(32 days)
The LED Turbo-Pen is a dental curing light that is designed for use in the optical polymerization of dental resins.
The LED Turbo-Pen consists of a handy unit and a battery charger. The handy unit contains a programmed control circuit, high intensity dental blue LED light source, a light guide and a optical fiber that conduct light to the treatment area on the patient. The control circuit which governs the output power rate. timing and monitoring the temperature of the LED.
The provided text is a 510(k) Premarket Notification summary for the LED Turbo-Pen dental curing light. While it describes the device, its intended use, and compares it to a legally marketed predicate device, it does not contain information about a specific study designed to prove the device meets acceptance criteria.
The section titled "Performance testing has been conducted..." indicates that some testing was performed, but it lacks the detailed methodology, acceptance criteria, results, and other specifics typically found in a study report. The document primarily focuses on establishing substantial equivalence to a predicate device based on technical specifications and intended use.
Therefore, many of the requested elements for describing the acceptance criteria and a study proving compliance cannot be fully answered from this document.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" for a study in the format usually requested. However, it does imply performance expectations by comparing the LED Turbo-Pen's specifications to its predicate device, the LED Turbo. The "reported device performance" is essentially the device's measured specifications.
| Characteristic | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (LED Turbo-Pen) |
|---|---|---|
| Light Intensity | 1600 mW/cm² | 500~1600 mW/cm² |
| Output Wavelength | 440nm~490nm | 440nm~490nm |
| LED Power Consumption | 5 Watt | 1 Watt and 5 Watt |
| Battery Use | 7.2V/1900mAh | 7.2V/1900mAh |
| Operating Voltage | AC100V~260V 50/60Hz | AC100V~260V 50/60Hz |
| Curing Time | 5, 10, 20, 40 seconds selectable | 5, 10, 20, 40 seconds selectable |
Note: The "acceptance criteria" here are implied by the specifications of the predicate device (LED Turbo) which the LED Turbo-Pen is claiming substantial equivalence to.
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 mentions "Performance testing has been conducted" but provides no details on the number of devices or materials tested.
- Data Provenance: Not specified. It does not mention the country of origin of the data or whether it was retrospective or prospective.
3. 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)
- Not specified. The document does not describe a study involving expert assessment for establishing ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not specified. There is no mention of any adjudication method.
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 device is a dental curing light, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study is not relevant to this device's function.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is generally relevant for AI/software devices. For a dental curing light, its "standalone performance" is its ability to cure resin and activate bleaching agents effectively, which is alluded to but not detailed as a standalone study in the provided text. The document states: "Performance testing has been conducted that confirms that the halogen light technology used for LED Turbo-Pen is able to cure resin and activate tooth bleaching agents within the specified timeframe without causing thermal damage to the tissue." However, no study details are provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For a dental curing light, "ground truth" would typically relate to objective measures like the degree of polymerization of dental resins or the efficacy of bleaching material activation, and the absence of thermal damage. The document mentions confirming these aspects but does not describe the specific ground truth measures or how they were established.
8. The sample size for the training set
- Not applicable. This device is a hardware product, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
- Not applicable for the same reason as above.
§ 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.