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The Tricera™ Arthroscopic System is indicated for use in orthopedic and arthroscopic procedures. The Fluid Management System of the Tricera™ Arthroscopic System provides fluid distension and irrigation of the knee, shoulder, ankle, elbow, wrist and hip, and fluid suction during diagnostic and operative arthroscopic procedures. The Shaver Blade/RF Probe of the Tricera™ Arthroscopic System provides abrasion, resection, debridement, and removal of bone through its shaver blade; removal, ablation, and coagulation of soft tissue; as well as hemostasis of blood vessels through its shaver blade and probe. Examples of uses of the product include resection of torn knee cartilage, subacromial decompression, and resection of synovial tissue in other joints.

The device description and principles of operation for the modified devices are equivalent to the device description of the predicate devices cleared per Primary Predicate-K233493 and additional predicate-K162770. A brief device description of the subject devices is provided in the table below.

The provided document is a 510(k) premarket notification letter from the FDA regarding the Tricera™ Arthroscopic System. It states that the device has been determined to be substantially equivalent to previously marketed predicate devices.

Crucially, this document is an administrative letter of substantial equivalence for a medical device (an arthroscopic system) and not an AI/ML-enabled medical device.

Therefore, the requested information regarding acceptance criteria and studies proving the device meets AI/ML-specific acceptance criteria (such as performance metrics for an algorithm, ground truth establishment, training/test set details, MRMC studies, etc.) is not applicable to this document's content.

The document describes a physical medical device (an arthroscopic system) and its accessories, including fluid management, shaver blades, and RF probes, used for orthopedic and arthroscopic procedures. The "performance data" mentioned (Section 8) refers to testing related to packaging, verification and validation, shelf life, and electromagnetic compatibility (EMC), which are standard for physical medical devices and do not involve AI/ML performance metrics.

In summary, because this is not an AI/ML device, I cannot provide the requested information related to AI/ML acceptance criteria and studies.

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The Relign Tricera Arthroscopic System is indicated for use in orthopedic and arthroscopic procedures. The Fluid Management System of the Relign Tricera Arthroscopic System provides fluid distension and irrigation of the knee, shoulder, ankle, elbow, wrist and hip, and fluid suction during diagnostic and operative arthroscopic procedures. The Shaver Blade/RF Probe of the Relign Tricera Arthroscopic System provides abrasion, resection, debridement, and removal of bone through its shaver blade; removal, ablation, and coagulation of soft tissue; as well as hemostasis of blood vessels through its shaver blade and probe. Examples of uses of the product include resection of torn knee cartilage, subacromial decompression, and resection of synovial tissue in other joints.

The device description for the modified device is identical to the device description of the predicate device cleared per K162770 with the exception of the sterilization methods for Relign's Shaver Handpiece, a component device of the Tricera Arthroscopic System, which is being changed as follows: Current Methods: STERRAD 100S, STERRAD 100NX, STERRAD NX. Proposed Methods: Steris V-PRO Lumen, Steam Autoclave. New Available Methods: STERRAD 100S, STERRAD 100NX, STERRAD NX, Steris V-PRO Lumen, Steam Autoclave.

This document is a 510(k) premarket notification for the Relign Tricera Arthroscopic System, specifically concerning a change in sterilization methods for its Shaver Handpiece component. It is not a study proving the device meets acceptance criteria for an AI or imaging diagnostic performance.

Therefore, the requested information regarding acceptance criteria for device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone algorithm performance, and ground truth establishment cannot be found in this document.

The document details the device, its predicate, and the reason for the 510(k) submission: the addition of new sterilization methods (Steris V-PRO Lumen, Steam Autoclave) for the Shaver Handpiece. The performance data presented relates solely to the validation of these new sterilization methods and the reprocessing functionality of the device after undergoing these methods.

Here's what can be extracted from the document regarding the "acceptance criteria" and "study" it does describe:

Acceptance Criteria and Study for Sterilization and Reprocessing Functionality

The "study" described in the performance data section is a sterilization validation and reprocessing functionality test for the changed component, not a clinical performance study measuring diagnostic accuracy or similar.

1. Table of Acceptance Criteria and Reported Device Performance (relevant to sterilization/reprocessing):

2. Sample size used for the test set and data provenance:

• This document does not specify exact sample sizes (e.g., number of units tested) for the sterilization and reprocessing validation. It states "The performance testing has validated..." and "The results of the verification indicated..." implying tests were conducted, but without numerical details.
• The data provenance is not specified beyond being part of the manufacturer's (Relign Corporation, a subsidiary of Zimmer Biomet) validation efforts. It is highly likely to be internal, prospective testing.

3. Number of experts used to establish the ground truth for the test set and qualifications of those experts:

• Not applicable. This is a sterilization and functionality study, not one requiring expert human interpretation of medical images or data for ground truth. The ground truth here is successful sterilization (SAL of $10^{-6}$) and maintained device performance, which are determined by engineering and microbiological standards and testing.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not applicable. No human adjudication is mentioned or implied for this type of testing.

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:

• Not applicable. This is not an AI or imaging-based device, nor a study on human reader performance.

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

• Not applicable. This is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• The "ground truth" for this engineering/sterilization study is defined by internationally recognized standards for sterility assurance (ISO 14937:2009, AAMI TIR12:2010) and established engineering performance criteria for device functionality.

8. The sample size for the training set:

• Not applicable. Product performance validation, not machine learning model training.

9. How the ground truth for the training set was established:

• Not applicable.

In summary: The provided document is an FDA 510(k) clearance letter for an Arthroscopic System, primarily addressing a change in sterilization methods for a component. It describes engineering validation studies (sterilization and reprocessing functionality) against established performance criteria, not clinical or AI-driven diagnostic accuracy studies. Therefore, most of the detailed questions regarding AI/imaging study methodology are not relevant to the content of this document.

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