FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The American Dental Technologies Dental Operative Units are standard electrical or pneumatically operated dental operative units that will be available in two product lines, the Gulliver and the Classe A, and several models. Both the Gulliver and Classe A Dental Operative Units consist of the following major components:

Patient Treatment Chair .
The Dentist's Instrument Board .
Assistants Board .
Cuspidor/Water system .
Overhead Dental Light .

AI/ML Overview

This 510(k) submission (K012213) for the American Dental Technologies Dental Operative Units (Gulliver and Classe A) is a pre-market notification for a Class I medical device. The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting novel performance data from clinical or human studies. Therefore, much of the requested information about acceptance criteria and study details for a new device's performance may not be directly applicable or available in this document.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a submission for a Class I dental operative unit, the "acceptance criteria" are primarily related to safety, electrical standards, and functional equivalence to the predicate device, rather than diagnostic accuracy or direct clinical outcomes. The document does not specify quantitative "acceptance criteria" for features like sensitivity, specificity, accuracy, or other performance metrics commonly associated with AI/ML devices.

Instead, the acceptance criteria are implicitly defined by compliance with recognized standards and substantial equivalence to the predicate device.

Acceptance Criteria (Implicit)	Reported Device Performance
Safety & Electrical Standards Compliance	Complies with the requirements of EN 60601-1 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance) and EN 60601-1-2 (Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic compatibility).
Intended Use Equivalence	Intended to supply power to and serve as a base for dental devices and accessories (same as predicate).
Design & Operational Equivalence	Uses similar components, and are similar in design, characteristics, and mode of operation to the predicate device. Both systems include a chair, dentist's instrument board, cuspidor, assistant's board, dental light, and footswitches.
Substantial Equivalence to Predicate Device (Sirona C8)	Declared substantially equivalent to the Sirona Dental Systems C8 (K983242).

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size for Test Set: Not applicable. This submission does not describe a test set or a clinical study involving patients or data to evaluate performance metrics in the way AI/ML devices do. Performance is demonstrated through compliance with standards and design similarity.
Data Provenance: Not applicable. No specific data is presented.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable. As no test set for clinical performance evaluation is described, there's no mention of experts establishing ground truth.

4. Adjudication Method for the Test Set:

Not applicable. There is no test set described for performance evaluation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No, a MRMC study was not done. This device is a dental operative unit, not an AI/ML diagnostic or assistive tool, so such a study would not be relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done:

No, a standalone algorithm performance study was not done. This is a physical dental unit, not an algorithm.

7. The Type of Ground Truth Used:

Not applicable in the context of typical AI/ML device evaluations. The "ground truth" for this device's safety and functionality assessment is compliance with established electrical and medical device standards (EN 60601-1, EN 60601-1-2) and the functional specifications of the predicate device.

8. The Sample Size for the Training Set:

Not applicable. There is no AI/ML algorithm involved, and therefore no training set.

9. How the Ground Truth for the Training Set was Established:

Not applicable. There is no AI/ML algorithm involved, and therefore no training set or ground truth for it.

Summary based on the document:

The provided 510(k) summary (K012213) for the American Dental Technologies Dental Operative Units is a regulatory submission for a traditional Class I medical device. Its acceptance criteria and supporting "study" primarily revolve around demonstrating:

Compliance with recognized electrical and safety standards: EN 60601-1 and EN 60601-1-2. This is the primary "performance testing" described.
Substantial equivalence to a legally marketed predicate device (Sirona C8): This equivalence is established by comparing intended use, design, components, characteristics, and mode of operation.

The document does not contain information related to AI/ML performance metrics such as sensitivity, specificity, clinical study design, expert ground truth, or training/test sets, as these are not relevant for this type of device and submission.

Summary

Regulation Number and Section

§ 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.