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510(k) Data Aggregation
(56 days)
TheraCal DC is indicated for use for:
- Pulpotomy
- Temporary Filling Material
- Repair of Root Perforations
- Repair of Furcation Perforations
- Repair of Perforating Internal and External Resorptions
- Root-End Filling in Endodontic Surgery
- Pulp Exposures (Direct Pulp Capping)
- Protective Liner (Indirect Pulp Capping) and Base for Use Under a Variety of Substrates
TheraCal DC is a biocompatible, dual-cured, resin-modified calcium silicate that is used to treat damaged dentin in both the crown and the root. TheraCal DC's precise placement allows its use in all deep cavity preparations and endodontic repairs. The dual-cure set permits immediate placement and condensation of the restorative material. Its proprietary formulation allows for a command set with a light curing unit while maintaining ease of placement due to its thixotropic properties.
This document is a 510(k) summary for TheraCal DC, a dental restorative material. The purpose of a 510(k) is to demonstrate that a medical device is substantially equivalent to a legally marketed predicate device. This document does not describe a study involving an AI-powered diagnostic device, but rather a dental material. Therefore, many of the requested categories for AI device studies are not applicable.
Here's an attempt to extract relevant information and note the inapplicable categories:
1. Table of Acceptance Criteria and Reported Device Performance
The document compares the "Modified TheraCal DC" (the subject device) to the "TheraCal DC (K143292)" (the predicate device). The acceptance criteria are essentially that the modified device performs equivalently to the predicate in key physical and mechanical properties.
| Characteristic / Property | Acceptance Criteria | Subject Device Performance (Modified TheraCal DC) |
|---|---|---|
| Indications for Use | Identical to predicate device (K143292) | Identical to predicate device (K143292), including pulpotomy, temporary filling, repair of perforations, etc. |
| Material / Chemical Composition | Chemically equivalent to predicate device | - Filler: Portland Cement (same as predicate)- Resin Composition: Hydrophilic resin to facilitate calcium release (same as predicate)- Method of polymerization: Dual-Cure (same as predicate)- Method of Application: bonding agent not required (same as predicate)- Ions Released: Calcium and hydroxide (same as predicate) |
| Radiographic Appearance | Radiopaque (same as predicate - ISO 4049:2009 7.14) | Radiopaque |
| Ions Released (Property) | Calcium releasing (same as predicate) | Calcium releasing |
| pH | Basic (same as predicate) | Basic |
| Shelf-Life | Improved shelf-life over predicate (predicate was 12 months) | 18 months (predicate was 12 months, this is an improvement) |
| Physical/Mechanical Properties | Equivalent performance to predicate in: Flexural strength, Compressive strength, Dimetral tensile strength, Working time, Bond strength, Radiopacity, Water sorption and solubility, Calcium release, pH. | Direct comparison testing demonstrates that TheraCal DC is equivalent to the predicate device. (Specific values not provided in this summary, but implied to meet equivalence.) |
| Biocompatibility | Meets requirements of ISO 7405:2008 and ISO 10993-1:2009 | An evaluation was conducted using these standards, and it is concluded that TheraCal DC meets the requirements of the testing. |
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: Not specified. The document states "direct comparison testing" and "evaluated" for physical/mechanical properties and biocompatibility, but the exact sample sizes for each test are not listed in this summary.
- Data provenance: Not specified, but standard ISO/ANSI/ADA test methods are referenced, implying laboratory testing. The company, Bisco, Inc., is based in Schaumburg, Illinois, USA. The testing would presumably have been conducted in a lab environment. The study is prospective in the sense that the testing was performed specifically to support this 510(k) application for the modified device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a material science study, not a clinical study requiring expert interpretation of results. The "ground truth" is established by adherence to recognized international and national standards for material testing (e.g., ISO 4049, ANSI/ADA Spec. No. 27, ISO 7405, ISO 10993).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study requiring adjudication of expert opinions.
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 is not an AI diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI diagnostic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the material's properties is defined by objective physical and mechanical measurements according to established international and national standards (e.g., ISO 4049:2009 for flexural strength and radiopacity, ANSI/ADA Spec. No. 27:1993 for compressive strength, ISO 7405:2008 and ISO 10993-1:2009 for biocompatibility).
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a "training set."
9. How the ground truth for the training set was established
Not applicable.
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