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Premium Plus C01/C02 Dental Curing Light is intended for use by trained dental professionals for the purpose of curing dental composites by light.

Premium Plus C01/C02 LED Curing Light is classified as an Ultraviolet Activator for Polymerization (21 CFR 872.6070) because it is used for polymerization of dental light cured materials by dental professionals. The device is based on blue LED (light emitting diode) technology. It has three curing modes. Using different modes gives dental professionals the flexibility to polymerize virtually almost all types of composites, boding agents and sealants available in the market.

Premium Plus C01/C02 LED Curing Light consists of a handpiece and a charging station, which is connected via a plug-in transformer to an AC outlet for charging. The handpiece contains high intensity dental blue LED light source and a fibre optic light guide(C01-1) that conduct light to the treatment area on the patients or direct light source head(C02-1). A protective light shield and transformer are accessories provided with Premium Plus C01/C02 LED Curing Light, which support the operation of the device. The protective light shield filters blue light to protect eyes of dental professionals and patients. An FDA cleared barrier sleeves must be used between each patient such as the Pac-Dent Barrier Sleeve.

This document is a 510(k) premarket notification for a dental curing light, the Premium Plus C01/C02 LED Curing Light. It aims to establish substantial equivalence to existing predicate devices. The information provided focuses on technical specifications and safety standards rather than clinical performance or AI algorithm validation.

Therefore, many of the requested details, such as acceptance criteria based on clinical metrics (e.g., sensitivity, specificity), sample size for test sets, ground truth establishment by experts, adjudication methods, or effects of AI assistance, are not applicable or not available in this document.

The document primarily relies on comparisons of technical characteristics and adherence to recognized safety and performance standards to demonstrate substantial equivalence.

Here's a breakdown of the available and unavailable information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in terms of clinical performance metrics (like sensitivity, specificity, or human improvement with AI). Instead, it relies on demonstrating that the device meets recognized industry standards and performs comparably to predicate devices based on technical specifications and safety tests.

Therefore, instead of a clinical performance table, below are the relevant technical and safety performance criteria that were met:

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

• Sample Size for Test Set: Not specified for any clinical or performance comparison study. The document refers to "Performance Tests" for Electrical Safety, EMI, LED lamps, and Depth of Cure, but the number of units or materials tested is not mentioned.
• Data Provenance: Not applicable as there's no patient data or clinical imagery discussed. All testing appears to be laboratory-based and related to device specifications and safety.

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

Not applicable. The "ground truth" here is adherence to technical standards and specifications, not clinical diagnoses or interpretations. These standards are established by regulatory bodies and consensus organizations, not individual experts in a test set.

4. Adjudication Method for the Test Set

Not applicable. There's no interpretive task that would require adjudication.

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. This device is a dental curing light, not an AI-powered diagnostic or assistive tool.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This device does not involve an algorithm for standalone performance.

7. The Type of Ground Truth Used

The "ground truth" for this device's approval is based on:

• Compliance with recognized international and national standards: IEC 60601-1 (Electrical Safety), IEC 60601-1-2 (Electromagnetic Compatibility), ISO 10650-2 / ANSI/ADA Specification No. 48-2 (LED Curing Lights).
• Demonstrated technical equivalence in key specifications (intended use, light source, wavelength, radiant intensity, operational modes, power, environmental factors, safety standards) to already approved predicate devices.

8. The Sample Size for the Training Set

Not applicable. There is no training set mentioned, as this is not an AI/machine learning device.

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

Not applicable. There is no training set for this device.

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The VALO® Grand is a source of illumination for curing photo-activated dental restorative materials and adhesives.

VALO® Grand is a battery operated, visible light activator for polymerization of dental resins of all photo-initiated dental materials. The VALO® Grand version functions the same as the predicate, VALO® Cordless, K110582, as a professional hand-held, LED-based, visible light curing device. The modified device, VALO® Grand, is manufactured from the same materials (anodized aluminum, rubber buttons, LED light source, printed circuit board, silicone adhesive, plastic), is used for the same indications, and has the same intended use as the predicate device. Both devices have three power output modes ranging from 800 – 2300 mW/cm². Both the new device and predicate cure dental composite materials in the 395 – 480 nm range using an LED light source. Differences from the predicate include an increased light head diameter to provide a larger curing area over a tooth, an additional LED activation ('power') button for better ergonomics, and the middle power mode setting has been changed from 1400 to 1600 mW/cm², which makes it more central between the Standard and Xtra Power modes.

The provided text describes a Special 510(k) Summary for the VALO® Grand dental curing light. While it outlines the device's characteristics and its substantial equivalence to a predicate device, it does not contain detailed acceptance criteria and the comprehensive study data typically requested for proving a device meets specific performance criteria.

Here's an analysis based on the information provided and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document mentions "Verification activities included curing hardness, depth of cure per ADA Specification No. 48, maximum light intensity measurements at 2 mm for all power modes, spectral irradiance plots of all power modes, and representative user testing."

However, it does not provide a table specifying the acceptance criteria (e.g., minimum curing hardness, minimum depth of cure) for these parameters, nor does it present the actual reported device performance values against such criteria. It only states that "Based on the results of verification testing, the differences in technological characteristics did not raise different questions of safety or performance..." without showing the data.

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

The document mentions "representative user testing" but does not specify the sample size for any of the verification activities (curing hardness, depth of cure, light intensity, spectral irradiance, or user testing).

The data provenance is also not explicitly stated (e.g., country of origin, retrospective or prospective). It simply refers to "verification testing."

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided in the document. The studies mentioned are primarily technical performance tests of the device itself (curing properties, light output), not expert-driven assessments requiring ground truth establishment in the typical sense for diagnostic or prognostic devices. "Representative user testing" is mentioned, but details about the users (experts or not, qualifications) and their role in establishing "ground truth" are absent.

4. Adjudication Method

This information is not applicable/provided. The verification activities described are objective measurements of the device's physical and curing properties, not subjective assessments requiring expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC comparative effectiveness study was not performed or mentioned. The device is a dental curing light, and the studies described focus on its physical performance in curing dental materials, not on human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance

A standalone performance study was not performed or mentioned. The device is a physical light-emitting product, not an algorithm.

7. Type of Ground Truth Used

For the performance tests mentioned (curing hardness, depth of cure, light intensity, spectral irradiance), the "ground truth" would be established by objective laboratory measurements against predefined physical and chemical standards (e.g., ADA Specification No. 48 for depth of cure, calibrated light power meters for intensity, spectrophotometers for spectral irradiance). The document implies these standard methods were used ("per ADA Specification No. 48"), but doesn't explicitly detail the "ground truth" creation process beyond that.

8. Sample Size for the Training Set

This information is not applicable. The device is not an AI/ML algorithm that requires a training set. The descriptions are of physical device verification.

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

This information is not applicable. As there is no training set for an algorithm, there is no ground truth to establish for it.

In summary:

The provided document is a 510(k) summary for a dental curing light, demonstrating substantial equivalence to a predicate device through engineering and performance verification. It focuses on physical and curing properties of the device. Consequently, many of the requested details, particularly those related to expert-driven ground truth, MRMC studies, or AI/ML algorithms, are not relevant or present in this type of submission. While it states that verification activities were performed, it lacks the specific quantitative results and acceptance criteria tables that would fully answer the request for "acceptance criteria and the study that proves the device meets the acceptance criteria."

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For light curing polymerization of dental composites, luting materials, cements and other light cured materials.

Hi-Light and Hi-Light plus are light-emitting diode (LED) type dental curing light that is used for polymerization of light cure resin based composites. They can be used on several different dental materials that are curable by light. The devices use LED that produce a narrow spectrum of blue light in the 420~490nm range, which is useful energy range for activating the CPQ molecule, most commonly used to initiate the photo polymerization of dental monomers. The devices are designed by considering lightweight and portability. They operate on a rechargeable battery, making it easier to carry and use.

The provided text describes a 510(k) summary for a dental curing light, Hi-Light and Hi-Light Plus. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical effectiveness through extensive clinical trials for new device types. Therefore, the information typically requested for AI/ML device performance studies (like sample sizes for test sets, number of experts for ground truth, MRMC studies, etc.) is not applicable here.

Instead, the acceptance criteria and proof of meeting them for this device are based on non-clinical performance testing and substantial equivalence to predicate devices.

Here's how to extract the relevant information within the context of a 510(k) for a dental curing light:

Acceptance Criteria and Device Performance for Hi-Light / Hi-Light Plus

For a 510(k) submission of a dental curing light, the primary "acceptance criteria" revolve around demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is achieved through comparisons of technological characteristics and performance specifications derived from non-clinical testing against recognized standards.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the specifications of the predicate devices and relevant industry standards. The reported device performance is presented in comparison to these.

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is described as "Non-Clinical Testing" and "Basis for Substantial Equivalence."

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

• Sample Size for Test Set: Not applicable in the context of typical AI/ML validation studies. For this device, the "test set" refers to physical units of the Hi-Light and Hi-Light Plus devices themselves that underwent non-clinical performance and safety testing. The document doesn't specify the number of units tested, but it would typically involve a statistically relevant sample from a production batch to ensure consistency.
• Data Provenance: The testing was non-clinical (laboratory/bench testing) performed on the physical devices. The document implies this testing was conducted by or for Dentall Corporation in the Republic of Korea, as they are the applicant. The data is thus prospective in that it was generated for this specific regulatory submission.

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

• Not applicable in the AI/ML sense. The "ground truth" for a dental curing light's performance (e.g., light intensity, wavelength, depth of cure) is established by using calibrated instruments and adherence to internationally recognized standards (ANSI/ADA, IEC, ISO). The "experts" would be qualified engineers and technicians proficient in conducting these specific tests according to the standards. No human experts are used to interpret images or diagnose conditions in this context.

4. Adjudication Method for the Test Set:

• Not applicable. Performance measurements are quantitative and are not subject to human interpretation or adjudication in the way clinical diagnostic studies are. Test results are compared against a numerical specification.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• Not applicable. This is not a diagnostic device that involves human readers interpreting cases.

6. Standalone (Algorithm Only) Performance:

• Not applicable. This is a medical device (hardware) with an intended physical function, not a software algorithm.

7. Type of Ground Truth Used:

• Instrumental/Standardized Measurements: The ground truth for performance characteristics (light intensity, wavelength, depth of cure, electrical safety, biocompatibility) is established through highly precise and calibrated measurement equipment and standardized test protocols as defined by ANSI/ADA, IEC, and ISO standards. For example, depth of cure is measured according to the methodology outlined in ADA/ANSI Specification No. 48.

8. Sample Size for the Training Set:

• Not applicable. There is no machine learning model involved that requires a "training set." The device is a hardware product.

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

• Not applicable, as there is no training set for an algorithm.

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