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The Consensus® All Poly Tibia is indicated for use in:

• 1. Primary intervention of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, or degenerative arthritis.
• 2. Failed osteotomy or unicompartmental replacements
• 3. Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock exists.

The Consensus® Knee All Poly Tibia component is manufactured from ultra-high molecular weight polyethylene (ASTM F648). It is a symmetric cruciate-retaining tibial component and is designed to articulate with the Consensus® Knee primary femoral component. Therefore, it has articulating surface geometry similar to the Consensus® Knee congruent tibial insert component. The inferior surface of each component employs dovetail grooves for macro-cement interdigitation between the implant and the bone. Each component has two titanium X-Ray markers for postoperative evaluation: one placed vertically in the distal end of the stem, and one placed horizontally in the central anterior aspect of the component. The design is available in six sizes and each size is available in five thicknesses. The minimum thickness of polyethylene under the articulating surface is 7.5mm for all sizes. The Consensus® All Poly Tibia will be provided sterile.

This document describes a medical device submission (510(k)) for a knee replacement component, specifically a Consensus® Knee All Poly Tibia. It is a traditional premarket notification seeking to demonstrate substantial equivalence to previously cleared devices, rather than a de novo submission that would require extensive clinical studies to establish safety and effectiveness from scratch.

Therefore, the information you're asking for, which is common for AI/ML-driven device submissions or those requiring novel performance data, is largely not applicable in this context. This submission relies on a comparison to predicate devices, not on specific performance criteria met through a dedicated study of the device itself.

Here's why and what information can be gleaned:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: For this type of submission, the "acceptance criteria" are not reported as specific performance metrics (like sensitivity, specificity, accuracy) but rather as the demonstration of substantial equivalence to predicate devices under 21 CFR 888.3560. This involves showing that the new device has the same intended use, similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness.
• Reported Device Performance: The primary reported performance is that "The device performs with substantial equivalence to predicate devices." No specific quantitative performance metrics are provided for the Consensus® Knee All Poly Tibia itself, as it's not a diagnostic or AI-driven tool.

2. Sample Size Used for the Test Set and Data Provenance:

• Not applicable. This submission doesn't involve a "test set" in the sense of a dataset used to evaluate an algorithm or a diagnostic device. The evaluation is based on a comparison of device characteristics to legally marketed predicate devices.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not applicable. This isn't a study involving human interpretation or "ground truth" establishment for diagnostic purposes. The ground truth for device equivalence is established by regulatory standards and comparison to established predicate devices.

4. Adjudication Method for the Test Set:

• Not applicable. No test set or adjudication process of this type was performed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No. This is a hardware device (a knee implant), not a diagnostic tool or algorithm where MRMC studies would be relevant.

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:

• For this type of submission, the 'ground truth' is effectively the established safety and effectiveness profile of the identified predicate devices. The new device is argued to be safe and effective because its characteristics are sufficiently similar to those already deemed safe and effective by the FDA.

8. The Sample Size for the Training Set:

• Not applicable. There is no "training set" for a physical medical implant in this context. Training sets are relevant for AI/ML algorithms.

9. How the Ground Truth for the Training Set was Established:

• Not applicable. As above, no training set was used.

Summary of Relevant Information from the Provided Text:

• Device Name: Consensus® Knee All Poly Tibia
• Manufacturer: US Medical Products, Inc.
• Classification: Prosthesis, knee, patello/femorotibial, semi-constrained, cemented, polymer/metal/polymer (21CFR888.3560)
• Intended Use:
  • Primary intervention of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, or degenerative arthritis.
  • Failed osteotomy or unicompartmental replacements.
  • Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock exists.
• Key Technological Characteristics: Symmetric UHMWPE cruciate-retaining tibial component, designed to articulate with Consensus® Knee primary femoral component, dovetail grooves for macro-cement interdigitation, two titanium X-Ray markers, available in six sizes/five thicknesses (minimum 7.5mm articulating surface thickness).
• "Study" (Basis for Equivalence): Comparison to predicate devices.
• Predicate Devices Identified:
  • Howmedica Duracon All Plastic Tibial component (K922048, Sep 8, 1992)
  • Intermedics Orthopedics All-Poly Tibia (K923443, Mar 31, 1993)
  • Johnson&Johnson PFC All Plastic Tibia (K910563, May 23, 1991)
• Performance Data: "The device performs with substantial equivalence to predicate devices."
• Clinical Data: "None Required"
• Non-Clinical Data: Implicitly, the comparison of technological characteristics to predicates.

In essence, this 510(k) submission doesn't involve a "study" to meet acceptance criteria in the way you might envision for a diagnostic or AI device. Instead, it argues that the device's design and materials are similar enough to already approved devices that it poses no new or different safety concerns and is equally effective.

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