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• FOR INCISION, EXCISION, ABLATION, AND VAPORIZATION OF SOFT TISSUE FOR 1. GENERAL DERMATOLOGY.
• THE 1064 NM WAVELENGTH IS INDICATED FOR: 2. DARK INK TATTOO REMOVAL TREATMENT OF PIGMENTED LESIONS SUCH AS NEVUS OF OTA. REMOVAL OR LIGHTENING OF HAIR. TREATMENT OF COMMON NEVL
• THE 532 NM WAVELENGTH IS INDICATED FOR: 3. REMOVAL OF LIGHT INK (RED, TAN, PURPLE, AND ORANGE) TATTOOS TREATMENT OF COMMON NEVI TREATMENT OF CAFÉ AU-LAIT SPOTS. TREATMENT OF SEBORRHEIC KERATOSES TREATMENT OF VASCULAR LESIONS, INCLUDING FACIAL AND LEG VEINS, TELENGIECTASIAS, ANGIOMAS, HEMANGIOMAS, PORT-WINE STAINS, AND MOST PICMENTED LESINS SUCH AS LENTIGINES, AND EPHELIDES.
• HERMINGLASER SYSTEM FROMAAMERICAN LASERS, INC. IS A SQLD STATE . Nd YAG LASER SYSTEM THAT PROVIDES TWO WAVELENGTHS, 1064nm AND 532nm FOR THE REMOVAL OF BLACK AND BLUE TATTOOS AS WELL AS SUPERFICIAL EPIDERMAL PIGMENTED LESIONS AND SMALL VASCULAR LESIONS.
• TATTOOS REMOVAL: THE 532nm WAVELENGTH CAN BE USED TO REMOVE RED, TAN, PURPLE, AND ORANGE TATTOO INKS. THE 1064mm WAVELENGTH CAN BE USED TO REMOVE DARK (BLACK) AND BLUE COLOR INKS.
• THE 532um WAVELENCIA CAN ALSO BLE USED POR REMOVAL OF SUPERIACAL BENIGN, PIGMENTED SKIN LESIONS SUCH AS LENTIGINES AND CAFE-AU-LAIT, TREATMENT OF COMMON NEVI, AND SEBORRHEIC KERATOSES. ALSO THE 532am WAVELENGTH CAN BE USED TO REMOVE SMALL VASCULAR LESIONS SUCH AS TELAGIECTASIAS, SMALL FACIAL AND LEG VEINS, ANGIOMAS, HEMANGIOMAS, PORT-WINE STAINS, AND MOST OTHER BENIGN PIGMENTED LESIONS SUCH AS LENTIGINES AND EPHELIDES. THE 1064mm WAVFI.ENGTH CAN ALSO RE USED TO TREAT PIGMENTED LESIONS SUCH AS THE NEVUS OF OTA, REMOVAL OR LIGHTENING OF HAIR, TREATMENT OF COMMON NEVI.

THE MINI_YAG LASER IS A Nd: YAG LASER WITH EMITTED WAVELENGTH AT 1064 NANOMETERS. WITH THE FREQUENCY DOUBLER INSTALLED, A 532 NANOMETER WAVELENGTH IS EMITTED. THE 1064 NM IS IN THE NEAR-INFRARED PORTION OF THE SPECTRUM, WHILE THE 532 NM IS VISIBLE AS A GREEN LIGHT, LASER ENERGY IS DELIVERED DIRECTLY TO THE SKIN LESION VIA THE HANDPIECE, WHICH PRODUCES A CIRCULAR BEAM ON THE SKIN. THE MINI-YAG LASER IS EQUIPPED WITH SAFETY FEATURES IN CONFORMANCE WITH 21CFR PART 1040.

The provided text is a 510(k) summary for the MINI-YAG LASER. It does not present any clinical study data or acceptance criteria for device performance. Instead, it relies on demonstrating substantial equivalence to predicate devices.

Therefore, I cannot provide the requested table or details about a study proving the device meets acceptance criteria, as such information is not present in the given document.

Here's why and what information is available:

The document explicitly states:

"THE SAFETY AND EFFECTIVENESS OF THE MINI-VAG LASER DERIVES FROM A DETERMINATION OF SUBSTANTIAL EQUIVALENCE TO THE PREDICATE DEVICES LISTED BELOW." (Section 0)

"THE MINI-YAG LASER FROM AMERICAN LASERS, INC. HAS THE SAME WAVELENGTHS, THE SAME SPOT SIZE, THE SAME PRINCIPLE OF OPERATION, ESSENTIALLY THE SAME FLUENCE LEVELS, AND THE SAME INTENDED USE AS THE PREDICATE DEVICES. THE MINI-YAG LASER DOES NOT RAISE NEW QUESTIONS OF SAFETY OR EFFECTIVENESS, AND IS SUBSTANTIALLY EQUIVALENT TO THE PREDICATE DEVICES LISTED ABOVE." (Section 1)

This means the regulatory submission process for this specific device did not involve new clinical trials or the establishment of novel acceptance criteria for device performance. Instead, it argued that because it is sufficiently similar to already approved predicate devices, it is presumed to be safe and effective.

Therefore, for each of your requested points:

1. A table of acceptance criteria and the reported device performance: Not applicable. No specific performance acceptance criteria or reported performance data is provided for the MINI-YAG LASER itself in this document. The "performance" is implicitly deemed equivalent to the predicate devices.
2. Sample size used for the test set and the data provenance: Not applicable. No test set or associated data is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No test set requiring ground truth establishment is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set is described.
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 device is a laser, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is a laser, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No ground truth for new performance data is described for the MINI-YAG LASER.
8. The sample size for the training set: Not applicable. This device is a laser, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established: Not applicable. This device is a laser, not a machine learning model.

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