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TO PRODUCE LIGHT RANGE BETWEEN 400 & SOCIE CURE COMPOSITES CURED DENTAL RESTORATIVE MATERIAL SUCH AS LIGHT CURE COMPOSITES, PIT AND FISSURE SEALANTS, BONDING AGENTS, ADESION AND ARRESPANCE PIT AND FISSORE OFADINATE, ESTIGRATION OF FUCTION AND APPEARANCE OF THE TEETH OF PATIENT.

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I am sorry, but based on the provided document, I cannot answer the request as most of the information required to address the prompt is missing. The document is a 510(k) clearance letter for a dental light cure unit (O-Lite 75 Light Cure Unit), not a study report or a technical specifications document.

Here's a breakdown of why the information is missing:

• Acceptance Criteria and Performance Table: The letter states the device is "substantially equivalent" to pre-amendment devices, but it does not specify any performance acceptance criteria or report actual device performance metrics. This is typical for a 510(k) clearance, which focuses on equivalence rather than detailed performance studies against specific criteria.
• Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone Performance, Ground Truth Type, Training Set Size, Training Set Ground Truth: All these points relate to specific studies and their methodologies (e.g., clinical trials, bench testing with quantified results, reader studies). The 510(k) letter does not contain any such study details. It merely confirms regulatory clearance based on substantial equivalence.

Therefore, I cannot extract the requested information from this document.

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TO PRODUCE LIGHT RANGE BETWEEN 400 & 500 NM TO POLYMERIZE LIGHT CURED DENTAL RESTORATIVE MATERIAL SUCH AS LIGHT CURE COMPOSITES, PIT AND FISSURE SEALANTS, BONDING AGENTS, ADHESION PRIMERS ETC. WHICH ARE APPLIED IN THE RESTORATION OF FUCTION AND APPEARANCE OF THE TEETH OF PATIENT.

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The provided text is a 510(k) premarket notification approval letter for a dental light cure unit (Cute-Lite I Light Cure Unit). This document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment related to an AI or algorithm-driven device.

The letter is a regulatory approval for a physical medical device (a light cure unit) based on its substantial equivalence to previously marketed devices, following the provisions of the Federal Food, Drug, and Cosmetic Act. It primarily discusses regulatory classifications, general controls, and compliance requirements.

Therefore, I cannot provide details for the requested questions as the input document does not contain this type of information.

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TO PRODUCE LIGHT RANGE BETWEEN 400 & 500 NM TO POLYMERIZE LIGHT CURE DENTAL RESTORATIVE MATERIAL SUCH AS LIGHT CURE COMPOSITES, PIT AND FISSURE SEALANTS, BONDING AGENTS, ADHESION PRIMERS ETC. WHICH ARE APPLIED IN THE RESTORATION OF FUCTION AND APPEARANCE OF THE TEETH OF PATIENT.

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I am sorry, but the provided text from the FDA letter about the Q-Luxpro V/Q-Luxpro II Light Cure Unit does not contain any information about acceptance criteria or a study proving that the device meets such criteria. The letter is a 510(k) premarket notification response, indicating that the device has been found substantially equivalent to a legally marketed predicate device.

The information provided is administrative and focuses on regulatory compliance for marketing the device. It does not include:

1. A table of acceptance criteria or reported device performance.
2. Sample sizes or data provenance for any test sets.
3. Number or qualifications of experts used for ground truth.
4. Adjudication methods.
5. Information on multi-reader multi-case (MRMC) comparative effectiveness studies.
6. Information on standalone algorithm performance.
7. The type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The letter simply states the device's indications for use: "TO PRODUCE LIGHT RANGE BETWEEN 400 & 500 NM TO POLYMERIZE LIGHT CURE DENTAL RESTORATIVE MATERIAL SUCH AS LIGHT CURE COMPOSITES, PIT AND FISSURE SEALANTS, BONDING AGENTS, ADHESION PRIMERS ETC. WHICH ARE APPLIED IN THE RESTORATION OF FUCTION AND APPEARANCE OF THE TEETH OF PATIENT." This describes the functionality but not performance metrics or how they were proven.

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TO PRODUCE LIGHT FOR FORME MATERIAL SUCH AS LIGHT CURE COMPOSITES, CURE DENTAL RESTORATIVE MATERIAL SUCH AS LIGHT CURE COMPOSITES , CURE DENTAL RESTORATIVE MATERIAL SUCH AS LIGHT CURE COMESSITES , CURE DENTAL SESTORATIVE BONDING AGENTS, ADENTS, ADHESTON PRIMERS ETC. PIT AND FISSURE SEALANTS, BONDING AGENTS, FECTION AND APPEARANCE WHICH ARE APPLIED IN THE RESTORATION OF FUCTION AND APPEARANCE OF THE TEETH OF PATIENT.

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The provided text is a letter from the FDA regarding a 510(k) premarket notification for a dental light cure unit. It does not contain information about acceptance criteria or a study that proves the device meets specific criteria. The letter primarily informs the manufacturer that their device, the CU-100A Light Cure Unit, has been determined substantially equivalent to legally marketed predicate devices.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, study details, sample sizes, expert qualifications, or ground truth from the provided text.

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Ask a specific question about this device

Ask a specific question about this device