(58 days)
ANTHOGYR's fully autoclavable contra-angles Implantology "MontBlanc" Control are devices intended for a wide range of dental procedures including: Implant surgery such as perforating the bone, tapping and threading procedures This range can be used with special accessories like depth stop.
ANTHOGYR has developed a full range of surgical contra angle intended to be used in implantology. The name of the range is "MontBlanc". ANTHOGYR Contra angles design, size and performance conform to N.F. EN ISO 7785-2 "Dental Handpieces -Part 2: Straight and geared angle handpieces: ".
This document describes a Special 510(k) submission for a modification to existing ANTHOGYR dental contra-angles. The information provided focuses on demonstrating substantial equivalence to predicate devices rather than presenting a standalone study with detailed acceptance criteria and performance data for a novel AI/software device.
Therefore, many of the requested sections regarding AI/software performance will be marked as "Not Applicable" or "Information Not Provided," as this submission does not pertain to such a device.
Here's an analysis of the provided text based on your request:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (from recognized standards) | Reported Device Performance |
|---|---|
| Material & Design: | |
| ISO 14971 (2001): Medical device risk management compliant | ANTHOGYR Contra angles & Handpieces conform. |
| ISO 15223 (2000): Medical device symbols compliant | ANTHOGYR Contra angles & Handpieces conform. |
| ISO 13402 (2002): Resistance against autoclaving, corrosion, thermal exposure | ANTHOGYR Contra angles & Handpieces conform. |
| ISO 7153-1 (1999): Surgical instruments - Metallic materials - Part 1: Stainless steel | ANTHOGYR Contra angles & Handpieces conform. |
| ISO 13485 (1996): Quality management system (specific to medical devices) compliant | ANTHOGYR Contra angles & Handpieces conform. |
| Performance (Mechanical/Functional): | |
| ISO 7785-2 (1995): Dental Handpieces - Part 2: Straight and geared angle handpieces | ANTHOGYR Contra angles design, size and performance conform to N.F. EN ISO 7785-2. |
| ISO 3964 (1982): Dental Handpieces - Coupling dimensions | ANTHOGYR Contra angles & Handpieces conform. |
| NF EN ISO 1797-1 (1995): Dental rotatory instruments Shanks Part 1: Shanks made of metal | ANTHOGYR Contra angles & Handpieces conform. |
| Sterilization: | |
| NF EN ISO 17664 (2004): Information for processing resterilizable medical devices | ANTHOGYR Contra angles & Handpieces conform. |
| Substantial Equivalence: | |
| Same fundamental scientific technology, operating principle, and intended use as predicate devices (K040674 and K060317). | The modification (addition of a depth stop option) is a design improvement of non-essential characteristics, maintaining the same fundamental scientific technology, operating principle, and intended use. |
Explanation: The acceptance criteria are primarily based on conformity to recognized international and national standards for dental handpieces and medical device quality management. The reported performance is a general statement that the device "conforms" to these standards. There are no numerical performance metrics or specific test results detailed in this summary.
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 Applicable. This submission describes a modification to a mechanical medical device (dental contra-angle), not a software or AI device that would typically have a "test set" in the context of diagnostic performance. Technical aspects are evaluated against engineering standards.
- Data Provenance: Not Applicable. The data provided refers to conformity with manufacturing and performance standards, not to clinical data or AI model output.
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)
- Number of Experts: Not Applicable. Ground truth as typically understood for AI/software devices (e.g., diagnostic labels) is not relevant here. Compliance with engineering standards is verified through testing and certifications, not expert annotation of a test set.
- Qualifications of Experts: Not Applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: 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
- MRMC Study: No. This is a mechanical device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not Applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: The "ground truth" for this type of device is compliance with established engineering and safety standards (e.g., ISO, NF EN standards) for mechanical performance, material properties, and quality systems. This is verified through testing procedures outlined within those standards, often conducted by manufacturers or certified testing bodies, rather than clinical outcomes or pathology data.
8. The sample size for the training set
- Sample Size for Training Set: Not Applicable. This is not an AI/machine learning device; there is no training set.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: 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.