(174 days)
The Expasyl Power Applicator is a dental handpiece intended to be used to dispense Expasyl, a hemostatic/gingival retracting agent. The paste is dispensed through a tip attached to the cartridge of Expasyl through the use of the Expasyl Power Applicator.
The Expasyl Power Applicator is a dental handpiece intended to dispense Expasyl, a temporary hemostatic/gingival retracting agent. The paste is dispensed through a tip attached to the cartridge of Expasyl through the use of the Expasyl Power Applicator. The Expasyl Power Applicator is connected to any micro-motor (air or electric) that has a coupling socket and a maximum speed of 40,000 rpm. When the capsule of Expasyl is empty, the plunger on the Expassyl Power Applicator rotates and the applicator makes a repetitive clicking noise which signals the micro-motor must be stopped. The capsule holder of the Expasyl Power Applicator is autoclaveable.
The provided text is a 510(k) Summary of Safety and Effectiveness for a dental device, the Expasyl Power Applicator. It's a regulatory document demonstrating substantial equivalence to a predicate device, not a study report proving specific performance criteria. Therefore, most of the requested information regarding acceptance criteria and study details for device performance cannot be extracted from this document.
The document primarily focuses on establishing that the Expasyl Power Applicator is substantially equivalent to the predicate device, Electro Medical Systems, EMS Air-Flow handy 2, for its intended use of dispensing a hemostatic/gingival retracting agent. Substantial equivalence in this context means the device performs in a similar manner and is intended for a similar use, rather than meeting specific quantitative performance metrics like a diagnostic AI model.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated with quantifiable measures. The acceptance criterion for a 510(k) is "substantial equivalence" to a predicate device. This is a regulatory standard, not a performance metric like sensitivity or specificity.
- Reported Device Performance: Not reported in terms of quantitative performance metrics (e.g., accuracy, precision). The document describes the device's function: "The Expasyl Power Applicator is a dental handpiece intended to dispense Expasyl, a temporary hemostatic/gingival retracting agent. The paste is dispensed through a tip attached to the cartridge of Expasyl through the use of the Expasyl Power Applicator." It also mentions "When the capsule of Expasyl is empty, the plunger on the Expassyl Power Applicator rotates and the applicator makes a repetitive clicking noise which signals the micro-motor must be stopped." These are functional descriptions, not performance results from a study against specific acceptance criteria.
2. Sample size used for the test set and the data provenance:
- Not applicable. This document does not describe a performance study with a test set of data samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There is no performance study described with a ground truth established by experts.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. There is no performance study described requiring adjudication.
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 dental handpiece for dispensing paste, not an AI or diagnostic tool that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a mechanical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. There is no performance study where ground truth was established.
8. The sample size for the training set:
- Not applicable. This document does not describe a machine learning algorithm or training set.
9. How the ground truth for the training set was established:
- Not applicable. There is no machine learning algorithm or training set.
In summary: The provided text is a 510(k) premarket notification for a dental handpiece, seeking substantial equivalence to a predicate device. It does not contain information about acceptance criteria, performance studies, test sets, ground truth establishment, or human-in-the-loop assessments as would be relevant for, for instance, an AI-powered diagnostic device.
§ 872.3660 Impression material.
(a)
Identification. Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.(b)
Classification. Class II (Special Controls).