(113 days)
The Self Adjusting file (SAF) is a mechanically operated endodontic file to be used for cleaning and shaping of root canals, as part of the procedure of root canal treatment.
The ReDent SAF is an endodontic file that is indicated for use in root canal treatment for cleaning and shaping of the root canal. The file portion of the SAF consists of a metal lattice hollow cylinder and is constructed from medical grade nickel-titanium-alloy. The file's cylindrical lattice structure permits compression when inserted into the root canal followed by gradual radial expansion to fill the root canal profile. The file is surface treated by sandblasting, enabling it to file dentin from the canal's interior surface.
The SAF is available in 3 standard lengths, 21mm and 25mm and 31 mm.
The SAF should be mounted on a vertical-motion vibration contra-angle handpiece with a 0.4mm amplitude and vertical vibration of 3000 - 5000 OPM (oscillations per minute). The file is attached to the handpiece via a polypropylene shank.
The provided 510(k) summary for the REDENT NOVA's SAF (Self Adjusting File) does not contain the detailed information requested regarding specific acceptance criteria, a quantitative study proving the device meets those criteria, or details about ground truth establishment, sample sizes for test and training sets, or expert involvement.
The summary states: "Performance tests were carried out to evaluate the properties of the SAF. In all instances the SAF functioned as intended and results observed were as expected." However, it does not provide the specifics of these tests.
Therefore, many of the requested fields cannot be filled. Based on the provided text, here is what can be extracted and what is missing:
Acceptance Criteria and Device Performance
| Acceptance Criteria (Stated) | Reported Device Performance |
|---|---|
| Functioned as intended | In all instances the SAF functioned as intended. |
| Results observed were as expected | Results observed were as expected. |
| Specific quantitative criteria (e.g., shaping efficacy, canal deviation, fracture resistance, etc.) | Not provided in the document. |
Note: The document broadly states the device "functioned as intended" and "results observed were as expected." This is a general statement and lacks quantitative or specific performance metrics that would typically define acceptance criteria for a medical device.
Study Information
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not provided. The document only mentions "Performance tests were carried out," but no details about the sample size or type of study (in vitro, in vivo, etc.) are given.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not provided. The summary does not describe a study involving "ground truth" established by experts in the context of diagnostic or interpretive performance. The performance tests mentioned appear to be mechanical or functional evaluations of the device itself.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable / Not provided. No information on adjudication is present as this type of study was not described.
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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. This device is an endodontic file, a mechanical tool, not an AI-assisted diagnostic or interpretive system. Therefore, an MRMC study related to interpretation would not be applicable.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a mechanical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable / Not provided. The document describes performance tests for a mechanical device. The "ground truth" would likely be defined by engineering specifications or established dental standards for root canal preparation, but the specifics are not detailed.
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The sample size for the training set:
- Not applicable. This device is a mechanical tool and does not involve a "training set" in the context of machine learning.
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How the ground truth for the training set was established:
- Not applicable. This device is a mechanical tool and does not involve a "training set" or "ground truth for a training set" in the context of machine learning.
Summary of what is known:
The REDENT NOVA's SAF (Self Adjusting File) is a mechanically operated endodontic file for cleaning and shaping root canals. Performance tests were conducted, and the manufacturer reported that the device "functioned as intended" and "results observed were as expected." The device was found substantially equivalent to predicate devices (Quantec Series 2000, ProFile Series 29, and ProTaper) based on similar intended use, indications, technological characteristics, principles of operation, and these performance data.
Key Missing Information:
The document lacks any specific, quantifiable acceptance criteria. It also does not provide details about the methodology, sample sizes, specific measurements, or results of the "performance tests" that were conducted. Without these details, a comprehensive description of how the device demonstrably meets quantitative acceptance criteria cannot be provided.
§ 872.4200 Dental handpiece and accessories.
(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.