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1. DENTAL SOFT TISSUE INDICATIONS
   The indications are identical to the previously cleared predicate systems.
   Incision, excision, vaporization, ablation of oral soft tissues including marginal and inter-dental givgival and epithelial lining of free gingival and the following specific indications:

• Exposure of Unerupted teeth
• Fibroma removal
• Frenectomy
• Gingival Troughing for crown impressions
• Gingivectomy
• Gingivoplasty
• Hemostasis and coagulation
• Gingival incision and excision hemostasis
• Implant recovery
• Incision and drainage of abscess
• Leukoplakia
• Operculectomy
• Oral papillectomies
• Pulpotomy as an adjunct to root canal therapy
• Reduction of gingival hypertrophy
• Soft tissue crown lengthening
• Gingival bleeding index
• Excisional and incisional biopsies
• Treatment of aphthous ulcer canker sores and herpetic.
• Vestibuloplasty

2. LASER PERIODONTAL INDICATIONS:

• Sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket to improve clinical indices including: probe depth, attachment loss and tooth mobility )
• Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium.

3. TOOTH WHITENING INDICATIONS

• Laser Assisted whitening/bleaching of teeth.
• Light activation for bleaching materials for teeth whitening.

4. PAIN INDICATIONS:

• Topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness minor arthritis pain, or muscle spasm, minor sprains and minor muscular back pain; the temporary increase in local blood circulation; the temporary relaxation of muscle.

The Zolar Technology & MFG Co. Inc. Soft Tissue Dental Laser PHOTON/PHOTON PLUS uses a solid state diode to emit infrared laser energy which is transmitted via a flexible fiber optic cable to the hand piece that emits the energy to the target site. A visible light (aiming beam) is emitted at the same time to visually assist in identifying the specific treatment location. The Photon/Photon Plus Laser Systems are comprised of a base consol, a detechable delivery system, tips and a wireless footswitch. The Photon/Photon Plus laser is intended to be used by dentist for a variety of oral soft tissue procedures

This document describes the Zolar Technology & MFG Co. Inc. Photon and Photon Plus dental diode lasers (K162114). The context for the device's acceptance is a 510(k) premarket notification, which establishes substantial equivalence to previously cleared predicate devices, rather than a novel device requiring extensive clinical trials to prove efficacy. The "study" referenced in the prompt is a performance assessment focusing on a specific new indication (pain relief) by demonstrating thermal effects.

Here's the breakdown based on the provided text:

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

For the specific "Pain Indications," the acceptance criteria involve demonstrating an increase in skin temperature to 40-45°C, maintained for at least 10 minutes, safely and effectively. The reported device performance meets these criteria.

For the other indications (Dental Soft Tissue, Laser Periodontal, Tooth Whitening), the acceptance criteria are based on substantial equivalence to predicate devices, meaning the device performs "as safe, as effective, and performs as well as" the predicate devices. The performance is reported as being similar or identical to the predicate devices.

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

• Sample size: For the "Pain Indications," the clinical test was conducted with "human subjects," but the exact number of subjects is not specified in the provided document.
• Data provenance: The document does not explicitly state the country of origin of the data. It mentions Zolar Technology & Mfg Co. Inc. is based in Mississauga, CA (Canada), but this doesn't confirm the location of the clinical test. The test was prospective as it involved a "clinical test... conducted with human subjects."

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)

This information is not provided in the document. The study described focuses on quantitative thermal measurements rather than expert interpretation of complex medical images or diagnoses.

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

This information is not provided. Given the nature of the "performance assessment" for pain relief (temperature measurement), formal adjudication as seen in imaging studies (e.g., for diagnostic accuracy) is not typically applicable in the same way.

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 is not an AI-assisted device, nor is it a diagnostic imaging device that would typically undergo an MRMC study. The device is a therapeutic laser.

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

Not applicable. This device is a laser intended for direct use by a dentist; it does not operate as an algorithm or with human-in-the-loop AI assistance. The performance assessment pertains to the device's physical effect on tissue.

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

For the "Pain Indications" where a performance assessment was conducted, the ground truth was physiological measurement (skin temperature) and observed effect (maintenance over time, safety, and effectiveness).

For other indications (Dental Soft Tissue, Laser Periodontal, Tooth Whitening), the "ground truth" for substantial equivalence is based on the established performance and safety of legally marketed predicate devices.

8. The sample size for the training set

Not applicable. This device is a hardware laser, not a machine learning algorithm that requires a training set. The performance assessment is a validation of the device's physical capabilities.

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

Not applicable (as explained in point 8).

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The Photon is intended for use by dentists for excision, vaporization, ablation and coagulation of oral soft tissue procedures. The specific applications are as follows: SOFT TISSUE: The metal handpiece with cutting fiber does not have any direct contact to the soft tissue, skin or cell during the operation. - . Exposure of Unerupted teeth . - . Fibroma removal - . Frenectomy - . Gingival Troughing for crown impressions - . Gingivectomy - . Gingivoplasty - . Hemostasis and coagulation - . Gingival incision and excision hemostasis - . Implant recovery - . Incision and drainage of abscess - . Leukoplakia - . Operculectomy - . Oral papillectomies - . Pulpotomy as an adjunct to root canal therapy - ' Reduction of gingival hypertrophy - . Soft tissue crown lengthening - . Gingival bleeding index - . Excisional and incisional biopsies - . Treatment of aphthous ulcer, canker sores and herpetic - . Vestibuloplasty. LASER PERIODONTAL PROCEDURES: - Sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket to . improve clinical indices including:, probe depth, attachment loss and tooth mobility) - Removal of highly inflamed edematous tissue affected by bacteria penetration of the . pocket lining and junctional epithelium Indications for Use for Photon Plus: The Photon Plus is intended for use by dentists for excision, vaporization, ablation and coagulation of oral soft tissue procedures. The specific applications are as follows: SOFT TISSUE: The metal handpiece with cutting fiber does not have any direct contact to the soft tissue, skin or cell during the operation. - . Exposure of Unerupted teeth - Excision of lesion or removal of Granulation tissue . - . Frenectomy - . Gingival Troughing for crown impressions - . Gingivectomy - . Gingivoplasty - . Hemostasis and coagulation - . Gingival incision and excision hemostasis - . Implant recovery - . Incision and drainage of abscess - . Leukoplakia - . Operculectomy - . Oral papillectomies - . Pulpotomy as an adjunct to root canal therapy - . Reduction of gingival hypertrophy - . Soft tissue crown lengthening - . Gingival bleeding index - Excisional and incisional biopsies . - . Treatment of aphthous ulcer, canker sores and herpetic - . Vestibuloplasty. LASER PERIODONTAL PROCEDURES: - Sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket to improve clinical indices including;, probe depth, attachment loss and tooth mobility) - Debridement of diseased epithelial lining . TOOTH WHITENING INDICATIONS - Laser assisted whitening/bleaching of teeth . - Light activation for bleaching materials for teeth whitening. .

Photon/Photon Plus Diode Laser is a surgical device at the cutting edge of technology, designed for a wide variety of oral soft tissue and tooth whitening procedures with the wavelength of 980nm and the power range of 100mW to 10W. Photon Series Diode Laser utilizes a solid state diode a laser energy source. The energy is delivered to the operating area by means of a delivery system consisting of a flexible fiber connecting the laser source and the handpiece. The device is activated by means of a footswitch.

The provided text describes a 510(k) summary for the Zolar Photon/Photon Plus dental diode lasers. This submission focuses on establishing substantial equivalence to predicate devices rather than proving specific performance criteria through a dedicated study with acceptance criteria.

Therefore, the requested information regarding acceptance criteria and a study proving their fulfillment is not explicitly present in the provided document, as the submission relies on demonstrating equivalence to already cleared devices. No clinical studies were performed.

However, based on the non-clinical tests performed, we can infer some aspects and highlight what is mentioned:

Inferred Acceptance Criteria and Reported Device Performance

Since no clinical studies were performed for this 510(k) submission, there are no specific performance criteria results from a clinical trial. The "acceptance criteria" here are inherent to demonstrating substantial equivalence and conformity to relevant safety standards.

• Wattage: 0.1-10W (Photon Plus), 0.1-3.0W/0.1-10W (Photon) (Comparable to predicates)
• Operating Modes: Pulsed or CW (Comparable to predicates) |
  | Intended Use Equivalence | Intended uses are substantially equivalent to predicate devices. |

Study Details (as per Request, but largely "Not Applicable" or "Not Provided" in this context)

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

   • Sample Size: Not applicable. No clinical test set. Non-clinical tests were performed on the device itself.
   • Data Provenance: Not applicable. The "study" here is a submission demonstrating substantial equivalence through non-clinical testing and comparison to predicate devices, not a clinical trial with patient data.

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

   • Not applicable. There was no clinical test set requiring expert ground truth establishment.

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

   • Not applicable. No clinical test set.

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:

   • Not applicable. This device is a laser surgical instrument, not an AI-assisted diagnostic or imaging device. No MRMC study was performed.

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

   • Not applicable. This is a physical medical device (laser), not an algorithm.

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

   • Not applicable for clinical ground truth. For non-clinical tests, engineering specifications and compliance to standards served as the "ground truth" for evaluating the device's performance against established safety and design requirements.

7. The sample size for the training set:

   • Not applicable. This is a physical device, not a machine learning model requiring a training set.

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

   • Not applicable.

Summary regarding the "Study":

The document explicitly states: "9. Discussion of Clinical Tests Performed: Not Applicable" and "10. Conclusion: We have demonstrated that there are no significant differences between the subject devices, and the predicate devices, Photon/Photon Plus and the predicate devices, Picasso/Picasso Lite Dental Diode Lasers, K102359, and stLase Dental Laser, K111689, in terms of safety and effectiveness based on electrical, mechanical and environmental test results."

This clearly indicates that no clinical studies with acceptance criteria, patient samples, or expert ground truth were conducted for this 510(k) submission. The regulatory pathway chosen was based on demonstrating substantial equivalence through non-clinical testing and comparison of technical specifications and intended uses with legally marketed predicate devices.

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