(125 days)
TSC is a paste containing a hemostatic agent which is intended to be used for the temporary retraction and hemostasis of the gingival margin during dental procedures such as, but not limited to, dental impressions, seating of temporary and permanent restorations, restorations of cavities and placement of a rubber dam.
TSC is a paste containing a hemostatic agent which is intended to be used for the temporary retraction and hemostasis of the gingival margin during dental procedures such as, but not limited to, dental impressions, seating of temporary and permanent restorations, restorations of cavities and placement of a rubber dam. TSC is a tissue management solution that allows clinicians to quickly and easily obtain sulcular expansion in clinical situations prior to an impression. Additionally, TSC will help stop bleeding and prevent the flow of crevicular fluid upon removal, further assuring accurate and complete impressions.
The device described in the provided text is "TSC, a gingival retraction/hemostatic paste." The document is a 510(k) summary for the device. An AI/ML study is not applicable here as the device is a dental paste, not an AI/ML powered device.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily focuses on biocompatibility and bench testing to demonstrate substantial equivalence to a predicate device, Expa-syl. No specific quantitative "acceptance criteria" are explicitly stated with target values for performance metrics like "viscosity" or "rinse time." Instead, the studies aim to show that TSC performs comparably to the predicate.
| Biocompatibility Study | Acceptance Criteria (Implicit: Non-toxic, Non-allergenic, Non-irritant) | Reported Device Performance (Result for TSC) |
|---|---|---|
| In Vitro Cytotoxicity | Non-cytotoxic | Non-cytotoxic |
| Sensitization | Elicited no skin reaction / weak allergenic potential | Elicited no skin reaction / weak allergenic potential |
| Oral Irritation | Non-irritant | Non-irritant |
| Bench Testing | Comparison to Predicate Device (Expa-syl) | Not explicitly stated, but implied to be comparable |
| Viscosity | Comparable to Expa-syl | Evaluated (result not detailed) |
| Rinse Time | Comparable to Expa-syl | Evaluated (result not detailed) |
2. Sample Size Used for the Test Set and the Data Provenance:
- Biocompatibility Studies: The sample sizes for the in vitro cytotoxicity, sensitization, and oral irritation tests are not specified in the provided document.
- Bench Testing: The sample sizes for the viscosity and rinse time comparisons are not specified in the provided document.
- Data Provenance: The document does not specify the country of origin of the data. Given it's a 510(k) submission to the US FDA, the testing was presumably conducted to meet US regulatory requirements, but the origin of the labs is not stated. The studies are prospective in nature, as they were conducted specifically for this submission to evaluate the device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
This question is not applicable to the provided context. The device is a dental paste, and the evaluation involved laboratory (biocompatibility) and bench (physical properties) testing, not interpretation of medical images or data by experts to establish a "ground truth" in the diagnostic sense. The "ground truth" for these tests would be the established scientific methods and accepted standards for biocompatibility and material properties.
4. Adjudication Method for the Test Set:
Not applicable. There was no "test set" in the sense of a collection of cases requiring expert review and adjudication. The studies were laboratory and bench tests with objective endpoints.
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. The device is a dental paste, not an AI-powered diagnostic tool, and therefore, no MRMC study or AI assistance evaluation was performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This question is not applicable. The device is a dental paste, not an algorithm.
7. The Type of Ground Truth Used:
- Biocompatibility Studies: The ground truth is based on established ISO standards (ISO 10993-5 and 10993-10) for evaluating biological responses to medical devices. This represents an accepted scientific standard for safety.
- Bench Testing: The ground truth for performance characteristics (viscosity, rinse time) is implicitly the performance of the predicate device (Expa-syl). The goal was to show comparable performance.
8. The Sample Size for the Training Set:
This question is not applicable. There is no "training set" for this type of device (a dental paste). Training sets are relevant for machine learning algorithms.
9. How the Ground Truth for the Training Set Was Established:
This question is not applicable for the same reason as point 8.
N/A