(330 days)
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.
| Acceptance Criteria (Inferred from Substantial Equivalence and Standards) | Reported Device Performance (from Non-Clinical Tests) |
|---|---|
| Safety (Thermal, Electrical, Mechanical) | Conformity to IEC 60825-1, IEC 60601-2-22 |
| Design Specifications | Met all design specifications |
| Compliance to Standards | Compliance to ANSI/AAMI ST79, AAMI TIR 12, ANSI/AAMI/ISO 17665-1, ANSI/AAMI ST77, ANSI/AAMI ST81, ISO 17664, ANSI/AAMI ST67, ANSI/AAMI ST8, EN 556 |
| Performance Equivalence | - Wavelength: 980nm (Photon Plus), 810nm/980nm (Photon) (Comparable to predicates) |
- 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)
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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.
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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.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No clinical test set.
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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.
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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.
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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.
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The sample size for the training set:
- Not applicable. This is a physical device, not a machine learning model requiring a training set.
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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.
§ 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.