(236 days)
Bisco LED, a visible-light dental curing device, is intended to provide the visible light required for polymerizing photo-initiated restorative materials used in dental practice.
Bisco LED is a dual peak wavelength visible-light dental curing device, with built-in variable time settings allowing for a selection of time and wavelength.
The provided text describes a 510(k) summary for a dental curing light, the Bisco LED (K052122). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing detailed acceptance criteria and a single study proving the device meets those criteria in the way a novel medical device might.
Here's an analysis based on the provided information, noting what is present and what is typically not included in a 510(k) summary for this type of device:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a quantitative, measurable sense for the Bisco LED. Instead, it relies on demonstrating equivalence to a predicate device. The tables compare properties of the Bisco LED to the predicate device, TRANSCURE.
| Property | Bisco LED (Reported Performance - as presented) | TRANSCURE (Predicate Device - as presented) | Substantial Equivalence Justification |
|---|---|---|---|
| Intended Use | Dental Curing Light | Dental Curing Light | Identical intended use. |
| Physical Properties | One Battery Powered, Handheld Unit containing both blue and purple LEDs | Two Battery Powered, Handheld Units with one for the blue and one for the purple LEDs | Although the physical configuration differs (one unit vs. two), both use LEDs for curing and are handheld. This isn't considered a difference affecting safety or effectiveness. |
| Mechanical Properties | Uses LED's to selectively output either the blue or purple light. (This is listed under "Mechanical Properties" in the original, but it describes the functional mechanism of light output) | Uses LED's to selectively output either the blue or purple light. | Identical functional mechanism for light output. |
| Wavelength | Dual peak wavelength visible-light (implied by "blue and purple LEDs") | Not explicitly stated in the table for TRANSCURE, but generally implied by "blue and purple LEDs" for both. | Implied equivalence in wavelength range for polymerization. |
| Time Settings | Built-in variable time settings | Not explicitly stated for TRANSCURE, but common for dental curing lights. | Implied equivalence in adjustability of curing time. |
Study Proving Acceptance Criteria:
The "study" proving the device meets acceptance criteria (or in this case, demonstrates substantial equivalence) is fundamentally a side-by-side comparison to a legally marketed predicate device. The text explicitly states: "Side by side comparisons of Bisco LED to the predicate device TRANSCURE clearly demonstrates that the applicant device is substantially equivalent to the legally marketed device."
This "study" is a comparison of:
- Intended Use: Both are "Dental Curing Light."
- Technology/Principles of Operation: Both use LEDs (both blue and purple) to polymerize photo-initiated restorative materials.
- Performance (General): Both are handheld, battery-powered devices. While the Bisco LED combines blue and purple LEDs into one unit and TRANSCURE uses two, this difference is presented as not affecting safety or effectiveness but rather a design variation.
- Materials: Not detailed in the provided text, but assumed to be biocompatible and similar to existing devices.
Crucially, a 510(k) for this type of device often relies on non-clinical performance data (e.g., light output intensity and spectrum measurements, heating effects, battery life) and possibly some clinical safety data (if there are new potential risks). However, none of that detailed data is provided in this summary. The summary focuses on the high-level comparison.
2. Sample Size Used for the Test Set and Data Provenance:
This information is not provided in the given 510(k) summary. For a 510(k) based on substantial equivalence, especially for a dental curing light, there typically isn't a "test set" in the sense of a patient cohort or a specific dataset for an algorithm. The "test" is the comparison against the predicate device based on its known performance and characteristics.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not applicable/not provided for this type of 510(k) submission. Dental curing lights are physical devices, and their performance is measured using instruments, not typically through expert consensus on a test set (e.g., images).
4. Adjudication Method for the Test Set:
This information is not applicable/not provided. There is no "test set" requiring adjudication by multiple experts in this context.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or is not mentioned. This type of study is relevant for diagnostic imaging devices where human readers interpret results, and an AI model might assist them. The Bisco LED is a physical device for curing materials; it does not involve human interpretation of output in that manner.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:
Not applicable in the traditional sense. The Bisco LED is not an algorithm; it is a physical dental device. Its "standalone performance" would be its light output parameters (intensity, spectrum, duration), and these would be compared to a predicate device or industry standards, but this is not an "algorithm only" study.
7. Type of Ground Truth Used:
The "ground truth" used for this 510(k) is the established performance and characteristics of the predicate device (TRANSCURE, Model 2910, K022862). The Bisco LED's performance is deemed acceptable if it is substantially equivalent to this existing, legally marketed device. This implies that the predicate device's safety and effectiveness were already established and accepted.
For the Bisco LED itself, the "ground truth" for its performance would be derived from:
- Instrumental measurements of light output (e.g., radiant power, spectral distribution)
- Results from curing efficacy tests (e.g., depth of cure, hardness of cured material)
- Safety testing (e.g., temperature rise, electrical safety)
However, these specific results are not detailed in the provided summary, as the summary focuses on the comparative argument.
8. Sample Size for the Training Set:
Not applicable/not provided. The Bisco LED is a physical device, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable/not provided. As above, this is not an AI algorithm.
§ 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.