(84 days)
The Siemens T1 LINE dental handpieces are intended for use in the dental operatory to prepare dental cavities for restorations such as fillings, and for cleaning teeth.
The Siemens T1 LINE Dental Handpieces are intended for use in the dental operatory to prepare dental cavities for restorations, such as fillings, and for dental cleanings. The devices can be either AC-powered or air-powered. They are reusable, ergonomically shaped, and are provided both with and without a fiber optic light system. Water delivery has optional one, two, and three spray outlets, and includes a one-way retraction valve to prevent the ingress of external air or liquid when the spray system is not in use. The device can be sterilized by the steam autoclave method.
The provided 510(k) summary for the Siemens T1 LINE Dental Handpieces describes performance testing rather than acceptance criteria and study results in the typical sense of a clinical trial for a diagnostic device. Dental handpieces are Class I devices, which generally have lower regulatory hurdles and typically rely on adherence to established consensus standards and mechanical performance testing rather than clinical effectiveness studies with human subjects.
Here's a breakdown of the information based on the provided text, addressing your questions where applicable and noting when information is not present:
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a Class I mechanical device, the "acceptance criteria" are compliance with relevant ISO standards and demonstrated durability/sterilization effectiveness.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Compliance with ISO Standard 1797-1: Dental Rotary Instruments - Shanks made of metal | "The Siemens T1 LINE Dental Handpieces comply with ISO Standard 1797-1" |
| Compliance with ISO Standard 3964: Dental Handpieces - Coupling dimensions | "The Siemens T1 LINE Dental Handpieces comply with ... ISO Standard 3964" |
| Compliance with ISO 7785-2: Straight and geared angle handpieces | "The Siemens T1 LINE Dental Handpieces comply with ... ISO 7785-2" |
| Sterilization Process Efficacy: Device effectiveness and integrity after repeated sterilization cycles | "Additional performance testing was conducted on the device to validate the sterilization process and device effectiveness following 2000 sterilization cycles." (No specific quantitative results provided in this summary, just that it was validated). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "sample size" in the context of clinical testing with patients or data. The testing mentioned refers to mechanical and sterilization validation.
- Test set sample size: Not applicable/not specified for clinical data. For the mechanical and sterilization testing, the sample size of handpieces tested is not listed.
- Data provenance: Not applicable for clinical data. The performance testing was conducted by Siemens AG, a German company (Bensheim, Germany).
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. The device is a mechanical tool, and its performance is assessed against engineering standards and functional tests, not by expert interpretation of clinical data.
4. Adjudication Method
Not applicable. There is no expert adjudication process described for the mechanical performance testing of the handpiece.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. A MRMC study is relevant for diagnostic devices where human readers interpret medical images or data. This is a mechanical dental tool, and as such, an MRMC study was not performed.
6. Standalone (Algorithm Only) Performance
No. The concept of "standalone performance" typically applies to AI algorithms or diagnostic tools operating without human intervention. This is a physical dental handpiece, so this concept is not applicable.
7. Type of Ground Truth Used
The "ground truth" for this device's performance is established by:
- Adherence to international engineering standards (ISO 1797-1, 3964, 7785-2).
- Demonstrated functionality and safety (sterilization effectiveness) through laboratory performance testing.
8. Sample Size for the Training Set
Not applicable. There is no mention of a "training set" as this device does not involve machine learning or AI algorithms that require training data.
9. How Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of 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.