(98 days)
X-Smart Easy is designed for use by dentists in standard endodontic procedures using rotary endodontic files and rotary endodontic drills (Gates-Glidden).
The X-Smart Easy is an electric motor-driven handpiece intended for root canal preparation procedures in endodontic industry.
The provided text describes the 510(k) submission for the X-Smart Easy dental handpiece. However, it does not include information about specific acceptance criteria related to a numerical performance target (e.g., sensitivity, specificity, accuracy) for an AI/CAD/imaging device, nor does it detail a study designed to prove such criteria.
The document discusses non-clinical performance tests for safety and substantial equivalence, but these are not equivalent to a performance study for an AI algorithm.
Therefore, I cannot fulfill all parts of your request.
Here's what can be extracted based on the provided text, and what cannot:
1. A table of acceptance criteria and the reported device performance
- Cannot provide. The document does not specify numerical acceptance criteria for clinical performance (e.g., accuracy metrics) for the device. It focuses on safety and electrical standards.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified for clinical performance/accuracy | Not specified for clinical performance/accuracy |
| Biocompatibility: Conformance to ISO 10993 | All patient contact components demonstrated biocompatibility. |
| Electromagnetic Compatibility (EMC): Conformance to IEC 60601-1-2 and IEC 61000-3-2 | Conforms to IEC 60601-1-2 and IEC 61000-3-2. |
| Electrical Safety: Conformance to UL60601-1 | Conforms to UL60601-1. |
| Substantial Equivalence: To predicate device K990682 | Demonstrated equivalence of intended use, similar features, and technical characteristics. |
2. Sample size used for the test set and the data provenance
- Cannot provide. The document does not describe a "test set" in the context of data for an AI/CAD/imaging device. The performance testing mentioned is for electrical safety, EMC, and hardware/software functions, not for diagnostic accuracy on a dataset.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Cannot provide. Ground truth and expert adjudication are not applicable to the non-clinical tests performed for this device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot provide. Adjudication is not applicable here.
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
- Cannot provide. This type of study is not mentioned as the device is a dental handpiece, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Cannot provide. Not applicable as this is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot provide. Ground truth is not applicable in the context of the safety and electrical performance tests. The "truth" for these tests would be whether the device meets the specified engineering standards.
8. The sample size for the training set
- Cannot provide. "Training set" is not applicable, as this is a physical device submission, not an AI/ML algorithm submission.
9. How the ground truth for the training set was established
- Cannot provide. Not applicable.
Summary of the Study that Proves the Device Meets Acceptance Criteria (as described in the document):
The document describes non-clinical performance testing rather than a clinical or AI-specific performance study. These tests were conducted to demonstrate the safety and effectiveness of the X-Smart Easy and its substantial equivalence to the predicate device (Prophy-Mate and Endo Mate Motor Handpiece, K990682).
Key areas of testing included:
- Biocompatibility Testing: Performed in accordance with ISO 10993. All patient contact components were evaluated and found to demonstrate biocompatibility.
- Electromagnetic Compatibility (EMC) and Electrical Safety: The device was tested for conformance to:
- UL60601-1 Medical Electrical Equipment, Part 1: General Requirements for Safety.
- IEC 60601-1-2 Medical Electrical Equipment, Part 1-2: General Requirements for Safety Collateral Standard Electromagnetic Compatibility.
- IEC 61000-3-2 Electromagnetic Compatibility (EMC) Part 3: Limits - Section 3: Limitations of Voltage Fluctuations.
The device was found to conform to these standards.
- Validation Testing: Included both hardware and software functions (details not specified beyond "validation testing").
Conclusion on Substantial Equivalence:
Based on these performance tests, the submitter concluded that the X-Smart Easy is substantially equivalent to the predicate device due to equivalence of intended use, similar features, and technical characteristics. The testing indicated that the device does not raise any new issues of safety, effectiveness, or performance.
§ 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.