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All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion.

Exactech Alteon HA femoral stems are intended for press-fit fixation.

The proposed Exactech Alteon HA Femoral Stems are intended for press-fit hip arthroplasty.

The Exactech Alteon HA Femoral Stems are manufactured from Ti-6A1-4V ELI (per ASTM F136, ASTM F620) with a grit blast surface and HA coating (per ISO 13779-2). The stem has a 12/14 taper. The Alteon HA Femoral Stems are available in various lengths with standard and extended neck offset configurations, and collarless configurations. The stem has a trapezoidal cross-sectional stem geometry with a distal taper, and it contains vertical and horizontal grooves along its bone contacting surfaces.

The Alteon HA Femoral Stems are compatible with the same femoral components as the predicate:

• Exactech Cobalt Chromium Alloy Femoral Heads (K041906, K121392)

• Exactech Ziramic Zirconia Femoral Heads (K050398, K060107)

• Exactech BIOLOX forte Alumina Femoral Heads (K032964, K051682)

• Exactech BioloxDelta and DeltaOption Femoral Heads and Adapters (K103012,K121392)

• AcuMatch L-series Unipolar endoprostheses (K010081)

• AcuMatch L-Series Bipolar Endoprostheses (K013211) .
  The Alteon HA Femoral Stems are compatible with the same acetabular components as the predicate:

• AcuMatch A-Series Acetabular Shells and Liners (K993082, K042906)

• AcuMatch A-Series Acetabular GXL Liners (K051556)

• AcuMatch A-Series Acetabular Cups, All-polyethylene, Cemented (K963313)

• Novation Crown Cup Acetabular Shells and Liners (K070479, K100269, K121392, K141960)

• Novation Crown Cup Acetabular Shells with InteGrip (K102975)

• Novation Crown Cup Constrained Liners and Rings (K071676)

• Exactech Integrip Acetabular Shells (K122798)

• Exactech Novation and AcuMatch E-HXL Acetabular Liners (K173583)

• Exactech Alteon Acetabular Cup System (K182502)

This document is a 510(k) premarket notification from the FDA for a medical device called "Alteon® HA Femoral Stems." It's important to understand that a 510(k) is a submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed predicate device, not a study proving device performance against specific acceptance criteria in the context of an AI/software device.

Therefore, the requested information pertaining to acceptance criteria and a study proving a device meets acceptance criteria in the context of an AI/software device is not applicable to this FDA submission. This submission is for a physical orthopedic implant (a femoral stem for hip replacement), not a "device" in the sense of an AI algorithm or diagnostic software.

The document focuses on demonstrating substantial equivalence to a previously cleared predicate device, not on proving performance against specific acceptance criteria for a new, innovative diagnostic or AI-driven capability.

Here's a breakdown based on the context of the provided document, addressing why many of the requested fields cannot be filled:

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

   • Acceptance Criteria: Not explicitly stated in the context of performance metrics for an AI/software device. The "acceptance" here is the FDA's determination of substantial equivalence.
   • Reported Device Performance: The document describes non-clinical testing performed to show the new HA coating does not negatively impact the device's essential characteristics, maintaining equivalence to the predicate. Performance is demonstrated through engineering analyses (Range of Motion, Stem Neck Fatigue, Distal Stem Fatigue) and characterization of the new HA coating, ensuring it meets standards like ISO 21535:2007, ASTM F2068-2015, ISO 7206-6:2013, ISO 7206-4:2010, ISO 13779-2, and USP , USP , ANSI/AAMI ST72. No quantitative performance metrics in the sense of sensitivity, specificity, etc., for a diagnostic task are provided or relevant.

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

   • This is not applicable. The "test set" in the context of this 510(k) refers to the physical devices undergoing mechanical and chemical testing. There's no data set of patient images or information from which "data provenance" would be relevant.

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. There is no ground truth, expert consensus, or image review involved for this type of medical device submission. The "ground truth" for a mechanical implant is its physical and chemical properties and mechanical integrity, which are assessed through engineering tests, not expert medical review.

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

   • Not applicable. This refers to adjudication of medical image interpretations, which is not part of this submission. Mechanical testing results are objective measurements against established standards.

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 for AI-powered diagnostic devices. The device in question is a physical orthopedic implant.

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

   • Not applicable. This is for AI algorithms.

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

   • Not applicable in the sense of a clinical ground truth for a diagnostic device. The "truth" for this device's performance is adherence to established engineering and material standards.

8. The sample size for the training set:

   • Not applicable. There is no AI model or "training set" for this physical implant.

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

   • Not applicable. There is no AI model or "training set" for this physical implant.

Summary of Relevant Information from the Document (Re-framed to align with the FDA 510(k) context):

The submission is for the Alteon® HA Femoral Stems, demonstrating substantial equivalence to the predicate device K162732 Exactech® Alteon® HA Femoral Stems. The key difference is the hydroxyapatite (HA) coating material/process.

The "study" conducted for this submission involves non-clinical testing and engineering analyses to demonstrate that the proposed device performs as intended and is substantially equivalent to the predicate.

Non-Clinical Tests and Analyses Done:

• Engineering analysis of Range of Motion (ROM): Per ISO 21535:2007.
• Engineering analysis of Stem Neck Fatigue Testing: Per ASTM F2068-2015 and ISO 7206-6:2013.
• Engineering analysis of Distal Stem Fatigue Testing: Per ASTM F2068-2015 and ISO 7206-4:2010.
• HA coating characterization: Per ISO 13779-2 and FDA Guidance document, "510(k) Information Needed for Hydroxyapatite Coated Orthopaedic Implants," dated February 1997.
• Bacterial endotoxins: Per USP , USP , and ANSI/AAMI ST72.

Conclusion from Testing:
The non-clinical testing and analysis found that the difference in the applied HA coating does not change the intended use, safety, or performance requirements of the proposed devices, nor does it adversely affect their safety or effectiveness. This supports the claim of substantial equivalence to the predicate device. No clinical testing was submitted.

To reiterate, the framework provided in the request is designed for evaluating AI/software-as-medical-device (SaMD) products, which is not what the Alteon® HA Femoral Stems are.

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Intended for the replacement of diseased or deficient bone in the proximal femur. It is indicated for: Limb salvage procedures where radical resection and replacement of the bone is required Painful and disabled joint resulting from avascular necrosis osteoarthritis, rheumatoid arthritis or traumatic arthritis Correction of varus, valgus or post traumatic deformity Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement Ligament deficiencies Tumor resections Treatment of non-unions, femoral neck and trochanteric fracture of the proximal femur with head involvement, unmanageable using other techniques Revision of previously failed total joint arthroplasty Trauma The METS® Modular Proximal Femur and its components are for single use only The METS® Modular Proximal Femur and its components are for cemented use only

The single use METS® Modular Proximal Femur is a standard modular system that is intended for the replacement of diseased or deficient bone in the proximal femur. The system is intended for cemented use only and comprises titanium (Ti) components including a trochanter section, shaft with or without an integral extension piece, stem and collar that is available hydroxyapatite (HA) coated or uncoated, stippled or smooth. The trochanter trunnion is made to interchange with Stanmore Implants Worldwide Limited's 28mm and 32mm Ø Cobalt Chrome femoral heads. The METS® Modular Proximal Femur is offered with an optional set of trochanters which are only to be used forhard tissue attachment using a plate and two screws, or Ti or cobalt chromium (CoCr) wire. The materials used in the manufacture of the systems include titanium (Ti), cobalt-chromium-molybdenum (CoCrMo)

I am sorry, but the provided text describes a medical device, the METS® MODULAR PROXIMAL FEMUR, which is a hip joint metal/polymer semi-constrained cemented prosthesis. The information focuses on its classification, intended use, indications for use, and a declaration of substantial equivalence to predicate devices based on non-clinical performance testing and clinical evaluation through published papers and post-market surveillance.

This document does not contain information about:

1. Acceptance criteria and reported device performance in a table format for AI/algorithm-based performance. The document refers to "non-clinical performance testing" for the device's physical attributes (disassembly force testing) and "clinical evaluation... based upon published papers and post market surveillance" to support its substantial equivalence. These are not performance metrics for an AI system.
2. Sample size used for the test set or data provenance related to AI validation.
3. Number or qualifications of experts used to establish ground truth for a test set.
4. Adjudication method for a test set.
5. Multi-reader multi-case (MRMC) comparative effectiveness study with human readers and AI assistance.
6. Standalone (algorithm-only) performance.
7. Type of ground truth used (expert consensus, pathology, outcome data, etc.) for AI models.
8. Sample size for the training set (for an AI model).
9. How the ground truth for the training set was established.

Therefore, I cannot fulfill your request to describe the acceptance criteria and study proving an AI device's performance, as the provided text pertains to a traditional medical implant and its regulatory submission, not an AI or algorithm-based device.

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The METS® Modular Total Femur is intended for the replacement of the total femoral bone.
Limb salvage procedures where radical resection and replacement of the bone is required
Painful and disabled joint resulting from avascular necrosis osteoarthritis, rheumatoid arthritis or traumatic arthritis
Correction of varus, valgus or post traumatic deformity
Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement
Ligament deficiencies
Tumor resections
Revision of previously failed total joint arthroplasty
Trauma
Treatment of non-unions, femoral neck and trochanteric fracture of the proximal femur with head involvement, unmanageable using other techniques
All of the METS® Modular Total Femur tibial and acetabular components are for cemented use only
All of the METS® Modular Total Femur and their components are for single use only

The single use METS® Modular Total Femur is a standard modular system that is intended for the replacement of diseased or deficient bone in the femur. The system is intended for cemented use only and comprises titanium (Ti) components including a trochanter section, shaft. The trochanter trunnion is made to interchange with Stanmore Implants Worldwide Limited's, 28mm and 32mm Ø Cobalt Chrome femoral heads. The METS® Modular Total Femur is offered with an optional set of trochanters which are only to be used for hard tissue attachment using a plate and two screws, or Ti or cobalt chromium (CoCr) wire. A range of shafts, femoral component (including axle, bushes and circlip), bumper and the SMILES knee (available in 3 types of arrangements and in a rotating or fixed configuration). The materials used in the manufacture of the systems include titanium (Ti), cobalt-chromium-molybdenum (CoCrMo) and ultra high molecular weight polyethylene (UHMWPE).

The provided text describes a medical device, the METS® MODULAR TOTAL FEMUR, and its regulatory clearance process (510(k) summary). However, it does not contain information related to software performance, AI algorithms, or detailed acceptance criteria for a study proving such performance.

The "Performance Data" section specifically states:

• Non Clinical Testing: "The results of the non-clinical performance testing demonstrate that the device is safe and effective and substantially equivalent to the predicate devices. The Performance testing included: knee fatigue and wear test, disassembly force testing for the taper connections, ASTM F1800-07." This refers to mechanical and material performance of the physical implant, not a software or AI component.
• Clinical Performance Conclusions: "Clinical evaluation was carried out based upon published papers and post market surveillance." This indicates a review of existing literature and real-world data, not a specific clinical study with defined acceptance criteria for a device's performance that would involve expert review or ground truth establishment in the way your request describes.

Therefore, I cannot provide the requested information, such as:

1. A table of acceptance criteria and reported device performance: This document does not define numerical acceptance criteria for "device performance" in the context of an algorithm or AI.
2. Sample size used for the test set and data provenance: No such test set is described for performance evaluation in the context of an algorithm.
3. Number of experts used to establish ground truth and their qualifications: Not applicable to the type of performance data presented.
4. Adjudication method: Not applicable.
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not conducted or reported for this device's performance as described.
6. Standalone (algorithm only) performance: Not applicable as this is a physical medical implant.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable as there is no mention of a training set for an algorithm.
9. How ground truth for the training set was established: Not applicable.

The document focuses on the mechanical safety and effectiveness of a femoral implant and its substantial equivalence to previously cleared predicate devices, based on physical testing and literature review. It is not an AI/software device and thus does not include the type of performance study details you are asking for.

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