(178 days)
The BDC Dental Unit is intended to supply power to and serve as a base for dental devices and accessories. This device includes a dental chair and is intended for use in the dental clinic environment and is designed for use by trained dental professionals, dentists and/or dental assistants.
The BDC dental unit is intended to supply air, water, vacuum and electrical power to allow the dental practitioner an intuitive control center for all common and normal patient treatment procedures performed in the dental operatory. The BDC dental unit consists of a patient chair, dentist element (tray table), assistant element (3-way syringe, high volume evacuator and saliva ejector), side cabinet support center, foot control, cuspidor and a dental operating light, which for patient to sit during the dental diagnosis, treatment and/or operation.
The provided text appears to be an FDA 510(k) clearance letter and summary for a dental unit. It describes a medical device (BDC Dental Unit) that is essentially a dental chair with integrated controls for air, water, vacuum, and electrical power for dental devices. The device's primary function is to serve as a base and power supply for other dental instruments used by trained dental professionals.
Based on the provided document, there is NO information about an AI/ML component or study involving acceptance criteria related to AI/ML device performance. The document focuses on establishing substantial equivalence to a predicate device (A-dec 500) through non-clinical testing of mechanical, electrical, software (non-AI), and biocompatibility aspects.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance for an AI/ML component.
- Sample size and data provenance for an AI/ML test set.
- Number and qualifications of experts for AI/ML ground truth.
- Adjudication method for an AI/ML test set.
- Multi Reader Multi Case (MRMC) comparative effectiveness study for AI assistance.
- Standalone (algorithm only without human-in-the-loop performance) study for an AI/ML component.
- Type of ground truth for an AI/ML component.
- Sample size for the training set (for AI/ML).
- How ground truth for the training set was established (for AI/ML).
The document explicitly states: "Clinical data is not needed to characterize performance and establish substantial equivalence. The non-clinical test data characterize all performance aspects of the device based on well-established scientific and engineering principles. Clinical testing has not been conducted on this product." This further reinforces that there was no study like the one you are asking for, especially not one involving human readers or AI performance metrics.
The "Software Verification and Validation Testing" section mentions: "The software for this device was considered as a 'BASIC' level of concern, since a failure or latent flaw in the software would not directly result in serious injury or death to the patient or operator." This implies standard software validation, not necessarily AI/ML model validation.
In summary, the provided text does not contain the information required to answer your prompt regarding acceptance criteria and studies for an AI/ML medical device. The device described is a conventional dental unit, and its clearance is based on substantial equivalence to a predicate device through standard non-clinical performance and safety testing.
§ 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.