(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.
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JUN 2 5 2003
510(k) Summary
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Name/Address of Submitter: NEKS Technologies 230, Bernard-Belleau, Bureau 221 Laval, Quebec H7V 4A9 Canada
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Contact Person: Daniel Fortin, DMD, MS Vice President for R & D Phone: (450) 973-3598 Fax: (450) 973-3881
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Date Summary Prepared: June 16, 2003
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Device Name: DETECTAR
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Predicate Devices: Probe®Perio 2000 System (K980749) DentalView®PerioView® System (K973492/K982480) DIAGNOdent Laser Fluorescence Caries Detection Device (K983658) Alpha 4 LS Automated Microtiterplate Processor (K973638) Manual periodontal probes [510(k) exempt]
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- Device Description and Intended Use:
DETECTAR is indicated for use in 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. The labeling includes the following statement:
- Device Description and Intended Use:
"CAUTION: The DetecTar™ unit is capable of detecting calculus particles as small as 0.1 mm2. CAUTION SHALL BE EXERCIZED TO AVOID OVERINSTRUMENTATION IN THE REMOVAL OF VERY SMALL PARTICLES OF CALCULUS. The significance of removal of calculus of 0.1mm is presently unknown. Clinically considered professional judgment shall be applied to the determination of whether detected calculus shall be removed."
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- Brief Description of Non-clinical Testing:
An in vitro evaluation comparing the DETECTAR with a periodontal probe was conducted by three experienced clinicians. A piece of pig gingiva was set on
- Brief Description of Non-clinical Testing:
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the root surface of the teeth to simulate the periodontium and conceal the root surface. To complete the model, drops of blood were introduced between the gingiva and the tooth before the clinician performed an evaluation. Seven variables were studied. The DETECTAR significantly outperformed the manual periodontal probe.
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- Conclusions Drawn: Substantially equivalent to the cited predicate devices.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 5 2003
NEKS Technologies C/O Mr. Charles H. Kyper Kyper & Associates, LLC 103 Nolen Lane Chapel Hills, North California 27516
Re: K023367 Trade/Device Name: DETECTAR Regulation Number: 872.4565, 872.1745 Regulation Name: Dental Hand Instrument, Laser Fluorescence Caries Detection Device Regulatory Class: II Product Code: EJB, NBL Dated: June 16, 2003 Received: June 17, 2003
Dear Mr. Kyper:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Kyper
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Susa Puma
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indication for Use
K0233667
510(k) Number ( if known):
Device Name: DETECTAR
Indication for Use: DETECTAR is indicated for the detection of subgingival dental calculus
Concurrence of CDRH Office of Device Evaluation
Prescription Use (per 21 CFR 801.109) OR
Over-the-counter Use _________________________________________________________________________________________________________________________________________________________
Kein Muly for MSD
(Division Sign Off)
nesthesiology, General Hospital, ontrol, Dental I
510(k) Number]
§ 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.