(260 days)
DETECTAR is indicated for use in the detection of subgingival dental calculus.
DETECTAR is indicated for the detection of subgingival dental calculus
The DETECTAR probe is similar in intended use, size, and shape to a manual periodontal probe. The DETECTAR probe contains an optical fiber that reads the optical signature of dental calculus and converts it into an electrical signal. From that electrical signal a computer analysis identifies the dental calculus.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated in the provided document. However, the study aims to show that DETECTAR performs better than a manual periodontal probe in detecting subgingival dental calculus. The reported device performance is that "The DETECTAR significantly outperformed the manual periodontal probe" in an in vitro evaluation.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Detects subgingival dental calculus effectively | DETECTAR significantly outperformed the manual periodontal probe |
| Better than or equal to manual periodontal probe in detection | DETECTAR significantly outperformed the manual periodontal probe |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The study involved a "piece of pig gingiva... on the root surface of the teeth" and a comparison with a manual periodontal probe. The number of teeth or calculus samples tested is not quantified.
- Data Provenance: In vitro evaluation. The country of origin is not specified but the submitter is from Quebec, Canada. Retrospective or prospective is not applicable for an in vitro study of this nature.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Three experienced clinicians.
- Qualifications: Described as "experienced clinicians." Specific qualifications (e.g., years of experience, specialty) are not provided beyond "experienced." The document implies these clinicians are performing the evaluations and their observations contribute to the findings.
4. Adjudication Method for the Test Set
The document does not describe an explicit adjudication method. The three experienced clinicians appear to have individually conducted the evaluations and their findings were then compared, leading to the conclusion that DETECTAR "significantly outperformed" the manual probe. It does not mention a consensus-building or tie-breaking process.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly described in terms of human readers improving with AI vs. without AI assistance. The study described is a comparison of a device (DETECTAR) against a manual instrument (periodontal probe) in vitro, with clinicians performing the evaluations. It's not a study of human readers' diagnostic accuracy before and after AI assistance.
6. Standalone Performance Study
Yes, a standalone (algorithm only without human-in-the-loop performance) study was effectively done. The DETECTAR device, which contains an optical fiber and uses "computer analysis" to identify dental calculus, was evaluated on its own in detecting calculus, with the output then presumably interpreted by the clinicians. The "significant outperformance" refers to the device's capability relative to a manual probe.
7. Type of Ground Truth Used
The ground truth used is implicitly the known presence or absence of subgingival dental calculus on the in vitro model (pig gingiva and tooth root). The "drops of blood" were introduced to simulate conditions, suggesting a controlled environment where the presence of calculus could be pre-established or observed reliably by the "experienced clinicians." It is not explicitly stated if a gold standard like histology or micro-CT was used to definitively label the calculus, but rather the clinicians' assessments appear to contribute to the understanding of ground truth or at least the comparative performance.
8. Sample Size for the Training Set
The document does not provide any information about a training set since this appears to be a direct evaluation of the device's performance rather than a validation of a machine learning model that would require a separate training phase. The "computer analysis" identifies dental calculus from an electrical signal, implying a pre-trained algorithm, but the details of that training are not included.
9. How Ground Truth for the Training Set Was Established
Not applicable, as information regarding a training set is not provided in the document.
§ 872.4565 Dental hand instrument.
(a)
Identification. A dental hand instrument is a hand-held device intended to perform various tasks in general dentistry and oral surgery procedures. The device includes the operative burnisher, operative amalgam carrier, operative dental amalgam carver, surgical bone chisel, operative amalgam and foil condenser, endodontic curette, operative curette, periodontic curette, surgical curette, dental surgical elevator, operative dental excavator, operative explorer surgical bone file, operative margin finishing file, periodontic file, periodontic probe, surgical rongeur forceps, surgical tooth extractor forceps, surgical hemostat, periodontic hoe, operative matrix contouring instrument, operative cutting instrument, operative margin finishing periodontic knife, periodontic marker, operative pliers, endodontic root canal plugger, endodontic root canal preparer, surgical biopsy punch, endodontic pulp canal reamer, crown remover, periodontic scaler, collar and crown scissors, endodontic pulp canal filling material spreader, surgical osteotome chisel, endodontic broach, dental wax carver, endodontic pulp canal file, hand instrument for calculus removal, dental depth gauge instrument, plastic dental filling instrument, dental instrument handle, surgical tissue scissors, mouth mirror, orthodontic band driver, orthodontic band pusher, orthodontic band setter, orthodontic bracket aligner, orthodontic pliers, orthodontic ligature tucking instrument, forceps, for articulation paper, forceps for dental dressing, dental matrix band, matrix retainer, dental retractor, dental retractor accessories, periodontic or endodontic irrigating syringe, and restorative or impression material syringe.(b)
Classification. Class I (general controls). If the device is made of the same materials that were used in the device before May 28, 1976, it is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.