(273 days)
TRAUS SIP20 is intended for use in dental surgery, implantology, for treatment of dental hard tissue and mechanial rotating root canal preparation.
TRAUS SIP20 is an AC-powered device that includes a hand-held motor, contra angle handpiece and foot controller for regulation of speed and direction of rotation or a contra-angle attachment for dental surgery.
This document describes a 510(k) premarket notification for a dental handpiece, the TRAUS SIP20. The primary purpose of a 510(k) submission is to demonstrate substantial equivalence to a predicate device, not necessarily to prove a device meets specific acceptance criteria through extensive clinical studies like those for novel AI devices or high-risk medical devices.
Therefore, the requested information regarding acceptance criteria, ground truth establishment, sample sizes for training/test sets, expert involvement, and MRMC studies, as typically applied to AI/ML clinical evaluations, is not present in this document. This submission primarily relies on comparing the new device's design and performance to an already cleared predicate device, demonstrating that any differences do not raise new questions of safety or effectiveness.
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Overview of Device and Study Type
The TRAUS SIP20 is a dental handpiece for use in dental surgery and implantology. The "study" proving its performance is a substantial equivalence evaluation, primarily through non-clinical bench testing and comparison to predicate devices, rather than a clinical trial with acceptance criteria for diagnostic performance (e.g., sensitivity, specificity).
1. Table of Acceptance Criteria and Reported Device Performance
This type of comprehensive table with explicit acceptance criteria for diagnostic performance (e.g., accuracy, precision) is not applicable to this document as it's a 510(k) submission for a non-AI dental handpiece. The "performance" is demonstrated by showing equivalence in intended use, design, and adherence to safety standards.
Instead, the document highlights:
| Feature/Test | Acceptance/Equivalence Claim | Reported Device Performance/Comparison |
|---|---|---|
| Intended Use/Indications for Use | Maintained substantial equivalence to predicate device. | TRAUS SIP20: "intended for use in dental surgery, implantology, for treatment of dental hard tissue and mechanical rotating root canal preparation." (Matches predicate TRAUS SIP10, with minor wording difference being "maxilla-facial surgery and endodontics for treatment of dental hard tissue and mechanical rotating root canal preparation.") |
| Principle of Operation | Maintained substantial equivalence to predicate device. | "Dental handpiece is driven by electrical micromotor and internal gearings. The micromotor and internal gearings are controlled by a control box." (Identical to predicate) |
| Electrical Safety | Compliance with recognized medical electrical safety standards. | Tests performed according to: IEC 60601-1:2005 + A1:2012, IEC 80601-2-60:2012. |
| Electromagnetic Compatibility (EMC) | Compliance with recognized medical EMC standards. | Tests performed according to: IEC 60601-1-2:2014. |
| Software Validation (Firmware) | Software designed, developed, verified, and validated for "MODERATE level of concern". | Information provided in accordance with FDA guidance for software in medical devices. |
| Biocompatibility | Maintained substantial equivalence to predicate device. | Evaluated and cleared through previous FDA 510(k)s (K123695 & K182892) using "same materials and same manufacturing process." No design changes to relevant models. Device has "same type of patient contacting parts." |
| Sterilization | Maintained substantial equivalence for applied components. | Validation evaluated and cleared through previous FDA 510(k)s (K123695 & K182892) using "same materials and same manufacturing process." No design changes to relevant models (micromotors and handpieces). |
| Nonclinical Performance (Bench Test) | Performance demonstrated according to relevant standards. | Conducted according to ISO 14457:2017. Specific results (e.g., torque, speed, run-out) are not detailed in this summary but are implied to be acceptable for substantial equivalence. |
| Differences from Predicate (Control Box, New Handpieces) | Differences do not raise new questions of safety or effectiveness. | New control box specifications (Gear Ratio: SIP20 adds 1:2, 1:5, 32:1; removes 27:1, 64:1 from SIP10. Max. Irrigation Volume: SIP20 90ml/min ± 20%; SIP10 75ml/min). New angle handpieces (TRAUS CRB46LN and TRAUS CRB46NN) included, these are identical to FDA cleared components of a reference device (K182892). Safety and performance test reports supported these differences. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable in the context of clinical diagnostic performance. The "test set" for this device relates to the number of units or components tested during bench testing (e.g., for electrical safety, EMC, performance per ISO 14457). The specific sample size for these non-clinical tests is not detailed in the summary but would be part of the full submission.
- Data Provenance: Not explicitly stated as "data" in the sense of patient images or outcomes. The data provenance would be the location where the safety and performance bench tests were conducted, likely within the manufacturer's R&D or a certified testing lab (e.g., in Republic of Korea).
- Retrospective or Prospective: Not applicable. This is a non-clinical, bench-testing and design comparison submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. This submission does not involve "ground truth" established by human experts for diagnostic purposes akin to image interpretation. The "truth" for this device is based on engineering specifications, adherence to standards, and physical performance measurements.
4. Adjudication Method for the Test Set
- Not applicable. There is no expert adjudication process described as this is not a diagnostic device relying on human interpretation.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC study was NOT done. This type of study is typically performed for AI-powered diagnostic tools to assess how AI assistance impacts human reader performance. This device is a mechanical dental handpiece, not an AI diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is a mechanical tool. There is no "algorithm only" performance to evaluate in this context. While it has firmware (software with "MODERATE level of concern"), its "standalone performance" refers to its function as a controlled rotary instrument, evaluated through bench tests, not diagnostic accuracy.
7. The Type of Ground Truth Used
- Not applicable in the common sense of diagnostic "ground truth" (e.g., pathology, clinical outcomes, expert consensus on images). The "ground truth" for this device's performance are engineering specifications, established international standards (e.g., ISO, IEC), and physical measurements from bench tests.
8. The Sample Size for the Training Set
- Not applicable. This device does not use machine learning, therefore, there is no "training set."
9. How the Ground Truth for the Training Set was Established
- Not applicable. No training set exists for this 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.