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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:

1. Acceptance Criteria Table & Reported Performance: Specific thresholds for metrics like sensitivity, specificity, F1-score, or accuracy.
2. Sample Size & Data Provenance: Details about the number of cases and their origin (e.g., retrospective US data).
3. Experts for Ground Truth: Number of radiologists, pathologists, etc., and their experience levels.
4. Adjudication Method: How disagreements among experts were resolved (e.g., 2+1, where two experts agree, or a third adjudicates).
5. 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.
6. Standalone Performance: The algorithm's performance without human intervention.
7. Type of Ground Truth: Whether it was pathology, clinical follow-up, or expert consensus.
8. Training Set Size: Number of samples used to train the AI model.
9. 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.

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Oral Applications: A source of illumination for curing photo-activated dental restorative materials, adhesives, pit and fissure sealants and activating tooth whitening materials via a light emitting diode (LED).

The Palmlight is a corded or cordless (battery operated) hand-held device. No filters are required to block out unnecessary rays. The light created by these diodes are specifically optimum for curing (430 to 500 nm). The Palmlight LED System is an instrument for use in the application of restorative compounds. sealants, and whitening compounds. The light is produced by a high intensity light emitting diode. With an adjustable light output of up to 500 Milliwatts. Therefore the applied for indications of use are warranted. Delivery devices (replacement tips) for the hand held probe are part of the package that allows the user to use the device with or without using direct current as rechargeable batteries are part of the handle.

The provided document describes the Palmlight dental curing light, a device intended to polymerize dental materials. It largely focuses on establishing substantial equivalence to existing predicate devices rather than presenting detailed performance studies with acceptance criteria in the typical sense for a novel device.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Since this submission is primarily about demonstrating substantial equivalence to predicate devices, the "acceptance criteria" are framed more in terms of matching the characteristics and performance of those predicates, especially concerning safety and fundamental functional parameters.

2. Sample Size Used for the Test Set and Data Provenance

• None provided. The submission explicitly states: "Clinical Performance Data: None included with this submission." This indicates that no specific test set or clinical study was conducted to demonstrate device performance in terms of clinical outcomes or direct comparison. The reliance is on established equivalence.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Not applicable (N/A). As no clinical performance data was included, there was no test set requiring expert-established ground truth.

4. Adjudication Method for the Test Set

• Not applicable (N/A). No test set, no adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. The document does not mention any MRMC study. The focus is on the device's characteristics and its equivalence to predicates, not on human reader performance with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not applicable (N/A). This is a hardware device (a curing light), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

• Since no original clinical performance data was provided, there was no ground truth explicitly established for this device's efficacy. The ground truth for its safety and effectiveness is implicitly tied to the established safety and effectiveness of the legally marketed predicate devices to which it claims substantial equivalence.

8. The Sample Size for the Training Set

• Not applicable (N/A). This is a hardware device, not a machine learning model, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established

• Not applicable (N/A). As there is no training set for a machine learning model, this question is not relevant.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" presented is a demonstration of substantial equivalence rather than an independent clinical or laboratory performance study with novel acceptance criteria. The Palmlight is shown to meet its "acceptance criteria" by demonstrating that its design, technological characteristics, and intended uses are similar or identical to legally marketed predicate devices.

Key points of this "study" (i.e., the substantial equivalence argument):

• Comparison to Predicates: The Palmlight is compared feature-by-feature to the Ultradent Palmlight and Jetlite 4000.
• Similar Indications for Use: All devices are for polymerizing dental materials using light.
• Similar Design Features: Light spectrum (430-500 nm), beam integrity, delivery power, energy type.
• Similar Control Systems: Safety systems like interlock devices.
• Identical Performance Characteristics: The Ultradent Palmlight is stated to be "identical in features and light output" to the submitted device, including variable light output and corded/cordless capability. The Jetlite 4000 also uses "similar transmission of light technology with similar light output."
• Regulatory Compliance: The device complies with 21 CFR Sub Chapter J and IEC 601-1 for electrical safety.

The conclusion is that because the Palmlight is substantially equivalent to existing, legally marketed devices and raises no new safety or effectiveness issues, it is deemed to have met its requirements. No new clinical performance data was provided or deemed necessary for this 510(k) submission.

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