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510(k) Data Aggregation
(88 days)
The C8+Dental Operative Unit with accessories is intended to supply power to and serve as a basc for dental devices and accessories. This product includes a dental The unit is intended for use in the dental clinic environment and used by chair. trained dentists and/or dental technicians and assistants.
The CB+ Dental Operative Unit is offered with the optional Sivision 3, an intraoral camera system intended to provide the dentist and patient with intraoral video images to view the condition of the teeth and oral cavity.
The C8+ is a modification of the C8 Dental Operative Unit and includes some features previously available on the Spirit S1 Dental Operative Unit. The C8+ consists of the following major components:
- Patient Treatment Chair ●
- . Dentist's Element
- Assistant's Element
- Water Unit with Cuspidor
- Overhead Dental Light
The C8+ can supply power to five (5) dental instruments, which may include an air water syringe, high and low speed turbines and electric motors, ultrasonic scalers, intraoral X -ray film viewer, fiber optic light instruments, dental curing light, water warmers, airscaler, and an air polisher. These accessories are not part of the C8+ dental operating unit 510(k). The C8+ also offers an optional built-in disinfection apparatus and an optional video system, SIVISION 3, which consists of an intraoral camera and a flat-screen LCD monitor.
This document is a 510(k) summary for the Sirona Dental Systems C8+ Dental Operative Unit with Accessories. It describes a medical device that combines features of existing predicate devices.
Based on the provided text, the device is a dental operative unit and accessories (dental chair, dental light, etc.) which also includes an optional intraoral camera system (Sivision 3). The K032543 submission is a claim of substantial equivalence to previously cleared devices (C8 Dental Operative Unit K983242 and Spirit S1 Dental Operative Unit K962071).
Crucially, this type of 510(k) submission for a non-diagnostic, non-AI-powered device generally does NOT include formal acceptance criteria, clinical studies demonstrating specific performance metrics, or sophisticated ground truth establishment methods as would be seen for diagnostic AI/ML devices.
The submission focuses on demonstrating that the new device has "the same intended use" and "similar components, and are similar in design, characteristics, and mode of operation" to already cleared predicate devices, without raising new questions of safety or effectiveness. The optional SIVISION 3 intraoral camera system is described as providing "intraoral video images to view the condition of the teeth and oral cavity," which is a descriptive function rather than a performance claim requiring specific accuracy metrics.
Therefore, many of the requested elements for acceptance criteria and study details are not applicable to this type of device and submission.
Here's how to address each point given the nature of the document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Intended Use Equivalence: Device must have the same intended use as predicate devices. | The C8+ Dental Operative Unit has the same intended use as the predicates, to "supply power to and serve as a base for dental devices and accessories." The Sivision 3 intraoral camera is intended "to provide the dentist and patient with intraoral video images to view the condition of the teeth and oral cavity." |
| Technological Characteristics Equivalence: Device must have similar components, design, characteristics, and mode of operation as predicate devices, without raising new questions of safety or effectiveness. | The C8+ includes "similar components, and are similar in design, characteristics, and mode of operation" to the C8 and Spirit S1. It includes a chair, dentist's instrument board, cuspidor, assistant's board, dental light, and footswitches. Additional features do not change fundamental technology or raise new safety/effectiveness questions. |
| Safety and Effectiveness: No new questions of safety or effectiveness are raised compared to predicate devices. | The FDA response states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices." This implies that no new questions of safety or effectiveness were raised. |
Explanation: For a Class I device (manual dental operative unit) seeking 510(k) clearance based on substantial equivalence, "acceptance criteria" are typically met by demonstrating that the device is as safe and effective as a legally marketed predicate device. This is primarily established through comparison of intended use and technological characteristics rather than specific performance metrics from a formal clinical study. The optional intraoral camera is descriptive of its functionality rather than a quantified performance.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This submission is for a medical device that does not involve diagnostic algorithms or require "test sets" of data in the typical sense. The "testing" involved would be engineering verification and validation against design specifications and relevant standards, not a clinical data-driven performance test.
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. As above, there is no "test set" and corresponding ground truth in this context for a device of this nature. The "ground truth" for the device's function is its ability to perform its mechanical and electrical functions as designed and intended (e.g., supply power, provide intraoral images), which are verified through engineering tests and comparison to predicate devices, not expert consensus on diagnostic data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set requiring expert adjudication for ground truth was used.
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 manual dental operative unit and an intraoral camera; it does not incorporate AI or machine learning algorithms, nor is it a diagnostic tool that would typically involve human readers or comparative effectiveness studies of this nature.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. As stated, this device does not contain an algorithm in the sense of AI/ML or diagnostic image analysis.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable in the typical sense of diagnostic devices. The "ground truth" for the device's substantial equivalence is established by comparing its design specifications, intended use, and technological characteristics to those of the predicate devices, and demonstrating that it adheres to relevant safety standards. This is a regulatory "ground truth" rather than a clinical one derived from patient data.
8. The sample size for the training set
Not applicable. This device does not use machine learning, therefore, there is no training set.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for a machine learning algorithm, there is no ground truth to establish for it.
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