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The REVIVAL™ Modular Revision Hip Stem is indicated in revision surgery of femoral components, following failure of primary cemented prosthesis. The indications for the REVIVAL™ Modular Revision Hip Stem include:

• Non-inflammatory degenerative joint disease including primary and secondary . osteoarthritis
• Rheumatoid arthritis
• Correction of functional deformity ●
• Treatment of non-union and femoral neck fractures
• Treatment of traumatic dislocations of the hip ●
• Failures of osteotomy ●
• Treatment of arthrodesis
  The REVIVAL™ Modular Revision Hip Stem is indicated for cementless, single use only.

The REVIVAL™ Modular Revision Hip Stem is a modular stem manufactured from titanium alloy (Ti6 Al 4V ELI) with a proximal component, a distal component and a locking screw. The modular proximal component is available in four lengths (40mm, 50mm, and 70mm) and two CCD angles (125° and 135°). The distal component is conical in shape and has longitudinal fins. The distal component design has four lengths (100mm, 160mm, and 240mm) and eight diameters (14mm, 16mm, 18mm, 19mm, 20mm, 22mm, and 24mm). The proximal and distal components are assembled using a 'Morse' taper 2° 51' so that the proximal component can be dialed into position to achieve the anteversion required. The locking screw is used to assemble and hold the 'Morse' taper cone in place. The REVIVAL™ Modular Revision Hip Stem has a surface finish obtained by abrasion with corundum to increase the contact surface for cementless fixation. The device is intended to be used with Corin (12/14 taper) modular heads.

Medical device documentation, such as the provided FDA 510(k) submission, typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific acceptance criteria and performance data in the same way one might for an AI/ML software device or a diagnostic test.

In this context, the "acceptance criteria" for a medical device like the REVIVAL™ Modular Revision Hip Stem are met by demonstrating that it is as safe and effective as a legally marketed predicate device. The "study that proves the device meets the acceptance criteria" refers to the non-clinical testing and engineering rationales provided to support this substantial equivalence.

Based on the provided text, here's a breakdown of the requested information, adapted to fit the context of a medical implant 510(k) submission:

Acceptance Criteria and Device Performance (Adapted for a 510(k) Submission)

Since this is a 510(k) for a hip stem, the "acceptance criteria" are implied by demonstrating substantial equivalence to predicate devices regarding safety, effectiveness, and performance. The "reported device performance" is primarily based on non-clinical testing showing mechanical integrity and design similarities.

• Finite Element Analysis (FEA)
• Mechanical Fatigue Testing
• Range of Motion Testing
• Engineering rationales demonstrated the subject device was not a new worst-case for axial disassembly testing, rotational disassembly testing, and ceramic head burst strength testing. |
  | Fixation Mechanism: Demonstrate effective fixation. | Surface finish obtained by abrasion with corundum to increase the contact surface for cementless fixation. |

Detailed Study Information (Adapted for a 510(k) Submission)

Given that this is a 510(k) for a medical implant and not a software/diagnostic device, many of the requested fields (e.g., sample size for test set, experts for ground truth, adjudication methods, MRMC studies, standalone performance) are not applicable in their original sense. The evaluation relies on non-clinical testing and comparison to predicate devices, not clinical studies or AI algorithm performance.

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

   • Test Set Sample Size: Not applicable in the context of clinical data for this 510(k). The "test set" here refers to physical prototypes of the device used for non-clinical mechanical testing. The exact number of prototypes/samples used for each non-clinical test (FEA, mechanical fatigue, range of motion, disassembly, burst strength) is not specified in this document. These would be standard engineering test samples.
   • Data Provenance: The non-clinical testing was conducted either internally by the manufacturer (Gruppo Bioimpianti, Italy) or by a qualified third-party testing facility. The document doesn't specify the exact location of the testing, but the manufacturer is based in Italy. The data is prospective, generated specifically for this submission.

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

   • Not applicable. "Ground truth" in this context typically refers to clinical diagnosis or pathology for a diagnostic device. For a hip stem, the "truth" is established through engineering and biomechanical principles verified by testing, and by comparison to the known performance of predicate devices. The "experts" involved are likely biomechanical engineers and regulatory specialists.

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

   • Not applicable. Adjudication methods are usually for human interpretation of clinical data. For non-clinical testing, results are typically evaluated against pre-defined engineering standards or comparative data from predicate devices.

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:

   • Not applicable. This is a physical medical device (hip stem), not an AI/ML software or diagnostic imaging device that involves human readers.

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

   • Not applicable. As above, this is not an AI/ML algorithm.

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

   • The "ground truth" for this device's safety and effectiveness is established through a combination of:
     • Engineering Principles and Standards: Compliance with industry-recognized standards for materials, design, and mechanical performance.
     • Predicate Device Performance: The known long-term clinical performance and safety profile of the legally marketed predicate devices (Biomet Arcos® Modular Femoral Revision System and Lima MODULUS stem).
     • Physical Testing Results: Data from non-clinical tests (FEA, fatigue, range of motion, disassembly, burst strength) demonstrating that the new device performs acceptably and is comparable to or better than the predicate devices in critical mechanical aspects.

7. The sample size for the training set:

   • Not applicable. There is no "training set" in the context of this traditional 510(k) for a hip stem. Design and engineering are based on established biomechanical principles and predicate device designs, not machine learning training.

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

   • Not applicable, as there is no training set. The "ground truth" for the overall device development and validation is derived from engineering standards, biomechanical science, and the clinical history of predicate devices.

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