(11 days)
The ATR5000, LC5000 and Implant System are intended for the preparation of intra-oral bone for implantology procedures. These ATR Surgical Micromotors are intended to prepare Intraoral bone for implantology procedures.
The ATR Surgical Micromotors ATR5000, LC5000 and Implant System, are microprocessor driven surgical micromotors used in implantology procedures. The ATR Surgical Micromotors ATR5000, LC5000 and Implant System consists of a microprocessor controlled unit, foot pedal, electric micromotor, support rods and sterile, disposable irrigation tubes. The units also house the peristaltic pump. The ATR Surgical Micromotors ATR5000, LC5000 and Implant System provide electronic control of velocity and torque. The ATR Surgical Micromotors ATR5000, LC5000 and Implant System can be programmed and retain programs in memory. The ATR Surgical Micromotors ATR5000, LC5000 and Implant System are fully operational from foot pedal.
This document describes acceptance criteria and testing for the ATR Surgical Micromotors (ATR5000, LC5000, and Implant System), which are microprocessor driven surgical micromotors used in implantology procedures.
Here's the breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The device's performance is demonstrated by its compliance with a series of electrical, safety, and electromagnetic compatibility (EMC) standards. The acceptance criteria essentially are compliance with these listed standards.
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| UL 2601-1 Standard for Medical Electrical Equipment, General requirements for Safety (IEC 60601-1 with U.S. deviations) | Complies with the standard |
| UL 601-1 Medical Electrical Equipment, General Requirement for Safety | Complies with the standard |
| IEC 60601-1 Medical Electrical Equipment Part 2, "General Safety Norms" | Complies with the standard |
| IEC 60601-1-2 Medical Electrical Equipment Part 1 EMC | Complies with the standard |
| EMC Conducted RF emissions IEC 55011 | Complies with the standard |
| Degrees of protection provided by enclosures (IP Code) IEC 60529 | Complies with the standard |
| IEC 61000-4-2 EMC Electrostatic Discharge Immunity | Complies with the standard |
| IEC 61000-4-3 Radiated RF immunity | Complies with the standard |
| IEC 61000-4-4 Fast Transient Immunity | Complies with the standard |
| IEC 61000-4-5 Pulse immunity | Complies with the standard |
| IEC 61000-4-6 Conducted RF immunity | Complies with the standard |
| IEC 61000-4-11 Supply Voltage Hole Immunity | Complies with the standard |
| Transformer safety IEC 61558-1 | Complies with the standard |
| IEC 61558-2-6 Transformer safety-Particular prescriptions | Complies with the standard |
| ISO 11498:1997 Dental handpieces Dental low-voltage electrical motors | Complies with the standard |
| Withstanding voltage test | Performed in conformance with UL 2601-1 requirements |
| Leak current test | Performed in conformance with UL 2601-1 requirements |
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not specify a numerical "sample size" in terms of number of devices tested. It refers to "All evaluation of the ATR 5000, LC5000 and Implant System" being performed. This implies at least one unit of each model (ATR5000, LC5000, and Implant System) was tested.
- Data Provenance: The tests were "performed by certified body Laboratory," but the specific country of origin for the data is not explicitly stated. The submitting company (ATR srl) is based in Italy, suggesting the testing might have been done in Italy or a European certified lab. The predicate device was also evaluated "with the same regulation standard," indicating historical consistency in testing approach.
- Retrospective or Prospective: Not applicable in the context of device performance testing against engineering standards. This is a prospective testing of the manufactured device models.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to this type of device submission. The "ground truth" here is compliance with established engineering and safety standards, not a medicaldiagnosis or interpretation by experts. The "certified body Laboratory" acts as the independent verifier of compliance.
4. Adjudication method for the test set
This information is not applicable. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies where conflicting expert interpretations need resolution. For compliance testing against engineering standards, the results are objectively measured against the standard's specifications.
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
This information is not applicable. MRMC studies and the concept of "human readers" improving with "AI assistance" are relevant to diagnostic imaging devices or other AI-enabled tools for interpretation. This submission is for surgical micromotors, which are hand-held mechanical and electronic devices, not AI-driven diagnostic tools.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable. This device is a surgical micromotor, not a software algorithm. Its performance is evaluated through physical and electrical tests, not algorithmic performance.
7. The type of ground truth used
The "ground truth" in this context is the specific technical requirements and limits defined by the listed international and national standards (e.g., UL 2601-1, IEC 60601-1, IEC 60601-1-2, IEC 61000 series, ISO 11498). The device is deemed safe and effective if its measured performance falls within the acceptable parameters set by these standards.
8. The sample size for the training set
This information is not applicable. Surgical micromotors are hardware devices that do not use machine learning algorithms, and therefore, there is no "training set."
9. How the ground truth for the training set was established
This information is not applicable for the same reason as above; there is no training set for this type of medical 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.