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The Harmony Lite is intended for use in aesthetic, cosmetic, and surgical applications requiring the ablation, vaporization, excision, incision, and photothermolysis (photocoagulation) of soft tissue in the medical specialties of dermatology, general and plastic surgery, and aesthetic applications.

Specific indications for use are listed for the following handpieces:

• 500-600 nm Dye VL Pro Module AFT Hand piece: Treatment of benign cutaneous vascular lesions and use on Fitzpatrick skin types I-V.
• 540-950 nm VP PRO AFT Hand piece: Treatment of benign pigmented epidermal lesions, cutaneous lesions, benign cutaneous vascular lesions, and use on all skin types (Fitzpatrick I-VI).
• 570-950 nm SSR Pro Module AFT Hand piece: Treatment of benign pigmented epidermal lesions, face and body vascular and pigmented lesions, cutaneous lesions, benign cutaneous vascular lesions, and use on all skin types (Fitzpatrick I-VI).
• 590 nm LED Module Handpiece: Provide topical heating to promote increased blood flow for temporary relaxation of muscle and relief of pain, and provide topical heating for the purpose of elevating and/or maintaining tissue temperature.
• 780-950 nm SHR PRO AFT Module Hand piece: Treatment of pseudofolliculitis barbae (PFB), removal of unwanted hair and to effect stable long-term or permanent hair reduction, and use on all skin types (Fitzpatrick I-VI), including tanned skin.
• NIR Large and Small Modules: Temporary relief of minor muscle pain and stiffness, temporary relief of minor joint pain associated with arthritis, temporary increase in local circulation where applied, and the relaxation of muscles; may also help muscle spasms, minor sprains and strains, and minor muscle back pain.
• Thermoelectric Cooler (TEC): Cooling the epidermis at the treatment site prior to, during and after light or laser treatment in general surgery, plastic surgery and dermatology to reduce pain, discomfort, minimize thermal injury, allow the use of higher light or laser fluences, and reduce potential side effects.

The Alma Lasers Harmony Lite Multi-Application Platform is comprised of the following main components:

• The main console unit that incorporates the touch-screen control panel, power supply modules, cooling system, switching module, service panel and isolating transformer.
• Variety of handpieces, including IPL, LED and NIR modules
• Footswitch.

The provided document is a 510(k) premarket notification from the FDA for a medical device called "Alma Harmony Lite." This type of document is for demonstrating substantial equivalence to a predicate device, not typically for reporting on a new device's acceptance criteria and related studies in the same way one would find for a novel device.

The "study" described here is primarily a comparative study against previously cleared (predicate) devices to establish substantial equivalence. It's not a study proving novel acceptance criteria for the new device itself, but rather demonstrating that the new device meets the performance and safety profiles of the predicate devices.

Therefore, the information you've requested regarding acceptance criteria and a study proving the device meets those criteria is framed within the context of establishing substantial equivalence to predicate devices, rather than an independent validation against pre-defined, standalone acceptance thresholds for a novel device.

Here's the breakdown of the information based on the provided text, interpreted in the context of a 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

In a 510(k) submission, "acceptance criteria" are implicitly derived from the technical characteristics and indications for use of the predicate devices. The "reported device performance" is the characteristics of the new device that are being demonstrated to be substantially equivalent.

Note on Acceptance Criteria: For a 510(k), the primary "acceptance criterion" is proving substantial equivalence to a predicate device in terms of indications for use, technological characteristics, and safety/effectiveness. The table above reflects this comparison, rather than an independent performance metric set for a novel device.

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

The document explicitly states:

• "Collateral animal data was presented on a pig study performed at the University of California for the Dye VL Pro handpiece."
• This study compared results from IPL experiments to acquired pulsed dye laser (PDL) data from a previous study.
• It does not specify the sample size (number of pigs or specific test cases) used for this study.
• Data Provenance: The study was performed at the University of California. The nature of the study (comparing IPL results to previous PDL data) suggests it's a prospective animal study for the IPL component, with historical (presumably retrospective) data used for comparison.

For other handpieces/modules: The submission primarily relies on comparing the technical characteristics and indications for use of the new device (Alma Harmony Lite) to those of the predicate devices (K072564 Alma Harmony XL Platform, K140009 The Modified Alma Lasers Soprano XL Family of Multi-Application and Multi-Technology Platforms). This implies that efficacy and safety for these other components are covered by the established profile of the predicate devices, rather than new human or animal test data being presented for every component.

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

The document does not mention human experts establishing ground truth for the animal study or any clinical test set. The animal study compares physiological effects (vascular shutdown) to previously acquired data. For the 510(k), equivalence is established by comparing technical specifications and intended uses, which does not typically involve human expert adjudication of a test set in the same way an AI diagnostic device would.

4. Adjudication Method for the Test Set

Not applicable, as there is no mention of a clinical or expert-adjudicated test set in the conventional sense for the Alma Harmony Lite's submission. The pig study's "ground truth" was likely derived from objective physiological measurements and comparison to historical data.

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 Alma Harmony Lite is a laser and light-based aesthetic/surgical platform, not an AI-powered diagnostic imaging device that would involve human "readers" or an "AI assistance" component in an MRMC study.

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

Not applicable. This device is not an algorithm, but a physical medical device (laser/light platform).

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the animal study on the Dye VL Pro handpiece:
"Ground truth" was established by physiological observations (persistent vascular shutdown) in pigs and comparison to previously acquired pulsed dye laser (PDL) data, which would have its own established ground truth for efficacy. The methodology ("Monte Carlo simulations to investigate the relationship between absorbed energy, wavelength, and penetration depth") indicates a biophysical basis for evaluating the treatment effect.

For the substantial equivalence of the other modules, the "ground truth" is the established safety and efficacy profile of the predicate devices (K072564 and K140009), based on their previously approved indications and technical characteristics.

8. The Sample Size for the Training Set

Not applicable. This is a hardware device (laser/light platform), not an AI algorithm that requires a "training set."

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

Not applicable, as there is no training set for an AI algorithm.

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