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The Acrylic is intended for the fabrication of temporary dental prostheses like temporary crowns and bridges, flippers, orthodontic retainers, and occlusal guards using the Inovativ, LLC Acrylic resin.

The Acrylic 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 text is a 510(K) summary for the "Inovativ Acrylic" device. This document is a premarket notification for a medical device which aims to demonstrate that the new device is substantially equivalent to a legally marketed predicate device. This type of submission generally relies on demonstrating similar design, materials, technological characteristics, and intended use, rather than presenting a study with specific acceptance criteria and performance metrics in the way that, for example, an AI diagnostic device would.

Therefore, many of the requested categories for acceptance criteria and study details are not applicable to this type of submission.

Here's a breakdown of what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not present in the provided text. The document asserts "substantial equivalence" based on similar fundamental characteristics and physical properties to a predicate device, rather than defining specific performance acceptance criteria and reporting against them.

2. Sample size used for the test set and the data provenance:

This information is not present. No specific "test set" or clinical study data is described. The submission is based on comparison to a predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not present. No ground truth establishment by experts is described as this is not a diagnostic device and no clinical data is presented in this summary.

4. Adjudication method for the test set:

This information is not present.

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 is not applicable. The device (Inovativ Acrylic) is a thermoplastic resin for dental prostheses, not an AI diagnostic tool. No MRMC study or AI assistance is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This is not applicable. The device is not an algorithm.

7. The type of ground truth used:

This information is not present. No ground truth for performance is established in the document. Substantial equivalence is based on physical and chemical properties as compared to a predicate device.

8. The sample size for the training set:

This information is not present. The device is not an AI algorithm and does not have a training set.

9. How the ground truth for the training set was established:

This information is not present.

Summary of what is present:

• Device Name: Acrylic
• Manufacturer: Inovativ, LLC.
• Predicate Device: Health-Dent International, Inc. "Dent-Temp Acrylic"
• Basis for Equivalence: Similar in design, function, physical properties, chemical composition, handling characteristics, and intended use to the predicate device.
• Intended Use: Fabrication of temporary dental prostheses like partial denture clasps, temporary crowns, and bridges (later expanded to include flippers, orthodontic retainers, and occlusal guards).
• Regulatory Classification: Class II, Temporary Crown and Bridge Resin (21 CFR 872.3770).

This document serves to demonstrate substantial equivalence to an existing legally marketed device, meaning it has the same intended use and the same technological characteristics as the predicate device, or if it has different technological characteristics, the information submitted demonstrates that the device is as safe and effective as the legally marketed device and does not raise different questions of safety and effectiveness. It does not typically involve the type of performance studies with acceptance criteria and ground truth typical of novel diagnostic devices or AI applications.

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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

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.

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The Polycarb is intended for the fabrication of temporary dental prostheses like partial denture clasps, temporary crowns, and bridges using the Inovativ, LLC Polycarb resin.

The Polycarb 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.

This document describes a premarket notification for a dental material called "Polycarb," a thermoplastic resin used for temporary dental prostheses. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting formal acceptance criteria and a detailed study with quantitative performance metrics for the new device.

Therefore, the requested information components related to quantitative performance, such as acceptance criteria tables, sample sizes for test sets, expert consensus, MRMC studies, or standalone algorithm performance, are not applicable to this submission as it primarily addresses the material's properties and equivalence.

Here's an analysis based on the provided text, addressing the applicable points:

1. A table of acceptance criteria and the reported device performance:
   Not applicable. The submission does not define specific quantitative acceptance criteria or report performance metrics in the way a clinical study for a diagnostic or AI device would. The "performance" assessment is based on demonstrating similar design, function, and physical properties 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):
   Not applicable. The submission focuses on the material's chemical and physical properties and its substantial equivalence. It does not describe a clinical "test set" in the context of evaluating a device's diagnostic or predictive performance.

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. There is no mention of a "test set" requiring expert ground truth establishment.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
   Not applicable. No test set or expert adjudication process is described.

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 is a submission for a dental material and does not involve AI assistance or human reader studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   Not applicable. This is a dental material, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   Not applicable. The evaluation is based on the material's characteristics and comparison to a predicate, not on generating a medical "ground truth" for diagnostic purposes. The "truth" in this context is the factual chemical and physical properties of the material.

8. The sample size for the training set:
   Not applicable. This submission does not involve a training set as it's not a machine learning or AI device.

9. How the ground truth for the training set was established:
   Not applicable.

Summary based on available information:

The Inovativ Polycarb premarket 510(k) notification (K022030) aims to demonstrate substantial equivalence to an existing predicate device, Flexible Dimensions, LLC "Direct Crown" polycarbonate resin.

• Acceptance Criteria (Implied by Substantial Equivalence): The device (Polycarb) must be similar in design, function, physical properties, and intended use to the predicate device. The submission provides a chemical analysis to support these claims. The intended use is for the fabrication of temporary dental prostheses like partial denture clasps, temporary crowns, and bridges.

• Study that proves the device meets the acceptance criteria: The study is described as a chemical analysis and a comparison of technological characteristics (design, material characteristics, physical properties, handling characteristics, intended use, and functionality) to the predicate device. The submission asserts that "Both the Polycarb and the predicate device are similar in design, material characteristics, physical properties, handling characteristics, intended use and functionality."

Limitations of the provided text for the requested fields: This 510(k) summary is a regulatory filing for a physical material, not for a diagnostic device, software, or AI system, which typically require detailed clinical performance studies with specific statistical measures, ground truth establishment, and expert involvement. Therefore, many of the requested data points (e.g., sample sizes, expert qualifications, adjudication methods, AI assistance) are not found or applicable in this type of submission.

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