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Hydro-Cast / Kay-See Dental Silicone Soft Liner is applied to acrylic dentures for the purpose of providing a soft tissuebearing surface to the denture for patient comfort.

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The provided document does not contain information about the acceptance criteria or a study proving device performance on those criteria. The document is a 510(k) premarket notification letter from the FDA to Kay-See Dental Manufacturing Company concerning their Hydro-Cast/Kay-See Dental Silicone Soft Liner II.

The letter states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices. This means that no new clinical studies were required to demonstrate the device's safety and effectiveness compared to a device already on the market prior to May 28, 1976, or one that has been reclassified.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies is not present in this document because the device's approval was based on demonstrating substantial equivalence, not on fulfilling specific performance criteria from a new clinical study.

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Hydro-Cast Acrylic Varnish is applied to cured materials such as dentures, partial dentures, dental splints and temporary crowns/bridges for the purpose of sealing the acrylic surface.

Acrylic varnish. Preparation of methyl methacrylate monomer, multifunction methacrylates, light sensitizer, polymerization.

Here's an analysis of the provided text, outlining the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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Hydro-Cast Dental Etching Gel is used to prepare the surface of the tooth before a dental adhesive is used. It is applied directly on the tooth, and after fifteen seconds, the tooth is rinsed and dried.

The Hydro-Cast Etching Gel is a 35% phosphoric acid solution. It can be applied with a micro-brush, syringe, or pipette.

The provided document describes the Hydro-Cast Dental Etching Gel and its substantial equivalence to a predicate device. This submission is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy through extensive clinical trials with acceptance criteria directly linked to clinical outcomes for the new device itself.

Therefore, the information you're requesting regarding acceptance criteria, specific studies proving the device meets those criteria, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies, is largely not present in this type of submission for this particular device.

Here's why and what information is provided:

1. Nature of the Device and Submission: The Hydro-Cast Dental Etching Gel is a material used to prepare a tooth surface. Its function is to create a suitable surface for bonding, which is a chemical/physical process. The submission is a 510(k), which aims to show that the new device is "substantially equivalent" to a legally marketed predicate device (Orthosource Etch Systems, K861245). Substantial equivalence is often demonstrated through a comparison of technological characteristics and performance data that shows the new device is as safe and effective as the predicate.

2. Focus on "Substantial Equivalence": For devices like this, the "acceptance criteria" are typically related to a demonstration that the new device performs similarly to or within acceptable parameters compared to the predicate, particularly in its intended use. There isn't a pre-defined set of clinical outcome metrics that the new device needs to meet independently, but rather a comparison to the established predicate.

Here's a breakdown based on the information available:

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

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

• Sample Size: "five random subgroups with three samples drawn from each" (total of 15 samples).
• Data Provenance: Not specified, but generally assumed to be from the manufacturer's internal testing facilities, likely in the US (Kansas City, MO, where the company is located). The testing is prospective for the purpose of this 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/mentioned. The "ground truth" for this device's performance is inferred from the physical outcome of etching and bonding, rather than expert interpretation of images or clinical diagnoses. The assessment of whether "the adhesive cured well, and the bond strength desired was attained" would likely be through standardized laboratory testing methods, not expert consensus on qualitative observations.

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

• Not applicable/mentioned. Adjudication methods are typically relevant for human interpretation tasks, not for the objective measurement of physical properties like bond strength.

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 device is a dental etching gel, not an AI-assisted diagnostic tool or an imaging device involving human readers.

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

• Not applicable. This is a physical product, not an algorithm.

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

• The "ground truth" here is based on objective physical measurements or observations of material performance:
  • Compositional analysis: Verifying the ingredients of the gel.
  • Bond strength testing: Measuring the strength of the bond formed after etching, compared to established standards for dental adhesives.
  • Curing observation: Verifying if the adhesive cured properly on the etched surface.

8. The sample size for the training set

• Not applicable. This device is not an AI/ML model that requires a training set. The "samples" referred to in the performance testing are physical samples of the product.

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

• Not applicable, as there is no training set for this type of device submission.

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Hydro-Cast Versa-Temp Eugenol-Free Provisional Cement is used for temporarily cementing crowns and bridges. Hydro-Cast Versa-Temp provides for easy seating of the temporary, very fast first stage cure with an excellent consistency that allows the removal of excess material from the work area and undercuts, and a rigid set combined with easy removal of the temporary.

The device is a syringe dispensing system that dispenses a eugenol free temporary dental cement

Acceptance Criteria and Study for Hydro-Cast Versa-Temp Non-Eugenol Provisional Cement

This document describes the acceptance criteria and the non-clinical performance testing conducted to demonstrate the substantial equivalence of the Hydro-Cast Versa-Temp Non-Eugenol Provisional Cement.

1. Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for Test Set

• Sample Size: 10 random subgroups of three samples each, totaling 30 samples.
• Data Provenance: The data was generated through internal non-clinical performance testing conducted by Kay-See Dental. The location of the testing is not explicitly stated beyond "Kay-See Dental performed test." It's a retrospective study of the device's characteristics.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. This study focuses on the physical properties of a dental cement, specifically its setting times. The ground truth for setting times is established by predefined physical characteristics (rubbery consistency for initial set, hardened material for final set) observed during the testing, not by expert consensus or interpretation of images.

4. Adjudication Method for Test Set

Not applicable. As described above, the ground truth for setting times is determined by direct observation of physical changes in the material, not through expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is a non-clinical performance test for a dental cement, not a study involving human readers or AI assistance.

6. Standalone (Algorithm Only) Performance

Not applicable. This is a non-clinical performance test for a dental cement, not an algorithm-based device.

7. Type of Ground Truth Used

The ground truth used was based on objective physical observations during the testing process:

• Initial Set: Defined as reaching a "rubbery consistency."
• Final Set: Defined as becoming "hardened material."

8. Sample Size for the Training Set

Not applicable. This document describes a non-clinical performance test to confirm specifications of a physical product. There is no mention of a "training set" in the context of this type of testing.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set for this type of non-clinical testing, the establishment of its ground truth is irrelevant.

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