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The Initia Knee System is intended for use in total knee arthroplasty for the following indications:

1. Painful and disabled knee joint resulting from osteoarthritis, traumatic arthritis where one or more compartments are involved.

2. Correction of varus, valgus, or posttraumatic deformity.

3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.

This device is for cemented use only.

The Kyocera Medical Technologies, Inc. (KMTI) Initia Knee System is a patellofemorotibial polymer/ metal/polymer semi-constrained prosthesis intended to replace a knee joint. The system consists of femoral, tibial and patella components intended for use with bone cement. The Initia Knee System includes both posterior-stabilizing (PS) and cruciate-retaining (CR) designs.

This document is a 510(k) summary for the Kyocera Medical Technologies, Inc. (KMTI) Initia Knee System. It details the device, its intended use, and its substantial equivalence to a predicate device, the KMTI A200 Knee System.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with specific pass/fail values. Instead, it lists various non-clinical performance tests that were conducted and states that the results were "acceptable." The implication is that the performance of the Initia Knee System met the requirements established for these tests, likely aligned with the standards cited.

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

• Sample Size: The document does not specify the exact sample sizes used for each individual non-clinical performance test. It mentions "components" and "trials" which implies multiple units were tested per category.
• Data Provenance: The data is generated from non-clinical performance tests conducted by Kyocera Medical Technologies, Inc. ("KMTI"). The provenance is therefore internal testing by the manufacturer. The document does not specify the country of origin of the data beyond the manufacturer's location in Redlands, CA, USA. The data is prospective in the sense that these tests were conducted specifically for this 510(k) submission to demonstrate device performance.

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

This section is not applicable as the document describes non-clinical performance testing for a medical device (knee prosthesis), not an AI/software device that requires expert-established ground truth for a test set. The "ground truth" for these tests are the established engineering principles, material science properties, and consensus standards (e.g., ASTM, ISO) that define acceptable performance for orthopedic implants.

4. Adjudication Method for the Test Set

This section is not applicable for the same reasons as point 3. Performance is evaluated against objective engineering criteria and consensus standards, not through expert adjudication of subjective interpretations.

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 section is not applicable. The subject device is a physical knee prosthesis, not an AI or software-based diagnostic or assistive tool. Therefore, a MRMC study involving human readers and AI assistance would not be relevant.

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

This section is not applicable. The subject device is a physical knee prosthesis, not an algorithm or software. No standalone algorithm performance was assessed for this device.

7. The Type of Ground Truth Used

For the non-clinical performance tests, the "ground truth" is based on:

• Established engineering principles and biomechanical requirements: These tests assess the physical and mechanical properties of the device.
• Consensus standards: The document explicitly lists numerous ASTM and ISO standards (e.g., ASTM F1672-14 for patellar prosthesis, ASTM F1800-12 for tibial tray fatigue, ISO 7207-2 for articulating surfaces). These standards define test methodologies and acceptable performance metrics, which serve as the "ground truth" for assessing device safety and effectiveness.
• Comparison to predicate device: The fundamental basis of a 510(k) submission is to demonstrate "substantial equivalence" to a legally marketed predicate device. Therefore, the predicate's known safe and effective performance also acts as a reference for the "ground truth" of what is considered acceptable.

8. The Sample Size for the Training Set

This section is not applicable. The subject device is a physical knee prosthesis. There is no concept of a "training set" as there would be for an AI/machine learning model. The design and manufacturing process are informed by established engineering knowledge and previous experience with similar devices.

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

This section is not applicable for the same reasons as point 8.

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The A200 Knee System is intended for use in total knee arthroplasty for the following indications:

1. Painful and disabled knee joint resulting from osteoarthritis, traumatic arthritis, traumatic arthritis where one or more compartments are involved.
2. Correction of varus, valgus, or posttraumatic deformity.
3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.
   This device is for cemented use only.

The Renovis A200 PS Knee System is a patellofemorotibial polymer/metal/polymer semiconstrained prosthesis intended to be implanted to replace a knee joint. The system consists of femoral, tibial and patella components intended for use with bone cement.

The subject of this 510k Premarket Notification are additional offerings to the Renovis A200 Knee System (K120038) resulting from customer requests to better meet patient need (anatomy and surgical technique). The additional offerings are part of the FDA cleared A200 Knee System and are called the A200 PS Knee System. The PS Knee System is a primary, posterior stabilized (PS), tri-compartmental knee replacement system to treat knee disorders resulting from degenerative diseases where the posterior cruciate ligament is absent.

The new A200 PS Knee System includes:

• Femoral components in nine (9) sizes (1, 2, 3, 3N, 4, 4N, 5, 6, and 7) in a posterior stabilized (PS) design, each for left and right sides, manufactured from CoCrMo in compliance with ASTM F75-18 Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants
• Tibial insert components in three (3) footprint sizes; each for the left and right sides; with articulating thicknesses ranging from 10 mm to 23 mm; in two levels of constraint - PS and PS Plus. The tibial inserts have a mechanical lock to the tray (snap mechanism). Tibial inserts are manufactured from highly cross-linked UHMWPE (with and without 0.1% by wt Vit E), and 1020 UHMWPE in compliance with ASTM F648-14 Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants and ASTM F2695 -12 Standard Specification for Ultra-High Molecular Weight Polyethylene Powder Blended With Alpha-Tocopherol (Vitamin E) and Fabricated Forms for Surgical Implant Applications
• Patellar components in five (5) sizes in sombrero and five (5) sizes in domed design. Patellar components are manufactured from highly cross-linked UHMWPE (with and without 0.1% by wt Vit E), and 1020 UHMWPE in compliance with ASTM F648-14 Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants and ASTM F2695 -12 Standard Specification for Ultra-High Molecular Weight Polyethylene Powder Blended With Alpha-Tocopherol (Vitamin E) and Fabricated Forms for Surgical Implant Applications
• FDA cleared (K120038) Tibial tray (baseplate) components in (9) sizes, each for the left and right sides, and in each in two designs, a conical design (CoCrMo) and a keeled design (Ti6A14V)

The system also includes reusable instrumentation.

The provided text is a 510(k) Premarket Notification for the Renovis A200 PS Knee System. This document focuses on demonstrating substantial equivalence to a predicate device and provides details on the device description, indications for use, and performance testing. However, it does not include information about user studies or clinical trials with human participants, which would be necessary to derive acceptance criteria and performance data for AI-assisted human reading or standalone AI performance.

Therefore, I cannot fulfill the request as the information regarding acceptance criteria, reported device performance (in the context of AI), sample sizes for test/training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for an AI device is not present in the provided document.

The document discusses bench testing of the physical knee implant components, such as fatigue strength and locking mechanisms, to ensure the device performs as expected. This type of testing is relevant to the mechanical integrity and functionality of the surgical implant itself, not to the performance of an AI diagnostic/assistive tool.

In summary, the provided content is for a knee implant device and does not contain the information requested about the acceptance criteria and study proving an AI device's performance.

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