(148 days)
Aid in diagnosis of dental pits and fissures and interproximal caries and aid in the detection of dental calculus.
The D-Carie probe contains optical fibers that read the optical scattering characteristic of dental carie thru healthy enamel structure above (the marginal ridge over the vulnerable inteproximal area) and convert it into an electrical signal. From that signal a computer analysis identifies the dental caries. The device can be in either in a new handheld or a tabletop (original) format with the addition or not of the calculus detection feature of the Detectar.
Here's a breakdown of the acceptance criteria and study information for the Neks Technologies, Inc. D-Carie/Detectar device based on the provided text:
Acceptance Criteria and Device Performance
The FDA 510(k) summary does not explicitly state numerical acceptance criteria in a table format. Instead, it indicates that the device's performance for interproximal caries detection is "at least equivalent in efficiency to the FOTI/DIFOTI devices or visual examination."
| Acceptance Criteria (Stated Goal) | Reported Device Performance |
|---|---|
| At least equivalent in efficiency to FOTI/DIFOTI devices or visual examination for interproximal caries detection. | Found to be "at least equivalent in efficiency to the FOTI/DIFOTI devices or visual examination" for interproximal caries detection. |
| D-Carie and Detectar performance equivalent when combined in a single unit. | Bench tests, in vitro, and in vivo trials showed "D-Carie and Detectar performance are equivalent to when they these functions are combined in a single unit." |
| Handheld format (Mini) equivalent to tabletop version in all important aspects. | Bench tests, in vitro, and in vivo trials showed "the handheld format (Mini) is at least equivalent to the tabletop version originally presented in all important aspects." |
Study Details
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Sample sizes used for the test set and data provenance:
- Test Set Sample Size: Not explicitly stated. The document mentions "in vitro and in vivo studies" but does not quantify the number of cases or subjects.
- Data Provenance: Not specified, but given the company is based in Quebec, Canada, it's plausible data was collected in Canada, though this is not confirmed. The document doesn't mention if it was retrospective or prospective.
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Number of experts used to establish the ground truth for the test set and qualifications of those experts:
- Number of Experts: Not specified.
- Qualifications: Not specified.
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Adjudication method for the test set:
- Not mentioned.
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If a multi-reader, multi-case (MRMC) comparative effectiveness study was done:
- No MRMC comparative effectiveness study is described where human readers improve with AI vs. without AI assistance. The comparison is between the device and existing methods (FOTI/DIFOTI, visual examination, bitewings x-rays) as a standalone diagnostic aid.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, the studies described assess the D-Carie/Detectar device as a standalone aid for diagnosis. The phrase "computer analysis identifies the dental caries" suggests an algorithmic analysis.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- "bitewings clichés or histological observation as a gold standard" were used. This indicates a combination of imaging (bitewings) and definitive histological examination (pathology).
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The sample size for the training set:
- Not specified. The document only refers to "in vitro and in vivo studies" and "bench tests" without providing sample sizes for any training that might have occurred for the "computer analysis."
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How the ground truth for the training set was established:
- Not specified. Given the lack of detail on a training set, the method for establishing its ground truth is also not provided.
§ 872.1745 Laser fluorescence caries detection device.
(a)
Identification. A laser fluorescence caries detection device is a laser, a fluorescence detector housed in a dental handpiece, and a control console that performs device calibration, as well as variable tone emitting and fluorescence measurement functions. The intended use of the device is to aid in the detection of tooth decay by measuring increased laser induced fluorescence.(b)
Classification. Class II, subject to the following special controls:(1) Sale, distribution, and use of this device are restricted to prescription use in accordance with § 801.109 of this chapter;
(2) Premarket notifications must include clinical studies, or other relevant information, that demonstrates that the device aids in the detection of tooth decay by measuring increased laser induced fluorescence; and
(3) The labeling must include detailed use instructions with precautions that urge users to:
(i) Read and understand all directions before using the device,
(ii) Store probe tips under proper conditions,
(iii) Properly sterilize the emitter-detector handpick before each use, and
(iv) Properly maintain and handle the instrument in the specified manner and condition.