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Circon ACMI's USA Elite System™ VaporTrode™ Vaporization Electrodes and VaporTome Resection Electrodes are indicated for use in urology for cutting, coagulation, and vaporization of soft tissue, including prostatic and bladder tissue and the treatment of benign prostatic hyperplasia (BPH) and bladder cancer.

CIRCON ACMI's USA Elite System™ VaporTrode™ Vaporization Electrodes and VaporTome™ Resection Electrodes are electrosurgical electrodes used in CIRCON ACMI's resectoscopes utilizing a direct connection between the electrode and the active cord of the electrosurgical generator.

This document, K973820, is a 510(k) Summary for the CIRCON ACMI USA Elite System™ VaporTrode™ Vaporization Electrode and VaporTome™ Resection Electrode. It asserts substantial equivalence to predicate devices and does not present data from a study demonstrating the device meets specific acceptance criteria in the typical contemporary sense of clinical or performance metrics. Instead, "acceptance criteria" here implicitly refer to the regulatory requirements for establishing substantial equivalence.

Here's an analysis based on the provided text, addressing your points where possible:

1. Table of Acceptance Criteria and Reported Device Performance

Study Details:

This 510(k) summary is based on a claim of substantial equivalence, not a performance study in the sense of demonstrating a device meets quantifiable metrics through a clinical trial or extensive bench testing against predefined acceptance criteria (apart from regulatory compliance). The "study" here is the regulatory comparison to predicate devices.

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

No explicit "test set" or sample size is mentioned in the context of a performance study. The evaluation is a comparative review of design, intended use, and technological characteristics against predicate devices. The data provenance is implied to be from the manufacturer's internal assessment comparing their new device to their own previously marketed (preamendments) devices.

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

Not applicable. There was no specific "test set" and thus no ground truth established by experts in the context of a performance study. The ground truth for the comparison is the established regulatory status and characteristics of the predicate devices.

4. Adjudication Method for the Test Set:

Not applicable. No performance test set or adjudication method is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No, an MRMC comparative effectiveness study was not done. This document is a 510(k) summary for establishing substantial equivalence, not a clinical effectiveness study. There is no mention of human readers or AI assistance.

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

Not applicable. This device is an electrosurgical electrode, not an algorithm or AI system. Its performance is directly tied to its physical interaction with tissue and operation by a medical professional.

7. The Type of Ground Truth Used:

The "ground truth" implicitly used for this submission is the regulatory status and established safety/effectiveness profile of the predicate devices (preamendments devices: Grooved Roller Electrodes and Resectoscope Cutting Loops by American Cystoscope Makers, Inc.). The argument is that the new device is fundamentally the same and therefore equally safe and effective.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the Ground Truth for the Training Set was Established:

Not applicable.

Summary of the "Study" and "Acceptance Criteria" in this context:

The "study" presented in this 510(k) is a comparative analysis of the new device against predicate devices based on:

• Intended Use: Identical.
• Technological Characteristics: Similar design considerations and operating principles.
• Performance: Implied to be equivalent due to similar characteristics, with no new questions of safety or effectiveness.

The "acceptance criteria" are the regulatory requirements for substantial equivalence under 21 CFR §876.4300 and the general provisions of the Federal Food, Drug, and Cosmetic Act. The device "meets the acceptance criteria" by demonstrating that it is substantially equivalent to legally marketed predicate devices, thereby allowing it to proceed to market without premarket approval. The FDA's letter explicitly states, "We have reviewed your Section 510(k) notification... and we have determined the device is substantially equivalent..." This regulatory determination constitutes the fulfillment of the "acceptance criteria" for marketing.

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