(382 days)
The Impla-NX (Model: ISE-270M) is intended for use in dental oral surgery and dental implant. The main unit is designed to be used with a specific dental micromotor that drives dental handpieces fitted with appropriate tools to cut hard tissues in the mouth.
As an engine to operate and control handpiece used for dental implant surgery, this device is composed of main body, BLDC motor and foot control.
With external power supply being provided, this device operates the main body through switching AC power to DC power and it performs dental implant surgery with handpiece being connected for rotation power generated through turning BLDC motor.
The provided text does not contain information about acceptance criteria for device performance with specific metrics like sensitivity, specificity, or AUC, nor does it detail a study proving the device meets such criteria in terms of clinical outcomes or diagnostic accuracy.
Instead, the document is a 510(k) summary for a dental handpiece and accessories, Impla-NX (Model: ISE-270M), demonstrating substantial equivalence to a predicate device (Surgic Pro by NSK Nakanishi, Inc.). The performance testing mentioned is primarily non-clinical bench testing against various ISO and IEC standards related to dental equipment, electrical safety, EMC, photobiological safety, and sterilization validation.
Therefore, most of the requested information cannot be extracted from this document as it pertains to clinical performance studies and AI/human reader assessments, which are not relevant to this device's regulatory submission as presented.
However, I can provide information based on the type of performance tests conducted and the general conclusion:
1. A table of acceptance criteria and the reported device performance:
The document lists various international standards that the device was tested against. The "acceptance criteria" would be compliance with these standards, and the "reported device performance" is that these tests were conducted and found to be compliant. Specific numerical performance metrics for each standard are not provided in this summary.
| Acceptance Criteria (Standards Compliance) | Reported Device Performance |
|---|---|
| ISO 3964 Dental Handpieces Coupling dimensions | Testing conducted, no violations of requirements. |
| ISO 7494-1 Dentistry - Dental units -Part 1: General requirements and test methods | Testing conducted, no violations of requirements. |
| ISO 14457:2017 Dentistry Handpieces and motors | Testing conducted, no violations of requirements. |
| ISO 17665-1, 2 Steam Sterilization Validation | Sterilization validation conducted, no violations of requirements. |
| IEC 60601-1, IEC 60601-1-2: Electrical safety and EMC | Electrical safety and EMC testing conducted, no violations of requirements. |
| IEC 80601-2-60: Particular Requirements For The Basic Safety And Essential Performance Of Dental Equipment | Testing conducted, no violations of requirements. |
| IEC 62471 Photobiological safety of lamps and lamp systems | Testing conducted, no violations of requirements. |
| Software Validation | Software validation conducted, no violations of requirements. |
2. Sample size used for the test set and the data provenance: Not applicable. The document describes non-clinical bench testing against standards, not a clinical study with a patient test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is not a study requiring expert-established ground truth for diagnostic purposes.
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. This device is a dental surgical engine, not an AI-assisted diagnostic tool.
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.): Not applicable for clinical ground truth. For the non-clinical tests, the "ground truth" would be the specifications and requirements defined by the respective ISO and IEC standards.
8. The sample size for the training set: Not applicable. This is not an AI/machine learning device requiring a training set.
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.