(122 days)
Hi-Tech Implant/HT Physio Implant are intended to prepare Intraoral bone for implantology procedures.
The HI TECH IMPLANT and HT PHYSIO IMPLANT consist of a microprocessor controlled unit, foot pedal, electric micromotor, support rods and sterile, disposable irrigation tubes. The unit also houses the peristaltic pump. The HI TECH IMPLANT and HT PHYSIO IMPLANT provide electronic control of velocity and torque. The HI TECH IMPLANT and HT PHYSIO IMPLANT can be programmed and retain programs into memory. The HI TECH IMPLANT and HT PHYSIO IMPLANT are fully operational from foot pedal.
The provided text describes a 510(k) submission for the BY DENTAL Hi-Tech Implant/HT Physio Implant. This is a medical device for preparing intraoral bone for implantology procedures, a surgical micromotor system. The submission focuses on demonstrating substantial equivalence to a predicate device and compliance with various safety and electrical performance standards.
Here's an analysis of the provided text, addressing your specific questions, though it's important to note that the description of a medical device submission, particularly for a traditional 510(k), primarily focuses on engineering and performance characteristics against established standards, rather than clinical efficacy studies involving human readers or sophisticated AI performance metrics that are common in more recent AI/ML device submissions.
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are adherence to specific international and European standards for medical electrical equipment and dental handpieces. The reported device performance is that the device complies with all these standards.
| Acceptance Criteria (Standards) | Reported Device Performance |
|---|---|
| IEC 55011 EMC Conducted RF emissions | Complies |
| IEC 60529 Degrees of protection provided by enclosures (IP Code) | Complies |
| IEC 60601-1 Medical Electrical Equipment Part 2, "General Safety Norms" | Complies |
| IEC 60601-1-2 Medical Electrical Equipment Part 1 EMC | Complies |
| IEC 61000-4-2 EMC Electrostatic Discharge Immunity | Complies |
| IEC 61000-4-3 Radiated RF immunity | Complies |
| IEC 61000-4-4 Fast Transient Immunity | Complies |
| IEC 61000-4-5 Pulse immunity | Complies |
| IEC 61000-4-6 Conducted RF immunity | Complies |
| IEC 61000-4-11 Supply Voltage Hole Immunity | Complies |
| IEC 61558-1 Transformer safety | Complies |
| IEC 61558-2-6 Transformer safety-Particular prescriptions | Complies |
| ISO 11498:1997 Dental handpieces Dental low-voltage electrical motors | Complies |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The text does not specify a "test set" in the context of clinical data or image-based AI testing. The "tests" performed were engineering and electrical safety evaluations of the physical device. Therefore, typical notions of sample size and data provenance for clinical studies do not apply here. The evaluation was performed by a "Notified Laboratory" (presumably in Italy, given the manufacturer's location).
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)
This type of information is not relevant to this 510(k) submission. The "ground truth" for compliance with electrical and safety standards is defined by the standards themselves, and testing is performed by qualified technicians/engineers at a certified laboratory, not medical experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Adjudication methods for clinical interpretation or data labeling are not applicable to the technical performance tests described in this 510(k). The compliance is determined by the test results against the specified standard requirements.
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
No such study was conducted or mentioned. This 510(k) is for a surgical micromotor system, which is a physical tool, not an AI-powered diagnostic or assistive technology for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No "standalone" algorithm performance testing was done, as this device is not an algorithm. It is a physical medical electrical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is established by the specifications and criteria outlined in the various international and European technical standards (e.g., IEC 60601-1, ISO 11498:1997). Compliance is objectively measured during laboratory testing against these predefined technical benchmarks, not against clinical outcomes or expert consensus.
8. The sample size for the training set
There is no concept of a "training set" for this type of medical device submission. The device is a hardware system, not a machine learning model.
9. How the ground truth for the training set was established
As there is no training set, this question is not applicable.
§ 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.