(163 days)
450 nm, 635 nm and 980 nm Diode Laser:
· Intended for intra- and extra-oral surgery including incision, hemostasis, coagulation and vaporization of soft tissue including marginal and inter-dental and epithelial lining of free gingiva and are indicated for: frenectomy; frenotomy; biopsy; operculectomy; implant recovery; gingivoplasty; gingival troughing; crown lengthening; hemostasis of donor site; removal of granulation tıssue; 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, 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 inability); pulpotomy; pulpotomy as adjunct to root canal therapy; fibroma removal; gingival incision; treatment of canker sores; herpetic ulcers of the oral mucosa; laser soft tissue curettage; reduction of gingival hypertrophy.
Whitening:
• Indicated for light activation for bleaching materials for teeth whitening and for laser-assisted whitening/bleaching of teeth.
Low Level Laser Therapy:
· Intended 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.
810 nm Diode Laser in dentistry:
· Surgical applications requiring the ablation, excision, incision, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, dentistry, gastroenterology, general surgery, otolaryngology, ophthalmology, and pulmonology
· Oral/Maxillofacial Indications; Incision, excision, vaporization, ablation and/or coagulation of soft tissue
- · Gingival troughing for crown impression
- · Gingivectomy
- · Gingivoplasty
- · Gingival incision and excision
- · Hemostasis and coagulation
- · Excisional and incisional biopsies
- · Fibroma removal
- · Frenectomy and frenotomy
- · Oral papillectomies
- · Soft tissue crown lengthening
- · Treatment of aphthous ulcers
- · Treatment of herpetic lesions
- · Periodontology;
- · Laser soft tissue curettage
- · Laser soft tissue curettage
- · Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket
- · Cosmetic Dentistry;
- · Laser-assisted bleaching/whitening of the teeth
- · Light activation for bleaching materials for teeth whitening
- · Implant recovery
810 nm Diode Laser in therapy:
· Temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, minor sprains and strains, and minor muscular back pain; the temporary increase in local blood circulation; the temporary relaxation of muscle.
1064 nm Diode Laser in dentistry:
- · Excisional and incisional biopsies;
- · Excision and vaporization of herpes simplex I and II;
- · Frenectomy and frenotomy;
- · Gingivectomy;
- · Gingivoplasty;
- · Gingival incision and excision;
- · Hemostasis;
- · Implant recovery;
- · Operculectomy;
- · Pulpotomy and pulpotomy as an adjunct to root canal therapy;
- · Removal of filling material such as gutta percha or resin as adjunct treatment during root canal therapy;
· Sulcular debridement or soft tissue curettage (removal of diseased or inflamed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss, and tooth mobility):
· Treatment of aphthous ulcers and herpetic lesions
The Dawn Diode Laser System manufactured by SWOT LASERS is a surgical device at the cutting edge of technology, designed for a wide variety of soft tissue procedures. The Dawn Diode Laser System utilizes a solid state diode as laser energy source. The energy is delivered to the operating area by means of a delivery system consisting of a flexible fiber connecting the laser source and the handpiece. The device is activated by means of footswitch.
This laser instrument consists of fiber connecting diode laser system, power supply system and microcomputer control system.
The Dawn Diode Laser System employs the diodes with wavelengths of 450nm, 635nm, 810nm, 980nm and 1064nm, and the device emits laser output energy in blue (450nm), red (635nm), orange (980nm) spectra respectively.
The provided text is a 510(k) summary for the "Dawn Diode Laser System." It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a dedicated study.
Therefore, most of the requested information regarding acceptance criteria, device performance tables, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies is not available in these documents. This is typical for a 510(k) submission where the primary goal is to show that a new device is as safe and effective as a legally marketed predicate device, often by demonstrating similar technological characteristics and performance through non-clinical testing.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance:
This information is not provided in the format requested. The document focuses on comparing the proposed device's technological characteristics to predicate devices. It states that "non-clinical tests" were performed to "verify the performance requirements" and that "the testing results do support substantial equivalence." However, it does not specify what those performance requirements (acceptance criteria) were or numerically report the device's performance against them.
The tables provided (Table 1 and Table 2) are comparison tables of technological characteristics between the proposed device and predicate devices, not performance against acceptance criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable/Not provided. The document explicitly states: "No human clinical data is needed for Dawn Diode Laser System." The non-clinical tests mentioned are likely laboratory-based and do not involve human subjects or data provenance in the clinical sense.
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):
Not applicable/Not provided. As no human clinical data was used, there was no "test set" requiring expert ground truth establishment in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable/Not provided. Given the absence of a human clinical test set, no adjudication method was used.
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/Not provided. This device is a laser system, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable/Not provided. This is a hardware device; the concept of "standalone performance" for an algorithm doesn't apply directly. The non-clinical tests assess the device's physical and functional properties.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable/Not provided. For non-clinical tests, "ground truth" would typically refer to established engineering standards or physical measurements, not clinical outcomes or expert consensus on patient data.
8. The sample size for the training set:
Not applicable/Not provided. There is no mention of a "training set," as this isn't an AI/machine learning device.
9. How the ground truth for the training set was established:
Not applicable/Not provided. No training set was used.
Summary of what is available regarding "acceptance criteria" and "study":
The document lists several non-clinical tests that were performed to demonstrate substantial equivalence and meet "performance requirements":
- Study Type: Non-clinical (laboratory/engineering) tests.
- Proof of Meeting Acceptance Criteria: The document states, "It shows that the testing results do support substantial equivalence." and "Demonstrated by the safety and performance tests, the characteristics of Dawn Diode Laser System are respectively equivalent to those of the predicate devices."
- Specific Standards/Tests Mentioned:
- IEC 60601-1 Edition 3.2 2020-08: Medical electrical equipment - General requirements for basic safety and essential performance.
- IEC 60601-1-2 Edition 4.1 2020-09: Electromagnetic disturbances.
- IEC 60825-1 Edition 2.0 2007-03: Safety of laser products - Equipment classification, and requirements.
- IEC 60601-2-22 Edition 3.1 2012-10: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment.
- IEC 62366-1 Edition 1.1 2020-06: Application of usability engineering to medical devices.
- IEC 62304 Edition 1.1 2015-06: Medical device software - Software life cycle processes.
- ISO 10993-1 Fifth edition 2018-08: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
- ISO 10993-5 Third edition 2009-06-01: Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity.
- ISO 10993-10 Fourth edition 2021-11: Biological evaluation of medical devices - Part 10: Tests for skin sensitization.
- ISO 10993-23 First edition 2021-01: Biological evaluation of medical devices - Part 23: Tests for irritation.
- ISO 14971 Third Edition 2019-12: Medical devices - Application of risk management to medical devices.
- IEC 60601-1-6 Edition 3.2 2020-07: Usability.
- IEC 60601-1-9: Requirements for environmentally conscious design.
- ISO 17664-1 First edition 2021-07: Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices.
The "acceptance criteria" can be inferred to be compliance with these international standards for safety, performance, EMC, biological compatibility, usability, and software. The "study" is the collection of tests performed according to these standards, which are stated to support substantial equivalence. No specific numeric performance results against these standards are detailed in this summary.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.