(88 days)
- Pulp capping agent
- Liner
Resin modified light cure pulp capping material / liner (indications from labeling).
This document is a 510(k) Pre-Market Notification from the FDA, which focuses on demonstrating substantial equivalence of a new medical device to a previously cleared predicate device, rather than proving the device meets specific performance criteria through a study with acceptance criteria.
Therefore, the requested information (1-9) about acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment cannot be fully provided directly from the given text. The document describes a comparison to a predicate, not a performance study against predefined acceptance metrics for the new device.
However, I can extract information related to the device comparison and the basis of the substantial equivalence claim.
Here's what can be inferred or directly stated from the provided text, while acknowledging the limitations regarding a "study that proves the device meets the acceptance criteria" in the traditional sense of a performance study:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria (Implicitly based on Predicate Equivalence): The document implies that the "acceptance criteria" for the new device, LC ResinCal PC, are that its performance and characteristics are "substantially equivalent" to the predicate device, TheraCal LC (Bisco). While explicit numerical acceptance criteria for a new performance study are not given, the goal is to match or be comparable to the predicate.
- Reported Device Performance (Comparative): The performance is reported in terms of similarities to the predicate across various attributes.
| Feature / Performance Aspect | Predicate Device (TheraCal LC) | Subject Device (LC ResinCal PC) | Comparison / "Performance" |
|---|---|---|---|
| Description | Resin-Modified Calcium Silicate Pulp Protectant/Liner | Resin modified light cure pulp capping material / liner | Similar |
| Intended Use | Light-cured resin-modified calcium pulp protectant/liner designed to perform as a barrier and to protect the dental pulpal complex. | Light cure resin reinforced pulp capping material with MTA-fillers, designed to perform as a barrier and to protect the pulp. | Similar |
| Mechanism of Action | Light curing | Light curing | Same |
| Indications | - Pulp capping agent |
- Liner | - Pulp capping agent
- Liner | Same |
| Ingredients (General) | - Portland cement - Photo initiators
- Resins (e.g. BIS-GMA*) | - Portland cement
- Photo initiators
- Resins (e.g. BIS-GMA*) | Very similar (stated as "general chemical composition... very similar") |
| Working Properties | (Not explicitly detailed, but implied to be similar) | (Not explicitly detailed, but implied to be similar) | Very similar (intensity, wavelength, curing time) |
| Physical Properties | (Not explicitly detailed, but implied to be similar) | (Not explicitly detailed, but implied to be similar) | Very similar (working time, depth of cure, barcol hardness, calcium release) |
| Form of Delivery | black syringe | black syringe | Same |
2. Sample size used for the test set and the data provenance
- This document does not describe a clinical or lab "test set" in the context of performance testing for the new device with a specific sample size. The "test" here is a comparison to a predicate device based on its known characteristics and regulatory clearance.
- Data Provenance: The data provenance for the comparison is based on the characteristics of the predicate device (TheraCal LC, K063237, introduced to the US market in 2006) and the detailed chemical composition and properties of the subject device (LC ResinCal PC). No information on country of origin for specific "test data" is provided, nor whether it's retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable in the context of this 510(k) summary. "Ground truth" in this document is effectively the established performance and safety profile of the predicate device, and the detailed specifications of the new device being compared. No experts were used to establish a "ground truth" for a test set in a diagnostic or clinical performance study.
4. Adjudication method for the test set
- Not applicable. There was no "test set" requiring adjudication in the context of a performance study. The "adjudication" is essentially the FDA's review and determination of substantial equivalence based on the provided comparative data.
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/imaging device, nor does the document describe any MRMC or comparative effectiveness study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the comparison is the established characteristics and regulatory clearance of the predicate device (TheraCal LC) as known and accepted by the FDA when it was cleared under K063237. For the new device, the "ground truth" of its properties is based on the manufacturer's internal testing and documentation of its chemical composition and physical properties.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/machine learning device.
§ 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.