(427 days)
The dental device is composed by two distinguished and physically connected equipments, that are:
- dental chair -
- dental unit (hydro-group)
The dental chair is an equipment whose function is to support and position the patient during the dental operations. The dental unit is an equipment connected to the dental chair whose function is to lodge, support and functionally supply the professional instruments used by the dentist and it is combined with accessories.
The dental device is composed by two distinguished and physically connected equipments, that are:
- dental chair -
- dental unit (hydro-group)
The dental chair is an equipment whose function is to support and position the patient during the dental operations. The dental unit is an equipment connected to the dental chair whose function is to lodge, support and functionally supply the professional instruments used by the dentist and it is combined with accessories.
This appears to be a 510(k) clearance letter from the FDA for medical devices (S200 and S300 Dental Operative Units). This type of document does not typically contain acceptance criteria or detailed study information for device performance as you've requested.
The FDA's 510(k) clearance process focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than requiring performance studies that prove specific acceptance criteria are met for all the parameters you've listed. For Class I devices like these, substantial equivalence is often established through detailed comparisons of technological characteristics, design, materials, and intended use to an existing device, along with verification and validation activities (which are usually summarized in the 510(k) submission but not fully detailed in the clearance letter itself).
Therefore, based on the provided text, I cannot extract the information you've requested about acceptance criteria and specific studies.
Here's why and what kind of information you can find in this document:
- Acceptance Criteria & Device Performance: Not present. The letter states the device is "substantially equivalent" to predicate devices, meaning it has met the regulatory threshold for market clearance, but it doesn't provide performance metrics or acceptance criteria for those metrics.
- Sample size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth (training/test sets): This level of detail would be found in the actual 510(k) submission, specifically in sections related to verification and validation testing, and potentially clinical data summaries if a clinical study was deemed necessary (which is less common for Class I devices like these without novel technology). The clearance letter itself does not include this.
- Device Type: Dental Operative Unit and Accessories (S200 and S300 models).
- Regulation Number: 21 CFR 872.6640 (Dental Operative Unit and Accessories).
- Regulatory Class: Class I.
- Product Code: EIA.
- Indication for Use: To support and position the patient during dental operations, and to lodge, support, and functionally supply professional instruments used by the dentist.
- Prescription Use: X (21 CFR Part 801 Subpart D).
To obtain the detailed information you're asking for, you would generally need to access the full 510(k) premarket notification file for K133412, which can be much more extensive than this clearance letter. However, even then, for a Class I device based on substantial equivalence, the type of rigorous, statistically powered performance studies, multi-reader studies, or large-scale clinical trials common for higher-risk or novel AI/CAD devices are typically not required or performed. Performance is usually demonstrated through bench testing, engineering verification, and comparison to the predicate device's established performance characteristics.
§ 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.