(43 days)
TheraCal LC is a light-cure resin-based, mineral trioxide aggregate (MTA) filled, liner designed Theracal De is a liner and pulp capping material. Its physical properties and uses are similar to the predicate device.
- Liner
- Pulp capping agent
TheraCal LC is a light-cured resin-based, mineral trioxide aggregate (MTA) filled, liner designed to perform as a barrier and to protect the dental pulpal complex. TheraCal LC's precise alacement allows its use in all deep cavity preparations. The light-cured set permits the practitioner immediate placement and condensation of the restorative material. Its proprietary practitioner intines for a command set with a visible light curing unit while maintaining ease of formulation anows for a ochimaners and one oprietary hydrophilic resin formulation creates a stable and durable liner or base.
This looks like a 510(k) summary for a dental product, TheraCal LC, which is a cavity liner and pulp capping material. The document states that the device is substantially equivalent to a predicate device, Prisma VLC Dycal.
However, the provided text does not contain the kind of detailed study information (acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) that you're asking for. In 510(k) submissions for devices like TheraCal LC, the "performance" typically refers to physical and chemical properties and biocompatibility, as compared to a predicate device, rather than diagnostic AI algorithm performance.
Here's a breakdown based on the absence of the requested information in the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Expected based on typical dental material evaluation) | Reported Device Performance (from text) |
|---|---|
| Biocompatibility: Non-toxic | "TheraCal LC was tested for biocompatibility and it was found to be non-toxic." |
| Intended Use: Liner & Pulp Capping Material | "TheraCal LC is a liner and pulp capping material." (Stated intent) |
| Chemical Composition: Light-cured, MTA filled, resin liner | "Light-cured, MTA (Mineral Trioxide Aggregate) filled, resin liner" |
| Mechanical/Physical Properties: Low viscosity, dispensable composite | "Low viscosity, dispensable composite" |
| Substantial Equivalence to Predicate | "Side by side comparisons of TheraCal LC to the predicate device Prisma VLC Dycal clearly demonstrates that the applicant device is substantially equivalent to the legally marked device." |
Critique: The provided text only broadly states "significant performance characteristics" and "side by side comparisons." It does not provide specific quantitative acceptance criteria (e.g., "flexural strength must be > X MPa") or the numerical results of those performance tests. It relies on a qualitative statement of "substantially equivalent."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not mentioned.
- Data Provenance: Not mentioned. The study is for a physical dental material, so "data provenance" in the AI sense isn't directly applicable. The testing would have been conducted in a laboratory setting.
- Retrospective or Prospective: Not applicable for this type of material testing.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not applicable. This device is a physical dental material, not an AI diagnostic device that requires expert-established ground truth for performance evaluation in the context of diagnostic accuracy.
4. Adjudication Method for the Test Set
- Not applicable. No expert review or adjudication process is described for this type of product testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No. An MRMC study is relevant for diagnostic imaging or AI systems where human readers interpret cases. This is a physical dental material.
- Effect Size: Not applicable.
6. If a Standalone (Algorithm Only) Performance Was Done
- No. This refers to AI algorithm performance. TheraCal LC is a physical dental material.
7. The Type of Ground Truth Used
- Not applicable in the context of diagnostic performance. For a dental material, "ground truth" would relate to objective measurements of physical, chemical, and biological properties (e.g., cytotoxicity tests, adhesion strength tests, etc.) compared against industry standards or the predicate device. The document only states "biocompatibility and it was found to be non-toxic" without detailing the specific tests or their "ground truth" values.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/ML device requiring a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable.
Summary of Study Information Provided:
The study referenced in the 510(k) summary is a "side by side comparison" of TheraCal LC to the predicate device, Prisma VLC Dycal. This comparison likely involved:
- Biocompatibility testing: "TheraCal LC was tested for biocompatibility and it was found to be non-toxic."
- Physical and chemical property testing: The summary mentions chemical composition and mechanical/physical properties (low viscosity, dispensable composite) being similar to the predicate. This would involve laboratory tests to measure these properties, though specific results or test methods are not detailed.
The core of the "study" is to demonstrate substantial equivalence to an already legally marketed device by showing similar intended use, technological characteristics, and performance, including safety (biocompatibility). The document effectively states that the device meets the acceptance criteria (especially non-toxicity and similarity to the predicate), but it does not provide the detailed quantitative data or methodologies one would expect for an AI diagnostic device's validation.
§ 872.3250 Calcium hydroxide cavity liner.
(a)
Identification. A calcium hydroxide cavity liner is a device material intended to be applied to the interior of a prepared cavity before insertion of restorative material, such as amalgam, to protect the pulp of a tooth.(b)
Classification. Class II.