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VALO Grand Corded: Source of illumination for curing photo-activated dental restorative materials and adhesives.

VALO Accessory Lenses: The VALO Accessory Lenses are multiple-use accessory lenses intended to provide illumination to aid in visualization during oral procedures and augment the VALO family of curing lights, which are a source of illumination for curing photo-activated dental restorative materials and adhesives. VALO Accessory Lenses are not intended for complete cure of photo-activated materials and adhesives.

VALO Grand Corded: With its broadband spectrum, VALO Grand Corded is designed to polymerize all light cured products in the wavelength range of 385-515nm per ISO 10650. VALO has a medical grade, international power supply and is suitable for power outlets from 100 to 240 volts. The handpiece is designed to rest in a standard dental unit bracket or can be custom mounted using the bracket included with the kit.

Accessory Lenses:

• . PointCure™ Lens - o Augments the VALO curing light to polymerize composite through a translucent prosthetic.
• . ProxiCure™ Ball Lens - o Augments the VALO curing light to polymerize composite and help shape contact area matrix of an interproximal restoration.
• TransLume™ Green Lens - Augments the VALO curing light to aid in visualization by providing longer wavelength light to o transilluminate teeth and dental prostheses.
• Black Light Lens - o Augments the VALO curing light to provide aid in visualization of fluorescing chemicals in dental resins.
• Interproximal Lens - Augments the VALO curing light to aid in visualization of teeth and dental prostheses. o
• White Light Lens - Augments the VALO curing light to provide a visual aid for accurate color/shade comparison or o whenever natural light is needed.

The provided text does not describe acceptance criteria for an AI/ML powered medical device, nor does it detail a study proving its performance. Instead, it is a 510(k) premarket notification for a dental curing light named "VALO Grand Corded and Accessory Lenses". This device is a traditional medical device, not an AI-powered one.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, or MRMC studies, as these concepts are not applicable to the non-AI device described in the document.

The document discusses the substantial equivalence of the "VALO Grand Corded and Accessory Lenses" to predicate devices based on:

• Intended use: Illumination for curing photo-activated dental restorative materials and adhesives, and aid in visualization during oral procedures.
• Technological characteristics: Power source, light source (LED, blue and violet wavelengths), operational modes (for curing and diagnostic purposes with accessory lenses), accessories, material composition, and technical specifications (light intensity, peak wavelength, depth of cure).
• Recognized standards: ISO 10650, IEC 80601-2-60, ISO 14971, IEC 62366-1, ISO 10993-1.
• Non-clinical testing: Radiant exitance and emission spectrum testing (ISO 10650:2018), illuminance and color temperature testing, beam profile testing, duty cycle testing, and disinfection validation testing.

The conclusion is that the device is substantially equivalent to the predicate devices and does not raise new concerns of safety or efficacy, which is the standard for 510(k) clearance for conventional medical devices.

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The source of illumination for curing photo-activated dental restorative materials and adhesives.

VALO® Grand Corded is a mains-powered, visible light activator for polymerization of dental resins of all photo-initiated dental materials. The VALO® Grand Corded version functions the same as the predicate, VALO® (K083647), as a professional hand-held, LED-based, visible light curing device. The modified device, VALO® Grand Corded, 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 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, and the middle power mode setting has been increased to make it more central between the Standard and Xtra Power modes. Additionally, VALO Grand Corded will include one pair of Blue Light Blocking Glasses, which will replace the Light Shield.

The provided text describes VALO® Grand Corded, a dental curing light, and its substantial equivalence to a predicate device, VALO®. However, it does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria in the way typically required for AI/ML medical devices.

Instead, the document focuses on demonstrating substantial equivalence to an existing predicate device based on similar technological characteristics, indications for use, and performance, as is common for medical devices without an AI/ML component.

Therefore, many of the requested categories for acceptance criteria and study details cannot be filled from the provided text. I will explain what information is present and what is missing.

Acceptance Criteria and Device Performance (Not applicable in the AI/ML sense)

The document claims substantial equivalence based on comparable technological characteristics rather than specific acceptance criteria for performance metrics. The performance aspects mentioned are for the device's operational characteristics, not accuracy, sensitivity, or specificity as would be expected for an AI/ML device.

1. A table of acceptance criteria and the reported device performance

No explicit acceptance criteria (e.g., minimum sensitivity, specificity) common for AI/ML devices are provided. The "performance" described is in terms of power output modes and light wavelength, which are design specifications, not performance against a clinical ground truth.

Regarding the study proving the device meets acceptance criteria:

The document describes "Device design validation and verification activities" performed according to FDA Guidance Document Dental Curing Lights – Premarket Notification [510(k)] and recognized standards (including ADA), and via internal testing protocols. These activities "confirm that VALO® Grand Corded performs equivalently to the predicate VALO® with the modifications that have been made."

The nature of these validation and verification activities is not detailed in the provided text beyond this general statement. It does not describe a clinical study or performance study in the way one would for an AI/ML device. The focus is on demonstrating that the physical and functional changes (e.g., larger head size, additional button, slight power mode adjustment) do not negatively impact safety and effectiveness and that the new device functions similarly to the predicate.

Missing Information (Not applicable or not provided for an AI/ML device in this document):

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 as this is not an AI/ML device or a clinical performance study. The "test set" would refer to internal validation tests for mechanical/electrical performance, which are not detailed here.

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. There is no mention of expert-established ground truth for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   • Not applicable. No 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. This is not an AI-assisted device.

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

   • Not applicable. This is a standalone dental curing light, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

   • Not applicable for an AI/ML device. The "ground truth" for this device would relate to its ability to cure dental restorative materials, which would be assessed through physical/chemical properties testing (not detailed).

8. The sample size for the training set

   • Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established

   • Not applicable. This is not an AI/ML device.

In summary:

This 510(k) submission establishes substantial equivalence for a physical dental device (a curing light) by comparing its design and functional characteristics to a previously cleared predicate device. It does not involve AI/ML technology, and therefore, the structure of the requested information (which is tailored for AI/ML device performance studies) does not align with the content of this document. The "study" mentioned refers to internal design validation and verification activities ensuring the modified device performs equivalently to the predicate, rather than a clinical performance study with specific acceptance criteria as you might see for an AI/ML diagnostic or prognostic tool.

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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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