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The AMS Coaguloop™ Resection Electrode has the same intended use as the Olympus™ Resectoscope Loop Electrode. These products are intended to be used for the resection, ablation, and fulguration of soft tissue.
The AMS Coaguloop™ Resection Flectrode is intended to be used for the resection, ablation, and fulguration in the prostate gland.

The Coaguloop™ consists of either a single or double conductor. The conductor(s) either form or are in electrical communication with a cutting loop that is designed to concentrate the current and cut and coagulate soft tissue as it is drawn along. The grooves at the tip of the electrode are designed with the intent to further enhance the current density at the tip of the grooves. This allows for cutting, and the utilization of the larger surface area on the underside of the grooves and loop, which generates the heat required for the coagulation of resected tissue.
The AMS Coaguloop™ Resection Electrode is designed for use in several resectoscope designs with general purpose monopolar electrosurgical generators. The AMS Coaguloop™ Resection Electrode is manufactured in four (4) configurations designed for use with the following manufactured resectoscopes: Storz™, Circon/ACMI™, Olympus™, and Richard Wolf™.

The provided text describes a 510(k) premarket notification for the AMS Coaguloop™ Resection Electrode, which seeks substantial equivalence to the Olympus™ Resectoscope Loop Electrode. The submission focuses on demonstrating the new device's similarity to the predicate device in terms of intended use, principle of operation, application, materials, design, and sterility.

Here's an analysis of the acceptance criteria and study information based on the provided text, formatted to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state quantitative "acceptance criteria" in the format of specific thresholds for metrics like sensitivity or specificity, as one might find in an AI/software device submission. Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to a predicate device through various bench tests and comparisons of characteristics. The "performance" is reported as meeting specifications or being comparable to the predicate.

"The results of the testing determined that the electrodes performed per specification." |
| Manufacturing Quality | "All components are manufactured using rigid conformance standards to ensure the safe and effective performance of the finished product. Frequent, detailed quality checks are carried out at each phase of the assembly process to verify that only those units meeting all parameters are released for sale." |
| Sterility | The electrode is delivered sterile and is designed for single-use only, sterilized by Gamma radiation. This is comparable to the predicate device which is "Sterile/disposable." |
| Material Composition | The AMS Coaguloop™ uses "Tungsten/Molybdenum wire insulated with non-conducting shrink wrap." The predicate uses "Tungsten wire insulated with non-conducting shrink wrap." (A slight difference in material, but not presented as a non-conformance for substantial equivalence within the context of the document.) |
| Design Characteristics | The AMS Coaguloop™ has a "Flat loop with multiple shallow grooves." The predicate has "A circular loop." (Again, a difference in design, but one that the manufacturer argues does not negate substantial equivalence, implying performance is maintained.) The grooves are intended to "further enhance the current density at the tip of the grooves" for cutting, and the larger surface area for coagulation. |

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

The document does not specify a distinct "test set" in the context of clinical trials or data for an AI/software device. The evaluations were primarily conducted through a series of bench tests and animal tests.

• Bench Tests: The document lists several bench tests (Fit, Destructive, Dielectric/Continuity, Metallurgical Analysis, Loop Area Calculations, Current Distribution, Packaging Tests I & II). The sample sizes for these tests are not provided, nor is their provenance (e.g., country of origin). These are typically laboratory studies.
• Animal Test and Histopathology: The document mentions an "Animal Test" and "Coaguloop Histopathology Analysis of Lapine and Canine Tissue Samples." This indicates that animal models (rabbits - lapine, and dogs - canine) were used for in-vivo testing to assess tissue effects. The specific number of animals or tissue samples used is not specified.

This is a premarket notification for a physical medical device (an electrosurgical electrode), not an AI/software device. Therefore, the concept of a "test set" in the context of large datasets for model evaluation is not applicable here. The "data provenance" is laboratory and animal study derived.

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

Since this is a physical medical device with bench and animal testing, the concept of "ground truth" derived from expert consensus on images or similar data is not directly applicable.

• Bench Test "Ground Truth": The "ground truth" for bench tests would be the established engineering specifications and physical properties of the materials and device. Compliance is determined against these specifications, likely by engineers and quality control personnel. No specific number or qualifications of 'experts' for this ground truth are mentioned.
• Animal Study "Ground Truth": For the "Coaguloop Histopathology Analysis," the ground truth would be established by veterinary pathologists who would examine the tissue samples for specific effects (e.g., degree of cutting, coagulation, tissue damage). The number of pathologists or their specific qualifications (e.g., years of experience) are not provided in this document.

4. Adjudication Method for the Test Set

Not applicable in the context of this 510(k) submission for a physical device. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies or expert reviews of diagnostic data, for which this submission does not provide details.

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

No, an MRMC comparative effectiveness study was not done. These studies are typically performed for diagnostic devices or AI algorithms where human readers interpret cases, and improvement with AI assistance is evaluated. This submission is for a surgical electrode.

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

Not applicable. "Standalone performance" refers to the performance of an AI algorithm without human involvement. This document describes a physical medical device.

7. The Type of Ground Truth Used

The "ground truth" for evaluating this device largely consisted of:

• Engineering Specifications and Material Properties: For bench tests (fit, destructive, dielectric, metallurgical analyses, loop area, current distribution, packaging).
• Histopathology: For animal studies, where tissue samples were analyzed to determine the effects of cutting and coagulation.
• Predicate Device Comparison: The ultimate "ground truth" for the 510(k) submission is the functional and safety profile of the legally marketed predicate device (Olympus™ Resectoscope Loop Electrode), against which the new device seeks to prove "substantial equivalence."

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device where "training sets" are used.

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

Not applicable. This is not an AI/ML device.

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