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Total knee components are indicated for:

1. Rheumatoid arthritis
2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity levels are compatible with an adequate long-term result.
3. Failed osteotomies, unicompartmental replacement, or total knee replacement.
4. The posterior-stabilized knee system is designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.

The Journey BCS STD Inserts are indicated for use without bone cement, and are single use devices.

Subject of this premarket notification is a review of changes to the High Performance Knee (previously cleared for market via premarket notification K042515) to result in the Revision Journey BCS STD Inserts. The subject devices are articular inserts manufactured from UHMWPE material. The devices will be available in left and right configurations in sizes 1-2, 3-4, 5-6, and 7-8 and thicknesses from 9-18mm.

When compared to the predicate High Performance Knee, the Revisoin Journey BCS STD Inserts have been modified as follows:

• Utilization of a modified articular insert-tibial baseplate locking mechanism
• Post Height Changes
• Increase in the blend radius at the bottom of the post

This document is a 510(k) premarket notification for a medical device called "Revision Journey BCS STD Inserts," which are components of a total knee prosthesis. It's a submission for changes to an already cleared device, the "High Performance Knee." The primary purpose of this type of submission is to demonstrate that the modified device is "substantially equivalent" to a legally marketed predicate device, meaning it is as safe and effective.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, there are no specific quantitative acceptance criteria or reported device performance metrics in the sense of accuracy, sensitivity, specificity, or similar statistical outputs found for AI/software devices. This document deals with mechanical changes to a physical implant.

Instead, the "acceptance criteria" are implied by the regulatory framework for medical devices, particularly regarding substantial equivalence (SE). The criteria revolve around demonstrating that the modified device's safety and effectiveness are not adversely affected by the changes, and that it performs comparably to its predicate.

The reported device performance is described as:

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

This document describes a submission for a physical medical device (knee implant components), not a software or AI device. Therefore, the concepts of "test set sample size" and "data provenance" (country of origin, retrospective/prospective) as they apply to AI/software performance studies do not apply here.

The "testing" mentioned refers to design verification testing on the physical components, likely involving mechanical tests, fatigue tests, wear tests, etc., in a lab setting rather than clinical trials with human subjects. The details of these specific tests (e.g., number of cycles, number of samples per test) are not provided in this summary.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This is not applicable for this type of device and submission. "Ground truth" established by experts is a concept primarily used in evaluating diagnostic accuracy for AI/software, where human expert interpretation is the gold standard. For physical device modifications, the "truth" is established through engineering and biomechanical testing standards.

4. Adjudication Method for the Test Set

This is not applicable for this type of device validation. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations in diagnostic studies, which is not relevant here.

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

This is not applicable. An MRMC study is relevant for evaluating the impact of AI on human readers' diagnostic performance. This submission is for a physical orthopedic implant component, not an AI diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not applicable. This question pertains to AI algorithm performance in isolation. This document is about a physical implant.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For this physical device, the "ground truth" (or demonstration of safety and effectiveness) is established through:

• Compliance with recognized engineering and biomechanical test standards: The document explicitly mentions "requirements outlined in FDA's Draft Guidance For the Preparation of Premarket Notifications (510(k)s) For Cemented, Semi-Constrained total Knee Prostheses dated April 1993." This guidance would specify the types of mechanical, material, and performance tests required.
• Comparison to a legally marketed predicate device: The core of a 510(k) is demonstrating "substantial equivalence," meaning that the new device performs similarly and is as safe and effective as a device already on the market. The predicate device (K042515 - High Performance Knee) serves as the benchmark.

8. The Sample Size for the Training Set

This is not applicable as this describes a physical medical device, not an AI/software device that would require a training set.

9. How the Ground Truth for the Training Set Was Established

This is not applicable for the same reasons as #8.

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