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The indications for use for the Generation 4® Polished Femoral Hip Prosthesis with Proximal Cement Spacer include:

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.
5. Revision of previously failed total hip arthroplasty.

The Generation 4® Polished Femoral Hip Prosthesis with Proximal Cement Spacer is intended for cemented use only and may be used in partial and total hip arthroplasties.

The Generation 4® Polished Femoral Hip Prosthesis with Proximal Cement Spacer is designed to replace the patient's natural hip femoral neck and head damaged due to disease or accident. The femoral hip prosthesis is made from forged Co-Cr-Mo per ASTM F799, and the proximal cement spacers are made from polymethylmethacrylate (PMMA). The implants are designed for use with bone cement. General implant surfaces are highly polished. In addition to the proximal cement spacer, an optional distal cement centralizer (cleared in K942479) is available for optimum stem placement within the canal.

Here's an analysis of the provided 510(k) summary regarding acceptance criteria and supporting studies for the Generation 4® Polished Femoral Hip System with Proximal Cement Spacer:

This device is not an AI/ML powered device, hence information regarding "AI/ML" is not applicable/not found.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify quantitative acceptance criteria in terms of performance metrics (e.g., specific thresholds for strength, durability, or clinical outcomes). Instead, the acceptance criteria are implicitly met through the demonstration of substantial equivalence to legally marketed predicate devices.

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

• Sample Size: The document does not specify a "test set" in the context of clinical data, as no clinical testing was necessary for the determination of substantial equivalence (as stated in the "Clinical Testing" section).
• Data Provenance: The primary "data" for demonstrating substantial equivalence comes from comparisons with existing, legally marketed predicate devices, and non-clinical laboratory testing. The provenance of this non-clinical data is not detailed (e.g., country of origin, retrospective/prospective), but it would have been conducted internally or by a contracted lab.

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

• This is not applicable as no clinical test set requiring expert ground truth establishment was used for the 510(k) submission. The FDA review process itself involves expert evaluation by agency staff, but this is distinct from experts establishing ground truth for a device's specific test set.

4. Adjudication Method for the Test Set

• This is not applicable as no clinical test set requiring adjudication was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• No, an MRMC comparative effectiveness study was not done. The submission explicitly states "No clinical testing was necessary for determination of substantial equivalence."

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

• This is not applicable as the device is a physical hip prosthesis, not an algorithm or AI-powered system.

7. The Type of Ground Truth Used

• The "ground truth" for this device, in the context of a 510(k) submission, is effectively the established safety and effectiveness of the identified predicate devices, combined with the results of non-clinical laboratory testing demonstrating the device's functional performance and equivalence in materials and manufacturing.
  • Predicate Device Performance: Historical clinical performance and regulatory clearances of the predicate devices (Generation 4® Polished Femoral Hip Prosthesis, A Rx-90™ Femoral Stems, A Rx-90™ Femoral Component) serve as the primary benchmark.
  • Non-Clinical Testing: Laboratory tests (e.g., mechanical testing, materials characterization) provide the ground truth for the physical and mechanical properties of the new device itself.

8. The Sample Size for the Training Set

• This is not applicable. As a physical medical device and not an AI/ML system, it does not involve a "training set" in the computational sense. The design and manufacturing processes are informed by engineering principles, material science, and the existing knowledge base from previous device designs (predicate devices).

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

• This is not applicable for the reasons stated in point 8.

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The indications for use of the "Generation 4" Polished Femoral Hip Prosthesis include:

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.
5. Revision procedures where other treatments or devices have failed.
   The "Generation 4" Polished Femoral Hip Prosthesis is intended for total hip arthroplasty, and is intended for cemented use only.

The Generation 4 Polished Femoral Hip Prosthesis is a series of implants meant to replace the patient's natural hip femoral neck and head due to disease or accident. The material is forged Co-Cr-Mo per ASTM F 799. They are designed for use with bone cement. General implant surfaces are highly polished and proximal and distal cement centralizers are offered for optimum stem placement within the canal. Stability within the cement mantle is enhanced by both a 4 mm medial collar designed to rest upon the calcar, and the bi-planer stem geometry which creates a wedge within the canal.
Implant sizing is graduated for different patient anatomies. Stem geometry is undersized to stated stem and instrument sizing so as to include a cement mantle. A trapezoidal neck design is offered on all sizes for increased range of motion. These devices accept a modular head used with associated acetabular reconstructive shells and liners. Contraindications are similar to comparable devices designed for replacement of the patient's natural hip femoral neck due to arthritic diseases or accident.

Acceptance Criteria and Study for "Generation 4" Polished Femoral Hip Prosthesis

This submission details the "Generation 4" Polished Femoral Hip Prosthesis, a femoral component for cemented use in total hip arthroplasty. The device is claimed to be substantially equivalent to the RX-90 Cemented Hip Prosthesis - Biomet Inc. (K023085).

1. Table of Acceptance Criteria and Reported Device Performance

Note: Specific quantitative acceptance criteria (e.g., minimum fatigue cycles, maximum wear rates) are not explicitly stated in the provided text for individual device performance metrics. Rather, the acceptance criteria are based on conformance to established standards and similarity to a predicate device.

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

• Sample Size for Test Set: 10 stems were tested.
• Data Provenance: The testing was "in house," implying that the data was generated within Biomet Orthopedics, Inc. The exact country of origin is not specified, but the applicant's address is Warsaw, Indiana, USA. The testing is non-clinical, meaning it's conducted in a laboratory setting, not on human subjects. This is a form of retrospective data in that it's performed on manufactured devices.

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

This device relied on non-clinical testing against ISO/ASTM standards and internal parameters. Therefore, no human experts were used to establish ground truth for a test set in the traditional sense of clinical opinion or diagnosis. The "ground truth" for non-clinical testing is compliance with established engineering and material standards and internal specifications, which would have been determined by engineers and material scientists. The document does not specify the number or qualifications of these internal experts.

4. Adjudication Method for the Test Set

The concept of an adjudication method (like 2+1 or 3+1) is typically applied in clinical studies where expert consensus is needed to establish a "ground truth" for patient cases. Since this study involved non-clinical, laboratory testing against predetermined standards, no adjudication method was used. The results of the mechanical tests were objectively measured against the established ISO/ASTM and internal parameters.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. The submission explicitly states: "Clinical Testing: No clinical testing was necessary for determination of substantial equivalence." This type of study would involve human readers (e.g., surgeons evaluating X-rays or clinical outcomes) both with and without AI assistance, which is not relevant to this device's regulatory pathway.

6. Standalone (Algorithm Only) Performance Study

No standalone performance study of an algorithm was done. This is a medical device (hip prosthesis), not an AI algorithm. The performance evaluation was based on non-clinical, mechanical testing of the physical implant itself.

7. Type of Ground Truth Used

The ground truth used for the non-clinical testing was conformance to established ISO/ASTM standards and internal parameters for material properties and manufacturing. Specific examples mentioned are "ISO / ASTM" and "in house parameters."

8. Sample Size for the Training Set

No training set was used. This device is a physical implant, not an AI or machine learning model that requires a training set. The development of the device would have involved engineering design and testing, but not in the sense of a "training set" for an algorithm.

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

As there was no training set for an AI algorithm (as this is a physical device), this question is not applicable. The "ground truth" for the device's design and manufacturing processes would be based on established engineering principles, material science, and prior knowledge from predicate devices and industry standards.

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