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An over the counter temporary Denture Reliner, intended to replace a worn denture lining.

ProSoft™ is an over the counter temporary Denture Reliner kit. The device contains a Polyethyl Methacrylate powder, a liquid Ethyl Alcohol, and a mixing stick. The material contains no Methyl Methacrylate Monomer, no Phtalate Plasticizer, no Bisphenol A, and no Cadmium colors.

The powder and the liquid are to be mixed together with the mixing stick to make the relining material. The relining material is then poured into the denture base and placed into the mouth to make the impression.

Once the impression has cured any excess material is trimmed with a sharp knife.

Can be easily removed with warm water or soaking in a solution of hydrogen peroxide and water overnight.

The provided text describes a 510(k) submission for a dental device, "ProSoft™ Denture Reliner." However, it does not include information about AI algorithms or studies that would typically relate to the acceptance criteria and performance metrics asked for in the prompt. The device is a physical product (denture reliner kit) and the evaluation focuses on substantial equivalence to predicate devices based on non-clinical bench testing, not AI performance.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, MRMC study, standalone performance, training set size) are not applicable to the provided document.

Here's an analysis of what is available in the document, framed as closely as possible to your request:

1. A table of acceptance criteria and the reported device performance

Explanation of "Acceptance Criteria": For a 510(k) submission of this type of device, the primary "acceptance criterion" from a regulatory perspective is demonstrating "substantial equivalence" to a legally marketed predicate device. This is achieved by showing that the new device is as safe and effective as the predicate. The document indicates that the device met this criterion through non-clinical bench testing and biocompatibility assessments.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Test Set Sample Size: Not applicable. The "test set" in this context refers to the samples used in the non-clinical bench testing. The document states "Bench testing was performed" and "Comparative testing data was provided" but does not specify the sample size of the materials or tests conducted.
• Data Provenance: The testing was "performed by a third party laboratory." The country of origin and whether the data was retrospective or prospective are not mentioned, but given it's a 510(k) in the US, it's presumed to be for the US market. The testing is implied to be prospective for the purpose of the submission.

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. This device does not involve a diagnostic or interpretive function that would require "experts to establish ground truth" as it would for an AI-powered image analysis device. The "ground truth" for its performance is assessed via established physical and chemical test methods.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. Adjudication methods like 2+1 are relevant for discrepancies in expert interpretations, which is not pertinent to this device's evaluation.

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

• No. An MRMC study was not done. This device is a physical denture reliner, not an AI-assisted diagnostic tool or an imaging device. Clinical testing was explicitly not conducted ("Clinical testing was not conducted").

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

• Not applicable. This device is a physical product and does not have an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Type of Ground Truth: For the functionality and biocompatibility, the "ground truth" would be established by established scientific and engineering principles, material science standards, and accepted testing protocols (e.g., for strength, adhesion, biocompatibility through ISO standards or similar). The FDA Guidance Document "OTC Denture Cushions, Pads, Reliners, Repair Kits, and Partially Fabricated Denture Kits" serves as a benchmark for what needs to be tested. The "ground truth" for showing substantial equivalence essentially means demonstrating that the new device's performance profiles, as measured by these tests, are comparable to those of the predicate device within acceptable limits.

8. The sample size for the training set

• Not applicable. This device is a physical product and does not involve AI/machine learning, therefore no training set is relevant.

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

• Not applicable. See #8.

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For over the counter temporary replacement of soft denture lining until a Dentist can be seen.
An over the counter temporary Denture Reliner, intended to replace a worn denture lining.

The subject device is a temporary OTC soft, clear denture reliner consisting of 2 parts (1) a monomer liquid and (2) a polymer powder which are mixed together prior to application. This results in a plastic resin paste which is then applied to the denture plate and set in the mouth to cure for a short period of time. Once setting is complete, the excess soft material is able to be trimmed by an enclosed spatula. The application is completely reversible by soaking the denture plate overnight in an over the counter solution of hydrogen peroxide and then removing it by hand. The material contains no Methyl Methacrylate Monomer, no Phthalate Plasticizer, no Bisphenol A, no leachable alcohol and no Cadmium colors.

This document is a 510(k) summary for the Majestic Drug Inc. Reline-It™ device. It outlines the regulatory process for an Over-The-Counter (OTC) denture reliner and asserts its substantial equivalence (SE) to already marketed predicate devices. However, it does not contain a study that would establish acceptance criteria for device performance in the manner typically seen for medical devices with diagnostic or treatment claims.

Here's why and what can be extracted from the provided text:

Lack of Performance Study and Acceptance Criteria:

The core of your request revolves around acceptance criteria and a study proving the device meets them. This type of detailed performance data (e.g., sensitivity, specificity, accuracy, or a specific metric with a defined threshold) is generally required for devices that perform a clinical function with measurable outcomes, such as diagnostic devices or treatment systems.

For an OTC denture reliner seeking 510(k) clearance, the primary focus is on demonstrating substantial equivalence to legally marketed predicate devices. This typically involves showing that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness. The "Performance Data" section in the summary (Page 1) merely states: "Articles and supporting documents are included in sections 'Conformance to Voluntary Standards' and 'Clinical and Scientific Studies'". However, the provided text does not include these sections or details of any specific performance study, acceptance criteria, or their results.

The summary emphasizes chemical composition and safety (e.g., "no Methyl Methacrylate Monomer, no Phthalate Plasticizer, no Bisphenol A, no leachable alcohol and no Cadmium colors") and the method of application/removal, rather than a quantifiable performance metric for "relining a denture."

Based on the provided text, the following information is either not applicable or not present:

1. Table of acceptance criteria and reported device performance: Not present. The 510(k) summary does not define specific performance metrics or acceptance criteria for its effectiveness as a denture reliner in a quantifiable way.
2. Sample size used for the test set and the data provenance: Not applicable, as no performance test set is described.
3. Number of experts used to establish the ground truth and their qualifications: Not applicable, as no ground truth for performance is described.
4. Adjudication method: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This type of study is for comparing human performance with and without AI assistance, which is not relevant to this device.
6. Standalone (algorithm only) performance: Not applicable. This device is a physical product, not an algorithm.
7. Type of ground truth used: Not applicable, as no performance study is detailed.
8. Sample size for the training set: Not applicable, as there's no machine learning model or "training set" for this device.
9. How the ground truth for the training set was established: Not applicable.

What the document does provide in relation to acceptance/equivalence:

The "acceptance criteria" in a 510(k) for such a device are intrinsically linked to demonstrating substantial equivalence to predicate devices. The "study" (or rather, the regulatory submission process) seeks to prove this equivalence.

• Acceptance Criteria (Implicit for 510(k) Substantial Equivalence):

  • Same Intended Use: The device aims to be "An over the counter temporary Denture Reliner, intended to replace a worn denture lining." This aligns with OTC denture reliners.
  • Similar Technological Characteristics: The device is described as "a monomer liquid and (2) a polymer powder which are mixed together prior to application... This results in a plastic resin paste..." and it highlights the absence of certain harmful chemicals (Methyl Methacrylate Monomer, Phthalate Plasticizer, Bisphenol A, leachable alcohol, Cadmium colors). This suggests its chemical composition and mechanism are similar to, or safer than, predicate devices.
  • No New Questions of Safety or Effectiveness: The submission argues that its "chemistry, methods of application and intended use are essentially identical" to predicate devices, implying it poses no new safety or effectiveness concerns.
  • Conformance to Guidance Documents: The submission explicitly states its purpose is to "follow the Food and Drug Administrations' Guidance document issued Aug 18, 1998 'OTC Denture Cushions, Pads, Reliners, Repair Kits, and Partially Fabricated Denture Kits'".

• The "Study" (i.e., the basis for clearance):

  • The entire 510(k) submission itself serves as the "study" demonstrating the device meets the implicit acceptance criteria of substantial equivalence.
  • Predicate Devices: The submission identifies three predicate devices:
    • DEN MAT CORP "DENTURE-TIGHT" K790589
    • LEE PHARMACEUTICALS "ACRYLINE 2" (510(k) unknown)
    • PERMA LABORATORIES PERMA SOFT II (510(k) unknown)
  • Argument for Equivalence: The submitter states, "Majestic Drug Inc. maintains that the subject device is substantially equivalent to the predicate devices in that they all are similar in technology, function and intended use." It further elaborates, "The subject device is substantially equivalent (materials, technology) to the above listed devices."
  • Data Provenance (for the basis of equivalence): The "data provenance" for the argument of equivalence relies on previously cleared devices (for which performance and safety would have been established at their time of clearance) and the general understanding of OTC denture reliners. The submission acknowledges that "technical data on formulation and a marketed sample was not available from present research efforts" for Den-Mat's product and that 510(k)s couldn't be found for the other predicates, necessitating reliance on the FDA's guidance document and the detailed formulation of the Reline-It™.

In summary, the provided document is a regulatory summary for a 510(k) submission focused on substantial equivalence for an OTC physical product. It does not contain a study with specified acceptance criteria and measured performance in the context of typical diagnostic or therapeutic medical devices.

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