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The REPIPHYSIS Limb Salvage Proximal Femur and REPIPHYSIS Limb Salvage Total Femur are indicated for cemented procedures where radical resection and replacement of the proximal or total femur is required in skeletally immature patients (weighing up to 67 lbs) with osteosarcoma.

REPIPHYSIS Limb Salvage Proximal and Total Femur devices are intended for cemented use only.

The REPIPHYSIS® Limb Salvage Proximal Femur is designed to replace the proximal femur with an expansion mechanism that has the identical internal components as the expansion mechanism in the previously cleared REPIPHYSIS® Limb Salvage System. The REPIPHYSIS® Limb Salvage Total Femur is designed to replace the entire femur with an expansion mechanism in the distal femoral portion that is identical to the expansion mechanism in the previously cleared REPIPHYSIS® Limb Salvage System.

REPIPHYSIS® Limb Salvage Proximal Femur

The REPIPHYSIS® Limb Salvage Proximal consists of a femoral stem, a femoral housing with expansion mechanism, and a femoral neck designed to be used with all previously cleared WMT 12/14 taper femoral heads. The components of the REPIPHYSIS® Proximal Femur are substantially equivalent to the components of the GUARDIAN™ Limb Salvage System for proximal femur replacement. The REPIPHYSIS® Limb Salvage Proximal Femur is custom assembled for each patient.

REPIPHYSIS® Limb Salvage Total Femur

The REPIPHYSIS® Limb Salvage Total Femur consists of a tibial base, axial bushing, axial pin, distal hinge femur housing with expansion mechanism, and a proximal femoral component. The components of the REPIPHYSIS® Total Femur are substantially equivalent to the components of the GUARDIAN™ Limb Salvage System for total femur replacement. The tibial base, axial bushing, axial pin, and distal hinge femur housing with expansion mechanism are identical to the components of the REPIPHYSIS® Limb Salvage System. The REPIPHY SIS® Limb Salvage Total Femur is custom assembled for each patient.

The provided text is a 510(k) summary for the REPIPHYSIS® Limb Salvage Proximal Femur and Total Femur. This document details the device's intended use, description, and claims of substantial equivalence to previously cleared devices.

Crucially, this document does not describe a study with acceptance criteria and reported device performance in the way a clinical trial or AI/software validation study would. Instead, it focuses on demonstrating substantial equivalence to predicate devices, which is a regulatory pathway for medical device approval.

Therefore, I cannot extract the information required for items 1-9 in your request, as the provided text does not contain a study with acceptance criteria, test sets, ground truth establishment, or performance metrics in that context.

Here's what I can provide based on the given document, addressing the spirit of your request where possible by noting what information is not present:

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

   • N/A. The document does not describe a study with specific acceptance criteria and reported numerical performance data. The regulatory pathway here is based on substantial equivalence.

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

   • N/A. This document does not describe a "test set" in the context of a performance study on humans or a software algorithm. The "test" here is a regulatory review based on comparing the new device to predicate devices.

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)

   • N/A. There is no "ground truth" establishment in the context of a performance study on a test set mentioned in this document.

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

   • N/A. No test set or adjudication method is described.

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

   • N/A. This device is a physical implant (limb salvage system), not an AI or imaging diagnostic tool. Therefore, an MRMC study is not relevant and was not performed.

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

   • N/A. This is a physical medical device, not an algorithm, so this concept does not apply.

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

   • N/A. No ground truth in the context of a performance study is described. The "truth" in this regulatory submission relies on the established safety and effectiveness of the legally marketed predicate devices.

8. The sample size for the training set

   • N/A. No training set is mentioned as this is not a machine learning or AI device.

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

   • N/A. No training set or ground truth for it is mentioned.

Summary of the Acceptance Criteria and Study as Implied by the 510(k) Process (Not a Clinical Performance Study):

The acceptance criteria for this device are inherently tied to demonstrating substantial equivalence to predicate devices. The "study" proving this is the 510(k) submission itself, which presents information to the FDA for review.

Acceptance Criteria (Implied by 510(k) Substantial Equivalence):

The "Study" Proving Compliance:

The "study" in this context is the premarket notification (510(k) submission) itself. The manufacturer, Wright Medical Technology, Inc., submitted detailed information (including device descriptions, comparison to predicate devices, materials information, and analysis data) to the FDA. The FDA's review of this submission against their regulatory standards for substantial equivalence constitutes the "proof" that the device meets the acceptance criteria for market clearance. The final determination of "Substantial Equivalence" by the FDA (as indicated by the letter from Mark N. Melkerson, Director, Division of General, Restorative and Neurological Devices) is the ultimate demonstration that these criteria have been met.

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