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The NeXtra™ arthroscopic pump and shaver system is intended to provide controlled fluid distension and suction, controlled cutting, burring, shaving and abrading of bone and tissue during orthopedic procedures of the knee, shoulder, elbow, wrist, ankle, hip, small joints and temporal mandibular joint (TMJ).

The NeXtra™ arthroscopic pump and shaver system is a dual pump system that provides inflow and outflow to and from the joint cavities during arthroscopy. It combines a built in shaver that allows the removal of bone and soft tissue during orthopedic procedures. The NeXtra™ console consists of the following components: A power supply, housing, a motherboard, two peristaltic roller heads, three tube rs power supply, nousing, and a touch screen LCD. The system has a user-friendly cassette load system with an intuitive LCD touch screen. Several asor friendry casbette four pedal and a remote control are available as optional features. The NeXtra™ is to be used exclusively with specific FMS tube sets.

The provided 510(k) summary for the NeXtra™ arthroscopic pump and shaver system does not contain information regarding detailed acceptance criteria or a specific study proving the device meets said criteria in the manner typically expected for AI/ML-driven medical devices.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through similarity in intended use, design, and technological characteristics, and compliance with general electrical safety and quality manufacturing standards.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or details about study design elements like sample size, ground truth establishment, or expert qualifications, as this information is not present in the given text.

Here's an analysis based on the provided document, highlighting the absence of the requested information:

Analysis of Acceptance Criteria and Performance Studies for NeXtra™ arthroscopic pump and shaver system (K041824)

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not provided in the submitted 510(k) summary. The document does not specify quantitative or qualitative performance criteria that the NeXtra™ system was intended to meet, nor does it report specific performance outcomes from any dedicated acceptance testing in a format like a table.

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

This information is not provided. The submission does not detail any specific test set (for performance evaluation), its sample size, or the provenance of any data.

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

This information is not provided. The concept of "ground truth" and its establishment by experts is not discussed in the context of device performance testing in this document.

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

This information is not provided. As no specific test set or performance evaluation study is detailed, an adjudication method is not mentioned.

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. The NeXtra™ arthroscopic pump and shaver system is a mechanical device, not an AI/ML diagnostic or assistive tool. Therefore, a multi-reader multi-case comparative effectiveness study involving human readers and AI assistance would not be relevant to this type of device and is not mentioned.

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

This information is not applicable/provided. The NeXtra™ system is a physical medical device. The concept of an "algorithm only" performance study is not relevant to its nature and is not discussed.

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

This information is not provided. Given the nature of the device, "ground truth" in the context of an AI/ML model (e.g., for diagnostic accuracy) is not relevant to this submission. The validation for this type of device would typically involve engineering specifications, safety testing, and functional testing, rather than a diagnostic ground truth.

8. The sample size for the training set:

This information is not applicable/provided. The NeXtra™ system is not an AI/ML-based device that would require a training set in the conventional sense.

9. How the ground truth for the training set was established:
This information is not applicable/provided. As the device is not AI/ML-based, the concept of a "training set" and its associated ground truth is not relevant.

Summary of the Study Proving the Device Meets Acceptance Criteria (as per the document):

The provided 510(k) summary does not describe a specific clinical or performance study designed to prove the device meets pre-defined acceptance criteria in the way a modern AI/ML device submission would.

Instead, the "Performance Data" section (VIII) states:
"The device complies with IEC 60601-1 (electrical Safety), IEC 60601-1-2 (Electromagnetic Compatibility), CE mark in accordance with the Medical Device Directive 93/42/EEC, manufactured in an ISO 9001 Version 2000 and ISO 13485 facility."

This indicates that the "study" proving the device meets (implicitly defined) acceptance criteria primarily relied on:

• Compliance with recognized international standards: IEC 60601-1 (electrical safety), IEC 60601-1-2 (electromagnetic compatibility), and CE mark (Medical Device Directive 93/42/EEC). These standards lay out technical requirements and testing methodologies, and compliance implies meeting their respective thresholds for safety and performance characteristics.
• Quality Management System Certification: Manufacturing in an ISO 9001 and ISO 13485 certified facility demonstrates adherence to quality management principles, which include processes for design control, risk management, and product testing, rather than a single "study."

The core argument for marketing clearance is Substantial Equivalence (Section VII). The submission argues that the NeXtra™ system is substantially equivalent to existing predicate devices (K954465, K913028, K932699, K940075) because their "intended use, design and technological characteristics are similar." The minor differences are asserted not to "raise any new issues of safety and effectiveness."

Therefore, for this device, the "proof" the device meets acceptance criteria is primarily tied to:

1. Demonstrated compliance with relevant safety and manufacturing standards.
2. Argument of substantial equivalence to legally marketed predicate devices, implying that if the predicates are safe and effective, and the new device is sufficiently similar and meets modern safety standards, it is also safe and effective.

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