(74 days)
The use of the PulseMaster laser for treatment of aphthous ulcers is substantially equivalent to the use of the PulseMaster laser for coagulation of other intraoral soft tissue.
Dental Laser System
This 510(k) summary for the PulseMaster Dental Laser System describes a new indication for use: treatment of aphthous ulcers. The provided text is a summary of the clinical evidence to support this new indication, focusing on substantial equivalence to existing uses.
Here's an analysis of the provided information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance (from cited studies) |
|---|---|
| Safety: No new safety risks compared to existing indications. | "There are no new safety risks for this laser procedure." (Conclusion of the summary) Also, in one case study, "The patients reported no discomfort during the procedure and no postoperative discomfort or other problems." |
| Effectiveness: Equivalent to standard of care for treatment. | "The laser treatment for recurrent aphthous ulcers is equivalent to the standard of care for treatment of recurrent aphthous ulcers in terms of effectiveness." (Conclusion of the summary) |
Detailed performance from the first study (21 patients):
- Immediate relief of pain: 63%
- Faster healing: 50%
- No recurrence within 6 months: 50%
- Less severe recurrences (for remainder): 75%
- Authors' conclusion: "the pulsed Nd: YAG laser treatment was effective in the control and relief of most aphthous lesions."
Detailed performance from the second study (3 case studies):
- Immediate relief of painful symptoms.
- Authors' conclusion: "laser treatment compared favorably with other treatments due to no side effects or contraindications, and immediate palliation of the lesions." |
| Substantial Equivalence: To existing intraoral soft tissue use. | "The use of the PulseMaster laser for treatment of aphthous ulcers is substantially equivalent to the use of the PulseMaster laser for coagulation of other intraoral soft tissue." (Summary asserts this based on study results). "The use of the PulseMaster laser for treatment of aphthous ulcers is substantially equivalent to the use of the PulseMaster laser for ablation and coagulation of other intraoral soft tissues." (Conclusion of the summary) |
2. Sample Size Used for the Test Set and the Data Provenance
- Test Set Sample Size:
- First study: 21 patients (8 with recurrent aphthous ulcers, 14 with herpes labialis lesions - it's unclear if all 21 had aphthous ulcers or if the 14 herpes patients were also treated for aphthous ulcers if present. The reported results focus on "those with aphthous ulcers.")
- Second study: 3 case studies (patients with recurrent aphthous ulcers).
- Data Provenance: Not explicitly stated (e.g., country of origin). Both studies are described as "Independent studies." No mention of retrospective or prospective; however, the description of follow-up periods and daily calendars suggests they were prospective studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- The text refers to "the investigator's evaluation at follow-ups" in the first study. It does not specify the number of investigators/experts or their qualifications (e.g., "radiologist with 10 years of experience").
- For the second study, "The authors' conclusion" is mentioned, implying expert evaluation, but again, no specific details on number or qualifications.
4. Adjudication Method for the Test Set
- The text explicitly mentions: "Results were based on both the investigator's evaluation at follow-ups and the patient's self evaluation." This indicates a dual assessment, but no formal adjudication method (like 2+1 or 3+1 consensus) between different investigators or in cases of disagreement between investigator and patient is described.
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
- No, an MRMC comparative effectiveness study was not done.
- The device is a direct treatment laser, not an AI diagnostic or assistance tool for human readers. Therefore, the concept of "human readers improve with AI" is not applicable here.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Yes, in spirit. The studies evaluate the laser device's direct performance as a standalone treatment without explicit human-in-the-loop diagnostic assistance within the evaluation itself. The human is operating the device, but the device's efficacy is being measured. The laser itself is not an "algorithm" in the typical sense of AI, but its effect is observed directly.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Combined Expert Evaluation and Patient Reported Outcomes (PROs):
- First study: "investigator's evaluation at follow-ups" (expert clinical assessment) and "patient's self evaluation" (patient-reported outcomes for pain relief, healing speed, recurrence).
- Second study: Based on "patients reported no discomfort," "immediate relief of the painful symptoms," and "The authors' conclusion" (expert clinical opinion).
- No mention of objective measures like pathology or specific outcomes data beyond clinical assessment and patient reporting.
8. The sample size for the training set
- Not applicable / Not explicitly mentioned. The provided text describes clinical studies evaluating the laser's performance. The laser itself is a physical device, not an AI/machine learning algorithm that requires a "training set" in the context of device development. The closest analogy would be prior clinical experience, but not a formally defined training set as per AI standards.
9. How the ground truth for the training set was established
- Not applicable. As above, there is no "training set" in the context of an AI algorithm, so no ground truth for a training set was established here. The existing literature and prior uses of the PulseMaster for other intraoral soft tissue coagulation might be considered analogous to establishing a baseline understanding, but not a formal ground truth for data for an AI training set.
§ 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.