(79 days)
ANTHOGYR's fully autoclavable contra-angles "MontBlanc" are devices intended for a wide range of dental procedures including:
- Implant surgery such as perforating the bone, tapping and threading procedures
- General dentistry such as removing carious material, cavity and crow preparation, finishing tooth preparations, restorations and polishing teeth
ANTHOGYR has developed a full range of surgical, reducing, multiplying and 1:1 contra angle intended to be used in implantology and general dentistry procedures. The name of the range is "MontBlanc". ANTHOGYR Contra angles design, size and performance conform to NF EN ISO 7785-2 "Dental Handpieces - Part 2: Straight and geared angle handpieces.
The provided document is a 510(k) summary for a dental device, specifically "ANTHOGYR DENTAL CONTRA-ANGLES AND HANDPIECES." This type of document is for medical device clearance, not for AI/ML software. Therefore, the questions related to AI/ML device performance, such as sample sizes for test and training sets, expert qualifications for ground truth, adjudication methods, multi-reader multi-case studies, and standalone algorithm performance, are not applicable.
The document describes a modification to an existing device (K040674) and focuses on demonstrating substantial equivalence to the predicate device by conformity to recognized consensus standards.
Here's the relevant information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standards Conformed To) | Reported Device Performance |
|---|---|
| ISO 14971 (2001) - Medical devices - Application of risk management to medical devices | ANTHOGYR Contra angles & Handpieces conform to this standard. |
| ISO 15223 (2000) - Medical devices Symbols to be used with medical device labels, labeling and information to be supplied | ANTHOGYR Contra angles & Handpieces conform to this standard. |
| ISO 13402 (2002) - Surgical and dental hand instruments - Determination of resistance against autoclaving, corrosion and thermal exposure | ANTHOGYR Contra angles & Handpieces conform to this standard. |
| ISO 7785-2 (1995) - Dental Handpieces - Part 2: Straight and geared angle handpieces | ANTHOGYR Contra angles & Handpieces conform to this standard. Also, "Validation test included within this submission demonstrates safety, effectiveness and conformity to the FDA recognized consensus standard ISO 7785-2 (1995)". |
| ISO 3964 (1982) - Dental Handpieces Coupling dimensions | ANTHOGYR Contra angles & Handpieces conform to this standard. |
| ISO 7153-1 (1999) - Surgical instruments Metallic materials Part 1 : stainless steel | ANTHOGYR Contra angles & Handpieces conform to this standard. |
| ISO 13485 (1996) - Medical devices Particular requirements for the application of the ISO 9001 | ANTHOGYR Contra angles & Handpieces conform to this standard. |
| NF EN ISO 1797-1 (1995) - Dental rotatory instruments - Shanks - Par 1: Shanks made of metal | ANTHOGYR Contra angles & Handpieces conform to this standard. |
| NF EN ISO 17664 (2004) - Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices | ANTHOGYR Contra angles & Handpieces conform to this standard. |
| Substantial Equivalence to Predicate Device (K040674) | The modified ANTHOGYR Contra-angles "Mont Blanc" have the same fundamental scientific technology, operating principle, and intended use as the predicate device. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified in the document. The document refers to "Validation test included within this submission," but doesn't detail the sample sizes for these tests.
- Data Provenance: Not specified. The submitter is ANTHOGYR from SALLANCHES, FRANCE.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable as this is a traditional medical device, not an AI/ML device relying on expert-annotated ground truth. Performance is demonstrated through conformance to engineering and medical device standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For this type of device, "ground truth" is established by demonstrating compliance with recognized engineering and medical device standards (e.g., ISO 7785-2 for dental handpiece performance, ISO 13402 for resistance to autoclaving/corrosion). These standards define the test methods and acceptance criteria for material properties, functional performance, and safety of the device.
8. The sample size for the training set
- Not applicable.
9. How the ground truth for the training set was established
- Not applicable.
§ 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.