equivalence to predicate devices. The implied acceptance is that the device passed these tests, meaning its performance in these simulated scenarios was deemed acceptable and comparable to existing, legally marketed devices.

Table of Non-Clinical Tests (Analogous to Performance Metrics):

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Indications for Restoration Modular Hip System

• · Noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis:
• · Rheumatoid arthritis;
• · Correction of functional deformity;
• · Revision procedures where other treatments or devices have failed; and,
  · Nonunions, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
  · The RESTORATION Modular Hip System is intended for primary and revision total hip arthroplasty as well as in the presence of severe proximal bone loss. These femoral stems are designed to be proximal femur.

Indications for Accolade C, Accolade HFx, SYSTEM 12 CROSSFIRE, ACCOLADE DISTAL SPACER, CITATION TMZF, PCA Duration Insert, PCA Femoral Head

• · Noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
• · Rheumatoid arthritis;
• · Correction of functional deformity;
• · Revision procedures where other treatments or devices have failed; and,
  · Nonunions, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques

Indications for Accolade II Stems
The indications for use of the total hip replacement prostheses include:

• · noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
• rheumatoid arthritis;
• · correction of functional deformity;
• · revision procedures where other treatments or devices have failed; and.
  · nonunions, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
  Additional indication specific to use of ACCOLADE II Femoral Stems with compatible Howmedica Osteonics Constrained Liners
  · When the stem is to be used with compatible Howmedica Osteonics Constrained Liners, the device is intended for use in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intraoperative instability.
  ACCOLADE II Femoral Stems are intended for cementless use only and are intended for total and hemiarthroplasty procedures.

Indications for OMNIFIT SERIES Acetbular Inserts, Omnifit Crossfire 10 Deg Inserts, Crossfire Inserts, Omnifit Crossfire Inserts, Trident Crossfire Inserts, Trident X3 Inserts, Trident X3 Eccentric Inserts
· Painful, disabling joint disease of the hip from: degenerative arthritis, theumatoid arthritis, posttraumatic arthritis or late stage avascular necrosis.
· Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
· Clinical management problems where arthrodesis or alternative techniques are less likely to achieve satisfactory results.
· Where bone stock is of poor quality or inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.

Indications for ALL POLY CONSTRAINED INSERT, TRIDENT 0 DEG CONSTRAINED INSERT, TRIDENT CONSTRAINED INSERT
A Constrained Acetabular Insert is indicated for use as a component of a total hip prosthesis in primary and revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability.

Indications for UHR Bipolar

• · Femoral head/neck fractures or non-unions.
• · Aseptic necrosis of the femoral head.
  · Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acetabular involvement or distortion.
  Other Considerations:
  · Pathological conditions or age considerations which indicate a more conservative acetabular procedure and an avoidance of the use of bone cement in the acetabulum.
  · Salvage of failed total hip arthroplasty

Indications for Artisan Bone Plug
These bone plugs are intended to be placed in the femoral canal prior to the introduction of bone cemented hip procedure.
The plug is placed distally to the femoral stem to help allow cement pressurization and to help prevent cement migration further down the femoral canal.

Indications for C-Taper Alumina Ceramic Heads, V40 Taper Alumina Ceramic V40™ Femoral Head
• Painful, disabling joint disease of the hip from: degenerative arthritis, theumatoid arthritis, posttraumatic arthritis or late stage avascular necrosis.
· Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
· Clinical management problems where arthrodesis or alternative techniques are less likely to achieve satisfactory results.
• Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum

Indications for BIOLOX Delta Ceramic Heads, C-Taper to Universal Taper Adapter Sleeve, Universal V40™ Taper Adapter Sleeve
For Use as a Total Hip Replacement:
· Painful disabling joint disease of the hip resulting from: degenerative arthritis, rheumatic arthritis or late stage avascular necrosis.
• Revision of previous cup arthroplasty or other procedures
· Clinical management problems where arthrodesis or alternative techniques are less likely to achieve satisfactory results.
· Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies in the acetabulum.
For Use as a Bipolar Hip Replacement

• · Femoral head/neck fractures or non-unions.
  · Aseptic necrosis of the femoral head.
  • Osteo-, rheumatoid, and post traumatic arthritis of the hip with minimal acetabular involvement or distortion.
  · Pathological considerations or age considerations which indicate a more conservative acetabular procedure and an avoidance of the use of bone cement in the acetabulum.
  · Salvage of failed total hip arthroplasty

Indications for ADM/MDM X3 Inserts, MDM Acetabular Inserts, MDM Acetabular Liners
The indications for use for total hip arthroplasty include:

1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
2. Rheumatoid arthritis;
3. Correction of functional deformity;
4. Revision procedures where other treatments or devices have failed; and,
5. Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
6. Dislocation risks
   MDM Liners are intended for cementless use only.

The devices included in this submission are femoral heads, acetabular inserts, distal spacers, and bone plugs, used in hip arthroplasty procedures. All devices have been previously deemed substantially equivalent in prior premarket submissions and are commercially available.

This document, K243784, is a 510(k) premarket notification from Stryker Orthopaedics for a "Hip Devices Labeling Update." It states that the purpose of the submission is to add a contraindication to the labeling of existing Stryker Orthopaedics Hip Devices.

Based on the provided document, the device in question is a physical medical device (hip implants and components) and the 510(k) submission is for a labeling update, specifically adding a contraindication. This is not an AI/ML-enabled medical device. Therefore, the questions regarding acceptance criteria and studies proving the device meets those criteria, particularly those related to AI/ML device performance (e.g., sample sizes for training/test sets, expert adjudication, MRMC studies, standalone algorithm performance, ground truth establishment), are not applicable to this submission.

The document explicitly states under "Non-Clinical Testing" and "Clinical Testing":

• "Non-Clinical testing was not required as a basis for substantial equivalence."
• "Clinical testing was not required as a basis for substantial equivalence."

This indicates that no performance studies (clinical or non-clinical in the context of device performance metrics) were conducted or needed to be submitted for this specific 510(k) approval, as the change is solely a labeling update concerning a contraindication, and the device itself (the physical hip implant) has previously been deemed substantially equivalent.

Therefore, I cannot populate the table or answer the specific questions related to acceptance criteria and performance studies for an AI/ML device, as this context does not apply to the provided document.

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The Stryker Scorpio Total Knee system components are intended for the replacement of the bearing and/or articulating surfaces of the distal femur and proximal tibia to remove pain, instability, and restriction of motion due to degenerative bone disease, including osteoarthritis, rheumatoid arthritis, failure of other devices or trauma. The devices are intended for single-use only, and are intended for cemented fixation in patients indicated for total knee arthroplasty.

The devices included in this submission are tibial inserts, and all-polyethylene patellar components used in total knee arthroplasty procedures. All devices have been previously deemed substantially equivalent in prior premarket submissions and are commercially available.

This document does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria.

The document is a 510(k) premarket notification letter from the FDA regarding a change in labeling for orthopedic knee implants (Scorpio Universal Dome Patella, Scorpio Total Stabilizer Insert, Scorpio-Flex Posterior Stabilized Tibial Insert, Scorpio-Flex Cruciate Retaining Tibial Insert, Scorpio NRG Tibial Bearing Insert – Cruciate Retaining Insert, Scorpio NRG Tibial Bearing Insert – Posteriorly Stabilized Insert).

The key takeaway from the document regarding the submission is:

• Reason for 510(k) Submission: "The purpose of this "Change Being Effected" bundled submission is to add a contraindication to the labeling of the subject Scorpio Total Knee System." (Page 7)
• Non-Clinical and Clinical Testing: "Non-Clinical testing was not required as a basis for substantial equivalence." and "Clinical testing was not required as a basis for substantial equivalence." (Page 10)

This means the submission is primarily administrative (a labeling change) and does not involve new performance testing or studies. Therefore, the requested information about acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment is not present in this document.

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General Total Knee Arthroplasty (TKR) Indications:
• Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis), rheumatoid arthritis or post-traumatic arthritis.
· Post-traumatic loss of knee joint configuration and function.
· Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.
· Revision of previous unsuccessful knee replacement or other procedure.

• Fracture of the distal femur and/or proximal tibia that cannot be standard fracture -management techniques.
  The Triathlon® Tritanium® Total Knee System components are indicated for both uncemented use. The Triathlon® Total Knee System beaded with Peri-Apatite components are intended for uncemented use only.
  The Triathlon® All Polyethylene tibial components are indicated for cemented use only.
  Additional Indications for Posterior Stabilized (PS) and Total Stabilizer (TS) Components:
• · Ligamentous instability requiring implant bearing surface geometries with increased constraint.
• · Absent or non-functioning posterior cruciate ligament.
  · Severe anteroposterior instability of the knee joint.
  Additional Indications for Total Stabilizer (TS) Components:
  · Severe instability of the knee secondary to compromised collateral ligament integrity or function.
  Indications for Bone Augments:
  · Painful, disabling joint disease of the knee secondary to: degenerative arthritis, rheumatic arthritis, complicated by the presence of bone loss.
  · Salvage of previous unsuccessful total knee replacement or other surgical procedure, accompanied by bone loss.
  Additional Indications for Cone Augments:
• · Severe degeneration or trauma requiring extensive resection and replacement
• · Femoral and Tibial bone voids
• Metaphyseal reconstruction
  The Triathlon TS Cone Augment components are intended for cemented or cementless use.

Triathlon Pro Posterior Stabilized Femoral Components Indications for Use:
General Total Knee Arthroplasty (TKR) Indications:
· Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis), rheumatoid arthritis or post-traumatic arthritis.

• · Post-traumatic loss of knee joint configuration and function.
  · Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.
  · Revision of previous unsuccessful knee replacement or other procedure.
  · Fracture of the distal femur and/or proximal tibia that cannot be standard fracture -management techniques. Additional Indications for Posterior Stabilized (PS) components:
• · Ligamentous instability requiring implant bearing surface geometries with increased constraint.
• · Absent or non-functioning posterior cruciate ligament.
• · Severe anteroposterior instability of the knee joint.
  The Triathlon® Pro PS Femoral Components are intended for cemented use only.

Triathlon Tritanium Tibial Baseplate Indications for Use:
General Total Knee Arthroplasty (TKR) Indications:
· Painful, disabling joint disease of the knee resulting from: non-inflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis or avascular necrosis) or rheumatoid arthritis

• · Post-traumatic loss of knee joint configuration and function
• · Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability
• · Revision of previous unsuccessful knee replacement or other procedure
• · Fracture of the distal femur and/or proximal tibia that cannot be standard fracture management techniques
  Additional General Total Knee Arthroplasty (TKR) Indications specific to the PS implant:
• · Ligamentous instability requiring implant bearing surface geometries with increased constraint
• Absent or non-functioning posterior cruciate ligament
• · Severe anteroposterior instability of the knee joint
  The Triathlon Tritanium Tibial Baseplates are indicated for both cemented and uncemented use.

Triathlon Low Profile Tibial Tray Indications for Use:
The Triathlon Low Profile Tibial Tray is intended to be used with commercially available Triathlon® femoral components and associated patellar components, and tibial bearing inserts in primary cemented total knee arthroplasty. The indications for the Triathlon® Low Profile Tibial Tray are outlined below:
Indications for Use:
· Painful, disabling joint disease of the knee resulting from: degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis.
· Post-traumatic loss of knee joint configuration and function.
· Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.

Triathlon Metal Backed Patella Indications for Use:

• · Noninflammatory degenerative joint disease including osteoarthritis or avascular necrosis;
• Rheumatoid arthritis;
• · Correction of functional deformity;
• · Revision procedures where other treatments or devices have failed;
• · Post traumatic loss of joint anatomy, particularly when there is patello-femoral erosion, dysfunction or prior patellectomy; and,
• · Irreparable fracture of the knee.
  These products are intended to achieve fixation without the use of bone cement.

Triathlon Partial Knee System Indications for Use:
Moderately disabling joint disease of the knee resulting from painful osteo- or post traumatic arthritis
· Revision of previous unsuccessful surgical procedures, either involving, or not involving, previous use of a unicompartmental knee prosthesis
· As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis
· Where bone stock is of poor quality or inadequate for other reconstructive techniques as indicated by deficiencies of the femoral condyle/tibial plateau.
These components are intended for implantation with bone cement.

Avon Patello-femoral Joint Prosthesis Indications for Use:
The Avon Patello-femoral Joint Prosthesis is intended to be used in cemented patellofemoral arthroplasty in patients with degenerative arthritis in the distal femur and patients with a history of patellar dislocation or patella fracture, or patients with failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release) where pain, deformity, or dysfunction persists. These components are single use only and are intended for implantation with bone cement.

Restoris Multi-Compartmental Knee System Indications for Use:
Restoris MCK is indicated for single or multi-compartmental knee replacement used in conjunction with RIO, the Robotic Arm Interactive Orthopedic System, in individuals with osteoarthritis of the tibiofemoral and/or patellofemoral articular surfaces.
The specific knee replacement configurations include:

• Medial unicondylar
• Lateral unicondylar
• Patellofemoral
• · Medial bi-compartmental (medial unicondylar and patellofemoral)
  Restoris Multi Compartmental Knee is for single use only and is intended for implantation with bone cement.

All of the subject devices have been found substantially equivalent in previous 510(k)s. All the subject devices have been cleared for MR conditional labeling in previous 510(k)s. The purpose of this submission is to modify the MR conditional information in the instructions for use to update the parameters in which a patient who has the device can be safely scanned, per testing conducted accordance to updated FDA guidance. There have been no changes made to the devices requiring 510(k) clearance - only the MR conditional information in the instruction for use is being modified.
An additional contraindication is being added to the components of the Triathlon Total Knee System. This contraindication regarding material sensitivity to implant materials is being added.

This document is a 510(k) premarket notification for knee arthroplasty devices, specifically for the Triathlon Knee System and related components. It is important to note that this document does NOT describe a study evaluating the performance of a device driven by an AI algorithm or software.

Instead, this submission is for physical medical devices (knee implants) and their associated labeling. The core purpose of this 510(k) submission is to modify the MR conditional information in the instructions for use for these existing, previously cleared devices due to updated FDA guidance on MR safety testing. The document explicitly states:

• "There have been no changes made to the devices requiring 510(k) clearance - only the MR conditional information in the instruction for use is being modified." (Page 16)
• "There have been no changes requiring 510(k) clearance to the technological characteristics of the Stryker Knee systems as a result of the revision to the labeling." (Page 19)
• "Clinical testing was not required as a basis for substantial equivalence." (Page 20)

Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI-driven device's performance (e.g., accuracy, sensitivity, specificity, human-in-the-loop studies) cannot be extracted from this document, as it pertains to entirely different types of evaluation (mechanical performance, biocompatibility, and in this specific case, MR safety of physical implants, not AI algorithm performance).

To explicitly answer your questions based on the provided document, even if they don't fully apply to the nature of this submission:

1. A table of acceptance criteria and the reported device performance:

   • Acceptance Criteria (Implicit for this submission): The new MR safety testing results must demonstrate that the device is safe for use in an MR environment under the updated parameters to justify the labeling changes, and that the device remains substantially equivalent to its predicates.
   • Reported Device Performance: The document states: "New testing was performed to comprehensively assess the RF-related heating effects induced by the subject devices when implanted into bone, following the FDA guidance document, "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment," dated May 20, 2021." (Page 19). While the specific quantitative results of this testing are not provided in this summary document, the FDA's clearance (the letter at the beginning) implies the acceptance criteria for MR safety were met.

2. Sample sized used for the test set and the data provenance:

   • This document describes non-clinical (laboratory) testing for MR safety. It does not involve "test sets" in the sense of patient data for AI evaluation. The "sample size" would refer to the number of physical implants tested for MR compatibility. This specific number is not provided in the summary.
   • Data Provenance: N/A for clinical data; the testing was performed per FDA guidance, implying controlled laboratory conditions.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • N/A. This is not a study requiring expert readers or ground truth establishment in the context of AI performance. The "ground truth" for MR safety is established by quantitative measurements in a laboratory setting based on physics principles and regulatory standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • N/A. Not a clinical study requiring human adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No. This document does not pertain to AI or human reader performance.

6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:

   • No. This document does not describe an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

   • N/A for artificial intelligence context. The ground truth for this submission relates to physical properties and safety in an MR environment, established through standardized physical testing and engineering measurements.

8. The sample size for the training set:

   • N/A. There is no training set mentioned or implied for an AI algorithm in this submission.

9. How the ground truth for the training set was established:

   • N/A. There is no training set mentioned or implied.

In summary, this 510(k) notification is for knee replacement components and deals with updating their MR conditional labeling based on physical testing, not with the performance evaluation of an AI-powered device.

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The Stryker Global Modular Replacement System, Modular Replacement System and Modular Rotating Hinge Knee Component are sterile, single-use devices intended for use in situations where there is a need for replacement of bone due to radical bone loss. This loss can be related to oncology, trauma or failed previous prosthesis. Specific Indications for Use are listed below.

Indications for the MRS Stems and Intercalary Stems (presented in K952970):

• This device is intended for use in patients requiring extensive reconstruction of the femur . and/or proximal tibia, including the hip or knee joint, resulting from extensive bone loss. Tumor resection for skeletal lesions (Oncology patients where radical bone resection and replacement may be required), revision surgery for failed arthroplasty, and acute trauma are the primary causes of extensive bone loss. These prostheses are intended for use with bone cement.
• The Intercalary System is intended for use in situations arising from femoral mid-shaft tumor resection, or for prosthetic knee fusion.

Indications for the Global Modular Replacement System (presented in K023087):

• Femoral and/or proximal tibial replacement and total femoral replacement in Oncology cases where radical resection and replacement of bone is required, and in limb salvage procedures where radical resection and replacement of the bone is required. Limb salvage procedures would include surgical intervention for severe trauma, failed previous prosthesis, and/or Oncology indications.

Indications for the GMRS Anteverted Proximal Femoral Component (presented in K032581):

• Femoral replacement in Oncology cases where radical resection and replacement of bone is required, and in limb salvage procedures where radical resection and replacement of bone is required. Limb salvage procedures would include surgical intervention for severe trauma, failed previous prosthesis, and/or Oncology indications. This component may also be used with the Distal Femoral segment components of the GMRS in total femoral replacement.

Indications for the Global Modular Replacement System Press Fit Stems with HA Coating (presented in K022403, and K031217):
Proximal femoral reconstruction secondary to:
o Trauma
o Failed previous prosthesis
o Tumor resection

Indications for the Modular Replacement System Cemented Stems (presented in K040749):
Femoral and/or proximal tibial replacement due to:
o Trauma
o Failed previous prosthesis
o Tumor resection

Indications for the Modular Rotating Hinge Knee System (presented in K002552):

• The Modular Rotating Hinge Knee System is intended for use with bone cement in cases where there is destruction of the joint surfaces, with or without significant bone deformity; the cruciate and/or collateral ligaments do not stabilize the knee joint; the ligaments are inadequate and/or the musculature is weak; and revision of a failed previous prosthesis where there is instability, with or without bone loss or inadequate soft tissue. Expanded indications include for use with bone cement in situations where there is extensive bone loss, including limb salvage procedures for severe trauma, failed previous prosthesis, and/or Oncology indications.

The Global Modular Replacement System (GMRS) is comprised of a number of components that are intended to be used in conjunction with each other, or in conjunction with components of the Modular Replacement System (MRS) or the Modular Rotating Hinge Knee System (MRH). The Modular Rotating Hinge Knee System is a tricompartmental knee system. The system consists of a stemmed femoral component and a stemmed tibial bearing component connected by a set of bushings and an axle. The MRH Tibial Rotating component is a part of the MRH system and mates with the GMRS Standard Proximal Tibia. These devices are intended to be used in clinical situations where there is radical bone loss of the femur and/or proximal tibia. This radical bone loss can be related to oncology (tumor), trauma or failed previous prosthesis.

The provided FDA 510(k) clearance letter and summary for the Stryker Orthopaedics Global Modular Replacement System, Modular Replacement System, and Modular Rotating Hinge Knee Component does not contain information regarding acceptance criteria or a study proving the device meets specific performance criteria.

This document is a clearance letter indicating a determination of "substantial equivalence" to previously marketed predicate devices. It does not present novel performance data or studies against pre-defined acceptance criteria.

The key statements from the document that confirm this are:

• "Non-Clinical Testing: Non-Clinical testing was not required as a basis for substantial equivalence." (Page 8)
• "Clinical Testing: Clinical testing was not required as a basis for substantial equivalence." (Page 8)

The submission focuses on adding a contraindication to the labeling, updating MRI Safety information, and making clerical updates to the Instructions for Use (IFUs). These changes do not necessitate new performance studies for substantial equivalence.

Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria and studies because the provided document explicitly states that such testing was not required for this particular 510(k) submission.

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1. Painful, disabling joint disease of the hip from: degenerative arthritis, rheumatoid arthritis, post traumatic arthritis or late-stage avascular necrosis.

2. Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.

3. Clinical management problems where arthrodesis or alternative techniques are less likely to achieve satisfactory results.

4. Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated of the acetabulum.

The subject 22.2mm Biolox® delta Ceramic V40™ Femoral Heads with neck length +0mm and +3mm are sterile, single-use devices that are manufactured with high-purity alumina matrix with zirconia reinforcement and are compatible with the 22.2mm ID sizes of compatible acetabular inserts and UHMWPE acetabular cups. The Biolox® delta Ceramic V40TM Femoral Heads may be used in conjunction with compatible V40™ taper femoral stems and acetabular shell components to achieve reconstructive replacement of the hip joint.

This document is a FDA 510(k) premarket notification letter for a medical device, specifically the 22.2mm Biolox® delta Ceramic V40™ Femoral Heads. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than detailed, de novo clinical or algorithmic performance studies typically seen for novel AI/ML or complex diagnostic devices.

Therefore, the request for "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML algorithm or a complex diagnostic cannot be fully answered by this document. This clearance is for a mechanical orthopedic implant.

However, I can extract the information relevant to device performance and substantiation as presented for this type of mechanical device, even if it doesn't align with the typical AI/ML study parameters.

Here's what can be extracted and how it relates to your request:

Understanding the Device and its Substantiation Approach:

The device is a femoral head for hip joint replacement, a mechanical implant. Its "performance" is assessed through engineering tests (mechanical strength, wear, range of motion, etc.) rather than clinical diagnostic accuracy or algorithmic output. The FDA's acceptance is based on demonstrating substantial equivalence to an existing, legally marketed device (the predicate). This means showing that the new device is as safe and effective as the predicate, typically through comparison of design, materials, intended use, and non-clinical (laboratory) performance data.

Addressing Your Specific Points (adjusted for a mechanical device 510(k) submission):

1. A table of acceptance criteria and the reported device performance:

   • Acceptance Criteria (Mechanical/Engineering Standards): For this type of device, the "acceptance criteria" are the performance specified by recognized consensus standards (ISO, ASTM) for orthopedic implants. The document lists the standards followed, implying the device met the requirements of these standards. It doesn't present a table with specific pass/fail values or measured results against those values, as that level of detail is typically in the underlying test reports, not the 510(k) summary.
   • Reported Device Performance:
     • "The device comparisons and performance testing show that the 22.2mm Biolox® delta Ceramic V40™ Femoral Heads are substantially equivalent to the cited predicate V40™ Biolox® delta Ceramic Femoral Heads cleared via K052718, based on intended use, indications for use, design, material, technological characteristics, operational principles, and non-clinical performance data."
     • Non-Clinical Testing Performed:
       • Burst testing, Fatigue testing and post-fatigue burst testing (ISO 7206-10 and ASTM F2345-21)
       • Axial Pull-off testing
       • Wear evaluation
       • Range of Motion
       • Torsional resistance (ISO 7206-13)
       • MRI Safety testing
     • Coating Characterization Standards (for compatible Accolade II hip stems):
       • ISO 13179-1
       • ASTM F1160
       • ASTM F1147
       • ASTM F1044
       • ASTM F1978
       • ASTM F1580
       • ASTM F1854

   Note: The document only lists the tests and standards; it does not provide the quantitative results or the specific acceptance criteria thresholds for each test. This information would be in the detailed engineering reports submitted to the FDA, not typically in the public 510(k) summary. The "performance" is implicitly stated as meeting the "substantial equivalence" criteria by successfully passing these tests.

2. Sample sizes used for the test set and the data provenance:

   • Sample Size: Not explicitly stated in this summary. For mechanical tests, sample sizes are typically determined by the specific ASTM/ISO standards followed (e.g., n=3 or n=6 for certain fatigue tests).
   • Data Provenance: Not specified for the non-clinical testing. These are laboratory tests, not clinical data from patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • This question is not applicable to this type of device and submission. "Ground truth" established by experts (like radiologists for AI/ML) is irrelevant for mechanical performance testing of an orthopedic implant. The "ground truth" here is objective physical measurement against established engineering standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • This question is not applicable. Adjudication is for subjective assessment, often in clinical trials or for establishing ground truth in image interpretation. Mechanical tests are objective.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • This question is not applicable. MRMC studies are for evaluating diagnostic performance of AI or human readers, typically with medical imaging. This is a mechanical implant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • This question is not applicable. This is not an algorithm. "Standalone performance" for this device would refer to its mechanical integrity and function. The non-clinical tests serve this purpose.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Ground Truth: For this mechanical device, the "ground truth" is defined by the objective performance requirements outlined in established international and national engineering standards (ISO and ASTM). Results of the physical tests are measured and compared against the pass/fail criteria defined in these standards.

8. The sample size for the training set:

   • This question is not applicable. This is not an AI/ML device, so there is no "training set."

9. How the ground truth for the training set was established:

   • This question is not applicable. No training set exists.

Summary for this specific document:

This FDA 510(k) clearance document is for a mechanical orthopedic implant, not an AI/ML or diagnostic device. As such, the typical criteria and study types asked about (AI performance, human readers, ground truth consensus, training/test sets for algorithms) are not relevant or applicable to this submission.

The "acceptance criteria" for this device are meeting the requirements of recognized industry standards for mechanical testing (e.g., ISO, ASTM) to demonstrate substantial equivalence in terms of safety and performance to a predicate device. The "study" proving this involves non-clinical (laboratory) testing, the results of which (though not detailed quantitatively in this summary) are presented as having successfully met the engineering specifications for substantial equivalence.

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DALL-MILES Cable System
The DALL-Miles System is indicated for reattachment of the trochanter in any hip procedure using the trochanteric osteotomy (total or partial) approach.
The DALL-MILES Mini Cleat is indicated for vertical reattachment or reinforcement of the trochanter in any situation where the surgeon feels that the trochanter is at risk for detachment. The Mini Cleat is intended for use with the DALL-MILES System for trochanteric reattachment only.
The DALL-MILES Cables and Cable Sleeves are indicated for trochanteric reattachment and trauma surgery of the hip; to stabilize bone graft material; and for supplementary cerclage fixation with plates and screws for fracture fixation.
The DALL-MILES Trochanteric Grips and Grip Plates are indicated for use in the fixation of the greater trochanter due to trochanteric fracture or osteotomy with intramedullary fixation as the primary device.
The DALL-MILES Trochanteric Grip Plate is additionally indicated for use in the fixation of the greater trochanter due to extended trochanteric osteotomies.

Femoral Heads
The indications for use for total hip and hemi hip arthroplasty include:

1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
2. Rheumatoid arthritis;
3. Correction of functional deformity;
4. Revision procedures where other treatments or devices have failed; and,
5. Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

Femoral Mesh
The indications for use for total hip and hemi hip arthroplasty include:

1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
2. Rheumatoid arthritis;
3. Correction of functional deformity;
4. Revision procedures where other treatments or devices have failed; and,
5. Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
   Surgical Mesh. Surgical Mesh is intended to be used to reinforce bone or tissue in any situation where additional strengthening and support is required due to poor bone/tissue quality.

Intramedullary Plug, Centralizer
The indications for use of total hip replacement prostheses include:
· noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
· rheumatoid arthritis;
· correction of functional deformity;
· revision procedures where other treatments or devices have failed; and,
· treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
The EXETER Centralizer is intended to be used to centralize the femoral stem within the intramedullary canal and is intended to be used with bone cement.
The EXETER 2.5mm Intramedullary Bone Plug is intended to be used to restrict the migration of bone cement down the femoral canal and permit cement pressurization during total hip arthroplasty and is intended to be used with bone cement.

Exeter X3 RimFit Cups
The indications for use for total hip arthroplasty include:

1. Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
2. Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
3. Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
4. Where bone stock is of poor quality or inadequate for other reconstructive techniques, such as cementless fixation, as indicated by deficiencies of the acetabulum.
   The Exeter X3 RimFit Cup is intended for cemented use only.

Femoral Stems
The indications for use for total hip and hemi hip arthroplasty include:

1. noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
2. rheumatoid arthritis;
3. correction of functional deformity;
4. revision procedures where other treatments or devices have failed; and,
5. treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
   The Exeter V40 Femoral Stem is intended for use in total or hemi hip replacement. It is intended for cemented use only.

The devices covered by this bundled submission are Stryker Total Hip Systems which include Dall-Miles cable system components, femoral heads, femoral mesh, Intramedullary Plug, Centralizer, acetabular cups, and femoral stems. All devices are commercially available and have been cleared in prior 510(k) submissions.

This FDA 510(k) letter and summary (K240418) is for a "Stryker Orthopaedics Hip Systems Labeling Update." This submission is not for a new medical device or an AI/software device that requires performance evaluation. Instead, it is a "Change Being Effected" bundled submission to add a contraindication to the labeling of existing, already cleared Stryker Orthopaedics Hip Systems.

Therefore, the provided document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. It explicitly states under "Non-Clinical Testing" and "Clinical Testing" that these were not required as a basis for substantial equivalence because the technological characteristics of the subject devices are identical to those of the predicate devices.

In summary, the request for information regarding acceptance criteria, device performance, sample sizes, ground truth, expert qualifications, adjudication methods, MRMC studies, or standalone performance is not applicable to this document, as it pertains to a labeling update for previously cleared devices, not a new device or a device requiring new performance data.

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The indications for use for total hip arthroplasty include:

• 1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
• 2. Rheumatoid arthritis:
• 3. Correction of functional deformity;
• 4. Revision procedures where other treatments or devices have failed; and,
• 5. Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

6. Dislocation risks
   MDM Liners are intended for cementless use only.

The subject device is an MDM X3 Insert with an inner diameter of 28mm and outer diameter of 38mm. It is a sterile, single-use device that will articulate within the inner surface of the highly polished cobalt chrome MDM Liner and will be compatible with 28mm Howmedica Osteonics femoral heads. The subject device is compatible with the same liners, cups, and femoral stems as the previously cleared Stryker dual mobility hip systems. The polyethylene MDM X3 Insert and femoral head combine to create the dual mobility bearing. The subject MDM X3 Insert is manufactured from sequentially crosslinked and annealed polyethylene, known as X3. The resin used is Type 1 (GUR 1020) which meets the requirements of ASTM F648.

The provided text is a 510(k) summary for a medical device: "28mm/38D MDM X3 Insert for MDM Liner," which is a component of a total hip arthroplasty system. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than proving a device meets specific acceptance criteria through a standalone study of a new type of device, especially concerning AI/Software performance.

Therefore, the information requested in your prompt regarding acceptance criteria, a study proving device performance (especially relating to AI or a "test set" and "ground truth"), sample sizes for test and training sets, expert involvement, and MRMC studies, is not present in this document.

This 510(k) summary explains that non-clinical testing (material testing, biocompatibility, sterilization validation, mechanical testing like wear, fatigue, range of motion, dislocation resistance, and MRI safety testing) was performed to demonstrate substantial equivalence to predicate devices. It explicitly states that clinical testing was not required as a basis to demonstrate substantial equivalence.

To answer your prompt directly based on the provided text:

1. A table of acceptance criteria and the reported device performance:

• Not Applicable. The document describes non-clinical engineering and material performance tests for substantial equivalence, not acceptance criteria for a novel AI/software-based device. The specific quantitative results of these tests and their corresponding acceptance limits are not detailed in this summary. It only lists the types of tests performed.

2. Sample sizes used for the test set and the data provenance:

• Not Applicable. This is not an AI/software device. The document does not describe a "test set" in the context of data for algorithms. For the non-clinical tests listed (e.g., wear testing, fatigue), the sample sizes are not explicitly mentioned in this summary but would typically be prescribed by relevant standards (e.g., ASTM, ISO).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable. This is not an AI/software device that requires expert-established ground truth from a test set (e.g., radiological reads).

4. Adjudication method for the test set:

• Not Applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not Applicable. This is a physical orthopedic implant component, not an AI-assisted diagnostic or therapeutic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not Applicable.

7. The type of ground truth used:

• Not Applicable. For a physical implant, "ground truth" typically refers to engineering specifications, material properties, and mechanical performance under defined test conditions, rather than a clinical ground truth for diagnostic accuracy.

8. The sample size for the training set:

• Not Applicable. This is not an AI/software device that involves a training set.

9. How the ground truth for the training set was established:

• Not Applicable.

In summary, the provided FDA 510(k) summary is for a physical medical device (an orthopedic implant component) and discusses demonstration of substantial equivalence through non-clinical testing, not the performance evaluation of an AI/software device against specific acceptance criteria as you've outlined in your prompt.

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ADM/MDM X3 Inserts, MDM Acetabular Inserts, MDM Acetabular Liners
The indications for use for total hip arthroplasty include:

• 1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
• 2. Rheumatoid arthritis:
• 3. Correction of functional deformity;

4. Revision procedures where other treatments or devices have failed; and.
5. Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
6. Dislocation risks
   MDM Liners are intended for cementless use only.

Universal Cement Restrictor, OmniFit Distal Cement Spacer
For cement spacers, mid-shaft restrictors and Cement Plugs:
· In cemented hip arthroplasty, when the cement spacer, restrictor and/or plug is thought to be advantageous.

Artisan Bone Plug
These bone plugs are intended to be placed in the femoral canal prior to the introduction of bone cemented hip procedure. The plug is placed distally to the femoral stem to help allow cement pressurization and to help prevent cement migration further down the femoral canal.

Trident® II Acetabular System (Trident II Cups (Clusterhold HA, Tritanium Clusterhole, Tritanium Multihole, Tritanium Solidback), 6.5mm Low Profile Hex Screw, Hex Dome Hole Plug
· Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatic arthritis or late stage avascular necrosis.
· Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
· Clinical management problems where arthrodesis or alternative techniques are less likely to achieve satisfactory results.
· Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.

When used with MDM Liners
· Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
• Dislocation risks
When used with Constrained Liner:
• The Trident Constrained Acetabular Insert is indicated for use in primary and revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability.
The Trident® II Acetabular Shells are indicated for cementless use only.

Restoration® Modular Hip System
The Restoration® Modular Hip System is indicated for use in:
· Noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;

• Rheumatoid arthritis
• · Correction of functional deformity;
• Revisions procedure where other treatments or devices have failed; and
  • Nonunions, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques
  Additional indications specific to the Restoration Modular Hip System
  The Restoration® Modular Hip System is intended to be used for primary and revision total hip arthroplasty, as well as in the presence of severe proximal bone loss. These femoral stems are designed to be press fit into the proximal femur.

Accolade II Femoral Stems, Anato Femoral Stem, Secur-Fit Advanced
The indications for use for total hip arthroplasty with stems include:

• · noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
• rheumatoid arthritis;
• · correction of functional deformity;
• · revision procedures where other treatments or devices have failed; and,
  · nonunions, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
  Additional indication specific to use of the Femoral Stem with compatible Howmedica Osteonics Constrained Liners:
  · When the stem is to be used with compatible Howmedica Osteonics Constrained Liners, the device is intended for use in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability.
  The Stems are intended for cementless use only and are intended for total and hemiarthroplasty.

TRIDENT AND TRITANIUM® ACETABULAR COMPONENTS
• Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatic arthritis or late stage avascular necrosis.

• · Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
  · Clinical management problems where arthrodesis or alternative techniques are less likely to achieve satisfactory results.
  · Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.
  The HOWMEDICA OSTEONICS TRIDENT and TRITANIUM Acetabular Shells are intended for cementless use only. Dome hole plug is indicated for cementless hip arthroplasty, when an acetabular shell plug is thought to be advantageous

Acetabular Dome Hole Plug
The Dome Hole Plug is an optional device which is available to seal the Howmedica Osteonics Acetabular Shell components during cemented or cementless applications of the Howmedica Osteonics Done Hole Plug is threaded into the dome hole of the shell.
Indications
• In cemented or cementless hip arthroplasty, when an acetabular shell plug is thought to be advantageous.

DALL-MILES® SYSTEMS
The DALL-MILES System is indicated for reattachment of the trochanter in any hip procedure using the trochanteric osteotomy (total or partial) approach.
The DALL-MILES Mini Cleat is indicated for vertical reattachment of the trochanter in any situation where the surgeon feels that the trochanter is at risk for detachment.
The Mini Cleat is intended for use with the DALL-MILES System for trochanteric reattachment only.
The DALL-MILES Cables and Cable Sleeves are indicated for trochanteric reattachment and trauma surgery of the hig; to stabilize bone graft material; and for supplementary cerclage fixation with plates and screws for fracture fixation.
The DALL-MILES Trochanteric Grips and Grip Plates are indicated for use in the greater trochanter due to trochanteric fracture or osteotomy with intramedullary fixation as the primary device.
The DALL-MILES Trochanteric Grip Plate is additionally indicated for use in the greater trochanter due to extended trochanteric osteotomies.

Exeter® V40™ Hip System (includes Orthinox V40 Femoral heads)
The Exeter® V40™ Femoral Hip System is indicated for:
· noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
• rheumatoid arthritis;

• correction of functional deformity;
• · revision procedures where other treatments or devices have failed; and,
  · treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
  The Exeter® V40™ Femoral Stem Hip System is intended for use in total or hemi hip replacement. It is intended for cemented use only.

Exeter Centralizer, EXETER Intramedullary Plug

1. noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis;

• 2. rheumatoid arthritis;
• 3. correction of functional deformity;
• 4. revision procedures where other treatments or devices have failed: and,

5. treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
   The Exeter Centralizer is intended to be used to centralize the femoral stem within the intramedullary canal. The Exeter Centralizer is intended to be used with bone cement.
   The Exeter Intramedullary Bone Plug is intended to be used to restrict the migration of bone cement down the femoral canal and permit cement pressurization during total hip arthroplasty. The Exeter Intramedullary Bone Plug is intended to be used with bone cement.

Exeter X3 RimFit Cups
The indications for use for total hip arthroplasty include:

1. Painful, disabling joint disease of the hip from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
2. Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
3. Clinical management problems where arthrodesis or alternative techniques are less likely to achieve satisfactory results.
4. Where bone stock is of poor quality or inadequate for other reconstructive techniques, such as cementless fixation, as indicated by deficiencies of the acetabulum.

Restoration GAP II Acetabular Shell
Painful, disabling joint disease of the hip resultive arthritis, rheumatoid arthritis, post- traumatic arthritis or late stage avascular necrosis.
Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
Clinical management problems where arthrodesis or alternative techniques are less likely to achieve satisfactory results.
Where bone stock is of poor quality or inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.
Segmental and/or cavitary acetabular defects which make it difficult to restore normal hip biomechanics or to reconstitute the normal structural continuity and integrity of the acetabulum, using standard total hip replacement acetabular components and procedures.

Gap Screws, Torx Screws, and Osteolock Bone Screws
HOWMEDICA OSTEONICS Torx Cancellous Bone Screws are intended for supplemental fixation of associated HOWMEDICA OSTEONICS cementless Acetabular Shells.
· HOWMEDICA OSTEONICS RESTORATION GAP Plate Screws are intended for fixation of the dome and illac plates of the associated HOWMEDICA OSTEONICS RESTORATION GAP Acetabular Shell, TRIDENT TRITANIUM Hemispherical Multihole Acetabular Shells, restoration Acetabular Augments, and Restoration Anatomic shells.

Insignia Hip Stem
Hip Arthroplasty Indications:
• Painful, disabling joint disease of the hip resulting from: noninflammatory degenerative joint disease (including osteoarthritis or avascular necrosis), rheumatoid arthritis or post-traumatic arthritis.
· Revision of previous unsuccessful femoral head replacement, hip arthroplasty or other procedure.
· Correction of functional deformity
· Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Additional indication specific to use of Insignia Hip Stems with compatible Howmedica Osteonics Constrained Liners: · When the stem is to be used with compatible Howmedica Osteonics Constrained Liners, the device is intended for use in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability.
Additional indication specific to use of Insignia Hip Stems with compatible ADM and MDM Acetabular Components: • When the stem is to be used with compatible Howmedica Osteonics ADM and MDM Acetabular Components, the device is indicated for Dislocation risks
Insignia Femoral Stems are intended for cementless use only and are intended for total and hemiarthroplasty procedures.

Omnifit HFX Femoral Stems
For use as a Bipolar Hip Replacement:

• Femoral head/neck fractures or non-unions.
• · Aseptic necrosis of the femoral head.
  · Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acetabular involvement or distortion.
  Other Considerations:
  · Pathological conditions or age considerations which indicate a more conservative acetabular procedure and an avoidance of the use of bone cement in the acetabulum.
  • Salvage of failed total hip arthroplasty.
  · Femoral neck fractures.
  For use as a Total Hip Replacement:
  • Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatic arthritis or late stage avascular necrosis.
  · Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
  · Clinical management problems where arthrodesis or alternative techniques are less likely to achieve satisfactory results.
  · Clinical circumstances which require an altered femoral resection level due to a proximal fracture, bone loss or calcar lysis.

Omnifit EON Cemented Femoral Stems
For use as a Bipolar Hip Replacement:
· Femoral head/neck fractures or non-unions.

• · Aseptic necrosis of the femoral head.
  · Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acetabular involvement or distortion. Other Considerations:
  · Pathological conditions or age considerations which indicate a more conservative acetabular procedure and an avoidance of the use of bone cement in the acetabulum.
  • Salvage of failed total hip arthroplasty.
• For use as a Total Hip Replacement:
  • Painful, disabling joint disease of the hip resulting from: degenerative arthritis, post-traumatic arthritis or late stage avascular necrosis.
• · Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
  · Clinical management problems where arthrodesis or alternative techniques are less likely to achieve satisfactory results.
  Indications for use as a Total Hip Replacement include:
  · noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
• rheumatoid arthritis;
• · correction of functional deformity;
• · revision procedures where other treatments or devices have failed; and,
  · treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

Restoration Anatomic Shell
• Painful, disabling joint disease of the hip from: degenerative arthritis, rheumatoid arthritis, posttraumatic arthritis or late stage avascular necrosis.
· Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
· Clinical management problems where arthrodesis or alternative techniques are less likely to achieve satisfactory results.
· Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.
When used with MDM Liners
· Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
• Dislocation risks
When used with Constrained Liner:
• The Trident Constrained Acetabular Insert is indicated for use in primary and revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability.

Trident Constrained Acetabular Insert/ Constrained Acetabular Insert
The Constrained Acetabular Insert is intended for use as a component of a total hip prosthesis in primary or revision patients at a high risk of hip dislocation due to a history of dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instability.

Trident X3, Trident Crossfire, and Trident X3/Crossfire Elevated Rim Acetabular Liners
· Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatic arthritis or late stage avascular necrosis.
· Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
· Clinical management problems where arthrodesis or alternative techniques are less likely to achieve satisfactory results.
· Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.

UHR Bipolar

• · Femoral head/neck fractures or non-unions.
• · Aseptic necrosis of the femoral head.
  · Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acetabular involvement or distortion.
  Other Considerations:
  · Pathological conditions or age considerations which indicate a more conservative acetabular procedure and an avoidance of the use of bone cement in the acetabulum.
• Salvage of failed total hip arthroplasty.

Unitrax V40 Head, V40 Adapter Sleeve and C-Taper Adapter Sleeve
The HOWMEDICA OSTEONICS Unitrax Endoprosthesis, and the V40 Modular Adaptor sleeves are used as a hemiarthroplasty device for the following indications: femoral neck fractures, idiopathic avascular necrosis, and nonunions. The C-taper sleeves are intended for use as a Hemi-Hip Replacement with the following indications: femoral head/neck fractures or nonunions, aseptic necrosis of the femoral head/neck and oster- and post traumatic arthritis. The patient's acetabular bone stock must be adequate to support articulation with the ad of the endoprosthesis.

BIOLOX Delta Ceramic Heads (V40, C-Taper and Universal and C-Taper to Universal Taper Adapter Sleeve)
The femoral heads are intended fixation to their mating hip stems, and can be used in cemented or cementless hip arthroplasty procedures.
For Use as a Total Hip Replacement:
· Painful disabling joint disease of the hip resulting from: degenerative arthritis, rheumatic arthritis or late stage avascular necrosis.

• · Revision of previous cup arthroplasty or other procedures
  · Clinical management problems where arthrodesis or alternative techniques are less likely to achieve satisfactory results.
  · Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies in the acetabulum.
  For Use as a Bipolar Hip Replacement
• Femoral head/neck fractures or non-unions.
• Aseptic necrosis of the femoral head.
• · Osteo-, rheumatoid, and post traumatic arthritis of the hip with minimal acetabular involvement or distortion.
  · Pathological considerations or age considerations which indicate a more conservative acetabular procedure and an avoidance of the use of bone cement in the acetabulum.
  The general intended use for these devices is "In general, these devices are intended for use in primary or revision hip arthroplasty."

Alumina C-Taper and V40 Ceramic Heads
For Use as a Total Hip Replacement:
· Painful disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
· Revision of previous cup arthroplasty or other procedures
· Clinical management problems where arthrodesis or alternative techniques are less likely to achieve satisfactory results.
· Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies in the acetabulum.
Additional indications for the Alumina C-Taper Ceramic Heads
For Use as a Bipolar Hip Replacement

• Femoral head/neck fractures or non-unions.
• · Aseptic necrosis of the femoral head.
• · Osteo-, rheumatoid, and post traumatic arthritis of the hip with minimal acetabular involvement or distortion.
  · Pathological considerations or age considerations which indicate a more conservative acetabular procedure and an avoidance of the use of bone cement in the acetabulum.
  · Salvage of failed total hip arthroplasty

Co Cr Femoral Heads (C-Taper and V40 Taper, LFIT and non-LFIT)
· Painful disabling joint disease of the hip resulting from: degenerative arthritis, rheumatic arthritis or late stage avascular necrosis.
· Revision of previous cup arthroplasty or other procedures
· Clinical management problems where arthrodesis or alternative techniques are less likely to achieve satisfactory results.
· Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies in the acetabulum.

Accolade C Femoral Stems, Accolade HFx Femoral Stems
Indications for use as a Total Hip Replacement include:
· noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;

• rheumatoid arthritis;
• · correction of functional deformity;
• · revision procedures where other treatments or devices have failed; and,
  · treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

Accolade TMZF and Accolade TMZF Plus Femoral Stems
The subject hip stem is a single-use device intended for use in total hip replacement. It is intended for the reconstruction of the head and neck of the femoral joint. This hip stem is intended for primary reconstruction of the proximal femur or revision total hip arthroplasty. This device is intended for use with any currently available Howmedica Osteonics acetabular component and V40TM femoral heads that can be mated with a TMZF 5° 40'trunnion.
Indications:
· Cementless primary hip surgery in cases of non-inflammatory degenerative joint disease including osteoarthritis.
avascular necrosis, rheumatoid arthritis, and correction of functional deformity.
• Treatment of nonunion, and femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
· Revision procedures where other treatments or devices have failed.

The devices covered by this submission are Stryker Total Hip components which include femoral stems, acetabular shells, liners, femoral heads, acetabular augments, acetabular bone screws, acetabular plugs, cables, trochanteric grips, cement restrictors, and distal femoral spacers. All devices are commercially available and have been cleared in prior 510(k) submissions.

All the subject devices have been cleared for MR conditional in previous 510(k)s. The purpose of this submission is to modify the MR conditional information in the instructions for use to update the parameters in which a patient who has the device can be safely scanned, per testing conducted accordance to updated FDA guidance. There have been no changes made to the devices requiring 510(k) clearance - only the MR conditional information in the instruction for use is being modified.

This document is a 510(k) Premarket Notification from the FDA regarding a labeling update for Stryker Orthopaedics Hip Systems. It explicitly states that no changes have been made to the devices themselves, only to the MR conditional information in the instructions for use.

Therefore, the usual format for acceptance criteria and studies proving the device meets those criteria (which would typically involve performance metrics for an AI/software-based device) is not applicable here. This submission is about demonstrating that the updated MR Conditional labeling information is safe, not about a new or modified device's performance against clinical endpoints.

However, I can extract information related to the testing performed to support the updated labeling, which serves as the "study" in this context.

Here's a breakdown of the relevant information:

1. Table of Acceptance Criteria (for MR Conditional Labeling Safety) and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: Not specified in terms of number of devices or scenarios tested, but the document mentions that testing was "comprehensively" performed.
• Data Provenance: The testing was conducted by the manufacturer, Stryker Orthopaedics, to obtain data for updating the MR conditional information in the labeling. This is non-clinical testing.
• Retrospective or Prospective: This would be considered prospective testing, as new tests were conducted specifically to gather data for the labeling update.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

• This concept is not applicable here. The "ground truth" for MR Conditional labeling is established through physical testing and engineering analysis according to regulatory standards and guidance documents, not expert consensus on medical images or clinical outcomes.

4. Adjudication Method for the Test Set:

• Not applicable. As the testing is non-clinical (device safety in an MR environment), there's no "adjudication" in the sense of clinician agreement on an outcome. The results are based on direct measurements from physical tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No. This type of study is for evaluating the clinical effectiveness of AI/software in assisting human readers (e.g., radiologists, pathologists). This submission is for a labeling update of a physical medical device (hip implants) regarding its MR compatibility and does not involve AI or human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• No. This is not an AI/algorithm-based device. It is a physical orthopedic implant.

7. The Type of Ground Truth Used:

• The "ground truth" for this submission is based on non-clinical testing results that demonstrate the safety of the device in an MR environment, specifically regarding RF-related heating effects. This is a combination of physical measurements and engineering analysis in accordance with FDA guidance documents. It is not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set:

• Not applicable. This product is a physical device, not an AI/machine learning algorithm requiring a training set.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable. See point 8.

In Summary:

This FDA 510(k) notification is for a labeling change related to MR compatibility of a hip implant system, not for a new or modified device's clinical performance or an AI/software device. The "study" referenced is non-clinical testing to ensure the safety parameters provided in the updated labeling are accurate and supported by data, specifically related to RF-induced heating. The acceptance criteria and "performance" are therefore framed around meeting the requirements of the FDA guidance document for MR safety testing.

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