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When coupled with a compatible electrosurgical unit, an arthroscopic wand electrode is intended for resection, ablation and coagulation of soft tissues and for hemostasis of blood vessels during arthroscopic procedures (of the knee, shoulder, ankle, elbow, and wrist) that utilize a conductive irrigant.

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The provided text is a 510(k) clearance letter from the FDA for reprocessed arthroscopic wands. It confirms that the devices are substantially equivalent to legally marketed predicate devices. However, this document does not contain specific acceptance criteria or a detailed study proving that the device meets such criteria in terms of performance metrics.

The letter explicitly refers to "supplemental validation data as required for reprocessed single-use devices by the Medical Device User Fee and Modernization Act of 2002," and mentions that the FDA "reviewed your supplemental validation data." However, the content of that validation data, including acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, or details of any comparative effectiveness studies, is not included in this clearance letter.

Therefore, I cannot provide the requested information based solely on the provided text. The document acts as an approval notice, not the study report itself.

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When coupled with a compatible electrosurgical unit, an arthroscopic wand electrode is intended for resection, ablation and coagulation of soft tissues, and for hemostasis of blood vessels during arthroscopic procedures (of the knee, shoulder, ankle, elbow and wrist) that utilize a conductive irrigant.

The arthroscopic wand electrode is bipolar electrosurgical probe comprised of a shaft with an electrode array at its distal end and a connector at its proximal end for coupling the electrode array to a high frequency power supply. The electrode array has at least one active electrode and at least one return electrode. Return electrodes are electrically insulated from the active ones and are spaced so as not to contact the tissue being treated. The spacing also ensures that the electrical circuit is always completed by a surrounding conductive fluid, and not simply arcing between electrodes. The electrode number and configuration can vary in number and spacing, electrode material, or angle of the distal tip. In use, the probe is positioned in close proximity to a target site within an electrically conducting liquid, such as an isotonic saline. The conducting liquid provides a current path between the active electrode(s) and the return electrode(s). When radio frequency voltage is applied between the active and return electrodes, high voltage gradients in the distal boundary of the active electrode(s) is sufficiently high to break down the tissue through molecular dissociation or disintegration. The ablative process can be precisely controlled to remove a layer of tissue as thin as a few cells. Formation of an ionized layer or plasma does not occur when the electrodes are activated with a lower voltage. In this case, electrical current passes through the tissue creating a thermal zone for coagulation of blood vessels and shrinkage of some collagenous tissues of the joints during arthroscopic surgery. Vanguard receives previously used arthroscopic wands from healthcare facilities; cleans, refurbishes (replaces shaft insulation), inspects, tests, repackages and sterilizes the devices; and returns them to the healthcare facility.

The provided text is a 510(k) Summary for a reprocessed medical device, the Vanguard Reprocessed Arthroscopic Wands. For such devices, the acceptance criteria and study focus on demonstrating substantial equivalence to the original predicate devices, primarily through performance, functional, and biocompatibility testing, rather than establishing de novo clinical efficacy or diagnostic accuracy.

Here's an analysis of the acceptance criteria and supporting study based on the provided document:

Acceptance Criteria and Reported Device Performance

The core acceptance criterion for this reprocessed device is that it performs as intended and is safe and effective, essentially being "substantially equivalent" to legally marketed predicate devices. This is established by demonstrating that its technological characteristics are essentially identical and that it maintains performance after reprocessing.

Study Details

The document describes several types of tests conducted, but does not outline a clinical study with a "test set" in the traditional sense of evaluating diagnostic or treatment accuracy with patient data. Instead, the studies are engineering and laboratory tests to confirm the physical and biological integrity and function of the reprocessed devices.

1. Sample size used for the test set and the data provenance:
   The document does not specify the sample size for each type of testing (sterilization, packaging, functional/performance, biocompatibility). It doesn't refer to a "test set" from a patient population, but rather laboratory samples of the reprocessed wands.
   Data provenance is not explicitly stated in terms of country of origin, but it would be laboratory testing conducted by or for Vanguard Medical Concepts, Inc. The studies are not retrospective or prospective in the clinical trial sense, but rather pre-market engineering and pre-clinical evaluations.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   This information is not applicable as the studies are technical validations (biocompatibility, performance, sterilization) of a reprocessed device, not clinical performance studies requiring expert interpretation of patient data to establish a ground truth. The "ground truth" here is the established specification and performance of the original OEM devices and relevant standards.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   Not applicable. There is no clinical test set requiring adjudication by experts. Adjudication methods are typically used in clinical trials or diagnostic accuracy studies where there is ambiguity in individual expert assessments.

4. 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:
   No. An MRMC study is relevant for evaluating the impact of an AI algorithm on human reader performance, typically in diagnostic imaging. This device is a reprocessed surgical tool, not an AI diagnostic or assistance system.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
   Not applicable. This is a physical, electrosurgical device, not a software algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   For a reprocessed device, the "ground truth" is largely established by:

   • Predicate device specifications and performance data: The original, legally marketed OEM devices serve as the benchmark for performance.
   • Relevant industry standards: For sterilization, biocompatibility, and electrical safety.
   • Engineering and functional tests: Demonstrating the reprocessed device meets the same functional output and safety parameters as the new OEM device without degradation.

7. The sample size for the training set:
   Not applicable. This document describes the re-validation of a physical medical device, not the training of an AI algorithm.

8. How the ground truth for the training set was established:
   Not applicable. (See point 7).

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