Search Results

Ionosit Bood is indicated for use in lining and basing applications under composite, amalgam ceramic and metal restorations.

Ionosit Bourd is a light-cure, glass ionomer liner/base material which is supplied in the form of a powder and liquid that are mixed prior to use. The liquid component contains a light sensitive polymerizable acid; the powder contains a fluoride-releasing special reactive glass.

Here's an analysis of the provided 510(k) summaries for acceptance criteria and supporting studies, based on your requested format.

Device: Ionosit Bond (K991172)

This 510(k) summary explicitly states that no performance or safety data was included in the premarket notification. Therefore, this device does not have explicit acceptance criteria or a study detailed in the provided summary that proves the device meets such criteria.

The basis for substantial equivalence for Ionosit Bond was solely on design and technical specifications compared to the predicate device, Vitrebond. The summary claims: "The materials, performance specifications and essential design characteristics of the Ionosit Bond material are equivalent to those of the predicate device. The proposed Ionosit Bond material complies with FDA's Guidance for Dental Cements as well as ISO 9917-Part 2 (dental water-based cements)."

Because no performance studies were conducted or provided in the submission for Ionosit Bond, the following sections cannot be populated:

1. A table of acceptance criteria and the reported device performance: Not available.
2. Sample size used for the test set and the data provenance: Not applicable.
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 (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Device: Unspecified Gloves (K991158)

This 510(k) summary provides acceptance criteria related to the physical characteristics and properties of the gloves. It explicitly states that "Performance data is the same as mentioned immediately above" (referring to the physical properties table) and that "Clinical data is not needed for gloves or for most devices cleared by the 510 (K) process."

Here's the breakdown based on your request:

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

   Acceptance Criteria	Reported Device Performance (as per table)
   Dimensions:
   Length (all sizes)	240 mm
   Width (XS)	80 111 mm
   Thickness - Cuff (min)	0.10 mm
   Thickness - Palm (min)	0.10 mm
   Thickness - Finger Tip (min)	0.10 mm
   Physical Properties (Before aging):
   Tensile Strength	21 Mpa
   Ultimate Elongation	700 % (min.)
   Physical Properties (After aging at 70°C 168 hrs.):
   Tensile Strength	16 Mpa
   Ultimate Elongation	600 % (min.)
   ASTM D 3578 Standard compliance	Meets ASTM D 3578 Standard
   FDA pinhole requirement compliance	Meets FDA pinhole requirement
   Labeling claim compliance	Meets labeling claim

   Note: For the physical properties like Tensile Strength and Ultimate Elongation, the values provided in the table seem to serve as both the acceptance criteria (minimums/targets) and the reported performance, implying the device met these values.

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

   • The 510(k) summary does not specify the sample size used for testing these physical properties.
   • The data provenance is not specified (e.g., country of origin, retrospective or prospective). This type of testing for gloves is typically conducted in a laboratory setting for compliance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. These are physical product specifications verified by laboratory testing, not expert consensus on medical interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. These are objective physical measurements.

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 glove, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a glove.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth is based on objective physical measurements as defined by industry standards (e.g., ASTM D 3578) and regulatory requirements (FDA pinhole requirement).

8. The sample size for the training set: Not applicable. This refers to a medical device where AI/algorithms are involved.

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

Ask a specific question about this device