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The Sterling Diode Laser is indicated for: Dental soft tissue indications:

Dental, oral and soft tissue surgery including:

Sulcular debridement of diseased or fibrous tisue, excision and biopsy, gingivectory and gingivoplasty, lesion (tumor) removal, fibroma removal, tissue retraction (troughing), aphthous ulcers, gingival hyperplasia (excision and recontour), crown lengthening, operculectomy, frenectomy, and photocoagulation.

Laser periodontal procedures, including:

Laser soft tissue curettage; laser removal of diseased, infected and necrosed soft tissue within the periodontal pocket; removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium.

The Sterling Diode Laser is a device for delivering laser energy to human soft tissue for a variety of surgical procedures and treatments. This energy is generated by solid-state diodes, which provide a consistent and reliable generation of laser energy at 810 ± 10nm for a maximum of 5 watts of energy is delivered to the surgical site by means of an optical fiber system, which allows for the safe transmission of laser energy to the site without creating undue risk to the patient or operatory staff by errant or collateral laser emissions. The target tissues absorb the laser energy converting it to heat. depending on the intensity or power output of the laser, the heat so generated can cell hemostasis, ablation, or vaporization. The device features some user definable settings, including a selectable 630nm aiming beam, adjustable power output for both the working beam and aiming beam, and continuous delivery or pulse delivery options.

The optical fiber is stored within the device and dispensed to the desired length according to the clinician's need. A fiber is passed through a reusable, sterilizeable handpiece assembly and terminated with a single-use disposable tip. The operator uses the handpiece to position and direct the laser energy to the intended treatment site. The activation of the working beam diodes is accomplished by use of a foot-actuated switch.

The provided document is a 510(k) premarket notification for the Sterling Diode Laser, seeking substantial equivalence to a predicate device. This type of regulatory submission focuses on comparing a new device to an existing legally marketed one, rather than presenting a detailed study proving the device meets specific performance acceptance criteria in the manner described for an AI/ML medical device.

Therefore, the information requested, which is typically relevant to AI/ML device studies, cannot be fully extracted or is not applicable to this document.

However, I can provide the available information that aligns with your request categories:

1. A table of acceptance criteria and the reported device performance:

The document doesn't explicitly define "acceptance criteria" in the sense of quantitative performance metrics for a study to prove the device meets them. Instead, it demonstrates substantial equivalence to a predicate device by comparing technical specifications and performance characteristics.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "Bench testing on an evaluation sample of the submitted device was performed consistent with internal requirements" but does not specify the sample size of devices tested or the data provenance. This is not a clinical study involving human data, but rather performance testing of the device itself.

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. The ground truth in this context is the physical and electrical performance of the device, measured against engineering specifications and compared to a predicate device, not against expert interpretations of medical data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is a technical performance comparison between two laser devices, not an assessment of diagnostic accuracy requiring adjudication.

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 medical laser device, not an AI/ML diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This device is a physical laser system, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this submission are the engineering specifications and measured performance characteristics of the Sterling Diode Laser, compared against the known specifications and performance of the legally marketed predicate device (Odyssey 2.4G Diode Laser) and relevant IEC/ANSI standards. This is a technical ground truth, not a medical one in the AI/ML sense.

8. The sample size for the training set

Not applicable. This is a hardware device, not an AI/ML algorithm requiring a training set.

9. How the ground truth for the training set was established

Not applicable. Again, this is a hardware device.

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