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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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The LiteDuo Dental Laser System is intended to aid during dental procedures performed in oral and maxillofacial surgery and dentistry.

The LiteDuo Dental Laser System is indicated for a variety of hard tissue (tooth and bone) applications, and for the incision, excision, cutting, ablation, vaporization, and coagulation of soft tissue in oral and maxillofacial surgery and dentistry. In addition, the system is intended for light activation of bleaching materials for teeth whitening.

This includes the following:

Er:YAG Laser:

Hard Tissue Indications of Erbium Laser Energy:

Caries removal, Cavity preparation, Enamel etching, Enameloplasty, excavation of pits and fissures for placement of sealant,

Bone Indications of Erbium Laser Energy:

Contact and non-contact cutting, shaving, contouring, and resection of oral osseous tissue (bone), Apicoectomy - amputation of the root end, Cutting bone to prepare a window access to the apex (apices) of the root(s), Osseoplasty, Osteotomy, Osseous crown lengthening

Soft Tissue and Periodontal Indications of Erbium Laser Energy:

Excisional and incisional biopsies, Exposure of unerupted teeth, Incision drainage of abscesses, Gingival incision and excision, and a Gingivoplasties, Gingivectomies, Gingivectomy in case of hyperplasias of the gingival or excision of hyperplasias, Gingival troughing for crown impressions. Hemostasis. Implant recovery. Frenectomies and frenotomies, Fibromatosis (fibroma removal), Benign and malignant lesion removal, Operculectomy, Oral papillectomies, Reduction of gingival hypertrophy, Soft tissue crown lengthening, Preprosthetic surgery: flabby alveolar ridge, vestibuloplasty, exposure of implants, hyperplasia, epulides, papillomas, fibromatoses benign growths, Vestibuloplasty, Sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility)

Endodontal Indications of Erbium Laser Energy:

Tooth preparation to obtain access to root canal, Pulpotomy, Pulpotomy as an adjunct to root canal therapy, Pulp extirpation, Root canal debridement and cleaning, Root canal preparation including enlargement.

Diode Laser:

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 tissue retraction, for impressions, papillectomy, abscesses. 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, pulpotomy as adjunct to root canal therapy and light activation of bleaching materials for teeth whitening.

The LITEDUO Dental Laser is an advanced microprocessor-controlled laser system, composed of the following units:

• . The control panel;
• . The Er: Y AG and Diode laser applicators;
• High-voltage power supply, capacitor bank and switching module;
• . Diode driver and Diode laser array;
• The cooling system;
• An Er: YAG laser energy verification module.

The provided text is a 510(k) summary for the LITEDUO Dental Laser System, which is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. This type of submission generally relies on established safety and efficacy of the predicate devices and existing scientific literature, rather than new primary clinical studies with specific acceptance criteria and detailed performance metrics of the device itself.

Therefore, the document does not contain the acceptance criteria and study details as requested in the prompt. The summary explicitly states:

"Due to the comprehensive animal and clinical study performed in scientific research and published in literature, and since the power, wavelength, pulse duration and frequency of the LITEDUO Dental Laser System are well within the previous cleared values, Light Instruments believes that animal and clinical studies are not required to determine the safety and efficacy of the device."

This indicates that Light Instruments is asserting that the device's safety and efficacy are already established by existing scientific literature and the performance of previously cleared devices, and thus a new study against specific acceptance criteria for the LITEDUO device was not performed or submitted in this 510(k).

The document mentions compliance with general performance standards (21 CFR 1040.10 and 21 CFR 1040.11 for Class IV Laser Products, and various EN and IEC standards), which are regulatory and safety standards, not performance metrics of the device in a clinical context against defined acceptance criteria.

In summary, the requested information cannot be extracted from the provided text because the 510(k) submission for the LITEDUO Dental Laser System did not involve a new clinical study to prove the device meets specific acceptance criteria.

Ask a specific question about this device