(75 days)
The SPECTRUM™ 800 CURING UNIT provides visible light irradiation for the curing of dental VLC resin products.
The SPECTRUM™ 800 CURING UNIT is a visible light emitting photopolymerization unit that produces light used to photoactivate dental resin products.
The provided text is a 510(k) summary for a dental curing light, the SPECTRUM™ 800 CURING UNIT. It describes the device and claims substantial equivalence to a predicate device, the Spectrum™ Curing Light (K951425). However, it does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the way a modern AI/software as a medical device (SaMD) submission would.
The document is a premarket notification for a physical medical device, not a software algorithm. Therefore, many of the requested categories (like sample size for test/training sets, experts for ground truth, MRMC studies, standalone performance, etc.) are not applicable or not provided in the context of this type of submission for this device.
Here's an analysis based on the information provided, highlighting what is present and what is absent:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Explicit acceptance criteria are not stated in the document for the SPECTRUM™ 800 CURING UNIT in the format of specific quantitative metrics. | The device is described as having "an increased wattage light bulb" and an "intensity adjustment feature" that "will ensure the operator quality repeat output performance every time the light is used." |
| The "same filter used for the Spectrum™ Curing Light is used for the SPECTRUM™ 800 CURING UNIT and controls the wavelength of light that is emitted by the unit." | |
| The device features a "digital type" radiometer in the base, replacing a "red light/green light type" in the predicate device. | |
| Overall Implicit Acceptance: Demonstrating substantial equivalence to the predicate device in terms of safety and effectiveness for its intended use. | Overall Implicit Performance: Achieved substantial equivalence to the Spectrum™ Curing Light (K951425) through similar technological characteristics and performance (e.g., controlling wavelength, providing light for curing VLC resin). No formal study results are provided in this summary. |
Missing/Not Applicable Information for AI/SaMD Context:
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable/Not Provided: This is a physical device, and the submission primarily relies on comparison to a predicate device and description of its technological characteristics. There is no mention of a "test set" in the context of data for an algorithm.
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 Applicable/Not Provided: There is no "ground truth" establishment in the context of evaluating an algorithm. The "truth" for this device would relate to its physical properties and functionality.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable/Not Provided: No test set or adjudication method described.
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/Not Provided: This is not an AI/SaMD device, so an MRMC study is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable/Not Provided: Not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not Applicable/Not Provided: Not an algorithm. Ground truth for a curing light would involve physical measurements (e.g., light intensity, wavelength) or performance characteristics (e.g., ability to cure resins), but no specific data is presented.
8. The sample size for the training set
- Not Applicable/Not Provided: There is no training set mentioned, as this is not an AI/SaMD.
9. How the ground truth for the training set was established
- Not Applicable/Not Provided: No training set, no ground truth establishment for a training set.
Summary of the Device's "Proof of Meeting Criteria" from the Document:
The "proof" in this 510(k) summary is based on demonstrating substantial equivalence to a previously cleared predicate device rather than presenting a performance study against explicit quantitative acceptance criteria. The key arguments for substantial equivalence are:
- Identical Intended Use: "The SPECTRUM™ 800 CURING UNIT provides visible light irradiation for the curing of dental VLC resin products." This is implicitly the same as the predicate.
- Similar Technological Characteristics:
- It uses the "same filter" as the predicate to control emitted light wavelength.
- The core function (visible light photopolymerization) is the same.
- Minor Changes: The differences are characterized as "cosmetic changes to the appearance and operating features," an "increased wattage light bulb," and a change from a "red light/green light type" radiometer to a "digital type." The "intensity adjustment feature" is presented as an improvement that ensures "quality repeat output performance."
The document states: "We believe that the similarity of the SPECTRUM™ 800 CURING UNIT to the predicate device and the performance and safety data provided support the safety and effectiveness of the SPECTRUM™ 800 CURING UNIT for the indicated use." This "performance and safety data" is not detailed in the provided summary but would have been part of the full 510(k) submission to the FDA. The FDA's letter (SEP 1 5 1998) confirms that they reviewed the submission and determined "the device is substantially equivalent...for the indications for use stated in the enclosure."
In essence, for this type of medical device submission from 1998, the "acceptance criteria" were met by successfully demonstrating substantial equivalence to a legally marketed predicate device, rather than explicit numerical thresholds detailed in this public summary.
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.