(56 days)
The Satelec i-Surge is intended to be used by qualified dental practitioners as an electric micro-motor handpiece with a straight, right or contra-angle attachment for oral dental surgical procedures including implantology, endodontia, periodontology, and dental maintenance.
The Satelec i-Surge is intended to be used by qualified dental practitioners as an electric micro-motor handpiece with straight, right or contra-angle attachment for oral dental surgical procedures including implantology, endodontia, periodontology, and dental maintenance.
Functions and settings are selected and adjusted by the footswitch and / or the front panel keyboard on the control unit.
This document is a 510(k) summary for the Satelec i-Surge dental handpiece. It primarily establishes substantial equivalence to a predicate device and does not contain information about a study proving the device meets specific acceptance criteria in the manner of an AI/software performance study.
Therefore, most of the requested information cannot be extracted from the provided text.
Here is what can be inferred or explicitly stated based on the given document:
1. A table of acceptance criteria and the reported device performance:
This information is not provided in the document. The 510(k) summary focuses on establishing substantial equivalence to a predicate device rather than detailing specific performance criteria and test results.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable. The document does not describe a clinical or performance study with a test set of data in the context of an AI or diagnostic device. It's about a physical dental handpiece.
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, as no such study is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as no such study 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:
Not applicable, as this is a dental handpiece, not an AI or diagnostic imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable, as this is a dental handpiece, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable, as no such study generating a quantifiable ground truth is described.
8. The sample size for the training set:
Not applicable, as this is a dental handpiece, not an AI device that undergoes training.
9. How the ground truth for the training set was established:
Not applicable, as this is a dental handpiece, not an AI device that undergoes training.
Summary of what the document does provide regarding device acceptance:
The primary "acceptance criterion" for this device, as detailed in the 510(k) process, is Substantial Equivalence to a legally marketed predicate device.
- Acceptance Criterion: The Satelec i-Surge is substantially equivalent to a predicate device in terms of intended use, technological characteristics, and safety and effectiveness.
- Study/Proof: The entire 510(k) submission serves as the "study" and "proof." It compares the i-Surge to its predicate, the Satelec Suni Max (K000049).
- Reported Device Performance (in relation to substantial equivalence):
- Intended Use: Both devices are "intended to be used by qualified dental practitioners as an electric micro-motor handpiece with straight, right or contra-angle attachment for oral dental surgical procedures including implantology, endodontia, periodontology, and dental maintenance."
- Technological Characteristics/Safety & Effectiveness: The document states, "Differences that exist between the devices relating to technical specifications, performances, and intended use are minor and do not affect the safety and effectiveness of the i-Surge."
In essence, the "acceptance criteria" here are that the new device is as safe and effective as the predicate device by having similar intended uses and minor, non-impactful differences in technical specifications. The "study" is the comparison made within the 510(k) submission itself.
§ 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.