(226 days)
ANTHOGYR's IMPLANTEO implantology and dental surgery motor unit are indicated to perform dental implant surgery, such as perforating the bone and tapping and threading procedures required before placement of implant prosthetics.
ANTHOGYR has developed "IMPLANTEO" implantology and dental surgery motor unit intended to perform dental implant surgery which is substantially equivalent to legally marketed and FDA cleared predicate devices. The ANTHOGYR "IMPLANTEO" implantology and dental surgery motor unit consist of design improvement of non essential characteristics of the device. The ANTHOGYR "IMPLANTEO" implantology and dental surgery motor unit has the same fundamental scientific technology, operating principle and intended use as ANTHOGYR IMPLANTEO (K041279) with ANTHOGYR implantology contra-angle (K090676) or BIEN-AIR CHIROPRO L (K092214) with NSK contra-angle (K970953) or W&H implantMED (K052741) with contra-angle (K080939).
Here's a breakdown of the acceptance criteria and study information for the "IMPLANTEO" Implantology and Dental surgery motor unit, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
For this device, the "acceptance criteria" are primarily established by conformity to recognized industry standards for dental handpieces and medical electrical equipment. The "reported device performance" is essentially that the device conforms to these standards and is substantially equivalent to predicate devices. The document does not provide specific quantitative performance metrics like accuracy, sensitivity, or specificity, as it's a hardware device designed for mechanical tasks.
| Acceptance Criteria (Standards Conformance) | Reported Device Performance |
|---|---|
| Medical Devices Labeling & Information | Anthogyr Contra angles & Handpieces conform to: |
| ISO 15223-1 (2007) "Medical devices – Symbols to be used with medical device labels, labeling and information to be supplied" | ✓ Conforms |
| Dental Handpieces - Electrical & Mechanical | |
| IEC 11498 (1997) "Dental Handpieces: Dental low-voltage electrical motors" | ✓ Conforms |
| ISO 7785-2 (1998) "Dental Handpieces Part 2: Straight and geared angle handpieces" | ✓ Conforms |
| ISO 3964 (1982) "Dental Handpieces Coupling dimensions" | ✓ Conforms |
| NF EN ISO 1797-1 (1995) "Dental rotatory instruments Shanks Part 1: Shanks made of metal" | ✓ Conforms |
| Medical Electrical Equipment - Safety & EMC | |
| IEC 60601-1 (2005) "Medical Electrical Equipment Part 1: General Requirements for safety" | ✓ Conforms |
| IEC 60601-1-2 (2001) "Medical Electrical Equipment part 1-2: General Requirements for safety - collateral standard: Electromagnetic Compatibility - Requirements and tests" | ✓ Conforms |
| Risk Management & Quality Systems | |
| ISO 14971 (2007) "Medical devices Application of risk management to medical devices" | ✓ Conforms |
| ISO 13485 (1996) "Medical devices Particular requirements for the application of the ISO 9001" | ✓ Conforms |
| Sterilization Information | |
| NF EN ISO 17664 (2004) "Sterilization of medical devices Information to be provided by the manufacturer for the processing of resterilizable medical devices" | ✓ Conforms |
| Substantial Equivalence | The device has the same fundamental scientific technology, operating principle, and intended use as the legally marketed predicate devices: ANTHOGYR IMPLANTEO (K041279), ANTHOGYR contra-angle (K090676), BIEN-AIR CHIROPRO L (K092214), W&H implantMED (K052741). |
Note: This is a 510(k) submission for a Class I mechanical device, so the "study" is primarily focused on demonstrating conformance to established safety and performance standards and substantial equivalence to existing devices, rather than a clinical trial with statistical performance metrics like those for diagnostic AI devices.
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a "test set" or "data provenance" in the way one would for an AI/software device. The performance data presented refers to conformity with technical standards for the physical device and its components. Therefore, there isn't a sample size of patient data or clinical images mentioned. The "test set" would implicitly be the manufactured device units themselves undergoing testing against the listed standards.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. For a mechanical device being validated against engineering standards, "experts" in a clinical sense (e.g., radiologists) are not used to establish a "ground truth." The ground truth is defined by the requirements outlined in the engineering and safety standards themselves.
4. Adjudication Method for the Test Set
Not applicable. There is no adjudication method described as would be used for subjective data in diagnostic evaluation. Conformity to standards is typically assessed through objective measurements and verification processes.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of AI-assisted diagnostic tools where human readers are involved. This submission is for a mechanical dental surgery motor unit.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This device is a mechanical motor unit, not an algorithm or AI. Its operation inherently requires a human operator.
7. The Type of Ground Truth Used
The "ground truth" for this device's validation is defined by:
- Engineering and Safety Standards: The technical specifications and requirements outlined in the explicitly listed ISO, IEC, and NF EN standards (e.g., electrical safety, mechanical dimensions, electromagnetic compatibility).
- Predicate Device Performance: The established safety and effectiveness of the legally marketed predicate devices to which this device claims substantial equivalence.
8. The Sample Size for the Training Set
Not applicable. This device is a mechanical motor unit, not an AI or machine learning model that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, 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.