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This material is intended for use in dentistry as a base or cavity liner under permanent restorations and for temporary restorations to teeth as an interim measure to protect cavities before a permanent restoration can be completed.

These materials consist of a powder and liquid which, when mixed together, form a setting mass suitable for their intended use.

The provided documentation is a 510(k) Premarket Notification for the "Super-Dent Intermediate Restorative Material," a temporary dental cement. The submission aims to demonstrate substantial equivalence to a predicate device (Temporary Dental Cement; 510(k) number K895487).

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

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a formal table of acceptance criteria with numerical targets. Instead, the "NON-CLINICAL DATA" section discusses the characteristics of the device in comparison to the predicate device. The primary acceptance criterion for a 510(k) submission is demonstrating substantial equivalence to a legally marketed predicate device.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: Not explicitly stated. The document refers to "the setting characteristics of these materials," "the compressive strength," and "the disintegration," implying that some tests were performed, but the number of samples or specimens used for these tests is not provided.
• Data Provenance: The document (specifically "NON-CLINICAL DATA") describes lab-based testing comparing the subject device to the predicate device. The location of these tests is not specified, but the applicant (S.S. White Manufacturing, Ltd.) is based in England, so it's plausible the tests were conducted there. The nature of the data is retrospective in the sense that it's a comparison to an existing predicate device, and the testing was likely performed specifically for this 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

• Not applicable as this is a materials science evaluation, not a diagnostic or interventional device requiring humanexpert interpretation for ground truth. The "ground truth" for material properties is established through standardized laboratory testing methods.

4. Adjudication Method for the Test Set:

• Not applicable for a materials science evaluation. The results are from physical and chemical property tests, not expert consensus.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

• No MRMC study was done. The device is a dental material, not an imaging or diagnostic device requiring human reader interpretation with or without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

• Not applicable. This is a dental material, not an algorithm or AI-powered device.

7. The Type of Ground Truth Used:

• The ground truth for the non-clinical data (setting characteristics, compressive strength, disintegration) is based on standardized laboratory testing methods for dental materials. These methods are designed to objectively measure physical and chemical properties. The comparison is made against the performance of a predicate device, which would have established its own performance characteristics through similar objective testing.

8. The Sample Size for the Training Set:

• Not applicable. This is not an AI/ML device that requires a training set. The "device" is a physical dental material.

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

• Not applicable. No training set is used for this type of device.

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These materials are intended for use in taking impressions of oral tissues for preparation of orthodontic prostheses and to create study models required in designing and fitting of such devices.

These materials consist of powders which, when mixed with water, form a setting gel suitable for taking impressions of oral tissues.

This 510(k) premarket notification for the Super-Dent Alginate impression material details non-clinical testing against ISO 1563:1990. However, it's important to note that no clinical data was applicable or presented for this submission. The device is considered substantially equivalent to a predicate device (JELTRATE, K883842) based solely on non-clinical performance.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

Notes on Acceptance Criteria: The document states that "Non-clinical tests are in accordance with ISO 1563:1990." This ISO standard defines requirements for alginate impression materials. While the specific numerical acceptance criteria for each test (e.g., minimum working time, minimum compressive strength) are not explicitly stated in the provided text, the submission implies that the Super-Dent Alginate met or exceeded these criteria by stating it was "at least comparable to the predicate product" or "faster setting and stronger when set."

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not specified. The document only mentions "Non-clinical tests" without detailing the number of samples used for each test.
• Data Provenance: The tests were non-clinical, likely conducted in a laboratory setting. There is no information regarding the country of origin of the data or whether it was retrospective or prospective in a clinical sense.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• This question is not applicable as the evaluation was based on non-clinical laboratory testing against an ISO standard, not on expert-adjudicated clinical data requiring ground truth establishment by experts.

4. Adjudication Method for the Test Set

• This question is not applicable as there was no clinical test set requiring adjudication. The evaluation was based on objective measurements in a laboratory setting against an ISO standard.

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

• This question is not applicable. This premarket notification is for a dental impression material, not an AI-powered diagnostic or assistive device. No MRMC study was conducted.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

• This question is not applicable. This premarket notification is for a physical medical device (dental impression material), not a software algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for the non-clinical tests was established by objective physical and chemical measurements as defined and specified by the ISO 1563:1990 standard for alginate impression materials. This standard sets technical specifications for characteristics like working time, setting time, strength, flexibility, etc.

8. The Sample Size for the Training Set

• This question is not applicable. This submission describes laboratory testing of a physical product, not a machine learning model that would require a training set.

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

• This question is not applicable for the reasons stated in point 8.

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These materials are intended for use in preparation of tooth material prior to restoration by etching of the surface.

These materials consist of a gel containing ortho-phosphoric acid.

This document is a 510(k) Premarket Notification for a dental etching gel, primarily focusing on demonstrating substantial equivalence to a predicate device. It explicitly states, "NON-CLINICAL DATA: Non-clinical testing includes tests for pH, acid content, adhesion and water washability. The tests indicate results for pH and acid content which are comparable within formulation and experimental accuracy. The test for adhesion indicates better adhesion of the subject device. The device is intentionally more viscous than the predicate device to improve adhesion after placement. The test for water washability indicates marginally easier washability for the predicate device. This is a direct result of the intentionally increased viscosity (and adhesion) of the subject device. The washability of the subject device is satisfactory on consideration of the method of removal. CLINICAL DATA: There is none applicable."

Therefore, based on the provided text, the device relies on non-clinical data for its acceptance criteria, and clinical data is not applicable. Without specific acceptance criteria being quantified (e.g., pH range, minimum adhesion strength, maximum washability time), a detailed table comparing acceptance criteria to device performance is not possible from this text alone.

Here's an attempt to outline the information based on the provided text, acknowledging the limitations:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Sample size for the test set: Not mentioned.
• Data provenance: Not explicitly stated, but the tests were "non-clinical." This typically implies laboratory testing conducted by the manufacturer. The manufacturer is based in England.

3. Number of Experts and Qualifications for Ground Truth

• Not applicable as the data is non-clinical and does not involve expert-established ground truth for a test set in the conventional sense (e.g., diagnostic interpretation).

4. Adjudication Method

• Not applicable.

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

• No, a MRMC study was not done. The document explicitly states: "CLINICAL DATA: There is none applicable."

6. Standalone Algorithm Performance Study

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

7. Type of Ground Truth Used

• The ground truth for the non-clinical tests would have been established through standardized laboratory testing methods and measurements for pH, acid content, adhesion, and washability. For example, pH would be measured with a pH meter, acid content through titration, and adhesion/washability through specific physical tests, with the predicate device serving as a benchmark for "comparable" or "satisfactory" performance.

8. Sample Size for the Training Set

• Not applicable. This is not a machine learning algorithm.

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

• Not applicable.

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