COOPERSURGICAL INFRARED COAGULATOR FOR ENT by COOPERSURGICAL, INC.

The CooperSurgical InfraRed Coagulator ("IRC") is indicated for the treatment of chronic rhinitis through the coagulative necrosis of the submucosal tissue of the inferior turbinate.

Device Description

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. Contact photocoagulation requires direct contact of the entire optical window of the disposable contact tip. The physician applies light mechanical pressure to the optical window against the tissue to be treated before depressing the activation trigger of the hand piece. To achieve coagulation, the user depresses the activation trigger. A built-in digital timer deactivates the lamp automatically according to the pulse duration setting preselected by the physician. If the desired treatment site is larger than the optical window, the physician may use overlapping exposures until the entire area is coagulated. waiting at least five seconds between exposures. 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.

AI/ML Overview

Here's an analysis of the provided text regarding the CooperSurgical InfraRed Coagulator, focusing on acceptance criteria and the supporting study information.

Executive Summary:

The provided document (a 510(k) Summary) for the CooperSurgical InfraRed Coagulator (IRC) does not describe an independent study to establish specific acceptance criteria for performance metrics or to directly prove device performance against such criteria. Instead, the basis for finding substantial equivalence – and thus, acceptance – is primarily reliance on previously cleared predicate devices and bench testing demonstrating similar performance in photocoagulation and non-stick characteristics.

Here’s a breakdown of the requested information, highlighting what is (and isn't) present in the text:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Not explicitly defined as quantitative performance metrics.	The device performs similarly to the Redfield IRC in terms of photocoagulation and non-stick characteristics.

Explanation: The document states that the CooperSurgical IRC is "essentially the same device" as the Redfield Corporation's InfraRed Coagulator and "identical" to a previously cleared CooperSurgical IRC for other indications, with minor differences. The "performance" is implicitly deemed acceptable because it is considered equivalent to devices already found safe and effective. No specific numeric thresholds for depth of coagulation, tissue necrosis, or other functional metrics are provided as acceptance criteria, nor are corresponding quantitative results from a study.

Study Details

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

Not Applicable. The document explicitly states the "safety and effectiveness of the CooperSurgical IRC for the treatment of chronic rhinitis is based on: (1) Redfield IRC's premarket clearances for the treatment of chronic rhinitis; and (2) CooperSurgical IRC's clearance for the treatment of genital condylomas and general warts." It also mentions bench testing for photocoagulation and non-stick characteristics. This means no clinical "test set" (e.g., patient data) was used in a new clinical study described in this 510(k) summary for the indication of chronic rhinitis. The data provenance would be from the predicate device clearances.

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. No new clinical study with a "test set" requiring expert ground truth establishment is described.

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

Not Applicable. As no new clinical test set was used, no adjudication method is relevant here.

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

No. This device is an infrared coagulator, not an AI or imaging device. Therefore, a MRMC study is not relevant.

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

Not Applicable. This is a physical medical device, not an algorithm.

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

Implicitly: The "ground truth" for the device's safety and effectiveness relies on the prior FDA clearances of the predicate devices. These clearances would have been based on clinical data, performance data, and potentially pathology or outcomes data from the predicate devices. For the CooperSurgical IRC itself, the bench testing provides "ground truth" on its physical performance characteristics (photocoagulation and non-stick) in comparison to the predicate.

8. The sample size for the training set

Not Applicable. No machine learning or AI model is described, thus no "training set."

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

Not Applicable. As there is no training set mentioned.

Summary

Regulation Number and Section

§ 876.4300 Endoscopic electrosurgical unit and accessories.

(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).