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The indications for use of the subject device are given below.

1. Dental soft tissue indications

Incision, excision, vaporization, ablation of oral soft tissues including marginal and inter-dental gingival and epithelial lining of free gingiva and the following specific indications:

• fibroma removal

• frenectomy

• frenotomy

• gingival troughing for crown impressions

• gingivectomy

• gingivoplasty

• hemostasis and coagulation

• implant recovery

• incision and drainage of abscess

• operculectomy

• pulpotomy

• soft tissue crown lengthening

• treatment of herpetic and aphthous ulcers of the oral mucosa.

• 2. Laser periodontal procedures

• laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket

• sulcular debridement (removal of diseased, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival bleeding index, probe depth, attachment loss and tooth mobility.)

• 3. Whitening

• light activation for bleaching materials for teeth whitening

• laser-assisted whitening/bleach of teeth

• 4. Pain Relief

• topical heating for the purpose of elevating tissue temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, minor sprains and minor muscular back pain; the temporary increase in local blood circulation; the temporary relaxation of muscle

The SOLASE dental diode laser is a surgical and therapeutic device produced by Lazon Medical Laser Co., Ltd., designed for dental soft tissue indications, laser periodontal procedures, as well as teeth whitening and pain relief. It cannot be used for oral hard tissue.

The SOLASE laser uses a laser diode as the beam source to radiate invisible infrared light, which is delivered to the operating area by optical fiber. It can generate a short laser pulse up to 10us of interval. The SOLASE laser provides two different models with two different wavelengths - 808nm and 976mm, to meet customers' various requirements.

The SOLASE laser is a Class 4 laser product which may cause injuries in improper handling. Therefore, it MUST be operated only by trained and qualified personnel.

Here's an analysis of the provided text regarding acceptance criteria and supporting studies:

The document (K180967) is a 510(k) Summary for a Dental Diode Laser System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials. As such, the information you've requested about specific acceptance criteria and detailed study designs in the context of AI/algorithm performance is largely not present in this document because it is not an AI-powered device, nor is it subject to specific performance criteria typical of diagnostic or AI-driven tools.

The "acceptance criteria" here primarily refer to meeting recognized safety and performance standards relevant to a medical laser system and demonstrating functional equivalence to a predicate device.

Here's a breakdown based on your questions, with explanations for what is and isn't available in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The term "acceptance criteria" is used more broadly in this context to refer to compliance with recognized standards and demonstration of similar technical specifications to predicate devices. There isn't a table presenting specific numerical acceptance criteria for diagnostic performance (e.g., sensitivity, specificity) and reported performance against those. Instead, the document focuses on compliance with established international standards for medical electrical equipment and laser safety.

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

• No specific "test set" in the context of an AI/algorithmic performance study is mentioned. The document is for a medical device (laser system), not an AI diagnostic tool.
• The tests conducted were non-clinical (e.g., electrical safety, EMC, laser safety, biocompatibility).
• For the biocompatibility tests (ISO 10993-5, -10), the sample size would refer to the number of biological samples or test articles used in the in vitro or in vivo (irritation/sensitization) studies, but this specific detail is not provided in the summary.
• Data provenance is not applicable in the sense of patient data in this submission.

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

• Not applicable. This information pertains to studies establishing ground truth for diagnostic AI, which is not the focus of this 510(k) submission for a laser device.

4. Adjudication Method for the Test Set

• Not applicable. This relates to human review of AI output or establishing ground truth, which is not part of this submission.

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

• No. This is a type of clinical study often done for diagnostic devices, especially those with AI components. The document explicitly states: "No clinical study is included in this submission." (Page 7)

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

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

7. The Type of Ground Truth Used

• For the non-clinical tests, the "ground truth" is defined by the standards themselves (e.g., acceptable electromagnetic emissions per IEC 60601-1-2, non-cytotoxic result per ISO 10993-5). The device is tested against the requirements of these standards.
• For the substantial equivalence claim, the "ground truth" is the technical specifications and indications for use of the predicate devices (Biolase Epic 10 Diode Laser System and Denmat Sapphire ST Portable Laser). The proposed device's characteristics are compared directly to these.

8. The Sample Size for the Training Set

• Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

• Not applicable. There is no "training set."

In summary, this 510(k) submission for the Dental Diode Laser System demonstrates substantial equivalence by:

• Compliance with recognized non-clinical performance and safety standards: AAMI/ANSI ES 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1, ISO 10993-5, and ISO 10993-10.
• Comparison of technical specifications and indications for use to two predicate devices (K121286 and K103667). The reported device performance aligns with or is comparable to the predicate devices and meets the requirements stipulated in the standards.

The document explicitly states that no clinical studies were included, which is typical for a 510(k) clearance where substantial equivalence can be demonstrated through non-clinical testing and comparison to legally marketed devices.

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