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K Number
K981862
Device Name
RESIN 4
Manufacturer
HARRY J. BOSWORTH CO.
Date Cleared
1999-02-09

(280 days)

Product Code
EBI
Regulation Number
872.3760
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

This device is for ratients requiring a heat-cured, non-cadmium pigment, containing denturi: base resin.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for a dental resin product called "RESIN 4".

This document does not contain information about acceptance criteria or a study proving device performance related to specific metrics like sensitivity, specificity, or accuracy.

Instead, it is a regulatory document stating that the FDA has reviewed the manufacturer's Section 510(k) notification and determined that the device is "substantially equivalent" to legally marketed predicate devices. This means it has similar intended use, technological characteristics, and safety and effectiveness as a device already on the market.

Therefore, I cannot provide the requested information, including:

  1. A table of acceptance criteria and the reported device performance: This document does not define such criteria nor report performance metrics in that format.
  2. Sample size used for the test set and the data provenance: Not mentioned. The substantial equivalence determination likely relies on comparison to a predicate device's characteristics rather than a new standalone clinical performance study with a test set.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
  4. Adjudication method: Not applicable.
  5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not mentioned. The concept of "human readers improve with AI" is not relevant to this type of dental material device.
  6. If a standalone performance study was done: Not explicitly mentioned in terms of performance metrics. The 510(k) process typically relies on demonstration of substantial equivalence, which may involve bench testing and material characterization, but not necessarily a clinical performance study with a "standalone" algorithm in this context.
  7. The type of ground truth used: Not applicable in the context of typical AI/diagnostic device ground truth.
  8. The sample size for the training set: Not applicable as this is not an AI/machine learning device.
  9. How the ground truth for the training set was established: Not applicable.

The document's purpose is to grant market clearance based on substantial equivalence, not to detail the results of a performance study against specific acceptance criteria.

§ 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.