(75 days)
ANTHOGYR's fully autoclavable contra-angles Implantology « Impulsion » 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 « Impulsion » . 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 describes a Special 510(k) for a modification to Anthogyr Dental Contra-Angles. This type of submission is typically for minor changes to a legally marketed device and often relies on conformance to recognized consensus standards rather than extensive clinical studies.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standard Conformance) | Reported Device Performance (Conformance Statement) |
|---|---|
| ISO 14971 (2001) - Medical devices - Application of risk management to medical devices | Conforms to ISO 14971 (2001) |
| ISO 15223 (2000) - Medical devices Symbols to be used with medical device labels, labeling and information to be supplied | Conforms to ISO 15223 (2000) |
| ISO 13402 (2002) - Surgical and dental hand instruments Determination of resistance against autoclaving, corrosion and thermal exposure | Conforms to ISO 13402 (2002) |
| ISO 7785-2 (1995) - Dental Handpieces Part 2: Straight and geared angle handpieces | Conforms to ISO 7785-2 (1995) and NF EN ISO 7785-2 |
| ISO 3964 (1982) - Dental Handpieces - Coupling dimensions | Conforms to ISO 3964 (1982) |
| ISO 7153-1 (1999) - Surgical instruments - Metallic materials - Part 1 : stainless steel | Conforms to ISO 7153-1 (1999) |
| ISO 13485 (1996) - Medical devices Particular requirements for the application of the ISO 9001 | Conforms to ISO 13485 (1996) |
| NF EN ISO 1797-1 (1995) - Dental rotatory instruments - Shanks - Part 1: Shanks made of metal | Conforms to NF EN ISO 1797-1 (1995) |
| NF EN ISO 17664 (2004) - Sterilization of medical devices Information to be provided by the manufacturer for the processing of resterilizable medical devices | Conforms to NF EN ISO 17664 (2004) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not report any specific test set sample size or data provenance for human-involved studies. The performance data section refers to conformance with recognized consensus standards, implying that the device was tested against the requirements of these standards. The nature of these standards (e.g., mechanical testing, material analysis, risk management processes) would dictate the "sample size" and "provenance" in a manufacturing and testing context, but this information is not detailed here.
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)
This information is not applicable and not provided in the context of this device. The regulatory submission relies on conformance to engineering and material standards, not diagnostic or clinical expert review of a "test set" in the way an AI algorithm might.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided. No expert adjudication method is described, as the evaluation is based on conformance to established standards.
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
A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted and is not relevant to this type of device (dental contra-angles). This is a hardware device, not an AI or diagnostic software.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable to a dental contra-angle device. There is no algorithm or AI component in this device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device is defined by the requirements and specifications within the referenced international and national standards. For example, for mechanical properties, the ground truth would be the defined acceptable limits and test methods in ISO 7785-2. For material composition, it would be the specifications in ISO 7153-1. These are established engineering and quality standards, not clinical "ground truth" derived from patient data or expert consensus in a diagnostic sense.
8. The sample size for the training set
This information is not applicable and not provided. This device is not an AI/ML product and does not have a "training set."
9. How the ground truth for the training set was established
This information is not applicable and not provided, as there is no training set for this type of device.
§ 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.