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The LPS - Continuum® TM Hybrid Tibia is intended for use where severe degeneration, trauma, or other pathology of the knee joint indicates cemented total knee arthroplasty. In addition, the LPS -Continuum® TM Hybrid Tibia is indicated for use in the presence of knee instability caused by a compromised or non-functional posterior cruciate ligament.

The LPS - Continuum TM Hybrid Tibia is manufactured from Trabecular Metal (Hedrocel Porous Tantalum) with direct compression molded ultra-high molecular weight polyethylene (UHMWPE).

This document (K012095) is a 510(k) summary for a medical device called "The LPS - Continuum TM Hybrid Tibia," a component for total knee arthroplasty. It is a submission to the FDA for market clearance, stating that the device is substantially equivalent to legally marketed predicate devices.

The document does not contain the specific information requested about acceptance criteria for device performance and a study proving it meets those criteria. The provided text is a regulatory submission for market clearance based on substantial equivalence, not a detailed technical report on performance testing.

Therefore, most of the requested information cannot be extracted from this document.

Here's what can be inferred or explicitly stated from the provided text:

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

   • Not available in the provided document. The document is a 510(k) summary, which focuses on substantial equivalence to predicate devices, not specific performance criteria and test results.

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

   • Not applicable/Not available. A "test set" in the context of performance criteria is not described in this regulatory submission. Animal or human clinical trial data with specific sample sizes for performance evaluation are not mentioned as part of this 510(k) summary focusing on substantial equivalence.

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

   • Not applicable/Not available. "Ground truth" is typically established in studies evaluating diagnostic or predictive devices. This document describes an orthopedic implant, not a diagnostic tool requiring such ground truth.

4. Adjudication method for the test set:

   • Not applicable/Not available. As above, this is for diagnostic/predictive device evaluation, not an orthopedic implant's 510(k) summary.

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/Not available. This is an orthopedic implant, not an AI-powered diagnostic or assistive tool.

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

   • Not applicable/Not available. This is an orthopedic implant.

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

   • Not applicable/Not available. "Ground truth" is not established for the purpose described in this 510(k) summary. The "truth" for substantial equivalence is comparison to legally marketed predicate devices, and the document explicitly states the device is "substantially equivalent to the identified predicate devices."

8. The sample size for the training set:

   • Not applicable/Not available. There is no mention of a "training set" as this device is not a machine learning or AI algorithm.

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

   • Not applicable/Not available. As above, no training set or ground truth in that context is mentioned.

Summary of what the document does provide:

• Device Name: The LPS - Continuum TM Hybrid Tibia
• Manufacturer: Implex Corp.
• Intended Use/Indications: For cemented total knee arthroplasty in cases of severe degeneration, trauma, or other pathology of the knee joint, and specifically for knee instability caused by a compromised or non-functional posterior cruciate ligament.
• Device Description: Manufactured from Trabecular Metal (Hedrocel Porous Tantalum) with direct compression molded ultra-high molecular weight polyethylene (UHMWPE), intended for use with Zimmer NexGen LPS Femoral components.
• Regulatory Clearance: K012095, cleared by FDA on July 26, 2001, based on substantial equivalence to predicate devices.

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