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The LuxIR is intended for the photocoagulation of soft tissue in dermatologic applications including but not limited to the treatment of warts and tattoos.

The Palomar LuxIR Handpiece delivers infrared light with a wavelength of 850-1350 & 1700-2500 nm. The complete system consists of a power source, chiller, a footswitch, and a handpiece connected to the power unit with an umbilical. In standard use, the handpiece is held in firm contact with the skin. The handpiece tip is water-cooled to provide active skin cooling. System parameters and other system features are controlled from the user interface panel on top of the power unit.

The provided text does NOT include details about acceptance criteria or a study proving device performance in the way requested. It is a 510(k) summary for a medical device (Palomar LuxIR Handpiece) seeking clearance based on substantial equivalence to predicate devices. This type of submission typically focuses on comparing the new device's specifications and intended use to existing, legally marketed devices, rather than presenting a performance study against specific acceptance criteria.

Therefore, for aspects like:

• Table of acceptance criteria and reported device performance
• Sample sizes for test or training sets
• Data provenance
• Number and qualifications of experts
• Adjudication methods
• MRMC comparative effectiveness studies
• Standalone performance
• Type of ground truth used
• How ground truth for training was established

The document contains no information.

The document states:

• Intended Use: The Palomar LuxIR Handpiece is intended for the photocoagulation of soft tissue in dermatologic applications including but not limited to the treatment of warts and tattoos.
• Performance Data: The summary mentions "Performance Data" as a header but provides no actual data, only a conclusion.
• Conclusion: "The differences in the specifications of the Palomar LuxIR Handpiece and the predicate device do not result in different performance or raise new questions of safety or efficacy. Based on the foregoing, the Palomar LuxIR Handpiece is substantially equivalent to the legallymarketed claimed predicate device."

This indicates that the clearance was based on demonstrating equivalence, not on a new clinical performance study establishing specific acceptance criteria for efficacy or safety.

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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.

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.

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

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.

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