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The BEAMAX/ FORMAX Pulsed Light Device Family and optional Handpies family are intended for use in aesthetic and cosmetic applications and in selective treatments required in the medical specialties of dermatology.

The BEAMAX/ FORMAX Pulsed Light Device Family and optional Handpies family with 415 - 950 nm wavelengths (with and without contact-cooling) are indicated for:

• Hair removal in all skin types (I-VI) to the Fitzpatrick scale. Permanent Hair Reduction. - Recommended wavelengths in the range of 635-950 nm or 580-950 nm
• Treatment of Vascular Lesions in all skin types (I-VI) to the Fitzpatrick scale -Recommended wavelength in the range of 535-950 nm
• Treatment of Inflammatory Acne (acne vulgaris) in skin types (I-V) to the Fitzpatrick scale - Recommended wavelength in the range of 535-950 nm
• Treatment of Benign Pigmented Epidermal and Cutaneous Lesions including warts, scars and striae in all skin types (I-VI) to the Fitzpatrick scale - Recommended wavelength in the range of 415-950 nm

The proposed BEAMAX/ FORMAX family system is a pulsed light energy device based on a filtered, Xenon flashlamp.

The total emission spectrum of a Xenon flashlamp is from around 300 nm in the UV to 1000 nm in the near IR. The light emitted from the lamp is collected by a reflector and focused into a rectangular, waveguide. Prior to entering the waveguide, the light is transmitted through a longpass optical filter which blocks all wavelengths below the "cut-off" wavelength of the filter. Thus when a 635nm filter is used, only light of wavelengths above 635 nm is emitted. Since the lamp is surrounded by a water cooling jacket, actual wavelength emission is up to about 950 nm, due to water absorption of longer wavelengths.

The BEAMAX/FORMAX family system is equipped with four different handpieces which can be attached for different clinical applications. These handpieces differ in the optical filter applied, hence in the optical spectrum emitted, as well as in the time duration of the pulses emitted. A microprocessor based system controller is used to monitor and direct all system functions and Man Machine Interface.

The provided document is a 510(k) summary for the BEAMAX/ FORMAX Pulsed Light Device Family. This document focuses on demonstrating substantial equivalence to predicate devices rather than conducting a new clinical study to establish acceptance criteria and device performance from scratch. Therefore, many of the typical elements of a study that prove a device meets acceptance criteria are not present.

However, based on the information provided, here's an attempt to answer the request by interpreting "acceptance criteria" as the criteria for substantial equivalence, and "study" as the comparison to predicate devices:

Acceptance Criteria and Device Performance Study for BEAMAX/FORMAX Pulsed Light Device Family

Overview

The BEAMAX/FORMAX Pulsed Light Device Family sought 510(k) clearance by demonstrating substantial equivalence to legally marketed predicate devices, as opposed to conducting a de novo clinical trial with new performance acceptance criteria. The "acceptance criteria" here therefore refer to the criteria for substantial equivalence, and the "reported device performance" is framed by its similarity to the predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a substantial equivalence submission, the "acceptance criteria" are the conditions under which the device is considered substantially equivalent to already cleared devices. The "reported device performance" is essentially that it matches or is comparable to these predicate devices for the specified indications.

2. Sample Size Used for the Test Set and the Data Provenance

• Sample Size for Test Set: Not applicable in the context of a 510(k) substantial equivalence submission, as direct human clinical outcome data from a "test set" for the new device is not provided. The "test" here is the comparison against the characteristics and established safety/effectiveness of predicate devices already on the market.
• Data Provenance: The "data" for comparison comes from the regulatory filings and established performance of the identified predicate devices, which are already marketed in the US. There is no mention of country of origin for new clinical data, nor is there a distinction between retrospective or prospective data for a newly conducted study for this submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• Number of Experts: Not applicable. Ground truth, in the context of a 510(k) for substantial equivalence, is established by the FDA's prior clearance of the predicate devices based on their safety and effectiveness. No new expert consensus panel was convened for this specific submission to establish a "ground truth" for a new test set.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Since there's no new test set with human subject data requiring expert review and adjudication for this submission, no adjudication method like 2+1 or 3+1 was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• MRMC Study: No, an MRMC comparative effectiveness study was not done. The documentation focuses on technological and indications-for-use equivalence rather than human reader performance with or without AI assistance. The device is a pulsed light system, not an AI diagnostic tool that assists human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Standalone Performance: Not applicable. This device is an energy-based medical device (pulsed light system), not an algorithm or AI system. Its performance is inherent in its physical operation and energy delivery for therapeutic purposes.

7. The Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" for this 510(k) submission is the established safety and effectiveness of the legally marketed predicate devices. The new device's characteristics, intended use, and indications are compared against these established "truths" to demonstrate substantial equivalence.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This is not an AI/ML device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

• How Ground Truth for Training Set Was Established: Not applicable. As there is no training set for an AI/ML algorithm for this device, there is no ground truth established for such a set.

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The BEAMAX is intended for aesthetic and cosmetic use. The device is specifically indicated for removal of hair by using selective light energy.

The BEAMAX applies thermal energy to human skin tissue. The energy is transmitted from a flash light source. It is transmitted to the target tissue by a hand piece that is in contact with the skin (contact mode). The device is constructed from a Man Machine Interface panel, an operating console, and a treatment hand piece.

This 510(k) submission for the BEAMAX device does not contain the detailed study information required to fully answer all aspects of your request. It's a summary document focusing on substantial equivalence, not a comprehensive clinical trial report. However, I can extract the available information and highlight the missing parts.

Here’s a breakdown based on the provided text:

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

The provided 510(k) summary is very high-level and does not specify quantitative acceptance criteria or detailed device performance metrics for effectiveness. It generally states: "Bench and clinical data demonstrate that the BEMAX meets the required specifications. No adverse affects have been detected."

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

• Test Set Sample Size: Not specified in the document.
• Data Provenance: "Bench and clinical data." The document does not specify the country of origin of the data, nor whether it was retrospective or prospective. It implies prospective data collection for safety and effectiveness, but details are absent.

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 specified in the document. The type of device (pulsed light hair removal) suggests that "ground truth" for effectiveness would likely be based on objective measures of hair reduction, potentially evaluated by trained technicians or practitioners, but no details are provided.

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

Not specified in the document.

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. The BEAMAX is a pulsed light hair removal system, not an AI-assisted diagnostic device that would involve human "readers" interpreting output. Therefore, an MRMC study or AI assistance effect size is not relevant to this device.

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

Not applicable. The BEAMAX is a physical device operated by a human, not an algorithm, so "standalone (algorithm only)" performance is not a relevant concept for this product.

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

The document does not explicitly state the "type of ground truth." For a hair removal device, effectiveness is typically measured by outcomes data such as hair count reduction, hair growth delay, or patient satisfaction, often assessed by trained personnel or through photographic comparison. Safety would be assessed via adverse event reporting.

8. The sample size for the training set

Not applicable. The BEAMAX is a physical medical device, not an AI/ML algorithm that requires a "training set" in the computational sense. The term "training set" would apply to machine learning devices.

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

Not applicable. As above, the device does not use a "training set" in the context of machine learning.

Summary of what's provided for K063249:

This 510(k) summary is a regulatory filing for marketing clearance based on substantial equivalence. It provides general information about the device, its intended use, and a declaration that it meets specifications and has no adverse effects. It explicitly references "Bench and clinical data" for safety and effectiveness but does not present the detailed methodology, sample sizes, specific criteria, or results of those studies. This level of detail is typically found in the full submission, not in the publicly available summary.

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