(69 days)
The Acetal is intended for the fabrication of temporary dental prostheses like preformed clasps using Inovativ, LLC Acetal.
The Acetal material is a thermoplastic resin that is used to fabricate dental prostheses. The resin is used in an injection molding or pressing device to fabricate the prostheses.
The provided document is a 510(k) summary for the Inovativ Acetal material, a thermoplastic resin used to fabricate dental prostheses, specifically preformed clasps. This summary primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria and device performance metrics in the typical sense of a diagnostic or therapeutic medical device.
Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not applicable to this type of submission. The "study" here is essentially the demonstration of substantial equivalence based on material characteristics and intended use.
Here's an attempt to address the request based on the available information:
Acceptance Criteria and Study Details for Inovativ Acetal
Given that this is a 510(k) submission for a material (thermoplastic resin) used in dental prostheses, the "acceptance criteria" are focused on demonstrating substantial equivalence to a legally marketed predicate device rather than meeting specific performance thresholds for a diagnostic or interventional outcome.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Implicit for Substantial Equivalence) | Reported Device Performance (as stated in the 510(k)) |
|---|---|
| Similar Design | The Acetal thermoplastic resin is similar in design to the predicate device ("Acetal Dental" Acetal resin). |
| Similar Function | The Acetal thermoplastic resin is similar in function to the predicate device. |
| Similar Physical Properties | The Acetal thermoplastic resin is similar in physical properties to the predicate device. |
| Similar Material Characteristics | The Acetal thermoplastic resin is similar in material characteristics to the predicate device. A chemical analysis of Acetal is provided. |
| Similar Handling Characteristics | The Acetal thermoplastic resin is similar in handling characteristics to the predicate device. |
| Similar Intended Use | The Acetal is intended for the fabrication of temporary dental prostheses like preformed clasps, which is similar to the intended use of the predicate device. |
| Similar Functionality | The Acetal thermoplastic resin is similar in functionality to the predicate device. |
2. Sample Size for the Test Set and Data Provenance
This information is not applicable as there is no "test set" in the context of a clinical performance study for an AI/diagnostic device. The substantial equivalence is based on a comparison of the material itself and its intended use with a predicate device. The "data provenance" would refer to the characteristics of the material itself and the predicate.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. There is no "ground truth" established by experts in the context of evaluating a material's performance against clinical outcomes. The evaluation is primarily based on material science and comparison to an already cleared device.
4. Adjudication method for the test set
This information is not applicable. There was no "test set" requiring adjudication in the context of a clinical performance study.
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
This information is not applicable. The device is a material for dental prostheses, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a material, not an algorithm.
7. The type of ground truth used
This information is not applicable in the sense of expert consensus, pathology, or outcomes data for an AI/diagnostic device. For a material, the "ground truth" for substantial equivalence lies in the established characteristics of the predicate device.
8. The sample size for the training set
This information is not applicable. The device is a material, not an AI model requiring a training set.
9. How the ground truth for the training set was established
This information is not applicable. The device is a material, not an AI model.
Summary of the "Study" (Demonstration of Substantial Equivalence):
The "study" presented in this 510(k) is a comparative analysis of the Inovativ Acetal material against a legally marketed predicate device: Pressing North America, Inc. material, "Acetal Dental" Acetal resin.
The conclusion of the "study" (as determined by the FDA's letter) is that the Inovativ Acetal device is substantially equivalent to the predicate device. This determination is based on the claim that:
- "The Acetal thermoplastic resin is similar in design, function, physical properties and intended use to the predicate device."
- "Both the Acetal and the predicate device are similar in design, material characteristics, physical properties, handling characteristics, intended use and functionality."
- A chemical analysis of the Acetal material was provided within the submission to support these claims.
The FDA's August 29, 2002 letter (K022032) confirms this substantial equivalence, allowing the device to be marketed.
§ 872.3285 Preformed clasp.
(a)
Identification. A preformed clasp or a preformed wire clasp is a prefabricated device made of austenitic alloys or alloys containing 75 percent or greater gold and metals of the platinum group intended to be incorporated into a dental appliance, such as a partial denture, to help stabilize the appliance in the patient's mouth by fastening the appliance to an adjacent tooth.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.