(86 days)
This product is a Dental Operative Unit with accessories that is intended to supply power to, and serve as a base for dental devices and accessories. This product includes a dental chair. The unit is intended for use in the dental clinic environment and used by trained dentists and/or dental technicians and assistants.
The Sirona C8 Dental Operative Unit and Accessories consist of the following components:
- Treatment Chair
- Dentist's Element which controls the pressure for the air and water, spray and drive adjustments for the instruments which can also be controlled by a foot pedal, and control of the optional Cuspidor feature
- Assistant's Element with Cuspidor, controls automatic and manual air vacuum and suction
- Dental Lamp
Here's an analysis of the provided text regarding acceptance criteria and device performance:
**Crucially, the provided document (a 510(k) summary for the Sirona C8 Dental Operative Unit) does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.
This 510(k) submission is focused on demonstrating substantial equivalence to a predicate device (Pelton & Crane's Spirit S1 - K962071), rather than proving the device meets specific performance criteria through a study.
The document's purpose is to show that:
- The Sirona C8 has the same intended use as the predicate device: "supply power to, and serve as a base for dental devices and accessories."
- The Sirona C8 has similar technological characteristics (components, design, and mode of operation) to the predicate device.
Because the device is a "Dental Operative Unit," it is generally subject to general controls and does not typically require performance studies to demonstrate safety and effectiveness for a 510(k) clearance if substantial equivalence can be demonstrated through comparison to a predicate device. Performance data would typically be required for devices with new technologies, different intended uses, or higher risk classifications.
Therefore, I cannot populate the requested table or answer most of your detailed questions based on the provided text.
Here's how I would answer your questions based solely on the provided information, highlighting the absence of the requested data:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document | Not specified in the document |
| The device is substantially equivalent to a predicate device (Pelton & Crane's Spirit S1 - K962071) in terms of intended use, general components, design, characteristics, and mode of operation. | The Sirona C8 Dental Operative Unit and Accessories are described as having components (Treatment Chair, Dentist's Element, Assistant's Element, Dental Lamp) and functions (controls for air, water, spray, drive, chair movements, water unit) that are similar to the predicate device. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not applicable; no performance study was conducted or reported in this 510(k) summary.
- Data provenance: Not applicable; no data from a test set is reported.
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)
- Not applicable; no test set or ground truth establishment by experts is reported.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable; no test set or adjudication is reported.
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; no MRMC comparative effectiveness study was conducted or reported. This device is a physical dental unit, not an AI or diagnostic imaging device that would typically involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable; this device is a physical dental unit, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable; no ground truth was established for this submission. The demonstration is of substantial equivalence to an already legally marketed device.
8. The sample size for the training set
- Not applicable; no training set was used or reported.
9. How the ground truth for the training set was established
- Not applicable; no training set or ground truth establishment is reported.
Summary of what is present in the document:
The document is a 510(k) premarket notification for a dental operative unit, seeking clearance based on substantial equivalence to an existing predicate device. It defines the device, its intended use, and compares its technological characteristics to the predicate. There is no information regarding performance testing, clinical studies, or data analysis against specific acceptance criteria.
§ 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.