(438 days)
Dental Soft Tissue Indications: Incision, excision, vaporization, ablation and coagulation of oral soft tissues, including marginal and inter-dental gingival and epithelial lining of free gingiva and the following specific indications: Excisional and incisional biopsies, Exposure of unerupted teeth, Fibroma removal, Frenectomy, Frenotomy, Gingival troughing for crown impressions, Gingivectomy, Gingivoplasty, Gingival incision and excision, Hemostasis and coagulation, Implant recovery, Incision and drainage of abscess, Leukoplakcia, Operculectomy, Oral papillectomies, Pulpotomy, Pulpotomy as an adjunct to root canal therapy, Reduction of gingival hypertrophy, Soft tissue crown lengthening, Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa, Vestibuloplasty, Tissue retraction for impression. Laser Periodontal Procedures, including: Laser soft tissue curettage, 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 mobility).
Principle: The semiconductor laser diode is excited by the generation power supply to generate the laser, which is effectively transmitted to the treatment site through the optical fiber tip. Intended operator: Dental surgeon. Component part: It is composed of laser host (including internal power system, laser drive system, optical path system, LCD screen, emergency stop button, laser) and optic fiber tip. Sterile: The Fiber optic tip and the handpiece cover require sterilization prior to use.
This document is a 510(k) premarket notification for a Class II medical device, the Dental Diode Laser, SOGA Laser, ILaser II. It focuses on demonstrating substantial equivalence to a predicate device (iLase™ by Biolase Technology, Inc., K093852) rather than proving meeting specific acceptance criteria through a performance study against a defined ground truth.
Therefore, the requested information regarding acceptance criteria, device performance, sample size, expert involvement, adjudication, MRMC studies, standalone performance, and ground truth establishment (which are typical for AI/ML-driven device performance studies) cannot be extracted from this document, as it describes a traditional medical device (a laser) and its regulatory submission based on substantial equivalence.
The document details the device's technical specifications and compares them to a predicate device to argue for substantial equivalence in safety and effectiveness, based primarily on non-clinical testing against recognized standards (e.g., IEC, ISO). Clinical testing was explicitly stated as not performed for this submission.
Here's what can be extracted based on the provided document, even though it doesn't align with the typical "acceptance criteria and study that proves the device meets the acceptance criteria" format for AI/ML devices:
1. A table of acceptance criteria and the reported device performance:
This document does not present quantitative performance metrics against specific acceptance criteria for a "study" in the way an AI/ML device would. Instead, it compares technical specifications to a predicate device to demonstrate substantial equivalence. The "acceptance criteria" here are effectively "being substantially equivalent to the predicate device in terms of safety and effectiveness."
| Comparison Item | Acceptance Criteria (based on Predicate Device) | Reported Device Performance (SOGA Laser, ILaser II) |
|---|---|---|
| Classification | GEX, Class II (21 CFR 878.4810) | GEX, Class II (21 CFR 878.4810) - Meets |
| Intended Use | Incision, excision, vaporization, ablation and coagulation of oral soft tissues, including marginal and inter-dental gingival and epithelial lining of free gingiva, and specific indications (listed on page 2) | Identical list of indications for use. - Meets |
| Patient Population | For use in all patients | For use in all patients; No restriction on the applicable population - Meets |
| Environment of Use | Hospital, clinic, and medical office setting (Predicate: Prescription Use - For professional) | Hospital, clinic, and medical office setting; For Dental surgeon - Meets |
| Principle of Operation | Energy delivered to treatment site via single-use fiber optic tip assembly. | Semiconductor laser diode excited by generation power supply to generate laser, effectively transmitted to treatment site through optical fiber tip. Comparison statement notes "almost the same technological characteristics" and states the difference "will not affect the core usage" and efficiency was "able to reach an equivalence level". Supported by literature [1] (not provided in this excerpt). - Deemed Equivalent |
| Size | 20.5 cm x φ 1.90 cm | φ18mm x 200mm. Comparison statement notes "slight difference in size" will not affect substantial equivalence. - Deemed Equivalent |
| Wavelength | 940 nm ± 10nm | 980nm ±20nm. Comparison statement notes differences verified by IEC 60825-1 and IEC 60601-2-22, and efficiency able to reach equivalence level. Supported by literature [1]. - Deemed Equivalent |
| Output Power | 3.0 W Max CW / 5.0 W Peak Power (Pulse Mode) | 3.0 W Max CW / 5.0 W Peak Power (Pulse Mode) - Meets |
| Power Accuracy | ± 20% | ± 5%. Comparison statement notes "slight difference in... Power Accuracy will not affect the core usage... or not bringing new safety and effectiveness concerns." - Better Performance, Deemed Equivalent |
| Pulse Mode | Continuous | Continuous - Meets |
| Duty Cycle | 9.09%~83.3% | 9.09%~83.3% - Meets |
| Aiming Beam | Laser diode, max 1 mW, 625-670nm, Class 1 | Laser diode, max 2 mW, 650nm±20nm, Class 1. Comparison statement notes "slight difference in... Aiming Beam and Power Accuracy will not affect the core usage... or not bringing new safety and effectiveness concerns." - Deemed Equivalent |
| N.O.H.D. | 2.61 meters | 3.03 meters. Comparison statement notes difference does not affect substantial equivalence. - Deemed Equivalent |
| Safety & Effectiveness | Verified according to relevant standards (e.g., Electrical, EMC, Performance, Biocompatibility). | Verified according to IEC 60601-1, IEC 60601-1-2, IEC 60825-1, IEC 60601-2-22, ISO 10993-5, ISO 10993-10. - Demonstrated Compliance with Standards |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not applicable. No clinical test set or data set for performance evaluation in the AI/ML sense was used. The submission relies on technical comparisons and non-clinical testing.
- Data Provenance: Not applicable for a "test set." The document refers to "literature referred [1]" for demonstrating efficiency equivalence but does not provide details of this literature.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No ground truth establishment for a test set was performed, as it was a technical comparison for substantial equivalence.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No adjudication was necessary as no test set requiring ground truth labeling 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:
- No MRMC study was done (or mentioned). This is a physical device (laser), not an AI-based diagnostic or assistive software.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical laser device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. The basis for safety and effectiveness is "substantial equivalence" to a legally marketed predicate device, supported by compliance with international electrical, laser, and biocompatibility standards.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable.
§ 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.