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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The ONVOY Acetabular System is intended for use in reconstruction of the articulating surface of the acetabular portion of the hip that is severely disabled and/or very painful resulting from:

1. Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, and avascular necrosis.
2. Rheumatoid arthritis.
3. Correction of functional deformity.
4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
5. Revision of previously failed total hip arthroplasty.
6. Dislocation risks.

The ONVOY Acetabular System is used in conjunction with Globus/StelKast Hip Systems. The acetabular components of this hip system are intended for cementless fixation.

The ONVOY™ additional implants consist of acetabular shells, liners, and dual mobility liners and bearings that are used as part of a complete total hip system in conjunction with a femoral head and femoral stem in total hip arthroplasty. New femoral head sizes are also being introduced. Implants are available in various configurations and sizes to fit a wide variety of patient anatomy. Shells are available in a cluster-hole design, liners are available in hooded, non-hooded, and lateralized designs used in conjunction with ONVOY shells. Dual mobility polyethylene bearings are used with dual mobility liners.

ONVOY™ acetabular shells are additively manufactured from titanium alloy powder per ASTM F3001. Acetabular liners and dual mobility bearings are manufactured from highly crosslinked ultra-high molecular weight polyethylene (UHMWPE) with Vitamin E. Dual mobility liners are manufactured from Cobalt Chrome (CoCr) alloy and femoral heads are manufactured from alumina matrix composite ceramic.

This document is an FDA 510(k) clearance letter for a medical device called the "ONVOY™ Acetabular System." It details the device's purpose, indications for use, and the basis for its substantial equivalence to other legally marketed devices.

However, it does not contain information about acceptance criteria and a study proving a device meets those criteria for an AI/Software as a Medical Device (SaMD).

This clearance is for an orthopedic implant (hip prosthesis components: acetabular shells, liners, dual mobility implants, and femoral heads), not a software device or an AI application. Therefore, the questions related to MRMC studies, ground truth establishment, training sets, and expert adjudication are not applicable to the content provided in this FDA 510(k) letter.

The "Performance Data" section solely refers to mechanical and material testing standards relevant to orthopedic implants (fatigue, wear, range of motion, material composition, etc.) and states that "Performance data demonstrate substantial equivalence to the predicate devices." It does not describe any clinical study involving human readers or AI performance metrics.

In summary, based on the provided text, I cannot describe acceptance criteria and a study that proves a device meets those criteria, as the document pertains to an orthopedic implant and not an AI/SaMD.

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The indications for the Trinity™ EVO Acetabular Shell as a total hip arthroplasty include:

• Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
• Rheumatoid arthritis.
• Correction of functional deformity.
• Developmental dysplasia of the hip (DDH)/Congenital dislocation of the hip (CDH)

The Trinity™ EVO acetabular shell is also indicated for use in revisions of a previously failed total hip arthroplasty.

The Trinity™ EVO Acetabular Shell is indicated for cementless use only.

The Trinity™ EVO acetabular shell forms part of a modular acetabular system. The Trinity™ EVO acetabular shell is a hemispherical press fit titanium alloy shell for use with cobalt chrome alloy (Trinity™ Dual Mobility only) or polyethylene liners and a dedicated range of ceramic and cobalt chrome alloy modular 12/14 taper femoral heads providing ceramic on polyethylene and metal on polyethylene articulations for use in total hip arthroplasty (THA) procedures using Corin metal stems with a 12/14 taper connection. The Trinity™ EVO acetabular shell has a porous structure manufactured from titanium alloy powder, produced via additive manufacturing using Laser Powder Bed Fusion (LPBF), and is available with or without an additional layer of electrochemically deposited calcium phosphate. The Trinity™ EVO acetabular shell is provided in sizes permitting the use of titanium bone screws to provide additional fixation, if required. The Trinity™ EVO acetabular shell is also available without screw holes. A titanium occluder is provided to occlude the apical introducer hole.

The Trinity™ EVO acetabular shell is intended for use in primary and revision THA in skeletally mature patients, to provide increased mobility and reduce pain by replacing the damaged hip joint articulation when there is evidence of sufficient sound bone to seat and support the components.

The provided document is a 510(k) Clearance Letter for the Trinity EVO Acetabular Shell. This type of submission focuses on demonstrating substantial equivalence to a previously cleared device, not necessarily proving clinical efficacy through a direct comparative study like a Multi-Reader Multi-Case (MRMC) study for an AI-powered diagnostic device.

Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the non-clinical performance testing conducted to show that the new device performs as safely and effectively as its predicate devices, rather than a clinical trial with human readers.

Here's a breakdown based on the provided document:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the standards and internal protocols cited for the non-clinical testing. The device is deemed to meet these criteria if the test results demonstrate comparable or acceptable performance to the predicate devices. The document states: "The results of this testing show that the Trinity™ EVO Acetabular Shell is substantially equivalent to the predicate devices."

Table of Acceptance Criteria and Reported Device Performance:

Study Information Specific to the Device Clearance (non-clinical)

The information provided in the 510(k) summary focuses on non-clinical testing. Questions related to "test set," "data provenance," "experts," "adjudication," "MRMC studies," "standalone algorithm performance," and "ground truth" are not applicable in the context of this specific regulatory submission as it's for a physical orthopedic implant, not a diagnostic AI software.

However, based on the general structure, here's what can be inferred or stated as "Not Applicable" for this type of device:

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: For mechanical testing, the "sample size" refers to the number of physical devices or representative specimens tested per condition, as per the respective ASTM/ISO standards. This specific number is not disclosed in the provided summary but would be detailed in the full submission.
   • Data Provenance: The data provenance is from the manufacturing and testing facility of Corin USA Limited, a medical device manufacturer. The tests are "non-clinical" and conducted on physical prototypes/products.

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

   • Not Applicable. This is a physical device, and "ground truth" is established by physical measurements and performance against established engineering standards and specifications, not expert interpretation of medical images or clinical outcomes in a diagnostic context. The "experts" involved would be engineers, materials scientists, and quality assurance personnel.

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

   • Not Applicable. Adjudication relates to resolving discrepancies in expert interpretations, which is relevant for diagnostic studies, not mechanical testing. Test results are objective measurements compared against predefined limits.

4. 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. An MRMC study is relevant for evaluating the impact of AI algorithms on human reader performance in diagnostic tasks. This device is a passive, physical implant.

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

   • Not Applicable. This is a physical orthopedic implant, not a software algorithm.

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

   • Engineering Standards and Specifications. The "ground truth" for the device's performance is defined by established international standards (ASTM, ISO) and internal engineering design specifications that ensure the device's mechanical integrity, biocompatibility, and functional characteristics are met.

7. The sample size for the training set:

   • Not Applicable. This is a physical device, not an AI/ML algorithm that requires a "training set." The design and manufacturing processes are refined through engineering development and quality control, not machine learning.

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

   • Not Applicable. (See point 7).

In summary, the 510(k) for the Trinity EVO Acetabular Shell demonstrates "substantial equivalence" based on extensive non-clinical (mechanical, materials, and physical) testing to established engineering standards, asserting that it performs as safely and effectively as its predicate devices, rather than through clinical studies involving human readers or AI algorithms.

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Mpact 3D Metal Augments are intended for cementless use to the bone interface and are affixed to a compatible Medacta Acetabular shell using bone cement in hip replacement surgeries.

Mpact 3D Metal Augments are indicated in cases of:

• Acetabular dysplasia;
• Acetabular fractures;
• Revision of previous implants in the presence of insufficient bone quality or seriously altered bone structures.

The Mpact 3D Metal Augment II is an acetabular implant intended to be used in Total Hip Arthroplasty cemented to its Medacta compatible Acetabular Shell. It is provided sterile and individually packaged to the end user.

The devices subject of this submission are:

• Mpact 3D Metal Augments II from size Ø46 to Ø80, made of Ti6Al4V according to ASTM F2924;
• Double Augment Technique Screw, made of Ti6Al4V according to ISO 5832-3.

The Mpact 3D Metal Augments II represent the second generation of the Mpact 3D Metal Augments cleared within K171966.

This FDA 510(k) clearance letter pertains to a medical device, specifically the Mpact 3D Metal Augments II, which are implants for hip replacement surgeries. The document focuses on establishing substantial equivalence to existing predicate devices based on design and performance testing. However, it does not describe a clinical study in the traditional sense, especially not one that involves human subjects or assesses AI performance.

The provided text details non-clinical performance data and validations to support the device's substantial equivalence to its predicate. It does not contain information about acceptance criteria for AI performance, sample sizes for test sets in an AI context, expert ground truth establishment, MRMC studies, or standalone algorithm performance.

Therefore, many of the requested sections (including specific tables for acceptance criteria and device performance based on AI metrics, details about test sets, ground truth establishment for AI, MRMC studies, and standalone performance) cannot be filled from the provided document.

Here's a breakdown of the information that is available:

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

The document describes performance testing as "Fatigue testing in single and double augment configurations" and "Rationale of comparison – EBM Additive Manufacturing Technology." It also mentions "Design Validation on Mpact 3D metal Augments II." However, it does not disclose specific acceptance criteria or quantitative performance results for these tests. It only states that "testing activities were conducted to written protocols" and these validations are "provided in support of the substantial equivalence determination." This is typical for a 510(k) summary, which generally summarizes the data rather than providing all raw or detailed results.

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

This information is not provided in the document. The "tests" here refer to non-clinical laboratory and material tests, not clinical studies involving patient data.

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 is not applicable to the type of device and study described. There's no "ground truth" to be established by experts in the context of material fatigue or design validation for an orthopedic implant as presented here.

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

This is not applicable to the type of device and study described. Adjudication methods are typically used in clinical trials or studies involving expert review of medical images or outcomes.

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

There is no MRMC or comparative effectiveness study mentioned, as this is a physical medical device (hip augments), not an AI-powered diagnostic or assistive tool for human readers.

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

This is not applicable. The device is an orthopedic implant, not an algorithm.

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

This is not applicable in the sense of medical diagnosis or AI performance. The "truth" for these non-clinical tests would be the physical properties and performance characteristics determined by established engineering and materials testing standards.

8. The sample size for the training set

This is not applicable, as there is no "training set" for an AI algorithm mentioned in this document.

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

This is not applicable, as there is no "training set" or "ground truth" for it in the context of AI.

Summary of what the document does provide regarding the study/testing:

The document describes non-clinical testing and validations performed to demonstrate the substantial equivalence of the Mpact 3D Metal Augments II to its predicate devices. These tests include:

• Design Validation: Performed on Mpact 3D Metal Augments II (details not provided).
• Performance Testing:
  • Fatigue testing in single and double augment configurations.
  • Rationale of comparison – EBM Additive Manufacturing Technology.
• Pyrogenicity: Control validated using bacterial endotoxin test (LAL test) per ISO11737-3 and European Pharmacopoeia §2.6.14, and in-vivo evaluation in rabbits per USP .
• Biocompatibility assessment.
• Shelf-life evaluation.

The document states that Medacta International S.A., based in Switzerland, submitted this 510(k). The tests are non-clinical, so data provenance regarding country of origin or retrospective/prospective does not apply in the same way as for clinical data. The studies are laboratory-based and conducted according to written protocols to ensure materials and design meet safety and performance standards for orthopedic implants.

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The KMTI Hip Replacement System is indicated for patients suffering from:

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
2. Rheumatoid arthritis;
3. Correction of functional deformity;
4. Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques; and
5. Revision procedures where other treatment or devices have failed.

The Initia T3 Acetabular Hemispherical Shell System is intended for cementless applications.

The Kyocera Medical Technologies, Inc. (KMTI) Initia T3 Acetabular Hemispherical Shell System is a cementless shell intended for use in the treatment of hip disorders requiring hip replacement surgery. The Initia T3 Acetabular Hemispherical Shell System includes several components including: Initia T3 Acetabular Hemispherical Shell, Initia Acetabular Liner, Initia Bone Screw, and Delta 22.2 Femoral Head.

The Initia T3 Acetabular Hemispherical Shell is a cementless porous shell manufactured from Ti-6Al-4V ELI per ASTM F136. The Initia Acetabular Liner attaches to the inner surface of the Initia T3 Acetabular Hemispherical Shell and is available in four different configurations. The Initia Acetabular Liner is used to provide a single articulation implant option and is manufactured from Vitamin E infused UHMWPE per ASTM F2695 or UHMWPE per ASTM F648. The femoral head is manufactured from Biolox® delta and is available in two offsets.

This document clears the Initia T3 Acetabular Hemispherical Shell System for marketing. However, the provided text does not contain acceptance criteria or detailed study results in the manner requested for AI/software devices.

This FDA 510(k) clearance is for a physical medical device (an orthopedic implant), not an AI-powered diagnostic or assistive tool. The "performance data" section details various mechanical and material tests conducted on the implant itself to ensure its structural integrity, durability, and biological compatibility. It does not involve "test sets," "ground truth," "expert adjudication," or "multi-reader multi-case studies" in the context of evaluating an AI algorithm's diagnostic performance.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance related to diagnostic accuracy, nor can I provide information on sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. These concepts are not applicable to the type of device described in the provided text.

The "performance data" described in the document relates to non-clinical (laboratory/mechanical) testing of the physical components of the hip replacement system.

If you intended to provide a different document related to an AI/software medical device, please provide that document.

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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 EMPHASYS Acetabular System is indicated for use in total hip replacement procedures.
Total hip replacement is indicated in the following conditions:

1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
2. Avascular necrosis of the femoral head.
3. Acute traumatic fracture of the femoral head or neck.
4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
5. Certain cases of ankylosis.
   EMPHASYS Acetabular Cups are indicated for cementless use only.

The subject devices in this line extension to the EMPHASYS Acetabular System (previously cleared through Primary Predicate 510(k) K221636) include three additional porous-coated titanium alloy Acetabular Shells in a multi-hole configuration and ten corresponding AOX polyethylene Acetabular Liners in three configurations (Neutral, +4 Neutral and ELV)

This is a medical device submission, not a software or AI device. Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, and MRMC studies are not applicable in the context of this document. This document pertains to the clearance of an acetabular system for total hip replacement, which involves physical device testing and comparison to predicate devices, not algorithmic performance.

Here's why each point is not applicable:

• A table of acceptance criteria and the reported device performance: This usually applies to diagnostic or AI algorithms where performance metrics like sensitivity, specificity, AUC are relevant. For a physical orthopedic implant, performance is assessed through mechanical and material testing against established standards, not necessarily a concise table of "acceptance criteria" as would be seen for software. The document states that testing was done for "Interconnection strength of shell and liner per ASTM F1820-22," implying adherence to a standard, but does not provide specific acceptance values or results in this summary.
• Sample sized used for the test set and the data provenance: Not applicable for a physical implant. "Test set" in an AI/software context refers to data. Here, it refers to physical units of the device tested in a lab.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth is generally for classification/detection tasks. For an implant, "ground truth" would be the physical properties confirmed through engineering tests.
• Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are used in expert reviews of data/images.
• 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 for AI-assisted diagnostic tools, not an orthopedic implant.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is for AI algorithms.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For a physical device, ground truth relates to its material properties and mechanical performance confirmed by standardized testing, not expert consensus on medical images or pathology.
• The sample size for the training set: Not applicable. This is for AI/machine learning models.
• How the ground truth for the training set was established: Not applicable. This is for AI/machine learning models.

Summary of Relevant Information (from the document) for a Physical Device:

• Performance Testing: The EMPHASYS Acetabular System subject devices were compared to predicate devices. Testing and analyses included:

  • Interconnection strength of shell and liner per ASTM F1820-22.
  • No new worst-case was identified for: Range of motion, Deformation, Impingement, Unsupported Shell Fatigue, Analysis of shell and liner thickness, Articular clearance, Wear Friction, MRI Safety.

• Substantial Equivalence: The device is substantially equivalent to identified predicates with respect to intended use, indications, materials, geometry, range of sizes, and method of fixation. Performance testing and analyses demonstrate that it performs as well as the predicate devices.

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The Pantheon Proximal Femur Reconstruction (PFR) System is a modular system intended to be used for the reconstruction of the proximal femur in the case of severe proximal femoral bone loss in hip revision surgery (due to infection, fracture, failed THA) or in the case of a bone tumor.

The FIXA Ti-Por cup is intended for cementless use.

The Pantheon PFR System is manufactured of Ti6A14V (except for femoral heads which are made of CoCrMo or ceramic and acetabular inserts made of cross-linked UHMWPE) and includes various components that can be combined to replace the hip joint and address major bone defects with various options depending upon the size and location of the defects of each patient. The Pantheon PFR System consists of:

• Pantheon Proximal Bodies made of Ti6Al4V Alloy additively manufactured.
• CoCrMo Alloy Femoral Heads Taper 12/14
• Biolox Delta Ceramic Femoral Heads Taper 12/14
• Pantheon Shaft made of Ti6Al4V Alloy
• Pantheon Bridging Collars made of Ti6Al4V Alloy additively manufactured
• Pantheon Cylindrical Bridging Collars made of Ti6A14V Alloy additively manufactured
• Pantheon Salvage Stem (Cemented) made of Ti6Al4V Alloy
• Pantheon Salvage Stem (Uncemented) made of Ti6A14V alloy
• Pantheon Proximal Body Locking Screw made of Ti6A14V Alloy
• Pantheon Salvage Plate Compression Screws made of Ti6Al4V Alloy
• Pantheon Salvage Plate with Spikes made of Ti6A14V Alloy
• Fixa Ti-Por Cup Acetabular Shells made of Ti6Al4V Alloy additively manufactured.
• Titanium Acetabular Screws made of Ti6A14V Alloy.
• Acetabular Inserts Flat made of Cross-Linked PE.
• Acetabular Inserts 15° Lipped made of Cross-Linked PE.

I am sorry, but the provided text describes a medical device called "Pantheon Proximal Femur Reconstruction (PFR) System" and its regulatory approval (510(k) submission) by the FDA. It does not contain any information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of an AI/ML device.

The document is a standard FDA 510(k) summary for a physical orthopedic implant. It details:

• The device name and manufacturer.
• Its intended use.
• The materials it's made from.
• Its components and sizes.
• The predicate devices it claims substantial equivalence to.
• The performance testing conducted on the physical device (e.g., fatigue testing, corrosion testing, ceramic head burst testing) against physical device standards, not AI/ML performance metrics.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, experts, adjudication methods, MRMC studies, standalone performance, or ground truth related to an AI/ML device, as this information is not present in the given text.

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The MobileLink Acetabular Cup System is indicated for patients with mobility-limiting diseases, fractures, or defects of the hip joint or proximal femur which cannot be treated by conservative or osteosynthetic procedures.

Indications:

• 1. Primary and secondary osteoarthritis
• 2. Rheumatoid arthritis
• 3. Correction of functional deformities
• 4. Avascular necrosis
• 5. Femoral neck fractures
• 6. Revision after implant loosening dependent on bone mass and quality

The MobileLink Dual Mobility Insert is additionally indicated for:
7) Dislocation risks

Additional indications specific to the TrabecuLink Augments:
Primary or revision surgery for hip replacement as a prosthetic alternative to structural allograft in cases of segmental acetabular deficiencies.

The MobileLink Acetabular Shells are intended for cementless fixation. The TrabecuLink Augments are intended for cementless fixation to the bone and for cemented fixation to the mating shell.

The MobileLink Acetabular Cup System is a versatile cup system, designed to provide several options for surgeons and patients within one system. This 510k adds several system components to the MobileLink Acetabular Cup System previously cleared in K182321, K192559, K200607, and K222066.

X-LINKed Inserts: The X-LINKed Inserts are manufactured from highly crosslinked polyethylene material. The inserts are available in the same sizes and designs as the previously cleared E-Dur inserts (K182321). The design variants include a neutral variant with or without offset, a shouldered variant with or without offset and 10° and 20° inclining variants with an offset. The inserts are fixed using a clamping system consisting of a combination of snap mechanism and conical clamping. Notches (tabs/recesses) at the rim further contribute to the rotational stability of the PE inserts.

TrabecuLink Augments: The TrabecuLink Metal Acetabular Augments are wedgeshaped components that conform to the shape of the acetabular shell. They are additively manufactured Ti6A14V alloy per ISO 5832-3 (chemistry and mechanical properties) and feature a porous structure (TrabecuLink) on the bone interfacing surface. They mate with the same MobileLink (TrabecuLink) Shells as previously cleared in K182321 and K222066 and they can be used with the same 6.5mm diameter bone screws cleared in K192559, or with new smaller diameter (4.5mm) bone screws introduced in this submission.

Bone Screws: The MobileLink Bone Screws are Ø 4.5mm in lengths from 15 -60mm (by 5mm increments). They feature the same head size/design as the previously cleared Ø 6.5mm screws and are made of the same wrought Ti6A14V alloy per ISO 5832-3 and ASTM F136 as the previously cleared Ø 6.5mm screws.

This document is a 510(k) Premarket Notification from Waldemar Link GmbH & Co. KG for their MobileLink Acetabular Cup System - Line Extension (Multiple). It's a submission to the FDA regarding new components for an existing hip replacement system.

The document does not describe a study involving acceptance criteria for a device's performance in a diagnostic or AI context. Instead, it is a regulatory filing for a medical device (hip replacement components). The "performance testing" section refers to non-clinical tests to ensure the mechanical and material integrity of the new components are comparable to existing, cleared devices.

Therefore, most of the requested information regarding acceptance criteria, sample sizes for test sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, and standalone algorithm performance cannot be extracted from this document, as it is not relevant to the type of device or study described.

Here's an attempt to fill in the table and address the relevant points based on the provided text, while noting where information is not applicable or available:

Acceptance Criteria and Reported Device Performance

1. A table of acceptance criteria and the reported device performance:
See the table above. The acceptance criteria essentially boil down to demonstrating "substantial equivalence" to predicate devices through various non-clinical performance tests. The reported performance for each test is that "The results... demonstrate that the device is as safe and effective as the predicate device, and therefore Substantially Equivalent." Specific numerical thresholds for acceptance are not detailed in this summary.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not provided in the document. The tests are non-clinical, likely bench testing on prototypes or manufactured samples, not patient data.

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. This is a non-clinical device performance study, not a diagnostic study requiring expert ground truth for interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This is a non-clinical device performance study, not a diagnostic study requiring 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:
Not applicable. This is not an AI/Software device, nor is it a diagnostic device where MRMC studies would be relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI/Software device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For the non-clinical performance tests, the "ground truth" would be the established engineering standards, material specifications (e.g., ISO 5832-3, ASTM F136, ASTM F543), and the performance characteristics of the predicate devices. The new components are tested to meet these established benchmarks.

8. The sample size for the training set:
Not applicable. This is not a machine learning or AI device.

9. How the ground truth for the training set was established:
Not applicable. This is not a machine learning or AI device.

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This device is intended for use in total hip arthroplasty. The device is intended for uncemented, press-fit use only in cases of:

• Notably impaired hip joints due to osteoarthritis, rheumatoid arthritis and/or post traumatic arthritis.
• Previously failed hip surgery.
• Fractures of the femoral neck or head.
• Avascular necrosis of the femoral head.
• Congenital dysplasia or other structural abnormalities where stock exists to properly seat the prosthesis.

The Legend® Acetabular Shell is a one-piece, hemispherical shell prostheses, designed for single, uncemented use. Device fixation is achieved via press-fit into a prepared acetabulum, which maximizes contact between the shell and bone.

The Legend® Acetabular Shell is manufactured from titanium alloy Ti-6A1-4V ELI per ASTM F136. The outer surface of the shells are coated with commercially pure titanium (CPT)(ASTM F1580) sintered porous coating. The inner surface of the shell is designed to lock together with the Escalade® and Legend® Acetabular Liners which are made from extensively cross-linked polyethylene. The Legend® Acetabular Shell is also designed to be used with cancellous bone screws and apical plugs.

The existing Legend® Acetabular Shell (K161080) is coated with commercially pure titanium (CPT) sintered bead coating. This submission allows a similar sintered coating to be applied by an additional supplier: Avalign Thortex (MAF-2607) in addition to the original supplier.

This document is a 510(k) premarket notification for a medical device called the "Legend® Acetabular Shell." It describes a submission to add an additional supplier for a porous titanium coating that is applied to an existing device.

Therefore, the submission does not involve the development or testing of an AI/ML device. The performance data section refers to mechanical testing of the coating material to ensure it meets established orthopedic implant standards, not the performance of an AI model.

As such, I cannot provide details regarding acceptance criteria and studies for an AI/ML device, as this documentation pertains to a traditional orthopedic implant. There are no mentions of AI, machine learning, deep learning, algorithms, or any related terms.

The sections you requested (acceptance criteria table, sample sizes, expert qualifications, ground truth, MRMC, etc.) are applicable to AI/ML device submissions, which are not present in this document.

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