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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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The Wolf 445nm is intended for incision, vaporization, ablation, hemostasis and coagulation of soft tissue.

The Wolf Diode Lasers are a family of products with a laser diode as the beam source. Dependent on the chosen diode the laser system can radiate one wavelength with either 445nm, 980nm or 1470nm. This submission refers to and includes only one model, the Wolf 445nm.

The Wolf 445nm is a compact diode laser with a high resolution color touchscreen for user control. The laser utilizes a green (532nm) aiming beam diode to indicate the area to be irradiated by the laser beam.

The provided document describes the FDA 510(k) summary for the "Wolf 445nm" diode laser system. This device is a laser surgical instrument, and the submission focuses on demonstrating its substantial equivalence to previously cleared predicate devices, not on proving new clinical effectiveness or diagnostic accuracy through AI performance studies.

Therefore, many of the requested details about acceptance criteria, study design, ground truth, and AI-specific metrics are not applicable to this type of regulatory submission. This document describes a medical device, but it is not an AI/ML medical device.

However, I can extract the information that is relevant to the device's performance demonstration.

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

For this type of device (a surgical laser), acceptance criteria are primarily related to safety and performance characteristics in comparison to established predicate devices. The "reported device performance" is demonstrated through non-clinical bench testing.

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

• Sample Size for Test Set: Not explicitly stated in terms of number of tissue samples or specific test parameters. The document mentions "histological samples" were evaluated but does not provide details on the quantity. This was a bench test, not a clinical study involving human patients.
• Data Provenance: The testing was "non-clinical" and involved "histological samples." No country of origin for the biological samples is provided. Given the manufacturer is German, it is likely the testing was conducted in Germany or a contracted lab. The testing is presumed prospective as part of the device development and submission process.

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)

• The document does not specify the number or qualifications of experts who evaluated the histological samples. This is common for non-clinical bench testing where expert histological analysis is implied rather than formalized as a "ground truth" establishment for a clinical accuracy claim.

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

• Not applicable/Not described. The non-clinical bench testing involved evaluating histological samples; there's no indication of a multi-reader or adjudication process as would be seen in a diagnostic imaging study.

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

• No MRMC study was done. This is a laser surgical instrument, not an AI-powered diagnostic tool. The submission is for substantial equivalence to predicates for soft tissue applications.

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

• Not applicable. This device is a physical laser system, not an algorithm.

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

• For the non-clinical tissue interaction testing, the "ground truth" was established by histological evaluation of "areas of visible alteration of depth and width of the incision as well as zones of thermal and mechanical damage." This represents a form of pathology/histology-based assessment.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device, so there is no training set for an algorithm.

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

• Not applicable. As there is no training set mentioned, this question does not apply.

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