(190 days)
The ESTETICA Dental Treatment Unit and Accessories are intended to supply power to and serve as a base for other dental devices and accessories by providing air, water, vacuum and low voltage electrical power to dental instruments and dental handpieces. The ESTETICA Dental Treatment Unit and Accessories are designed for use by a trained professional in the field of general dentistry.
The ESTETICA Dental Treatment Unit and Accessories serves as a base that includes components to deliver air, water, electrical power, and vacuum to dental handpieces, instruments, and accessories. The device includes a patient chair, foot control, dentist element, assistant element and a water unit. The unit may also include a dental operating light and a monitor. Various handpieces and accessories can be added to the ESTETICA Dental Treatment Unit and Accessories. These include, but not limited to, pneumatic handpieces, electric motors with handpieces, scalers, intra-oral cameras, curing lights, air/water syringes and SE and HVE vacuum instruments.
The provided text describes the 510(k) premarket notification for the ESTETICA Dental Treatment Unit and Accessories. It focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. Here's a breakdown of the requested information based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not present specific acceptance criteria in a table format with corresponding reported device performance metrics in the way one might see for a diagnostic AI device (e.g., sensitivity, specificity thresholds). Instead, the acceptance criteria are implicitly defined by conformance to various international and national standards for dental operative units and medical electrical equipment. The "reported device performance" is broadly stated as "Performance bench testing according to international standards for dental operative units has been conducted to determine conformance" and "the performance of the ESTETICA Dental Treatment Unit and Accessories has been verified utilizing the following standards."
Here's an interpretation based on the provided text, outlining the areas of conformance:
| Acceptance Criteria (Implicit by Conformance to Standards) | Reported Device Performance |
|---|---|
| Biocompatibility (ISO 7405, ISO 10993-1) | All applicable components meet biocompatibility requirements. |
| Sterilization (ISO 17665-1, AAMI ANSI ST79) | Applicable components meet sterilization requirements. |
| Software Documentation (FDA Guidance Document for Software Contained in Medical Devices) | Software documentation for moderate level of concern completed. |
| Comparative Performance of Integrated Accessories | Performance of integrated accessories is comparable to cleared standalone devices. |
| Wireless Foot Pedal - Software Verification/Validation | Software verification/validation of functions conducted. |
| Wireless Foot Pedal - EMC Testing (IEC 60601-1-2) | EMC testing performed to evaluate communication loss risk. |
| Wireless Foot Pedal - Electrical Safety (IEC 60601-1-1) | Electrical safety tests conducted. |
| General Requirements & Test Methods for Dental Units (ISO 7494-1) | Performance verified per standard. |
| Water and Air Supply for Dental Units (ISO 7494-2) | Performance verified per standard. |
| Hose Connectors for Air Driven Dental Handpieces (ISO 9168) | Performance verified per standard. |
| Handpieces and Motors (ISO 14457) | Performance verified per standard. |
| Basic Safety and Essential Performance (Medical Electrical Equipment) (IEC 60601-1, ANSI/AAMI ES60601-1) | Conformance demonstrated. |
| Electromagnetic Compatibility of Medical Electrical Equipment (IEC 60601-1-2) | Conformance demonstrated. |
| Medical Device Software Life Cycle Processes (IEC 62304) | Conformance demonstrated. |
| Risk Management (ISO 14971) | Application of risk management to medical devices demonstrated. |
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 detail specific sample sizes for particular performance tests. It refers to "Performance bench testing" and "Comparative performance testing" but does not specify the number of units or test subjects used in these tests. The provenance of the data (country of origin, retrospective/prospective) is also not specified, as these are non-clinical bench tests, not clinical studies.
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 product is a dental treatment unit, not an AI or diagnostic device that requires expert-established ground truth for its performance evaluation in the typical sense of medical image analysis. The "ground truth" here is adherence to engineering and safety standards, verified through bench testing. Therefore, there were no experts used to establish ground truth in the context of clinical interpretation or diagnosis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As a device undergoing non-clinical bench testing for conformance to standards, there is no "adjudication method" in the clinical sense (e.g., for conflicting expert opinions). Performance is evaluated against documented technical specifications and 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
Not applicable. This device is a dental operative unit, not an AI-assisted diagnostic or interpretative tool. Therefore, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This device does not involve an "algorithm only" component for diagnostic or interpretative tasks. It is a physical medical device that provides power and functions for dental procedures. Performance evaluations were done on its physical and electrical characteristics according to relevant standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance evaluation of the ESTETICA Dental Treatment Unit and Accessories is the set of specifications and requirements outlined in the international and national standards listed (e.g., ISO 7494-1, IEC 60601-1). Performance is assessed based on whether the device operates within the parameters defined by these standards. No expert consensus, pathology, or outcomes data were used for establishing ground truth in this context.
8. The sample size for the training set
Not applicable. This device is not an AI/ML product and does not involve a "training set" for an algorithm.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this device.
§ 872.6640 Dental operative unit and accessories.
(a)
Identification. A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.(b)
Classification. Class I (general controls). Except for dental operative unit, accessories are exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.