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The DePuy Preservation™ Unicondylar Knee is intended to provide increased patient rnobility and reduced pain by replacing the damaged knee joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.

Caution: This knee prosthesis component is intended for cemented use only. Candidates for unicondylar knee replacement include elderly patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or a failed previous implant. In candidates for unicondylar knee arthroplasty, only one side of the joint (the medial or lateral compartmental) is affected. Unicondylar knee replacement may be considered for younger patients if, in the opinion of the surgeon, an unequivocal indication for total unicondylar knee replacement outweighs the risks associated with the age of the patient, and if limited demands regarding activity and knee joint loading can be assured. This includes severely crippled patients with multiple joint involvement for whom again in knee mobility may lead to an expectation of significant improvement in the quality of their lives.

The DePuy Preservation™ Unicondylar Tibia consists of a polycthylene insert that assembles to Co-Cr-Mo tibial tray. The insert has a posterior tab and anterior clips that connect to the peripheral rim of the tray. The undersurface of the tibia tray consists of a grooved single keel that runs anterior-posterior and is designed to provide fixation. It is available in five sizes, 1 through 5, and in three thicknesses, 9.5, 11.5, and 13.5 mm. All insert sizes are designed to articulate with all five sizes of the DePuy Preservation Unicondylar Knec femoral component.

The provided document is a 510(k) premarket notification for a medical device, specifically the DePuy Preservation™ Unicondylar Tibia. This type of submission aims to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials with acceptance criteria and statistical analysis as would be found in a PMA.

Therefore, the document does not contain the information requested regarding acceptance criteria or a study proving the device meets them in the way clinical trials typically do. The core of a 510(k) is a comparison to a predicate device.

Here's why the requested information isn't present in this document:

• Acceptance Criteria and Reported Device Performance: This document states the device has the "same intended use, indications, sterilization method, packaging, method of manufacture, and similar materials and designs" as its predicate devices. It does not present specific performance metrics or acceptance criteria for those metrics.
• Sample Size, Data Provenance, Expert Ground Truth, Adjudication, MRMC Study, Standalone Performance, Ground Truth Type, Training Set Sample Size, Training Set Ground Truth: None of these details are typically required or provided in a 510(k) submission for substantial equivalence based on prior predicate devices for a device of this type (a knee prosthesis component). The 510(k) process relies on demonstrating the new device is as safe and effective as a device already on the market, primarily through comparison of design, materials, and intended use, rather than new clinical outcome studies.

Summary of Device Comparison (from document):

The submission argues for Substantial Equivalence based on the following:

• Predicate Devices:
  • DePuy Preservation™ Unicondylar Knee System (K010810, cleared April 18, 2001)
  • PFC® Sigma Uni-Compartmental Knee System (K954481, cleared October 10, 1996)
• Basis for Equivalence: "The fundamental scientific technologies of the DePuy Preservation Unicondylar Tibia Prosthesis have not changed from the FDA cleared DePuy Preservation Unicondylar Knce System (K010810) and PFC Sigma Uni-Compartmental Knee System (K954481). They have the same intended use, indications, sterilization method, packaging, method of manufacture, and similar materials and designs."

In conclusion, this document demonstrates substantial equivalence, not proof of meeting specific acceptance criteria through a clinical study.

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