(78 days)
The Siemens T1 CONTROL high speed dental handpiece is intended for use in the dental operatory to prepare dental cavities for restorations, such as fillings.
The Siemens T1 CONTROL high speed dental handpiece is intended for use in the dental operatory to prepare dental cavities for restorations, such as fillings. The device is an air-powered, high speed handpiece constructed of titanium. The device is reusable, is ergonomically shaped, and includes a solid fibre optic rod built-in light system. The water delivery geometry includes three spray nozzles in the device head with one-way retraction valves to prevent the ingress of external air or liquid when the spray system is shut down. The device can be sterilized by the steam autoclave method.
This 510(k) summary describes a dental handpiece and focuses on its compliance with international standards and its similarity to predicate devices rather than clinical performance data with specific acceptance criteria in the context of diagnostic accuracy. Therefore, several requested sections cannot be fulfilled from the provided text.
Here's an analysis of what information is available and what is not:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| ISO Standard 7785-1 (High Speed Air Turbine Handpieces) | Complies |
| ISO Standard 1797 (Dental Rotary Instruments - Shanks) | Complies |
| ISO Standard 9168 (Dental Handpieces - Hose Connectors) | Complies |
| Sterilization process validation | Testing conducted |
| Device effectiveness | Testing conducted |
2. Sample size used for the test set and the data provenance
- Not provided. The text mentions "additional performance testing was conducted on the device to validate the sterilization process and device effectiveness" but does not specify sample sizes or data provenance for these tests. The compliance with ISO standards implies adherence to specified testing procedures within those standards, but the specifics of those tests (e.g., how many handpieces were tested for compliance) are not detailed here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not provided. This device is a dental handpiece, not a diagnostic tool requiring expert interpretation for ground truth establishment. The performance testing focuses on mechanical and sterilization efficacy, likely against engineering specifications or standard protocols, not expert consensus on diagnostic images.
4. Adjudication method for the test set
- Not applicable/Not provided. As the device is not a diagnostic tool, an adjudication method for a test set based on expert interpretation is not relevant.
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. This device is a mechanical dental handpiece, not an AI-powered diagnostic tool. Therefore, an MRMC study or AI assistance is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a mechanical dental handpiece, not an algorithm.
7. The type of ground truth used
- The "ground truth" for this device would be defined by the specifications and requirements outlined in the cited ISO standards (e.g., turbine speed, bur retention force, dimensions, connector compatibility). For sterilization, the ground truth would be the absence of viable microorganisms after the sterilization process, validated against established microbiological testing protocols. For "device effectiveness," this would likely refer to its ability to perform its intended function of preparing dental cavities, assessed against performance benchmarks.
8. The sample size for the training set
- Not applicable. This device is a mechanical handpiece; there is no "training set" in the context of machine learning. Its design and manufacturing are based on engineering principles and industrial standards.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
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K965238
MAR 1 9 1997
510(k) SUMMARY SIEMENS AG T1 CONTROL HIGH-SPEED DENTAL HANDPIECE
DATE PREPARED 1.
December 30, 1996
2. SUBMITTER
Siemens AG Medical Technology Dental Systems Fabrikstrasse 31 64625 Bensheim Germany
CONTACT 3.
Mr. Hermann Landgraf コース | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 011-49-62-51-16-2359
4. DEVICE NAME
| Proprietary Name: | T1 CONTROL High Speed Dental Handpiece |
|---|---|
| Common/Usual Name: | Dental Handpiece |
| Classification Name: | Air-powered Dental Handpiece |
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ડ. DEVICE CLASSIFICATION
Air-powered dental handpieces and accessories have been classified under Section 513 of the Act as Class I devices by the Dental Devices Panel.
Classification Regulation: 21 CFR 872.4200 Product Code: 76 EFB
ર્. DEVICE DESCRIPTION AND COMPARISON TO PREDICATE PRODUCTS
The Siemens T1 CONTROL high speed dental handpiece is intended for use in the dental operatory to prepare dental cavities for restorations, such as fillings. The device is an air-powered, high speed handpiece constructed of titanium. The device is reusable, is ergonomically shaped, and includes a solid fibre optic rod built-in light system. The water delivery geometry includes three spray nozzles in the device head with one-way retraction valves to prevent the ingress of external air or liquid when the spray system is shut down. The device can be sterilized by the steam autoclave method.
The Siemens T1 CONTROL high-speed dental handpiece is similar in design, function, and intended use to other high-speed dental handpieces currently in U.S. commercial distribution. Examples of substantially equivalent devices include the Tradition high-speed handpiece manufactured by Midwest (K863677), the Star Dental 430 series high-speed handpiece manufactured by DEN-TAL-EZ. Inc. (K960719), and the W&H 898 Top Light high-speed handpiece manufactured by A-DEC, Inc. (K944710).
7. PERFORMANCE TESTING
The Siemens T1 CONTROL Dental Handpiece complies with ISO Standard 7785-1 for High Speed Air Turbine Handpieces, ISO Standard 1797 for Dental Rotary Instruments - Shanks, and ISO Standard 9168 for Dental Handpieces - Hose Connectors. Additional performance testing was conducted on the device to validate the sterilization process and device effectiveness.
Siemens AG 510(k) T1 Dental Handpiece
3/18/97
§ 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.