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The AMS Coaguloop™ Resection Electrode is intended to be used for resection, ablation, and fulguration in the prostate gland and the bladder.

The AMS Coaguloop™ Resection Electrode is an electrosurgical device designed for use with commercially available resectoscopes and general purpose monopolar electrosurgical generators. The Coaguloop™ Resection Electrode is designed to remove and coagulate soft tissue by means of radio frequency electrical current.

This specific 510(k) summary for the AMS Coaguloop™ Resection Electrode does not contain information about acceptance criteria or a study proving the device meets them in the context of device performance testing.

The document primarily focuses on establishing substantial equivalence to predicate devices (AMS Coaguloop™ Resection Electrode K971512 and Circon/ACMI Vaportome™ Resection Loop Electrode K973820) rather than presenting a performance study with specific acceptance criteria. This is common for 510(k) submissions, where the principal method of demonstration is often comparison to an already cleared device.

Therefore, the requested information (points 1-9) cannot be extracted from the provided text for device performance.

However, I can provide information on other aspects as presented in the document:

Regarding "Acceptance Criteria" in the context of regulatory compliance (not performance):

The document implies that the "acceptance criteria" for the device, from a regulatory standpoint, were demonstrating substantial equivalence to predicate devices based on:

• Similar Indications for Use: The Coaguloop™ Resection Electrode is intended for "resection, ablation, and fulguration in the prostate gland and the bladder," which aligns with the predicate devices.
• Similar Design and Features: The device is described as an electrosurgical device designed for use with commercially available resectoscopes and general purpose monopolar electrosurgical generators, consistent with predicate devices.
• Sterilization Methodology: The sterilization method (gamma radiation to achieve a minimum SAL of 10^-6) and its adherence to ANSI/AAMI and ISO 11137 guidelines serve as "acceptance criteria" for sterility.
• Biocompatibility: Following the recommendations of FDA Blue Book Memorandum #G95-1 and ISO-10993 serves as "acceptance criteria" for biocompatibility.

Absence of Performance Study Details for the AMS Coaguloop™ Resection Electrode in this document:

The provided 510(k) summary does not include a study demonstrating specific performance metrics (e.g., cutting efficiency, coagulation depth, tissue damage profiles) with associated acceptance criteria. This type of detailed performance testing might have been conducted by the manufacturer but is not reported in this summary.

In summary, as per the provided text:

1. Table of acceptance criteria and reported device performance: Not available for device performance metrics. The document's closest equivalent is a statement of substantial equivalence to predicate devices based on indications, design, and features.
2. Sample size used for the test set and data provenance: No performance test set specified.
3. Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable as no performance test set is described.
4. Adjudication method for the test set: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: No such study is mentioned.
6. Standalone (i.e. algorithm only without human-in-the loop performance) study: Not applicable (this is a physical medical device, not an AI algorithm).
7. Type of ground truth used: Not applicable for performance. For regulatory acceptance, the "ground truth" was the characteristics and performance of the legally marketed predicate devices.
8. Sample size for the training set: Not applicable (no AI algorithm or typical "training set" in the machine learning sense).
9. How the ground truth for the training set was established: Not applicable.

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