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The CooperSurgical InfraRed Coagulator ("IRC") is indicated for tattoo removal through the coagulative necrosis of tattoo pigmented tissue.

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 tattoo removal. With the exception of four minor changes, the CooperSurgical IRC is identical to the CooperSurgical IRC that is cleared for the treatment of genital condylomas and general warts.

The provided text is a 510(k) summary for the CooperSurgical InfraRed Coagulator (IRC) for tattoo removal. It does not include a study that proves the device meets specific acceptance criteria. Instead, it relies on substantial equivalence to predicate devices already cleared by the FDA. Therefore, many of the requested sections regarding acceptance criteria and performance studies cannot be extracted from this document.

Here's a breakdown of what can be extracted and what cannot:

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

• Cannot be provided. The document does not specify quantitative acceptance criteria (e.g., specific coagulation depth, treatment efficacy percentages, safety margins) or report performance metrics from a dedicated clinical study for tattoo removal. The basis for clearance is substantial equivalence to existing devices, not a study demonstrating new performance metrics against predefined criteria.

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

• Cannot be provided. No specific test set or clinical study for the CooperSurgical IRC for tattoo removal is mentioned in the document. Its clearance is based on the predicate devices.

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)

• Cannot be provided. As there is no specified test set or clinical study for the CooperSurgical IRC for tattoo removal, there's no mention of experts establishing ground truth for such a set.

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

• Cannot be provided. No test set or clinical study 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

• Cannot be provided. This device is an infrared coagulator, not an AI-assisted diagnostic tool. Therefore, an MRMC study and AI performance metrics are not applicable and not mentioned.

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

• Cannot be provided. This device is a medical instrument used directly by a physician, not an algorithm. Standalone performance is not applicable.

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

• Cannot be provided. No new clinical data or ground truth establishment is described for theCooperSurgical IRC regarding tattoo removal. The regulatory approval is based on the previously established safety and effectiveness of the predicate devices.

8. The sample size for the training set

• Cannot be provided. This is a hardware medical device, not an AI model. Therefore, the concept of a "training set" in the AI sense does not apply.

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

• Cannot be provided. Not applicable (see point 8).

Summary of what the document does provide regarding its basis for substantial equivalence:

The safety and effectiveness of the CooperSurgical IRC for tattoo removal is based on:

1. Predicate Device 1: Redfield Corporation's Infrared Coagulator, which was already cleared by FDA for tattoo removal.
2. Predicate Device 2: CooperSurgical's IRC, which had previously received clearance for the treatment of genital condylomas and general warts.
3. Additional Testing: CooperSurgical's testing of the PVC contact tips (presumably for biocompatibility and function, though details are not provided).

Essentially, the document states that the CooperSurgical IRC is "essentially the same device" as Redfield Corporation's Infrared Coagulator for tattoo removal, with "four minor changes" that are not detailed but are presumably considered insignificant enough not to require new extensive clinical trials for this specific indication.

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