(396 days)
TORQTECH transmits rotation of the motor to dental burrs and reamers which cut or grind teeth or dentures with the same or transformed rotation.
The TORQTECH device is a dental handpiece to be attached to an electric or air powered dental motor, designed for polishing, grinding, and drilling of teeth/dentures. The device transmits rotational force from the motor to the rotor shaft through a clutch, and the dental burrs or reamers chucked on the shaft are able to polish, grind or cut the teeth/dentures of the patient receiving these rotations. There are two types of the TORQTECH device: one is a "straight" linear model (Model ST-DH) while the other is angled and geared (Models CA-DC, CA-DC-O, and CA-5IF-O). The geared models vary based on angle and rotation due to the gear between the clutch and rotor shaft. An optional headlight is available, fed through the light-guide from the motor portion.
Here's an analysis of the provided text regarding the TORQTECH device's acceptance criteria and the study proving it, structured according to your request:
Acceptance Criteria and Device Performance for TORQTECH Dental Handpiece
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance (Summary) |
|---|---|
| Performance: Conformity to ISO 7785-2:1995 (dental handpieces - Part 2: straight and geared angle handpieces) | Device was developed and tested in accordance with this standard. (No specific performance metrics are provided, but compliance with the standard implies acceptable performance.) |
| Coupling Dimensions: Conformity to ISO 3964 (dental handpieces - coupling dimensions) | Device was developed and tested in accordance with this standard. |
| Risk Management: Conformity to ISO 14971:2007 (medical devices - application of risk management to medical devices) | Device was developed and tested in accordance with this standard. Risk analysis under ISO 14971:2007, combined with biological evaluation, demonstrated the spray's suitability. |
| Biocompatibility (General): Conformity to ISO 10993-1:2003 (biological evaluation of medical devices -- Part 1: evaluation and testing) | Device was developed and tested in accordance with this standard. |
| Biocompatibility (Cytotoxicity): Conformity to ISO 10993-5:2009 (biological evaluation: test for in vitro cytotoxicity) | Device was developed and tested in accordance with this standard. Cytotoxicity test results demonstrated the spray's suitability. |
| Biocompatibility (Sample Prep): Conformity to ISO 10993-12:2007 (biological evaluation: sample preparation and reference materials) | Device was developed and tested in accordance with this standard. |
| Sterilization Information: Conformity to ISO 17664:2004 (information to be provided by the manufacturer for the processing of resterilizable medical devices) | Device was developed and tested in accordance with this standard. |
| Labeling (Graphical Symbols): Conformity to EN 980:2008 (graphical symbols for use in the labeling of medical devices) | Device was developed and tested in accordance with this standard. |
| Labeling (Information Supplied): Conformity to EN 1041:2008 (information supplied by the manufacturer with medical devices) | Device was developed and tested in accordance with this standard. |
| Spray Biocompatibility (Sensitization/Irritation): No sensitization, no irritation. | Results of sensitization and irritation testing under ISO 10993-1 showed the spray to not cause sensitization and that it is not an irritant. |
| Spray Propellants: Safety for clinical use. | The same gases (propane, butane, isobutane) have been cleared for use in the predicate Kavo device (K#012308). |
| Substantial Equivalence: To predicate devices K#080677, K#061701, K#070074, K#012308 in terms of intended use, principle of operation, and technological characteristics. | The information provided demonstrates substantial equivalence based on comparative tables and descriptions, concluding that differences do not raise new questions of safety or effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance
The provided summary does not mention a "test set" in the context of a clinical study or a specific dataset used for performance evaluation of the device against a ground truth. The primary method for proving the device meets acceptance criteria appears to be adherence to recognized standards and a substantial equivalence comparison to predicate devices, rather than a direct performance test against a separate "test set" as one might find in software or diagnostic device submissions.
The provenance of data is not applicable in the sense of patient data as no clinical tests were performed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. No "test set" with ground truth established by experts is described in the document. The evaluation relies on compliance with technical standards and comparison to predicate devices.
4. Adjudication Method for the Test Set
Not applicable. No "test set" requiring adjudication 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. This device is a dental handpiece, not an AI or diagnostic imaging device. Therefore, no MRMC study or AI assistance evaluation was conducted.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a manual dental instrument, not an algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's acceptance is primarily established by:
- Compliance with recognized international standards (ISO, EN).
- Demonstrated substantial equivalence to legally marketed predicate devices, implying that if the device is similar in technology, intended use, and performance characteristics to a device already deemed safe and effective, it is also safe and effective.
- Results of specific non-clinical tests (sensitization, irritation, cytotoxicity) against relevant ISO standards.
8. The Sample Size for the Training Set
Not applicable. This device is a hardware dental handpiece, not a machine learning model. Therefore, there is no "training set" in the AI sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set 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.