(70 days)
ANTHOGYR's fully autoclavable contra-angles Implantology "MontBlanc" and 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 crown preparation, finishing tooth preparations, restaurations and polishing teeth.
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 NF EN ISO 7785-2 Dental Handpieces -Part 2: Straight and geared angle handpieces".
ANTHOGYR has developed a full range of general dentistry contra angle intended to be used in general dentistry. The name of the range is "MontBlanc". ANTHOGYR Contra anales design, size and performance conform to NF EN ISO 7785-2 "Dental Handpieces - Part 2: Straight and geared anale handbieces".
The provided text describes a 510(k) premarket notification for "ANTHOGYR DENTAL CONTRA-ANGLES." This document focuses on demonstrating substantial equivalence to predicate devices and adherence to recognized standards, rather than presenting a study with specific acceptance criteria and detailed device performance metrics in the format requested.
Therefore, much of the requested information regarding acceptance criteria, specific study details, and performance data from a clinical or extensive bench study is not available within this document. The submission relies on compliance with established international standards for dental handpieces and risk management.
Here's a breakdown of what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: The acceptance criteria are implicitly defined by compliance with the referenced international standards. The document states that "ANTHOGYR Contra angles design, size and performance conform to NF EN ISO 7785-2 Dental Handpieces -Part 2: Straight and geared angle handpieces." Other standards listed (ISO 14971, ISO 15223, ISO 13402, ISO 3964, ISO 5832-1, ISO 13485, NF EN ISO 1797-1, NF EN ISO 17664, NF EN ISO 17665-1) also serve as acceptance criteria for various aspects like risk management, labeling, resistance to autoclaving/corrosion, coupling dimensions, and material properties.
- Reported Device Performance: The document generally states that the devices conform to these standards. It does not provide specific quantitative performance metrics (e.g., torque values, RPMs, durability cycles, temperature ranges, or specific sterilization effectiveness rates) from a dedicated study that would allow a direct comparison to numerical acceptance thresholds.
| Aspect of Performance | Acceptance Criteria (Implicit from Standards) | Reported Device Performance |
|---|---|---|
| Design, Size, Performance | Conformance to NF EN ISO 7785-2 (2008) "Dental handpieces -- Part 2: Straight and geared angle handpieces" | Devices "conform to NF EN ISO 7785-2" |
| Risk Management | Conformance to ISO 14971 (2007) "Medical devices - Application of risk management to medical devices" | Devices "conform to ... ISO 14971" |
| Labeling | Conformance to ISO 15223 (2007) "Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied" | Devices "conform to ... ISO 15223" |
| Autoclaving, Corrosion, Thermal Exposure Resistance | Conformance to ISO 13402 (2007) "Surgical and dental hand instruments Determination of resistance against autoclaving, corrosion and thermal exposure" | Devices "conform to ... ISO 13402" |
| Coupling Dimensions | Conformance to ISO 3964 (1982) "DENTAL HANDPIECES COUPLING DIMENSIONS" | Devices "conform to ... ISO 3964" |
| Metallic Materials | Conformance to ISO 5832-1 (2008) "IMPLANTS FOR SURGERY -- METALLIC MATERIALS -> PART 1: WROUGHT STAINLESS STEEL" | Devices "conform to ... ISO 5832-1" |
| Quality Management System | Conformance to ISO 13485 (2004) "Medical devices - Particular requirements for the application of the ISO 9001" | Devices "conform to ... ISO 13485" |
| Rotating Instruments Shanks | Conformance to NF EN ISO 1797-1 (1995) "Dental rotatory instruments - Shanks - Par 1: Shanks made of metal" | Devices "conform to ... NF EN ISO 1797-1" |
| Sterilization Instructions (Manufacturer Provided) | Conformance to NF EN ISO 17664 (2004) "Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices" | Devices "conform to ... NF EN ISO 17664" |
| Sterilization Process (Moist Heat) | Conformance to NF EN ISO 17665-1 (2006) "Sterilization of health care products Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices" | Devices "conform to ... NF EN ISO 17665-1" |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- This information is not provided in the document. The submission refers to compliance with standards, implying that testing was conducted according to the methodologies prescribed within those standards, but doesn't specify the sample sizes or data provenance for each test.
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/provided. The submission is not for an AI/diagnostic device that requires expert ground truth establishment for a test set. It's for a dental handpiece, where ground truth would relate to physical and mechanical properties measurable against defined standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not applicable/provided. As above, this type of adjudication is typically for subjective assessments in AI or diagnostic studies, not for the objective physical/mechanical testing implied by compliance with ISO standards for a dental handpiece.
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
- This information is not applicable/provided. This is a medical device for general dental and implantology procedures (contra-angles), not an AI-assisted diagnostic or imaging system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This information is not applicable/provided. This is a mechanical dental instrument, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device would be the specifications and requirements stipulated by the referenced international standards (e.g., specific dimensions, material compositions, resistance levels, torque outputs, sterilization efficacy as defined by the standards). These are objective, measurable criteria, not subjective expert assessments or pathology findings.
8. The sample size for the training set
- This information is not applicable/provided. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
- This information is not applicable/provided. As above, this is not an AI/machine learning 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.