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Partial replacement of the articulating surfaces of the knee when only one side of the joint is affected due to compartmental primary degenerative or posttraumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty.

The devices covered by this 510(k) are intended to be used with a Repicci Femoral component.

The device is a single use implant intended for implantation with bone cement.

The Repicci II Unicondylar Knee system consists of a femoral and tibial component. The femoral components have been cleared through a previous 510(k) as have thicker sizes of the all poly tibial component.

The all polvethylene tibial component is universal in geometry so separate components are not necessary for left and right knees. A waffle pattern and recessed holes on the under surface assists in fixation with bone cement. Due to the radiolucency of polyethylene, a wire is molded within the component.

The provided text is a Summary of Safety and Effectiveness for the Biomet Repicci II Unicondylar Knee All Poly Tibial Components, along with an FDA clearance letter. This type of document is a pre-market notification (510(k)) and primarily focuses on demonstrating substantial equivalence to a previously legally marketed device, rather than proving a device meets specific acceptance criteria through a standalone study with detailed performance metrics.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, MRMC studies, and standalone performance is not present in the provided text, as these are typically part of a clinical trial or performance study, which is not the primary purpose of a 510(k) submission for this type of device.

The document states that "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent...". This means the FDA found it equivalent to similar devices already on the market based on its intended use, design principles, and materials, without requiring new, independent performance data against specific acceptance criteria like you would find for a novel diagnostic AI algorithm.

However, I can extract information related to the device and its intended use, which are implicitly part of the "acceptance" for market clearance:

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

Since specific quantitative acceptance criteria and performance data from a dedicated study are not presented, I cannot create this table as requested. The "performance" demonstrated for a 510(k) is typically by demonstrating equivalence to a predicate device in terms of materials, design, and intended use, rather than achieving specific numerical performance thresholds in a clinical study for this type of implant.

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

Not applicable. The document does not describe a "test set" or a study designed to evaluate performance metrics. It's a 510(k) submission for substantial equivalence.

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. No "test set" and no related ground truth establishment by experts are described.

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

Not applicable. No "test set" or adjudication method are 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:

Not applicable. This is not an AI diagnostic device, and no MRMC comparative effectiveness study is mentioned.

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

Not applicable. This is a physical implant, not an algorithm.

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

Not applicable. No study requiring ground truth is described.

8. The sample size for the training set:

Not applicable. This is a physical implant, not a machine learning model, so there's no concept of a "training set" in the context of the provided document.

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

Not applicable. There is no training set involved.

Summary of what IS available in the document regarding "acceptance" for market clearance:

• Intended Use (Implicit Acceptance Criteria for Market Clearance): The device is intended for "Partial replacement of the articulating surfaces of the knee when only one side of the joint is affected due to compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty."
• Design and Materials (Implicit Acceptance Criteria for Market Clearance): The device is an all-polyethylene tibial component, universal in geometry, with a waffle pattern and recessed holes for cement fixation, and a molded wire for radiolucency. It is intended for use with a Repicci Femoral component.
• Safety (Implicit Acceptance Criteria for Market Clearance): The potential risks are acknowledged to be "the same as with any joint replacement device."
• Clinical Performance (Implicit Acceptance Criteria for Market Clearance): The FDA clearance is based on the device being "substantially equivalent" to predicate devices already on the market, implying that its performance is expected to be comparable and acceptable based on the history of those predicate devices. No new clinical performance study is detailed in this document.
• Specific Limitations/Conditions for Market Clearance from the FDA:
  • Thinnest tibial component is nominal 6.5mm, with a minimum polyethylene thickness of 6.5mm.
  • May not be labeled or promoted for non-cemented use.
  • All labeling must prominently state that it is for cemented use only.
  • Non-cemented fixation is considered investigational and requires IDE regulations (21 CFR, Part 812) and IRB/FDA approval.

In conclusion, the document is a 510(k) pre-market notification that demonstrates substantial equivalence, not a clinical study report with detailed performance metrics against specific acceptance criteria.

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