(147 days)
The American Dental Technologies, Inc. PulseMaster Dental Laser Systems are indicated for use for selective ablation of enamel (first degree) dental caries.
The American Dental Technologies PulseMaster Dental Laser Systems are Nd:YAG lasers producing laser emission at 1064 nm. The lasers consist of two interconnected sections: The cabinet which houses the laser head, the power supply, the cooling system and the microprocessor with control panel; and the fiber optic delivery system.
The provided text describes the 510(k) summary for the American Dental Technologies PulseMaster Dental Laser Systems (K984486). While it discusses the device's intended use and general performance data, it does not explicitly state specific numerical acceptance criteria or detail a formal study designed to prove the device meets such criteria.
Here's an analysis based on the information provided, addressing your requested points where possible, and noting where information is absent:
Acceptance Criteria and Device Performance
The document states that the device is "substantially equivalent" to predicate devices, which is the primary mechanism for 510(k) clearance. This means the performance is deemed acceptable if it's comparable to existing, legally marketed devices for the same intended use.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Safety for Intended Use: (Based on historical safety of predicate devices and histology results) | "The histology indicated that the device is safe for the intended use." This is a qualitative statement without specific metrics or thresholds. |
| Effectiveness for Selective Ablation of First-Degree Enamel Caries: (Based on comparison to predicate laser and high-speed handpiece) | "Clinical data from a multi-center, blinded, randomized study comparing the PulseMaster to the highspeed handpiece established the safety and effectiveness of the PulseMaster Dental Laser Systems for the Intended use." No specific numerical performance metrics (e.g., success rate, ablation depth, side effect rates) are provided. |
| Equivalence in Temporal Pulse Structures and Effects on Enamel Caries: (Bench test comparison to a pulsed Er:YAG Dental Laser) | "Bench test data... measured the temporal pulse structures and effects on enamel caries and found the two lasers to be equivalent." Again, this is a qualitative statement of equivalence without specific numerical data. |
Study Details for Demonstrating Acceptance Criteria
The document mentions both nonclinical (bench) and clinical performance data.
2. Sample size used for the test set and the data provenance:
- Bench Test: No sample size is provided. The provenance is "under controlled scientific conditions" but no country or retrospective/prospective status is specified.
- Clinical Study: "An extracted tooth study" for histology and a "multi-center, blinded, randomized study" for safety and effectiveness. No sample sizes for either are provided. The provenance is not explicitly stated beyond "multi-center," so country of origin is unknown, but it was a prospective study (randomized).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Bench Test: Not applicable, as it involved physical measurements.
- Extracted Tooth Study (Histology): Not specified. Likely involved a pathologist or histologist, but their number and qualifications are not mentioned.
- Clinical Study: Not specified how ground truth (e.g., initial caries diagnosis, assessment of ablation) was established or by whom.
4. Adjudication method for the test set:
- Not specified for any of the studies mentioned.
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 device is a dental laser, not an AI-assisted diagnostic or imaging device for human readers. The clinical study compared the laser to a high-speed handpiece, which is a comparison of two treatment methods, not an AI-reader performance study.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a medical device (laser system), not an algorithm. Its performance is inherent to its physical operation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Bench Test: Physical measurements of temporal pulse structures and effects on enamel caries.
- Extracted Tooth Study: Histology (likely considered a form of pathology).
- Clinical Study: Not explicitly detailed, but would involve clinical assessment of caries and treatment outcomes, likely by dentists or dental professionals.
8. The sample size for the training set:
- Not applicable. This is a hardware medical device, not a machine learning model that requires a training set in that context.
9. How the ground truth for the training set was established:
- Not applicable. (See 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.