Search Results

Acetabular Liners:
The Trabecular Metal™ Revision Shell Liner is indicated for cemented use in the Trabecular Metal Revision Shell for initial placement or as an in situ replacement polyethylene bearing surface for joint instability, wear and/or damage.

Constrained Liners:
The Trabecular Metal Acetabular Revision System Cemented Constrained Liner is intended to be cemented into a Trabecular Metal Acetabular Revision System shell; the shell is intended for cementless fixation into the acetabulum. The Trabecular Metal Acetabular Revision System Cemented Constrained Liner is indicated for use as a component of a total hip prosthesis in complex 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 and for whom all other options to constrained acetabular components have been considered.

The Trabecular Metal Acetabular Revision System (TMARS) Acetabular Liner and Cemented Constrained Liner are polyethylene/metal acetabular liners, which, when used with a Trabecular Metal Acetabular Revision System Shell, forms the acetabular component of a total hip prosthesis. The acetabular liner constructs are manufactured from Longevity highly cross-linked ultra-high molecular weight polyethylene (UHMWPE). The cemented constrained liners are manufactured from Longevity highly cross-linked UHMWPE and contain a titanium alloy constraining ring. All devices in the scope of this 510(k) are sterile, single-use items.

The provided FDA 510(k) clearance letter (K243571) for the Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific performance acceptance criteria through the kind of study layout often associated with novel AI/software devices.

This submission is for a medical device (hip joint prosthesis components) and the "studies" conducted are non-clinical bench tests to ensure the new device performs similarly and safely to already approved devices. Therefore, the response will reflect the information provided, which is typical for a traditional medical device 510(k) clearance.

Here's an analysis of the provided document against your requested criteria:

Acceptance Criteria and Device Performance for Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners (K243571)

Based on the provided 510(k) summary, the device's acceptance criteria are primarily demonstrated through non-clinical bench testing, ensuring the new device's performance is comparable to its predicate devices and meets relevant material standards. The goal is to establish substantial equivalence, not to demonstrate a specific improvement in performance over a human baseline or a novel AI-driven diagnostic accuracy.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not detail specific sample sizes for each non-clinical test (e.g., how many liners were tested for push-out). These are typically bench tests conducted on a sufficient number of samples to statistically validate the mechanical properties. The "data provenance" in this context is from laboratory bench testing, not patient data. Therefore, concepts like country of origin or retrospective/prospective don't apply as they would for clinical studies.

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

This information is not applicable (N/A) for this type of device submission. Ground truth, typically established by expert consensus or pathology in diagnostic studies, is not a concept used for evaluating mechanical components of a hip prosthesis in a 510(k) de novo submission. The "ground truth" here is adherence to engineering standards and comparison to predicate device performance through physical testing.

4. Adjudication Method for the Test Set

This information is not applicable (N/A). Adjudication methods (like 2+1, 3+1, none) are relevant for studies involving human interpretation (e.g., radiologists reviewing images) where disagreements need resolution to establish a ground truth. For mechanical bench testing, the results are objectively measured against defined criteria or compared to predicate performance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of diagnostic algorithms, often comparing human readers with and without AI assistance on a set of cases. This 510(k) is for an orthopedic implant, not a diagnostic AI device.

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

This information is not applicable (N/A). This product is a physical medical device (an acetabular liner), not an AI algorithm. Therefore, "standalone algorithm" performance is not relevant.

7. The Type of Ground Truth Used

As mentioned in point 3, the concept of "ground truth" in the diagnostic AI sense (expert consensus, pathology, outcomes data) is not applicable here. The "truth" or reference for this device's performance is established by:

• Engineering specifications and material standards (e.g., ASTM F648).
• Performance of legally marketed predicate devices (demonstrating substantial equivalence through comparative bench testing).
• Biocompatibility standards (ISO 10993-1).

8. The Sample Size for the Training Set

This information is not applicable (N/A). This device is not an AI/ML algorithm that requires a "training set."

9. How the Ground Truth for the Training Set was Established

This information is not applicable (N/A). As there is no training set for an AI algorithm, there is no ground truth to establish for it.

Ask a specific question about this device

The b-ONE® Total Hip System is intended for primary or revision total hip replacement in skeletally mature patients with a severely disabled hip joint and/or hip damage due to the following conditions: Osteoarthritis, traumatic arthritis, avascular necrosis of the femoral head, noninflammatory degenerative joint disease (NIDJD), slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis and congenital dysplasia: treatments of nonunion, acute traumatic fracture of the femoral head or neck; failed endoprosthesis, femoral osteotomy, or Girdlestone resection: and fracture-dislocation of the hip.

The b-ONE® Total Hip System KOSMO™ HA coated stems and Grit-Blasted stems are intended for cementless use only.

The b-ONE® Total Hip System KOSMO™ Stainless Steel stems are intended for cemented use only.

The b-ONE® Cement Restrictor is intended to restrict bone cement migration into the distal medullary canal and aid in cement pressurization during total hip arthroplasty.

b-ONE® Total Hip System components are not intended for use with other total hip systems.

b-ONE Total Hip System KOSMO Femoral Stem consists of cementless and cemented bone compacting stem options. The b-ONE KOSMO Femoral Stems Sizes are offered in 12 femoral stem sizes ranging from size 0 to 10 with half size of 4.5 for Cementless Collared Standard, High, and Proportional Offset families and 11 femoral stem sizes ranging from size 1 to 10 with half size of 4.5 for Cementless Collarless/Collared Coxa Vara families and Cemented Standard and Proportional Offset families.

The subject stems are laser marked with the catalog number, company logo, size, and material. The KOSMO Femoral Stem is composed of titanium alloy Ti-6A1-4V-ELI (ASTM F136) for cementless stems and Stainless Steel (ASTM F1586) for cemented stems. The cementless stems are offered as either HA coated or Grit-blasted.

The b-ONE Cement Restrictor is made from UHMWPE (ASTM F648/ISO 5834-1). The restrictor is offered in 7 different sizes with a major diameter of 9, 11, 13, 15, 17, 20, and 23mm and have a total length of 17mm. The cement restrictor is to be used for cement implantation. This b-One Cement Restrictor is intended to restrict bone cement migration into the distal medullary canal and aid in cement pressurization during total hip arthroplasty.

I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets acceptance criteria. The document is an FDA 510(k) clearance letter for the b-ONE® Total Hip System, which primarily discusses the substantial equivalence of the subject device to legally marketed predicate devices.

The content focuses on:

• The FDA's decision regarding the 510(k) submission (K240528).
• Regulatory information, classifications, and requirements for the device.
• Indications for Use for the b-ONE® Total Hip System.
• A comparison of technological characteristics with predicate devices.
• A list of non-clinical performance tests conducted, but not the acceptance criteria for these tests, nor the detailed results proving they were met.

Therefore, I cannot fulfill your request to create a table of acceptance criteria and reported device performance, or describe the study details (sample size, ground truth, expert qualifications, adjudication, MRMC, or standalone performance) because that information is not present in the provided text.

Ask a specific question about this device

Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.

Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, atthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.

Total hip systems may be indicated for use (i) without bone cement, or (ii) for use with or without bone cement. Refer to the product labeling and literature for specific applications.

The Anthology Hip System, CPCS Cemented Hip System, and Synergy Hip System are for primary surgeries only.

The TANDEM Unipolar and Bipolar Hip System is indicated for use in patients not suitable for total hip arthroplasty, with a non-functional femoral head due to femoral neck fracture.

Acetabular Hip Components are individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of degenerative joint disease or any of its composite diagnoses of osteoarthritis, avascular necrosis, and traumatic arthritis.

Hip components are also indicated for inflammatory degenerative joint disease including theumatoid arthritis, congenital dysplasia. femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques, and fracture-dislocations of the hip.

The Constrained Liners are indicated for primary or revision patients at hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease or intraoperative instability and for whom all other options to constrained acetabular components have been considered.

The purpose of this Traditional 510(k) is the following:

• 1. To add the MR safety information to the product labels and update the MR information within the package insert for the Smith & Nephew Hip Systems included within the scope of this 510(k), and
• 2. To address several iterative legacy design changes made to the subject hip system components.

This document is a 510(k) premarket notification for hip system components and does not describe an AI medical device. Therefore, I cannot provide information on acceptance criteria or studies related to AI algorithms.

The document primarily focuses on demonstrating substantial equivalence of the described hip system components to previously cleared predicate devices. The "Performance Data" section specifically mentions Magnetic Resonance Imaging (MRI) compatibility testing and "additional testing [...] to assess the modifications made to the subject Smith & Nephew Hip Systems devices against their predicates." This indicates performance data related to physical device properties, not AI performance.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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 in 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 Modular Replacement System Cemented Stems (cleared in K040749):

· Femoral and/or proximal tibial replacement due to:
- Trauma
- Failed previous prosthesis
- Tumor resection

The Global Modular Replacement System 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 or the Modular Rotating Hinge Knee System. 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 subject Global Modular Replacement System components are unchanged since the last premarket notification for the devices in K222056.

This document is entirely focused on a 510(k) premarket notification for a medical device called the "Global Modular Replacement System." It is a request for approval to market the device, and the content details its intended use, a comparison to legally marketed predicate devices, and a summary of its technological characteristics.

Crucially, this document does not contain any information about acceptance criteria, device performance testing results, ground truth establishment, sample sizes for training or test sets, expert qualifications, or MRMC studies for an AI/software device. The request is specifically for a physical medical device (hip and knee prostheses) and its purpose is to update labeling, including adding a contraindication and updating MRI safety information.

The sections you've requested (acceptance criteria, study details, sample sizes, expert qualifications, ground truth, MRMC studies) are typically relevant for AI/Software as a Medical Device (SaMD) submissions where software algorithms are being evaluated for diagnostic or prognostic purposes.

Therefore, I cannot fulfill your request as the provided text does not contain the information you are asking for. It explicitly states:

"No additional testing was conducted for this submission, as the only changes being made are to modify the labeling to add a contraindication and an update to the MRI safety information to align with an FDA guidance document. Testing performed in the previously cleared premarket notifications is applicable to this submission." (Page 10)

This confirms that no new performance studies, as would be required for an AI/Software component, were performed or are detailed in this 510(k) submission.

Ask a specific question about this device