(136 days)
- 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
- 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.
- TOOTH WHITENING INDICATIONS
- Laser Assisted whitening/bleaching of teeth.
- Light activation for bleaching materials for teeth whitening.
- 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.
| Acceptance Criteria (Pain Indications) | Reported Device Performance |
|---|---|
| Increase skin temperature to 40-45°C | Demonstrated that the device can increase the skin temperature to 40-45°C |
| Maintain the effect for at least 10 minutes | Maintained the effect for at least 10 minutes |
| Safely and effectively | Performed safely and effectively |
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).
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.