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Intended Use / Indications for Use
(970nm and 445nm): Intra- and extra-oral surgery including incision, excision, hemostasis, coagulation and vaporization of soft tissue including marginal and inter dental and epithelial lining of free gingiva and is indicated for: frenectomy; frenotomy; biopsy; operculectomy; implant recovery; gingivectomy; gingivoplasty; gingival troughing; crown lengthening; hemostasis of donor site; removal of granulation tissue; laser assisted flap surgery; debridement of diseased epithelial lining; incisions and draining of abscesses; tissue retraction for impressions; papillectomy; vestibuloplasty; excision of lesions; exposure of unerupted/partially erupted teeth; removal of hyperplastic tissues; treatment of aphthous ulcers; leukoplakia; laser removal of diseased, infected, inflamed and necrosed soft tissue within the periodontal pocket; sulcular debridement(removal of diseased, infected, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth inability); pulpotomy; pulpotomy as adjunct to root canal therapy; fibroma removal; gingival incision and excision; treatment of canker sores; herpetic ulcers of the oral mucosa; laser soft tissue curettage; reduction of gingival hypertrophy.

Whitening(970nm and 445nm): For light activation for bleaching materials for teeth whitening and for laser-assisted whitening/bleaching of teeth.

Low Level Laser Therapy(660nm and 970nm): To emit energy in the red and infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, and for the temporary increase in local blood circulation and/or temporary relaxation of muscles.

The 445nm, 970nm and 660nm laser radiation of the MateLaser is generated via different laser diodes inside the control unit and guided to the treatment region via quartz fibers. The laser radiation is absorbed by the tissue and converted to heat used for cutting, coagulation, germ reduction and desensitization, muscle relief. The device primarily consists of the main unit, a fiber optic handlpiece, a Type-C cable, and a power adapter.

The device operates in two distinct emission modes: CW (Continuous Wave) mode, which provides a continuous, uninterrupted laser beam and ISP (pulse) mode, which interrupts the laser beam at regular intervals with adjustable duty cycles. The MateLaser Medical Diode Laser Systems (Model ML-DLS-30) features a home screen interface that allows operators to configure treatment parameters including wavelength selection (445nm, 660nm, or 970nm), power settings, duty cycle, frequency, and treatment time. During operation, users navigate through the home screen to set parameters, switch from standby to ready mode, and initiate and initiate laser emission while monitoring battery status, total energy output, and treatment countdown. The device specifications include optical power ranges of 0.2-3W for 445nm and 970nm wavelengths and 25-100mW for 660nm.

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810 nm and 980 nm wavelength:
MateLaser Medical Laser Therapy Systems (Model: ML HIL 30/60) emit energy in the invisible and near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and the temporary relaxation of muscle.

980 nm wavelength:
MateLaser Medical Laser Therapy Systems (Model: ML-HIL-60) are also indicated for use in surgical applications requiring hemostasis, ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including aesthetic (dermatology and plastic surgery), gastroenterology, general surgery, genitourinary surgery (urology), gynecology (GYN), neurosurgery, otolaryngology (ENT), ophthalmology, arthroscopy, podiatry, pulmonology, thoracic surgery; and Laser Assisted Lipolysis.

980 nm wavelength:
MateLaser Medical Laser Therapy Systems (Model: ML-HIL-60) are also indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and Trichophyton mentagrophytes, and/or yeasts Candida albicans, etc.)

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I'm sorry, but based on the provided FDA 510(k) clearance letter for the MateLaser Medical Laser Therapy Systems (ML-HIL-30, ML-HIL-60), there is no information provided regarding acceptance criteria or the study that proves the device meets those criteria.

The 510(k) clearance letter itself is a formal notification from the FDA stating that the device is substantially equivalent to a legally marketed predicate device. It confirms the product's classification, regulation numbers, and permissible indications for use.

Crucially, a 510(k) letter does not typically contain the detailed information about the performance studies, acceptance criteria, ground truth establishment, or expert reviews that would be submitted to the FDA as part of the 510(k) premarket notification. This detailed information is part of the manufacturer's submission package, which is reviewed by the FDA, but the clearance letter is merely the outcome of that review.

Therefore, I cannot populate the table or answer the specific questions you've posed using only the provided text. To answer your questions, one would need access to the actual 510(k) submission documentation, which is not publicly available in this format.

Here's what I can tell you based on the provided text, and why I cannot answer your specific questions:

• Device: MateLaser Medical Laser Therapy Systems (ML-HIL-30, ML-HIL-60)
• Regulation Number/Name: 21 CFR 878.4810, Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology
• Regulatory Class: Class II
• Product Codes: GEX, ILY, PDZ
• Indications for Use (810 nm and 980 nm wavelength):
  • Topical heating for temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm.
  • Temporary increase in local blood circulation.
  • Temporary relaxation of muscle.
• Indications for Use (980 nm wavelength only for ML-HIL-60):
  • Surgical applications requiring hemostasis, ablation, vaporization, excision, incision, and coagulation of soft tissue in various medical specialties.
  • Temporary increase of clear nail in patients with onychomycosis.
• Type of Use: Prescription Use

Without the actual study data and methodology from the 510(k) submission, I cannot provide any information regarding:

1. Acceptance criteria and reported performance: Not in the letter.
2. Sample size and data provenance: No study details are provided.
3. Number of experts and qualifications: Not mentioned.
4. Adjudication method: Not mentioned.
5. MRMC study details or effect size: Not mentioned, and generally not applicable for a laser therapy system unless there's a strong AI component for diagnosis/treatment planning, which isn't evident here.
6. Standalone (algorithm only) performance: Not applicable for a physical laser device in this context.
7. Type of ground truth used: Not mentioned.
8. Training set sample size: Not mentioned (as it's a physical device, "training set" in the context of an AI/ML model is not directly relevant here unless there's an embedded AI component for specific functions, which isn't described).
9. Ground truth establishment for training set: Not applicable for this type of device based solely on the provided letter.

The 510(k) clearance process primarily relies on demonstrating substantial equivalence to a predicate device, which can involve performance testing, but the details of those tests are not part of the clearance letter itself.

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