(51 days)
The ECLIPSE® WAX REMOVER is used as an accessory to Eclipse® Prosthetic Resin System to remove wax and aid in adhesion to other acrylic resins in (1) the fabrication of dentures, appliances, and prostheses; (2) repair of dentures, and prostheses; and (3) relining of denture surfaces.
The ECLIPSE® WAX REMOVER is an accessory to the Trubyte® Denture Base Resin System (Eclipse® Prosthetic Resin System). It facilitates the effective removal of wax from cured Eclipse® resin substructures and promotes adhesion to other acrylic resins.
The provided text is a 510(k) summary for the ECLIPSE WAX REMOVER, a dental device. It does not describe an AI/ML-enabled medical device or any study that proves its performance against acceptance criteria in the way typically expected for such technologies (e.g., using metrics like sensitivity, specificity, or AUC).
Instead, this document is for a conventional medical device (a chemical accessory for denture fabrication). The "acceptance criteria" and "study" described are focused on demonstrating substantial equivalence to a predicate device and confirming basic safety and biocompatibility, not on evaluating the performance of an algorithm.
Here's a breakdown of why many of your requested points cannot be answered from this document and what information can be extracted:
Information Not Applicable or Not Found in the Document (for an AI/ML context):
- A table of acceptance criteria and the reported device performance (in an AI/ML sense): Not available. The document refers to "performance data" generally, but not specific metrics against acceptance criteria for an AI model.
- Sample sized used for the test set and the data provenance: Not applicable for this type of device.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a chemical product isn't established by expert consensus on images.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the AI/ML sense. The "ground truth" here would be established chemical or physical properties, not diagnostic classifications.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Information Applicable (Interpreted for a Conventional Device):
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A table of acceptance criteria and the reported device performance
- Acceptance Criteria (Implied from the document):
- Facilitates effective removal of wax from cured Eclipse® resin substructures.
- Promotes adhesion to other acrylic resins.
- Components previously used in legally marketed devices and/or found safe for dental use.
- Passes biocompatibility testing for cytotoxicity.
- Substantial equivalence to the predicate device (Trubyte Denture Base Resin System, K011560) for its intended use.
- Reported Device Performance:
- "We believe that the prior use of the components of ECLIPSE® WAX REMOVER in legally marketed devices, the performance data provided, and the biocompatibility data provided support the safety and effectiveness of the ECLIPSE® WAX REMOVER for the indicated use."
- Specifically states: "ECLIPSE® WAX REMOVER has been evaluated and passed biocompatibility testing for cytotoxicity."
- Acceptance Criteria (Implied from the document):
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document does not specify sample sizes for "performance data" or "biocompatibility testing."
- Data provenance is not mentioned.
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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 this is a chemical product, not an AI/ML diagnostic device requiring expert ground truth in this context.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable.
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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
- No. This is not an AI-enabled device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an AI-enabled device.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- For biocompatibility: established testing standards for cytotoxicity.
- For performance (wax removal/adhesion): Likely laboratory testing against established benchmarks or comparative testing against the predicate device, but specific details are not provided.
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The sample size for the training set
- Not applicable; this is not an AI/ML device.
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How the ground truth for the training set was established
- Not applicable; this is not an AI/ML device.
In summary, this document describes a traditional medical device (a chemical solution) being brought to market via the 510(k) pathway, which primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device and basic safety/performance, not the evaluation of an AI/ML algorithm.
§ 872.3760 Denture relining, repairing, or rebasing resin.
(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.