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iPulseLight IPL System (HS 300C, HS 650) are identical with regard to indications for use including recommended filters to be used with Fitzpatrick skin type. Both models are intended for medical use in the treatment of the following dermatologic conditions:

· Permanent hair reduction- long-term stable reduction in number of hairs re-growing after a treatment regimen.

· Treatment of:

• Moderate inflammatory acne vulgaris .
• Benign pigmented epidermal lesions including dyschromia, hyperpigmentation, . melasma, ephelides (freckles).
• . Cutaneous lesions including scars
• Benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, erythema of rosacea, leg veins,

spider anglomas and venous malformations.

The integrated thermal cooling is indicated for use in cooling the treatment site prior to, during, and after light treatment in general aesthetic dermatologic and plastic surgery procedures.

• Reduce pain during light treatment (via partial anesthesia from cooling) ..
• Reduce discomfort during and/or associated with light treatment .

Minimize thermal injury, including thermal necrosis, to non-target skin and skin i s tructures during and/or associated with light treatment, thus reducing possible complications such as scabbing, scarring, hyper - and/or hypo pigmentation

Allow the use of higher light or laser fluencies for light treatments (such as for hair removal and the treatment of . vascular or pigmented lesions)

Reduce potential side effects of light treatments (such as for hair removal and the treatment of vascular or pigmented i lesions)

iPulseLight IPL System is a type of intensive, broadband, coherent light source which has a wavelength spectrum of 420 nm -1200 nm. With these special properties, the IPL has a wide application in non-ablative therapies based on theory of human skin tissue's selective absorption and photothermolysis of light sources. Meanwhile, IPL treatment is more effective, with no downtime and can make the patients get recovered more quickly than conventional therapies.

This document is a 510(k) Pre-Market Notification for the iPulseLight IPL System (HS 300C, HS 650). It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the typical sense of a clinical trial for diagnostic AI.

Here's an analysis based on your request, explaining why certain sections are not applicable to this type of submission:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of "Acceptance Criteria" in this context: For a 510(k) submission, "acceptance criteria" are generally not defined as quantitative performance targets from a clinical study for a novel device. Instead, the primary "acceptance criterion" is demonstrating substantial equivalence to a previously legally marketed predicate device. This means the new device must have the same intended use, and the same technological characteristics, or if there are differences in technological characteristics, those differences must not raise new questions of safety or effectiveness and be demonstrated to be as safe and effective as the predicate. The table above reflects this comparison.

2. Sample size used for the test set and the data provenance

This document does not describe a specific study with a test set of data. The submission is a 510(k) premarket notification for substantial equivalence, which primarily relies on comparing the new device's technical specifications and intended use to a predicate device. It does not present clinical performance data from a "test set" in the way an AI/diagnostic device would. Therefore, sample size and data provenance are not applicable here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. There is no mention of a test set, ground truth, or experts establishing it in this document.

4. Adjudication method for the test set

Not applicable. There is no mention of a test set or adjudication.

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 is not an AI-assisted diagnostic device, nor does the document describe an MRMC study.

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

Not applicable. This is a medical device (IPL system), not an algorithm or AI system.

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

Not applicable. The document does not describe a study involving ground truth determination.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable. As above, this is not an AI/machine learning device.

Summary of the Study (as described in the document):

The "study" or evaluation presented in this 510(k) submission is a comparison to a predicate device (Accelawave System K082484) to claim substantial equivalence. The document doesn't detail a traditional clinical trial or performance study with acceptance criteria in the sense of quantitative metrics for a novel technology. Instead, it systematically compares the iPulseLight IPL System (HS 300C, HS 650) to the Accelawave System across various specifications, including:

• Intended Use: The intended uses are listed as identical, covering a wide range of dermatologic conditions and thermal cooling benefits.
• Technological Characteristics: Parameters like wavelength range, energy output, pulse duration, output mode, pulse width, accessories, power consumption, applicator spot size, charge time, and cooling method are compared. Most are identical or very similar. The pulse width for the iPulseLight is 2-20 ms compared to the predicate's 2-15 ms, and the spot sizes are different, but these are implied to be within acceptable variation and not to raise new safety or efficacy questions.
• Performance (implied): The document states "The device complies with the European Medical Directive Standards: 93/42/EEC concerning medical devices," indicating adherence to European safety and performance standards relevant for medical devices. However, no specific clinical performance data from a study is presented.

The conclusion is that based on this comparison, the iPulseLight IPL System is substantially equivalent to the predicate device and does not raise new questions of safety or efficacy.

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