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The D-Storm system is intended to aid during dental procedures performed in oral and maxillofacial surgery and dentistry.
The D-Storm diode laser system is indicated for:

• Incision, excision, cutting, ablation, vaporization, and coagulation of soft tissue in oral and maxillofacial surgery and dentistry
• Light activation of bleaching materials for teeth whitening
  The D-Storm specific indications include the following:
  Marginal and interdental gingiva and epithelial lining of free gingiva, frenectomy, frenotomy, biopsy, operculectomy, implant recovery, gingivectomy, gigngivioplasty, gingival troughing crown lengthening, hemostasis of donor site, removal of granulation tissue, laser assisted flap surgery, debridement of diseased epithelial lining, incision and draining of abscesses, tissue retraction, for impressions, papillectomy, vestibuloplasty, excision of lesions, exposure of unerupted/partially erupted teeth, removal of hyperplastic tissues, treatment of aphtous ulcers, leukoplakia, sulcular debridement (removal of diseased or inflamed soft tissue, in the periodontal pocket), pulpotomy as adjunct to root canal therapy and light activation of bleaching materials for teeth whitening.

The D-STORM Diode Laser is an advanced microprocessor-controlled laser system, composed of the following units:

• Control panel; .
• . Diode laser
• Safe System Control .
• . Cooling System
• A hand-piece and foot panel; .

Here's an analysis of the provided text regarding the D-STORM Diode Laser System and its acceptance criteria and supporting study information:

Acceptance Criteria and Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative performance metric sense (e.g., sensitivity, specificity, accuracy against a threshold). Instead, the acceptance criteria for this device appear to be based on:

1. Substantial Equivalence: The primary acceptance criterion for a 510(k) submission is demonstrating substantial equivalence to legally marketed predicate devices. This means the device must have the same intended use and technological characteristics as the predicate, or if there are different technological characteristics, they must not raise new questions of safety or effectiveness.
2. Compliance with Standards: Meeting recognized performance standards for laser products and medical electrical equipment.

• EN 60601-1 (Medical Electrical Equipment-Part 1: General Requirements for Safety)
• EN 60825-1 (Safety of laser products)
• EN 60601-2-22 (Particular Requirements for safety and diagnostics and therapeutic laser equipment)
• IEC 60601-1-2 (Electromagnetic compatibility (EMC)) |
  | Clinical Performance (Safety & Efficacy) | Safety and efficacy of diode laser devices with similar wavelengths and power are well established in scientific research and literature. It is asserted that "clinical studies are not required to determine the safety and efficacy of the device" due to comprehensive existing literature and the device's technical parameters being within previously cleared values. This implies that the device is expected to perform comparably to established devices. |

Study Details

Based on the provided text, a new clinical study to demonstrate the device's performance against specific acceptance criteria was not conducted for this 510(k) submission. Therefore, most of the requested fields are not applicable in the traditional sense of a performance study on the D-STORM Diode Laser System itself.

1. Sample size used for the test set and the data provenance:

   • N/A. No new clinical test set was used for the D-STORM Diode Laser System. The submission relies on existing published scientific research and literature. The "data provenance" would therefore refer to a broad body of pre-existing scientific literature.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • N/A. As no new clinical study data were generated for this submission, there was no expert panel needed to establish ground truth for a test set. The validation relies on the expertise embedded in the existing scientific literature.

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

   • N/A. No test set requiring expert adjudication was used.

4. 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:

   • N/A. This device is a laser system, not an AI-assisted diagnostic tool or an imaging modality requiring interpretation by "readers." Therefore, an MRMC study is not relevant to its regulatory pathway.

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

   • N/A. This is a medical device (laser system), not a software algorithm.

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

   • The "ground truth," in an indirect sense, is derived from the established safety and efficacy of diode laser devices through "scientific research and literature," which would include published clinical outcomes, expert consensus on best practices, and histological/pathological evidence for the effects of laser on tissues in those prior studies.

7. The sample size for the training set:

   • N/A. This device is not an AI/ML algorithm that requires a training set. Its design and validation are based on engineering principles and comparison to existing, cleared devices.

8. How the ground truth for the training set was established:

   • N/A. Not applicable, as there is no training set for this type of device.

In summary: The D-STORM Diode Laser System obtained 510(k) clearance primarily through demonstrating substantial equivalence to predicate devices and adherence to relevant safety and performance standards. The manufacturer explicitly states that "clinical studies are not required to determine the safety and efficacy of the device" because the technology (diode lasers with similar parameters) is well-established in scientific literature.

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