(179 days)
Endo Motor, Ai-Motor and Endo Radar Plus are cordless endodontic treatment motorized handpiece with root canal measurement capability. It can be used for preparation and enlargement of root canals, or measuring the canal length. And it can be used to enlarge the canals while monitoring the file tip inside the canal.
The Endo Motor Series includes a cordless hand-piece with charging adapter. The device has a chuck for holding rotary instruments such as dental files, and is mainly used in Endodontic surgeries. The device can enlarge the root canal by filing the dentin and measuring the root canal length, and may also be used for cutting and grinding for the preparation of root canal surgery. The rotary speed and the torque range can also be adjusted.
The provided document, K203320, is a 510(k) premarket notification for an "Endo Motor" device. This device is a dental handpiece with root canal measurement capability. The 510(k) summary focuses on demonstrating "substantial equivalence" to a predicate device through non-clinical testing and comparison of technical specifications. It does not present a study proving the device meets specific acceptance criteria based on clinical performance metrics (e.g., accuracy, sensitivity, specificity) of an AI/algorithm-driven device.
The document states that "Performance Comparison Testing of Root Canal Measurement Passed," but it does not provide details on the acceptance criteria or how this testing was conducted (e.g., sample size, ground truth, expert involvement).
Therefore, I cannot fully answer your request for information regarding acceptance criteria and the study proving the device meets them, as the provided document lacks the empirical data and methodology typically found in studies for AI/algorithm-driven devices concerning clinical performance.
However, I can extract the information provided about the non-clinical testing performed to support substantial equivalence:
Acceptance Criteria & Device Performance (Based on Non-Clinical Testing for Substantial Equivalence)
The document primarily relies on non-clinical testing and comparison to a predicate device to demonstrate substantial equivalence, rather than a clinical performance study with explicit acceptance criteria for an AI/algorithm.
| Acceptance Criterion (Non-Clinical) | Reported Device Performance | Comments |
|---|---|---|
| Cytotoxicity testing per ISO 10993-5 | Passed | |
| Sensitization testing per ISO 10993-10 | Passed | |
| Electrical safety testing per IEC 60601-1 | Passed | |
| Electromagnetic Disturbance (EMD) testing per IEC 60601-1-2 | Passed | |
| Software verification and validation per IEC 62304/FDA Guidance | Met Requirements | No specific details on software performance are provided beyond meeting general requirements. |
| Usability per IEC 62366-1 | Met specifications | |
| Shipping Containers and Systems Performance, per ASTM D4169 | Demonstrates package integrity maintained | |
| Dental Performance Requirements, per IEC 80601-2-60 | Passed | General statement, no specific metric given. |
| Processing of Medical Device, per ISO 17664 | Passed | |
| Development, Validation and Routine Control of Sterilization Process, per ISO 17665-1 | Passed | |
| Moist Heat Sterilization, per ISO TS 17665-2 | Passed | |
| Dentistry - Handpieces and Motors, per ISO 14457 | Passed | General statement, no specific metric given. |
| Performance Comparison Testing of Root Canal Measurement | Passed | Crucially, no specific acceptance criteria (e.g., accuracy range in mm, error rate) for the root canal measurement capability are explicitly stated, nor are the details of this "Performance Comparison Testing" provided (e.g., sample size, methodology, ground truth establishment). This is the closest the document comes to a performance metric relevant to its "measurement capability." |
Detailed Answers to Specific Questions:
1. A table of acceptance criteria and the reported device performance
See table above. Note that for "Performance Comparison Testing of Root Canal Measurement," while it states "Passed," no quantitative acceptance criteria or specific performance metrics are provided in the document.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable / Not provided. The document primarily reports non-clinical engineering and biological tests, and a comparison of technical specifications to a predicate device. There is no mention of a clinical "test set" with a specified sample size or data provenance in the context of root canal measurement performance.
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)
Not applicable / Not provided. There is no mention of expert involvement for establishing ground truth for any performance study in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable / Not provided. No test set or adjudication method is described.
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
No. The device is an "Endo Motor," a physical dental handpiece. It is not an AI/software device that would involve "human readers" or AI assistance in the way described for an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The description implies that the device's "root canal measurement capability" is integral to the motor's function. While there's a "Performance Comparison Testing of Root Canal Measurement Passed," the document does not provide details on whether this was a true "standalone" algorithm performance evaluation with explicit metrics, or simply a functional test. Given the regulatory class (Class I, reserved) and the nature of the device (a physical handpiece), it is highly unlikely that a rigorous clinical standalone performance study, as typically seen for AI/ML devices, was conducted or required.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not provided. For the "Performance Comparison Testing of Root Canal Measurement," the document does not specify how the "ground truth" for root canal length was established.
8. The sample size for the training set
Not applicable / Not provided. This device is not described as an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable / Not provided. This device is not described as an AI/ML device that requires a training set.
In summary, the provided FDA 510(k) document (K203320) focuses on demonstrating "substantial equivalence" of a physical dental device (Endo Motor) through a comparison of design, intended use, and non-clinical testing results against a predicate device. It does not contain the kind of clinical performance study details (e.g., acceptance criteria for diagnostic accuracy, sample sizes of test/training sets, ground truth establishment by experts, MRMC studies) typically associated with AI/algorithm-driven medical devices. The "Performance Comparison Testing of Root Canal Measurement" is mentioned as "Passed," but without any specifics provided in this document regarding its methodology or quantitative results.
§ 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.