(342 days)
Sulcular Debridement
Dental Laser System
This 510(k) summary describes a clinical study for a new indication for use of the PulseMaster laser system: sulcular debridement and bacterial reduction. The provided document focuses on the clinical study's findings regarding safety and efficacy, drawing comparisons between laser treatment and standard treatment. However, it does not explicitly state specific acceptance criteria (e.g., target accuracy, sensitivity, specificity thresholds) that the device was expected to meet. Therefore, I cannot provide a table of acceptance criteria and reported device performance with specific metrics.
Based on the provided text, here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
As mentioned, explicit, quantitative acceptance criteria are not stated in the provided text. The study aimed to demonstrate equivalence.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety: No new safety risks compared to other soft-tissue removal procedures in the oral cavity. | - No changes observed in the surface condition of any teeth from pre-treatment to post-treatment. |
- No differences in pulp condition between laser treatment and standard treatment.
- "No new safety risks for this laser procedure. All teeth in the study were healthy out to six months." |
| Efficacy (Short-term): Equivalence to standard treatment in improving clinical indices and microbiological measurements. | - Significant differences between treated teeth and no-treatment teeth in several indices at one month and three months. - Laser treatment and standard treatment showed equivalent results. |
| Efficacy (Long-term): Not explicitly stated, but "By six months all treatment differences had disappeared" suggests a return to baseline or similar long-term outcomes for both treatments. | - By six months all treatment differences had disappeared. |
2. Sample Size and Data Provenance:
- Sample Size: The document does not specify the exact number of patients or quadrants included in the study. It only states, "The patients were treated with standard treatment, laser treatment, or no-treatment on different quadrants of the mouth which were randomly assigned."
- Data Provenance: Not explicitly stated. The document describes a "clinical study," implying a prospective design, but it does not specify the country of origin.
3. Number of Experts and Qualifications for Ground Truth of Test Set:
- The document mentions "blinded evaluators" performing pulp evaluations and tooth surface conditions for safety. It does not state the number or specific qualifications of these evaluators or if they were considered "experts" for establishing ground truth for efficacy endpoints.
- For efficacy, "clinical indices and microbiological measurements were made." It's not specified who performed these measurements or if they were considered experts for ground truth establishment.
4. Adjudication Method for the Test Set:
- The document does not describe any specific adjudication method (e.g., 2+1, 3+1). It mentions "blinded evaluators" for safety assessments, implying independent assessment, but further detail is lacking.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:
- No, a MRMC comparative effectiveness study is not described. The study compares a laser treatment to a standard treatment, not human readers with and without AI assistance. The device in question is a medical device (laser system), not an AI diagnostic tool.
6. Standalone Performance:
- This is not applicable in the context of this document. The PulseMaster laser system is a treatment device, not a diagnostic algorithm, so "standalone (i.e., algorithm only without human-in-the-loop performance)" does not apply. The study assesses the performance of the treatment performed by the device, likely by a human operator.
7. Type of Ground Truth Used:
- For Safety: Clinical observation by "blinded evaluators" regarding pulp evaluations and tooth surface conditions.
- For Efficacy:
- Clinical indices: These would be standardized clinical measurements (e.g., probing depth, bleeding on probing, clinical attachment levels) typically collected by trained dental professionals.
- Microbiological measurements: Laboratory tests to quantify or identify specific bacteria.
8. Sample Size for the Training Set:
- The document does not describe a "training set" as this is a clinical trial, not an AI model development. The entire patient cohort where the treatments were applied serves as the study population.
9. How Ground Truth for the Training Set Was Established:
- Not applicable as there is no "training set" in the context of this traditional clinical trial for a medical device. The "ground truth" for evaluating the treatment effectiveness was established through the clinical and microbiological measurements taken across the study's duration.
§ 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.