(310 days)
The ELECTROtorque TLC 4893 is intended to convert pneumatic output from a dental treatment center to electrical energy to drive the INTRAmatic KL 702 motor for operation of electricallydriven dental handpieces. These devices are designed for use by a trained professional in the field of general dentistry.
The ELECTROtorque TLC 4893 dental control unit is a stand-alone system for operating electrically-driven KaVo handpieces. External power supply provides electric power to the unit. The 4-hole tubing connected to the unit supplies chip /cooling air, water and pressure signal. The speed of the electric handpiece is controlled by air pressure. The control unit is positioned close a treatment unit at the location preferred by the dentist. The ELECTROtorque TLC 4893 system consists of a base unit with a motor hose, an electrical motor, a transformer, and a power cord. The ELECTROtorque TLC 4893 dental control unit is a software-driven device. The software controls the following features: (1) Motor control, (2) Motor start / stop behavior, (3) Motor speed, (4) Motor performance, (5) Measuring power consumption, (6) Monitoring power consumption, and (7) SAFEdrive. The new SAFEdrive software feature monitors the power consumption of electrical hand pieces to reduce the probability or severity of overheating, thus minimizing the risk of burns to the patient. The user can navigate through the software menu via the control panel (see Figure 2.0).
The INTRAmatic KL 702 motor is an electrical low-voltage motor for dental purposes according to ISO 11498 type 2. The motor connects onto the KaVo specific tubing of the dental treatment unit ELECTROtorque. The speed of the INTRAmatic KL 702 is controlled by air pressure of the dental treatment center. The converted pneumatic output signal (electrical energy) from a dental treatment center drives the motor to operate an electrically-driven dental handpiece. Electricallydriven dental handpiece, which conform to ISO 3964, can be attached on the motor. The INTRAmatic KL 702 is intended only for dental treatment by a dental professional.
The provided text describes a medical device, the ELECTROtorque TLC 4893 with INTRAmatic KL 702, which are dental handpieces and accessories. It details the device's function, its similarities and differences to predicate devices, and the non-clinical tests performed. It explicitly states that "Clinical testing has not been conducted on these products."
Therefore, I cannot provide information on acceptance criteria or a study proving the device meets those criteria from the given text, as no clinical studies were performed. The document focuses on demonstrating substantial equivalence to legally marketed predicate devices through non-clinical testing and functional similarity.
However, I can extract the information provided about the non-clinical testing that was performed:
Non-Clinical Test Data (Acceptance Criteria and Study Details)
1. Table of Acceptance Criteria and Reported Device Performance
| Test Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| SAFEdrive Software Function | Capable of detecting electrical handpieces to reduce probability/severity of overheating; minimizing patient burn risk. | The ELECTROtorque TLC 4893 software has been successfully validated to confirm the performance of the device. The software validation included testing of the new SAFEdrive software function to demonstrate that with this added function, the ELECTROtorque TLC 4893 is capable of detective electrical handpieces to reduce the probability or severity of overheating, thus minimizing the risk of burns to the patient. |
| Electromagnetic Compatibility | In accordance with applicable recognized consensus standards. | Testing of electromagnetic compatibility has been conducted in accordance with applicable recognized consensus standards. |
| Electrical Safety | In accordance with applicable recognized consensus standards. | Testing of electrical safety has been conducted in accordance with applicable recognized consensus standards. |
| Sterilization (INTRAmatic KL 702) | Safe and effective. | Sterilization studies were done to determine the safety and effectiveness of the INTRAmatic KL 702. |
| Biocompatibility (INTRAmatic KL 702) | Safe and effective. | Biocompatibility studies were done to determine the safety and effectiveness of the INTRAmatic KL 702. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document does not specify the sample size for any of the non-clinical tests.
- Data provenance is not explicitly mentioned (e.g., country of origin, retrospective/prospective). The tests were likely conducted internally or by a contracted lab.
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 as no clinical studies or human expert ground truth establishment for software validation are detailed in the provided text. The "ground truth" for the non-clinical tests would be defined by engineering specifications, regulatory standards, or predetermined performance parameters.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable; no adjudication method for a test set is mentioned for these non-clinical tests.
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; no clinical studies, and therefore no MRMC studies, were conducted. The device (ELECTROtorque TLC 4893) includes a software feature (SAFEdrive) but is not described as an "AI" system in the context of improving human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The SAFEdrive software function was validated. This would be a standalone evaluation of the algorithm's performance in monitoring power consumption and detecting overheating. The text states: "The software validation included testing of the new SAFEdrive software function to demonstrate that with this added function, the ELECTROtorque TLC 4893 is capable of detective electrical handpieces to reduce the probability or severity of overheating, thus minimizing the risk of burns to the patient." This implies an algorithm-only performance assessment against predefined overheating conditions.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the SAFEdrive software validation, the ground truth would likely be established through engineered scenarios simulating various power consumption and overheating conditions. This would involve specific temperature and energy parameters as mentioned ("Temperature and energy studies have been conducted to determine the parameters for the new SAFEdrive software function").
- For electromagnetic compatibility, electrical safety, sterilization, and biocompatibility, the ground truth is established by adherence to applicable recognized consensus standards.
8. The sample size for the training set
- Not applicable; this device is not described as involving a machine learning/AI model that requires a training set in the context of the provided text. The software validation is for a rule-based or algorithmic function.
9. How the ground truth for the training set was established
- Not applicable for the same reasons as point 8.
§ 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.