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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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The Relign Arthroscopic System is indicated for use in orthopedic and arthroscopic procedures. The Fluid Management System of the Relign Arthroscopic System provides fluid distension 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 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 Relign Arthroscopic System is a combination radiofrequency controller, shaver system, and fluid management system. The integrated system simultaneously controls a reusable shaver handpiece with disposable shaver blades and probes that include electrosurgical energy, as well as fluid management through inflow and outflow pumps that operate on the peristaltic principle. The system is comprised of five (5) major system components: The Relign Controller that includes a Footswitch, a reusable Shaver Handpiece, a disposable sterile single-use Combination Shaver Blade, a disposable sterile single-use Reciprocating RF Probe, and a disposable sterile single-use Fluid Management Accessories.

Here's an analysis of the provided text regarding the ReLIGN Arthroscopic System's acceptance criteria and studies, organized by your requested information:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of "acceptance criteria" alongside specific reported performance metrics in the way one might expect for a diagnostic AI device (e.g., sensitivity, specificity, AUC). Instead, it describes performance testing conducted to ensure the device meets its design specifications and complies with various standards. The "reported device performance" is essentially that the device "satisfies design specifications and acceptance criteria" and that various tests were "found to be acceptable."

Here's a summary of the performance claims based on the text:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document provides very limited detail on specific sample sizes for most tests, particularly for the " cadaver testing" or "simulated use" that would involve a "test set" in the context of evaluation of AI/diagnostic devices.

• Human Factors/Usability Testing: "User testing" was performed, but no number of users is specified.
• Other Performance Tests (Flow rate, pressure, mechanical, durability, etc.): No specific sample sizes (e.g., number of devices, number of repetitions) are provided in this summary.
• Data Provenance: Not mentioned. It's a medical device submission, typically implying company internal testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. The ReLIGN Arthroscopic System is a surgical tool, not a diagnostic AI device that would typically involve "ground truth" established by experts in the context of a diagnostic dataset. The "cadaver testing" and "human factors testing" would involve users (surgeons, nurses, technicians) but their role would be as operators or participants, not necessarily "experts establishing ground truth" in the diagnostic sense.

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

This information is not applicable/provided. As above, the device is a surgical tool, not a diagnostic system requiring adjudication of diagnostic outcomes.

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 information is not applicable/provided. This is a surgical device, not an AI-assisted diagnostic tool for "human readers." MRMC studies are specific to diagnostic performance evaluation.

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

This information is not applicable/provided. The ReLIGN Arthroscopic System is a physical device operated by a human, not a standalone algorithm.

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

This information is not applicable/provided in the context of diagnostic "ground truth." For a surgical device, "ground truth" would relate to the successful execution of surgical tasks, device functionality (e.g., actual flow rates matching set flow rates, tissue ablation matching expectations), and safety. The document indicates that "cadaver testing" was performed, which would serve as a form of "ground truth" for surgical performance in a simulated environment, but no specifics on how success was measured or by whom are given in this summary.

8. The sample size for the training set

This information is not applicable/provided. Since the device is a physical surgical tool and not an AI/ML algorithm that requires a "training set" in the conventional sense, this concept does not apply.

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

This information is not applicable/provided as the device is not an AI/ML algorithm with a training set requiring ground truth establishment.

Summary of Device Type and Document Limitations:

It's important to note that the provided document is a 510(k) summary for a surgical device (arthroscopic system), not an AI/ML-driven diagnostic device. Therefore, many of the requested points, particularly those related to "test sets," "ground truth," "experts," "adjudication," and "MRMC studies," are not directly applicable or are described using different terminology. The evaluation of this device focuses on its functional performance, safety, sterility, biocompatibility, and substantial equivalence to legally marketed predicate devices, rather than the diagnostic accuracy or impact on human reader performance that would be pertinent for AI/ML diagnostic tools.

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