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The stLase with surgical laser operation (Automatic Power Control) that can be used in contact or non-contact technique, is indicated for dental soft tissue indications including: 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/uncovery, gingivectomy, gingivoplasty, gingival troughing, crown lengthening, 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, and sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket).

The stLase with surgical laser operation that can be used in contact or non-contact 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 is intended to be used in contact or non-contact technique 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/uncovery, 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, vestibuloplasty, 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 soft tissue surgical laser system indicated for use in dental applications. It can generate up to 25 W at 980 nm wavelength in fiberoptic output used for a variety of dental and oral surgical applications, including cutting and coagulation of intraoral and extraoral soft tissues.

This document is a 510(k) Summary of Safety and Effectiveness for the Dental Photonics stLase, a soft tissue surgical laser system. It describes the device, its intended use, and argues for its substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not specify formal acceptance criteria in terms of performance metrics (e.g., accuracy, sensitivity, specificity) for the device's function. Instead, the "acceptance criteria" presented here is based on demonstration of substantial equivalence to a predicate device. The performance is reported by showing that the technical specifications of the current device are identical to the predicate device.

The study that proves the device meets "acceptance criteria" (in this context, substantial equivalence) is the technical comparison and bench testing to demonstrate that the new stLase (K111689) has the "same material design, mechanism of action, technical specifications and function" as the predicate device (stLase K094049).

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

The document exclusively relies on a comparison of technical specifications and bench testing. There is no test set of patient data, clinical data, or imaging data mentioned for evaluating the device's performance in terms of diagnostic or therapeutic outcomes. The provenance of the data is a comparison of published specifications of two laser devices, presumably from internal company documentation and previous 510(k) submissions. This is not retrospective or prospective patient data.

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

Not applicable. There is no test set with patient data requiring expert-established ground truth. The "ground truth" for the technical specifications are the validated specifications of the predicate device, which would have been established through engineering and performance testing at the time of its initial clearance (K094049).

4. Adjudication Method for the Test Set:

Not applicable, as there is no test set of patient data.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. This device is a surgical laser, not a diagnostic imaging device typically evaluated with MRMC studies comparing human readers with and without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. This device is not an AI algorithm. It is a surgical laser that requires human operation. The performance assessment is based on its physical characteristics and functionality, not an AI algorithm's standalone performance.

7. The Type of Ground Truth Used:

The "ground truth" used for demonstrating substantial equivalence is the technical specifications and established performance characteristics of the predicate device (K094049) as determined by engineering validation and previous regulatory clearance. This is not pathology, outcomes data, or expert consensus on clinical cases.

8. The Sample Size for the Training Set:

Not applicable. This device does not involve a training set as it is not an AI/machine learning device.

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

Not applicable, as there is no training set for an AI/machine learning algorithm.

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