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The CooperSurgical IRC is indicated for the treatment of hemorrhoids, especially bleeding, non-prolapsed internal hemorrhoids, as a means of hemostasis in the treatment of hemorrhoids by routine excision, or to coagulate external thrombotic hemorrhoids that have been removed ("collectively referred to as hemorrhoids") through the coagulative necrosis of the mucosa proximal to the base of the hemorrhoid.

The Cooper IRC delivers short pulses of visible and infrared light through a small contact tip applicator that is applied to the tissue. This light causes thermal coagulation that results in tissue necrosis. The user sets the pulse duration control knob depending on the depth of the tissue necrosis required. The depth of coagulation is directly related to the pulse length delivered to a given area of tissue. The area(s) to be treated may be locally anesthetized at the physician's discretion.

The CooperSurgical IRC consists of the following main components: (1) a console unit; (2) a hand piece; (3) a removable light guide; and (4) a disposable contact tip.

This document is a 510(k) summary for CooperSurgical, Inc.'s Infrared Coagulator (IRC), seeking clearance for the treatment of hemorrhoids. It details the device's intended use, principles of operation, technical characteristics, and the basis for its substantial equivalence to previously cleared devices.

Here's an analysis of the provided information, specifically addressing the questions about acceptance criteria and supporting studies:

1. A table of acceptance criteria and the reported device performance

   The document does not explicitly state specific acceptance criteria in terms of numerical performance metrics (e.g., sensitivity, specificity, accuracy, or a specific success rate for treatment). Instead, the basis for clearance is substantial equivalence to predicate devices. This means the device is deemed safe and effective because it is essentially the same as a device already on the market.

   Acceptance Criteria	Reported Device Performance
   Implicit Criterion: Substantial Equivalence to Predicate Devices for the Treatment of Hemorrhoids. (This implies it must perform similarly in safety and effectiveness as the predicate devices for the same indication.)	The CooperSurgical IRC is "essentially the same device" as Redfield Corporation's Infrared Coagulator already cleared for hemorrhoid treatment. It is also "identical" (with the exception of four features which are not specified as relevant to hemorrhoid treatment or the PVC tips) to CooperSurgical's own IRC cleared for genital condylomas and general warts. The safety and effectiveness for hemorrhoid treatment are based on the FDA's prior clearance of these predicate devices and "CooperSurgical's testing of the PVC contact tips."
   Implicit Criterion: The device's technical characteristics (console unit, hand piece, removable light guide, disposable contact tip) must be comparable to the predicate devices and suitable for its intended use.	The technical characteristics are described as: "The CooperSurgical IRC consists of the following main components: (1) a console unit; (2) a hand piece; (3) a removable light guide; and (4) a disposable contact tip. The CooperSurgical IRC is essentially the same device as Redfield Corporation's Infrared Coagulator that has already been cleared by FDA for the treatment of hemorrhoids. With the exception of four features, the CooperSurgical IRC is identical to the CooperSurgical IRC that is cleared for the treatment of genital condylomas and general warts." The functioning principle (delivery of short pulses of visible and infrared light, causing thermal coagulation and tissue necrosis) is also described, aligning with known IRC technology. The user can set pulse duration based on desired depth of tissue necrosis.
   Implicit Criterion: The PVC contact tips used with the device must be safe and effective.	"CooperSurgical's testing of the PVC contact tips" was performed. (No details on the nature or results of this testing are provided in the summary.)

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   The document does not report any clinical study data from a "test set" in the traditional sense (i.e., a clinical trial comparing the device's performance against a reference standard or control group). The basis for clearance is substantial equivalence. Therefore, there is no sample size, data provenance, or information on retrospective/prospective studies mentioned that specifically tested this version of the CooperSurgical IRC for hemorrhoids. The "testing of the PVC contact tips" is mentioned, but no details regarding sample size or nature of testing are provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

   Not applicable. As noted above, there is no disclosed "test set" and thus no mention of experts establishing ground truth for performance metrics.

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

   Not applicable. No "test set" or clinical performance study for this specific device for this indication is described.

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

   Not applicable. This device is an Infrared Coagulator, a treatment device, not an AI-assisted diagnostic or interpretation device. Therefore, no MRMC study or AI assistance is relevant.

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

   Not applicable. This device is a manual medical instrument, not an algorithm.

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

   Not applicable. The clearance is based on substantial equivalence, not on a de novo clinical trial with explicit ground truth determination for performance evaluation. The "ground truth" for the predicate devices' clearance would have established their safety and effectiveness, but those details are not provided here.

8. The sample size for the training set

   Not applicable. This device is not an AI/ML-based device that requires a training set.

9. How the ground truth for the training set was established

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

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