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The LITETOUCH dental laser system is intended to aid during dental procedures performed in oral and maxillofacial surgery and dentistry.

The Erbium: Y AG laser 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. This includes the following:

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 and drainage of abscesses
• Gingival incision and excision
• 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

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

• Control panel
• Laser accessory, including the Erbium laser assembly and water spray equipment
• High-voltage power supply, capacitor bank and switching module
• Cooling unit
• Tip power detection module

The provided text is a 510(k) summary for the LITETOUCH Dental Laser System. It focuses on demonstrating substantial equivalence to predicate devices and adherence to regulatory standards rather than presenting a study with acceptance criteria and device performance metrics in the way one might find for a diagnostic or AI-driven medical device.

Therefore, many of the requested details about acceptance criteria, specific study designs (like MRMC or standalone performance), sample sizes, expert qualifications, and ground truth establishment are not applicable or available in this document.

Here's an analysis based on the provided text, highlighting what is and isn't available:

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

This information is not explicitly provided in the document. The document states that the device "complies with U.S. Federal Performance Standards 21 CFR 1040.10 and 21 CFR 1040.11 for class IV Laser Products" and other international standards (EN 60601-1, EN 60825-1, etc.). While these standards define criteria for performance and safety, the document does not present them as "acceptance criteria" for a specific study comparing the device's measured performance against those criteria. It asserts compliance but doesn't detail the performance metrics or the specific ranges that would constitute "acceptance."

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

This information is not applicable/provided. The document explicitly states: "Due to the comprehensive animal and clinical study performed in scientific research and literature, and since the power, wavelength, pulse duration and frequency of the LITETOUCH 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 means no new "test set" of data was generated or used for a specific clinical or performance study of this device. The submission relies on existing scientific literature and the established performance of similar predicate devices.

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

This information is not applicable/provided for the reasons stated above (no new test set, reliance on literature).

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

This information is not applicable/provided for the reasons stated above (no new test set, reliance on literature).

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

This information is not applicable/provided. The LITETOUCH Dental Laser System is a physical medical device (a laser system) for direct dental procedures, not a diagnostic or AI-powered imaging device that would involve "human readers" or AI assistance in interpretation.

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

This information is not applicable/provided. As above, this is a physical laser device, not an algorithm.

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

This information is not applicable/provided in the context of a specific study for this device. The "ground truth" for its safety and efficacy is considered to be established by the "comprehensive animal and clinical study performed in scientific research and literature" for similar Er:YAG laser devices. This implies that the effectiveness of this type of laser for its indicated uses (e.g., caries removal, soft tissue incision) has been independently validated by general medical and dental research, likely through various methods including clinical outcomes, pathological examination where relevant, and expert consensus over time.

8. The sample size for the training set

This information is not applicable/provided. There is no "training set" as this is not an AI/machine learning device.

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

This information is not applicable/provided. There is no "training set" as this is not an AI/machine learning device.

Summary of Device and Study (as presented in the 510(k) Summary):

• Device: LITETOUCH Dental Laser System (Erbium:YAG laser)
• Intended Use: Aid during dental procedures in oral and maxillofacial surgery and dentistry, covering hard tissue (tooth and bone) and soft tissue applications, including endodontal and periodontal indications.
• Predicate Devices: OpusDent Family of Dental Laser Systems (K040270) and Hoya ConBio VersaWave™ Dental Er:YAG Laser System (K041710).
• Basis for Substantial Equivalence: The manufacturer asserts that the safety and efficacy of Er:YAG laser devices with similar specifications (2.94 micron wavelength, power up to 8.5 Watts) are "well established in scientific research and literature." They argue that because the LITETOUCH's power, wavelength, pulse duration, and frequency are "well within the previous cleared values," new animal or clinical studies are not required.
• Compliance: The device complies with U.S. Federal Performance Standards 21 CFR 1040.10 and 21 CFR 1040.11 for Class IV Laser Products, as well as European Medical Directive 93/42/EEC and specific EN/IEC/CISPR standards related to medical electrical equipment, laser safety, and EMC.

In essence, this 510(k) relies on the well-established safety and efficacy of the technology (Er:YAG lasers) and demonstrates that the LITETOUCH device adheres to relevant performance and safety standards, making it substantially equivalent to previously cleared devices. It does not present a de novo clinical study with specific acceptance criteria that the device's measured performance statistically met.

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