(253 days)
The stLase™ with surgical laser operation that can be used in contact or noncontact technique is intended for use in general surgery for incision/excision, vaporization, ablation and coagulation of soft tissue, and The stLase™ with dental laser operation that can be used in contact or non-contact technique is intended for incision, excision, vaporization, ablation, hemostasis, or coagulation of intraoral and extraoral soft tissue (including marginal and interdental gingiva and epithelial lining of free gingiva). Examples include: 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, vestibuloplasy, excision of lesions, exposure of unerupted/partially erupted teeth, leukoplakia, removal of hyperplastic tissues, treatment of aphthous ulcers, sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket), pulpotomy, pulpotomy as an adjunct to root canal therapy, and light activation of bleaching materials for teeth whitening.
The Dental Photonics stLase™ is a 980 nm wavelength diode laser intended for use in general surgical applications and dental laser applications.
Here's an analysis of the provided text regarding the acceptance criteria and study information for the stLase™ device:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided 510(k) summary, there are no specific, quantitative acceptance criteria or corresponding reported device performance metrics like sensitivity, specificity, accuracy, or other statistical measures typically found for diagnostic or predictive AI devices.
Instead, the device's acceptance is based on:
| Acceptance Criteria Type | Reported Device Performance (as stated in the document) |
|---|---|
| Substantial Equivalence to Predicate Devices | "Substantial equivalence of the stLase™ is demonstrated by similarity in technical specifications to the predicate devices." |
| "The stLase™ has the same intended use, material design and function as predicate devices for dental laser applications: Biolitec Ceralas D980 family of lasers K081015; the Kavo GentleRay 980, K072262; and the same intended use, material design and function as the predicate device for general surgery laser applications: Dornier Medilas D family of lasers, K982629." | |
| Compliance with Regulatory Standards (Laser Safety) | "As a laser device, the stLase™ complies with 21 CFR 1040.10 and 1040.11 and other applicable laser and electrical safety standards." |
| Intended Use Alignment | The stated intended uses for general surgery and dental applications (listed extensively) are deemed equivalent to those of the predicate devices. |
| Device Description Alignment | The device's description as a "980 nm wavelength diode laser intended for use in general surgical applications and dental laser applications" is deemed similar to predicate devices. |
Explanation of Device Type: This device is a surgical laser, not an AI/ML-driven diagnostic or predictive tool. Therefore, the "acceptance criteria" and "study" are not based on performance metrics like AUC, sensitivity, or specificity relative to a ground truth established by experts. Instead, the acceptance is based on demonstrating substantial equivalence to previously cleared predicate devices through shared technical specifications, intended uses, and compliance with general safety and performance standards for laser devices.
2. Sample size used for the test set and the data provenance
Not applicable. The document describes a direct comparison and substantial equivalence to predicate devices rather than performance testing on a specific data set. There is no "test set" in the context of AI/ML performance evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. There is no "test set" or ground truth established by experts in the context of AI/ML performance evaluation for this device. The evaluation focuses on technical specifications and functional equivalence to predicate devices, and compliance with general laser safety standards.
4. Adjudication method for the test set
Not applicable. No test set or expert adjudication process 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 is a surgical laser device, not an AI-assisted diagnostic tool. No MRMC study or AI assistance is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (a surgical laser), not a standalone algorithm. Its operation inherently involves a human operator.
7. The type of ground truth used
Not applicable in the context of AI/ML performance. The "truth" for this device's clearance is its compliance with regulatory standards (e.g., laser safety, electrical safety) and its demonstrated functional and intended use equivalence to legally marketed predicate devices. This is a regulatory "ground truth" rather than a clinical ground truth established for an AI model.
8. The sample size for the training set
Not applicable. There is no AI/ML training set mentioned or implied.
9. How the ground truth for the training set was established
Not applicable. There is no AI/ML training set.
§ 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.