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K Number
K051976
Device Name
PROVEN REVISION MODULAR TIBIAL TRAY
Manufacturer
STELKAST COMPANY
Date Cleared
2005-10-17

(88 days)

Product Code
JWH
Regulation Number
888.3560
Type
Traditional
Panel
OR
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The StelKast Proven Revision Modular Tibial Tray is intended for cemented use only in total knee replacement with the following indications:

  1. osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems;
  2. revision of failed previous reconstructions where sufficient bone stock and soft integrity are present.
Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for the "StelKast Proven Revision Modular Tibial Tray." This document concerns the regulatory approval of a medical device and does not contain any information about acceptance criteria, device performance studies, or AI/software analysis.

Therefore, I cannot fulfill your request for information regarding:

  1. A table of acceptance criteria and reported device performance.
  2. Sample size, data provenance, ground truth establishment for a test set.
  3. Number and qualifications of experts for ground truth.
  4. Adjudication method.
  5. MRMC comparative effectiveness study or human reader improvement with AI.
  6. Standalone algorithm performance.
  7. Type of ground truth used.
  8. Sample size for the training set.
  9. How training set ground truth was established.

This document is solely about the FDA's determination of substantial equivalence for a physical medical implant (a knee joint component) to a legally marketed predicate device, allowing it to be marketed. It does not involve any AI or software-based diagnostic or prognostic device, or performance studies that would typically include the details you are asking for.

§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.