(103 days)
Doctor Smile A-810 Laser is intended for use in the following procedure: Soft Tissue, Laser Periodontal procedures and tooth whitening. Intra- and extra oral surgery including incision, excision, vaporization, ablation, haemostasis and coagulation of oral soft tissues, Laser soft tissue curettage, whitening. Following specific indications: Excisional and incisional biopsies, Exposure of unerupted teeth, Fibroma removal, Frenectomy, Frenotomy, Gingival troughing for crown impressions, Gingivoplasty, Gingival incision and excision Haemostasis and coagulation, Implant recovery, Incision and drainage of abscess Leukoplakia, Operculectorny, Oral papillectornies, Pulpotomy as an adjunct to root canal therary, Reduction of gingival hypertrophy, Soft tissue crown lengthening, Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa. Vestibuloplasty, Laser removal of diseased, 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 gingiyal index, gingival bleeding index, probe depth, attachment loss and tooth mobility.). Light activation of whitening/bleaching material. Doctor Smile B-980 Laser is intended for use in the following procedure: Surgical applications requiring the ablation, vaporization, excision, incision, hemostasis, or coagulation of soft tissue in medical specialties including dentistry, gastroenterology, dermatology, general surgery, gynecology, opthamology, pulmonology, otolaryngology, othopedics. Dental applications: Frenectomy, Frenotomy, Biopsy, Operculectomy, Implant Recovery, Gingivoplasty, Gingivolasty, Gingival Troughing, Crown Lengthening, Haemostasis of Donor Site, Removal of Granulation Tissue, Laser-assisted Flap Surgery, Debridement of Deseased Epithelial Lining, Incisions and Draining of Abscesses, Tissue Retraction for Impressions. Papillectory, Vestibuloplasty, Excision of Lesions, Leukoplakia, Exposure of Unemupted Partially Erupted Teeth, Removal of Hyperplastic Tissues, Treatment of Aphthous Ulcers, Sulcular Debridement, Pulpotomy, Pulpotomy as an Adjunct to Root Canal Therapy, and Light Activation of Bleaching Materials
Doctor Smile A-810, B-980 Lasers are the same standard diode medical lasers respectively with 810, 980 nm wavelength. Doctor Smile A-810, B-980 Lasers are portable instruments which transmit laser energy via a contact fiber optic delivery system and each unit is compromised of the following main components: -a laser system console (including display panel, software and control); -a fiber optic delivery system; -one or more handpieces -protective eye ware
This document is a 510(k) Summary for the Doctor Smile A-810 and B-980 Lasers. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study with acceptance criteria and performance data in the context of an AI/medical device.
Therefore, most of the requested information cannot be extracted from this document, as it pertains to clinical performance studies typically conducted for novel devices or AI-powered diagnostics.
However, I can provide the following based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
This document does not present acceptance criteria for clinical performance (e.g., sensitivity, specificity) or report device performance in that manner. Instead, it states compliance with general device standards and substantial equivalence to predicate devices.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not applicable (No clinical performance criteria are stated in this 510(k) summary) | Not applicable (No clinical performance data is reported in this 510(k) summary) |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not applicable. This document does not describe a clinical study with a test set of patient data.
- Data Provenance: Not applicable.
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 activity is described for a test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No adjudication method is described.
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. This document is for a laser surgical instrument, without any AI component or human-in-the-loop performance described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This document is for a laser surgical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. No ground truth for clinical performance is described. The "ground truth" in this context is the safety and effectiveness of the predicate devices.
8. The sample size for the training set:
- Not applicable. This refers to a laser device, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable.
Summary of Device-Specific Information from the document:
This 510(k) submission establishes substantial equivalence of the Doctor Smile A-810 and B-980 Lasers to predicate devices, based on:
- Identical or similar indications for use.
- Similar principles of operation.
- Overall technical and functional capabilities.
- Compliance with the same safety and performance standards:
- IEC 60601-1:1998+A1:1991+A2:1995
- IEC 60601-2-22:1995
- IEC 60825-1:1993+A1:1997+A2:2001
- 21 CFR 1040.10 and 1040.11
The document highlights the device's technological characteristics and compares them to predicate devices, noting that the Doctor Smile A-810, B-980 Lasers are portable instruments that transmit laser energy via a contact fiber optic delivery system, consisting of a laser system console, fiber optic delivery system, handpieces, and protective eyewear.
§ 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.