(28 days)
For light activated polymerization of dental materials such as composites, luting cements, adhesives, and sealants using visible and near-UV light.
The Palmlight 10 is a dental curing light source that employs high power light emitting diodes (LED's) to generate light in the wavelengths between 390 and 500nm. This wavelength of light is readily absorbed by photoinitiators in a variety of dental compositions. Such initiators begin a polymerization reaction that causes these dental compositions to harden. The device features an internal rechargeable battery, allowing the device to be used in a cordless fashion. The device can be placed in a charging cradle when not in use, or can be attached to a power supply such that the device can be used or charged while attached to the power supply. The device features the ability to select from preset time increments for activating the device. The user can also select from 4 different output modes. The device features and on/off button to activate and deactivate the LED's. The device features a power down program such that the unit's display is deactivated if the unit is dormant for an extended period of time. The charging cradle features a power output display to assist the end user in determining the performance of the device.
The provided document describes the Palmlight 10, an LED dental curing light, and its substantial equivalence to predicate devices. However, this document is a 510(k) summary and does not contain a detailed report of clinical performance data or studies that would allow for a comprehensive description of acceptance criteria and how a device meets them in the way described in your request.
Specifically, the document states: "## Clinical Performance Data See Part 7: Performance Data" and "## Conclusion The Palmlight 10 is substantially equivalent to the listed dental curing light devices without raising any issues of safety or effectiveness. This device shares similar intended uses, and similar functional and performance characteristics. The device is designed to comply with relevant federal and international safety and priformance standards."
This indicates that clinical performance data, if it exists to prove specific acceptance criteria, would be in a separate "Part 7" of the submission, which is not included in the provided text. The submission focuses on demonstrating substantial equivalence based on technological characteristics and functional performance, rather than detailed clinical trials with acceptance criteria for specific performance metrics like sensitivity, specificity, or reader improvement with AI.
Therefore, I cannot provide the requested information for the Palmlight 10 based on the text provided, as the study details are not present. The device is a curing light, not an AI-assisted diagnostic tool, so many of the requested categories (like MRMC studies, ground truth establishment, expert adjudication) are not applicable in the context of this device type.
If this were an AI-powered diagnostic device, I would look for information on:
- Acceptance Criteria Table & Reported Performance: Specific thresholds for metrics like sensitivity, specificity, F1-score, or accuracy.
- Sample Size & Data Provenance: Details about the number of cases and their origin (e.g., retrospective US data).
- Experts for Ground Truth: Number of radiologists, pathologists, etc., and their experience levels.
- Adjudication Method: How disagreements among experts were resolved (e.g., 2+1, where two experts agree, or a third adjudicates).
- MRMC Comparative Effectiveness Study: If human reader performance (e.g., AUC, accuracy) was measured with and without AI assistance, and the effect size of that improvement.
- Standalone Performance: The algorithm's performance without human intervention.
- Type of Ground Truth: Whether it was pathology, clinical follow-up, or expert consensus.
- Training Set Size: Number of samples used to train the AI model.
- Training Set Ground Truth Establishment: How the ground truth for the training data was determined.
Since the Palmlight 10 is a physical device (LED dental curing light), its "performance" would typically relate to power output, wavelength, curing depth, bond strength of the cured material, and safety standards compliance. The provided text indicates compliance with IEC 60601-1:1998+A1, IEC 60601-1-2:2004 and IEC 60825-1:1993+A1+A2 as performance standards, but doesn't detail the specific acceptance criteria within those standards or the studies performed to meet them.
§ 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.