(257 days)
Thor 700 Electric Handpiece System is intended to convert pneumatic output from a dental treatment center to electrical energy for operation of electrically-driven dental handpiece.
Thor 700 Electric Handpiece System is composed of a system unit, which is connected to a : power supply and a control tube, that system unit drives a dental drive device. The system unit converts pneumatic output from the dental treatment unit to control the torque, speed and directional rotation of the dental drive device. The dental drive device, in turn, provides the control for motorized dental handpieces. The inputs to the system unit are supplied by a dental treatment unit. Inputs can also be controlled by the foot pedal of the treatment unit.
This submission package for the Thor 700 Electric Handpiece System primarily focuses on demonstrating substantial equivalence to a predicate device (Siro Torque L, K031584) through a comparison of technical specifications and non-clinical performance testing. It does not describe an AI/ML-based device, therefore, many of the requested details concerning acceptance criteria and studies for AI performance metrics are not applicable.
Here's an analysis based on the provided document:
Acceptance Criteria and Reported Device Performance (Table)
The document evaluates the Thor 700's performance against established standards and safety requirements, rather than against specific clinically relevant accuracy metrics typically associated with AI/ML devices. The "acceptance criteria" here are generally compliance with international standards and direct comparison of specifications to the predicate device.
| Acceptance Criteria / Performance Metric | Target (Predicate/Standard) | Thor 700 Reported Performance | Study/Test Conducted |
|---|---|---|---|
| Electrical Safety | IEC 60601-1 | Complies | IEC 60601-1 testing |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2 | Complies | IEC 60601-1-2 testing |
| Software Validation | FDA Guidance "General principle of Software Validation; Final Guidance for Industry and FDA staff", Jan 11, 2002 | Successfully validated | Software validation |
| Performance (Noise) | ISO 11498 | Complies | ISO 11498 performance testing |
| Sterilization Validation (132°C for 15 min, drying 30 min) | ANSI/AAMI ST79:2010 | Complies | Sterilization validation (132°C/15min, 30min drying) |
| Biocompatibility (Erythema & Oedema) | ISO 10993-10 (Response "negligible") | No erythema, no oedema; "negligible" response | ISO 10993-10 testing on rabbits |
| Intended Use Equivalence | Matches Predicate (Siro Torque L) | Substantially equivalent | Comparison of intended uses |
| Components Equivalence | Comparable to Predicate | System unit, power supply, control tube, dental drive device | Comparison of components |
| Principle of Operation Equivalence | Comparable to Predicate | Similar power, cooling, and foot pedal control | Comparison of operating principles |
| Material Composition Equivalence | Identical to Predicate | Aluminum, Stainless Steel, Plastic | Comparison of materials |
| Patient Contact | None (Matches Predicate) | No contact with patients | Technical comparison |
| System Unit Presence | Yes (Matches Predicate) | Yes | Technical comparison |
| Speed Control | Yes (Matches Predicate) | Yes | Technical comparison |
| Digital Speed Readout | Yes (Matches Predicate) | Yes | Technical comparison |
| Installation Capability | Predicate: internal/external | Thor 700: external | Technical comparison |
| Individually Programmable Settings | 2 (Matches Predicate) | 2 | Technical comparison |
| Forward/Reverse Switches | Yes (Matches Predicate) | Yes | Technical comparison |
| Spray Water Pressure | Predicate: 29 psi (2.0 bar) | Thor 700: 36 psi (2.5 bar) | Technical comparison |
| Spray Air Pressure | Predicate: 39 psi (2.7 bar) | Thor 700: 29 psi (2.0 bar) | Technical comparison |
| Voltage Input | AC: 100-240V, 50/60 Hz (Matches Predicate) | AC: 100-240V, 50/60 Hz | Technical comparison |
| Voltage Output | Predicate: DC: 24V DC | Thor 700: DC: 48V DC | Technical comparison |
| Motor Speed | 2000-40000 rpm (Matches Predicate) | 2000-40000 rpm | Technical comparison |
| Motor Diameter | Predicate: 21 mm | Thor 700: 22 mm | Technical comparison |
| Torque | Predicate: 2.4 N-cm maximum | Thor 700: 3 N-cm maximum | Technical comparison |
| Weight | Predicate: 100 grams | Thor 700: 62 grams | Technical comparison |
| Cooling Air Pressure | 30 NL/min (Matches Predicate) | 30 NL/min | Technical comparison |
| Coupling Dimensions | According to ISO-3964 (Matches Predicate) | According to ISO-3964 | Technical comparison |
| Hose Connections | According to ISO-9168 (Matches Predicate) | According to ISO-9168 | Technical comparison |
Details for AI-Specific Questions (Not Applicable for this Device)
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. This is a hardware device (electric handpiece system) and does not involve an AI/ML component or a "test set" of data in the context of diagnostic or predictive performance. The testing involved
- Electrical safety and EMC testing (IEC standards).
- Software validation (internal process, not a clinical data set).
- Performance testing (ISO 11498 for noise, likely empirical measurements of mechanical properties).
- Sterilization validation (empirical testing in a lab).
- Biocompatibility testing (animal studies - rabbits).
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. No ground truth in the context of AI/ML classification or prediction was established. "Ground truth" for this device relates to compliance with engineering standards and physiological safety, typically assessed by qualified engineers and toxicologists/biocompatibility experts with appropriate certifications, not medical specialists for diagnostic accuracy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No test set requiring expert adjudication for ground truth was used.
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 an electric handpiece system, not an AI-assisted diagnostic or therapeutic tool for human readers. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This is not an algorithm-only device. Software validation was performed, but it pertains to the control and operation of the hardware, not an AI for interpretation or diagnosis.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not Applicable in the AI/ML sense. The "ground truth" for this device's performance is defined by compliance with established international standards (IEC, ISO, ANSI/AAMI) for electrical safety, EMC, mechanical performance (e.g., speed, torque, noise), software functionality, and biocompatibility. The predicate device's specifications also serve as a comparative benchmark.
8. The sample size for the training set
- Not Applicable. This device does not use an AI/ML model that requires a training set of data.
9. How the ground truth for the training set was established
- Not Applicable. No training set was used.
§ 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.