(35 days)
Intended Use: The Calset unit is used to warm dental composite materials and whitening bleach to130°F (54°C) or 155°F (68°C). It is also used to warm anesthetic carpules to 98°F (37°C) (body temperature).
The Calset is a warming device used to heat dental materials prior to their use in the mouth. It consists of a base unit that contains a heating element a temperature control circuit with LED indicators, a removable metal tray that is designed to hold different materials and a low voltage wall transformer that provides power to the unit.
Here's an analysis of the provided text regarding the Calset Composite Heater, focusing on the acceptance criteria and study information:
The provided text is a 510(k) summary for a medical device called the "Calset Composite Heater." This document is used to demonstrate substantial equivalence to a predicate device, not to provide detailed study results for performance acceptance criteria in the way one might find for a novel, high-risk device requiring extensive clinical trials.
Therefore, many of the typical questions about AI/ML algorithm studies (like training set size, ground truth for training, MRMC studies, specific performance metrics for algorithms) are not applicable to this type of submission. The focus here is on demonstrating the device functions as intended and is safe, primarily through comparison to an already-approved predicate device and basic performance testing.
Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the intended use and the comparison to the predicate device. The performance is reported directly in the description.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Temperature Settings: | |
| - Warm dental composite materials to 130°F (54°C) or 155°F (68°C) | The Calset has three temperature settings: 98°F (37°C), 130°F (54°C) or 155°F (68°C). |
| - Warm anesthetic carpules to 98°F (37°C) (body temperature) | The Calset has three temperature settings: 98°F (37°C), 130°F (54°C) or 155°F (68°C). The 98°F setting on the Calset is used together with a removable metal tray that holds anesthetic carpules. |
Study that Proves the Device Meets Acceptance Criteria:
The document describes the device and its intended uses, and implicitly relies on the technical specifications and comparison to the predicate device to prove it meets the criteria. It does not provide a detailed "study" in the sense of a clinical trial or a performance study with a separate test set, ground truth, or statistical analysis. This is typical for Class I or Class II devices undergoing 510(k) clearance, where substantial equivalence is the primary focus.
The "study" here is more of an engineering verification that the device achieves the stated temperatures.
Additional Requested Information:
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- N/A. The document does not describe a "test set" in the context of clinical data or image data. The performance claims are based on the device's engineering specifications. There is no indication of clinical data provenance.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- N/A. Ground truth for a diagnostic or AI algorithm is not relevant here. The ground truth for device performance would be a calibrated thermometer measuring the actual temperature achieved by the heater.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. Not applicable, as there is no test set in the context of diagnostic or AI-driven performance.
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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:
- N/A. This device is a composite heater, not an AI-assisted diagnostic tool. Therefore, MRMC studies are not applicable.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This is a hardware device; there is no embedded algorithm in the sense of AI/ML that would have standalone performance. Its "performance" is its ability to heat to specified temperatures, which is a physical characteristic.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the temperature claims, the ground truth would be physical measurement with calibrated instruments (e.g., thermometers). This is not explicitly stated but is implicitly assumed for any device that makes temperature claims.
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The sample size for the training set:
- N/A. There is no training set mentioned or implied, as this is not an AI/ML device.
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How the ground truth for the training set was established:
- N/A. No training set exists.
§ 872.6070 Ultraviolet activator for polymerization.
(a)
Identification. An ultraviolet activator for polymerization is a device that produces ultraviolet radiation intended to polymerize (set) resinous dental pit and fissure sealants or restorative materials by transmission of light through a rod.(b)
Classification. Class II.