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Use for virtually all etching and bonding needs in restorative dentistry for patients of all ages. Peak Universal Bond is used for desensitizing/sealing of tooth structure.

Peak Universal Bond adhesive bonds to the following materials:

• · Dentin and Enamel
• · Porcelain, Zirconia
• Metal
• · Composite

Peak™M Universal Bond is a bottle, syringe, or unit dose delivered bonding resin. It can be used with selfetch or with total etch techniques. It is 7.5% filled with an ethyl alcohol solvent carrier and will cure with most high intensity lights including LEDs. Peak Universal Bond adhesive contains 0.2% chlorhexidine which may ensure long term bond strengths. Its mode of action produces a mechanical occlusion of dentin tubules by the resins, thus reducing tooth hypersensitivity.

This is a 510(k) premarket notification for a resin tooth bonding agent, not an AI/ML device. Therefore, the requested information regarding acceptance criteria and study details for AI/ML performance is not found in this document.

The document discusses the substantial equivalence of the "Peak Universal Bond" device to a predicate device, focusing on its physical properties, technological characteristics, and indications for use in dentistry. It references non-clinical testing performed to establish this equivalence, specifically to ISO standards for bonding agents.

Here's why the requested information cannot be provided from this document:

• No AI/ML Component: The device, Peak Universal Bond, is a traditional medical device (a resin tooth bonding agent). It does not involve artificial intelligence or machine learning for diagnosis, prognosis, or treatment.
• Non-Clinical Testing: The "study" mentioned is "verification and validation testing" to show substantial equivalence. This involves testing physical properties according to ISO standards (e.g., ISO 29022 for shear bond strength, SEM imaging for dentinal tubule blockage) and simulated use by dental professionals. This is not a clinical study in the typical sense for AI/ML performance, nor does it generate the metrics you've requested.

Therefore, the specific points of inquiry about acceptance criteria, device performance, sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types are not applicable and not present in this regulatory submission for a conventional dental bonding agent.

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FORMA Composite is designed for restorations in anterior and posterior teeth.
FORMA™ Composite is used for direct and indirect restorations in both the anterior and posterior regions.

FORMA™ Composite is a Bis-GMA-based restorative composite. FORMA™ composite is designed for restorations in anterior and posterior teeth and is suitable for occlusal surfaces. Its formula contains a zirconia/silica inorganic filler combination and barium glass. FORMA™ composite is shaded based on the VITA shade guide, and is radiopaque. FORMA™ composite has a radiopacity value greater than 2 mm of aluminum has a radiopacity equivalent to that of dentin. Thus, 1 mm of material having a radiopacity equivalent to 1 mm of aluminum has a radiopacity equivalent to that of dentin and 2 mm of aluminum is equivalent to enamel.
FORMA™ composite A3D is filled 78% w/w. FORMA™ composite is a nanohybrid composite with nanoparticles entombed within the composite's formulation.

The provided text describes a 510(k) premarket notification for a dental composite material called FORMA Composite. This document is a regulatory submission to the FDA demonstrating substantial equivalence to a legally marketed predicate device, not a study performing statistical comparisons for AI/ML performance.

Therefore, the information required to answer most of your numbered points (especially those related to AI/ML device study parameters like sample size for testing/training set, expert ground truth establishment, MRMC studies, or standalone algorithm performance) is not present in the provided document.

The document focuses on the physical, chemical, and biological properties of the dental composite, and its comparison to a predicate device, as required for a Class II dental device submission. It does not describe an AI/ML medical device.

However, I can extract the following information that is relevant to "acceptance criteria" and "proof of meeting criteria" as it relates to this dental composite device:

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

The document outlines physical properties that serve as "acceptance criteria" by comparing the subject device (FORMA Composite) to the predicate device and asserting compliance with ISO standards.

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size: Not specified in terms of number of experimental units (e.g., number of samples for each physical test). The document states "Full testing to ISO 4049:2019, surface hardness evaluation, drop test ship testing, and an assessment on the curing wavelength, curing intensity and curing time were completed for the product verification testing." It also mentions "Simulated use and validation testing was conducted by dental professionals." The specific number of tests or samples is not provided.
• Data Provenance: Not explicitly stated, but assumed to be internal laboratory testing performed by Ultradent Products, Inc. (manufacturer). No country of origin for data is mentioned. The testing is implied to be prospective, as it was conducted for this specific submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable in the context of defining "ground truth" for a physical dental composite.
• "Dental professionals" were used for "simulated use and validation testing," but their number and specific qualifications (other than being dental professionals) are not detailed.

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

• Not applicable. This is for consensus-based labeling or image interpretation, not physical product testing.

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:

• No. This is a dental composite material, not an AI/ML diagnostic or assistive device. MRMC studies are not relevant here.

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

• No. This is a dental composite material, not an AI/ML device.

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

• For physical/chemical properties: Standardized Laboratory Testing/Measurements according to ISO standards (e.g., ISO 4049:2019 for dentistry - polymer-based restorative materials, and ISO 7405:2018 and ISO 10993-1:2018 for biological evaluation). The "ground truth" is established by the methods outlined in these international standards.
• For usability: Simulated use by dental professionals validated against predefined user needs and indications for use.

8. The sample size for the training set:

• Not applicable. This document describes a traditional medical device (dental composite), not an AI/ML device that requires a "training set."

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

• Not applicable. See point 8.

In summary, the provided document details the regulatory submission for a physical dental material and does not contain information related to AI/ML device studies or their associated evaluation metrics and methodologies.

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•Temporary restorations
•Splinting between implant copings for impressions to resist impression material distortion
•To provide structure for isolation clamping and to act as a barrier for endodontic irrigants
• Bite ramps and temporary occlusal buildups during orthodontics

J-Temp temporary resin is a flowable resin material designed to be durable enough to stay in place after being applied. It is delivered via syringe and light cured.

This document does not contain information about acceptance criteria and study details for device performance. It is an FDA 510(k) premarket notification for a dental resin material named "J-Temp", primarily focusing on its substantial equivalence to a predicate device ("Clip Flow" by Voco).

While a table comparing technological characteristics is provided, it outlines similarities and differences between the new device and predicate devices in terms of intended use, composition, physical properties, etc. However, this table does not include:

• Specific acceptance criteria (e.g., numerical thresholds for performance metrics).
• Reported device performance against such criteria.
• Details about a study designed to prove the device meets acceptance criteria, including sample sizes, ground truth establishment, expert involvement, or comparative effectiveness.

The document states that the device "successfully passed all verification and validation testing," but it does not provide any specifics about these tests, the acceptance criteria used, or the results obtained.

Therefore, I cannot provide the requested information from the given text.

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VALO X curing light is a source of illumination for curing photo-active materials and adhesives. It is also intended to provide illumination to aid in visualization during oral procedures. VALO X curing light accessory/ diffusor lenses are not intended for complete cure of photo-activated materials and adhesives.

VALO™ X:
With its broadband spectrum, VALO™ X curing light is designed to polymerize all light-cured products in the wavelength range of 380-515 nm per ISO 10650:2018.
The VALO X curing light can be used in a corded or cordless configuration using the Ultradent VALO rechargeable batteries or provided VALO X cord adapter. The curing light is designed to rest in a standard dental unit bracket or can be custom-mounted using the VALO surface mounting bracket included with the kit.

VALO™ X Accessory Lenses:
Accessory: PointCure Lens, Mode: Curing Mode, Description: Augments the VALO X curing light to polymerize composite through a translucent prosthetic.
Accessory: ProxiCure Ball, Mode: Curing Mode, Description: Augments the VALO X curing light to polymerize composite and help shape contact area matrix of an interproximal restoration.
Accessory: Diffuser Lens, Mode: White Light Diagnostic Aid Mode, Description: Augments the VALO X curing light to provide a visual aid for accurate color/shade comparison or whenever natural light is needed.
Accessory: Diffuser Lens, Mode: Black Light Diagnostic Aid Mode, Description: Augments the VALO X curing light to provide visualization of fluorescing chemicals in dental resins.
Accessory: Interproximal Lens, Mode: White Light Diagnostic Aid Mode, Description: Augments the VALO X curing light in visualization of teeth and dental prostheses.
Accessory: Translume, Mode: Curing or Diagnostic Aid Modes, Description: Augments the VALO X curing light in visualization by providing longer wavelength light to transilluminate teeth and dental prostheses.

I am unable to provide the detailed information requested regarding the acceptance criteria and study proving device performance for the VALO X and VALO X Accessory Lenses.

The provided text is a 510(k) Summary and FDA clearance letter for a dental curing light. While it describes the device, its intended use, and a comparison to a predicate device, it does not contain the specific acceptance criteria or the detailed results of performance studies that prove the device meets those criteria.

Medical device submissions to the FDA, particularly 510(k)s seeking substantial equivalence, generally involve performance data, but the public summary (like the one provided) often only broadly states that testing was performed and confirms that the device is substantially equivalent to a predicate. It typically references standards applied and types of tests conducted (e.g., radiant exitance, biocompatibility, EMC), but does not present the granular data, acceptance criteria tables, sample sizes, or expert review details that you are asking for.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance values.
• Sample sizes used for test sets or data provenance (beyond mentioning "internal testing protocols").
• Information on ground truth establishment, including the number and qualifications of experts or adjudication methods.
• Any details about Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
• Information on standalone algorithm performance (as this is not an AI/software device).
• Details on training set sample sizes or how their ground truth was established.

The document states that "Device design validation and verification activities have been performed to FDA Guidance Document... and recognized standards and via internal testing protocols." It lists several ISO and IEC standards that were applied during non-clinical testing. This general statement, however, does not provide the specific performance results or acceptance thresholds.

Therefore, I cannot fulfill your request based solely on the provided text. To get such detailed information, one would typically need access to the full 510(k) submission not just the public summary or clearance letter.

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UltraCal XS calcium hydroxide paste is indicated to be used for:

• temporary dressing for root canals
• apexification and/or perforation
• vital pulpotomy
• direct pulp capping
• indirect pulp capping
• root resorption
• root canal filling for primary teeth

UltraCal XS calcium hydroxide paste is an aqueous, 12.0 to 12.5 pH, radiopaque, premixed paste for direct application.

This document is a 510(k) submission for a medical device called UltraCal XS, a calcium hydroxide paste used in dentistry. It's a "substantial equivalence" determination, not a study proving the device meets specific performance acceptance criteria in the way an AI/ML device would. Therefore, most of the requested information for an AI/ML study (like sample size for test sets, expert ground truth, MRMC studies, standalone performance, training sets, etc.) is not applicable here.

However, I can extract and infer some related information regarding the device's technical characteristics and how its equivalence to predicate devices was established.

Here's a breakdown of the applicable information:

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

The document does not specify "acceptance criteria" in the typical sense of numerical thresholds for clinical performance metrics (e.g., sensitivity, specificity, AUC) that an AI/ML study would define. Instead, it demonstrates "substantial equivalence" to legally marketed predicate devices based on technological characteristics, intended use, and safety. Its performance is implicitly shown through comparison to these predicates and successful completion of verification and validation testing.

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. This is a 510(k) submission for a dental filling material, not an AI/ML device relying on a "test set" of clinical data to evaluate algorithmic performance. The submission relies on laboratory testing and comparison to existing devices.

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.

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

Not applicable.

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.

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

Not applicable.

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

Not applicable. The "ground truth" for this device's safety and effectiveness is established through adherence to recognized standards (e.g., ISO 7405 for biocompatibility) and demonstrated substantial equivalence to legally marketed predicate devices, supported by laboratory characterization of its physical and chemical properties.

8. The sample size for the training set

Not applicable.

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

Not applicable.

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UltraTemp REZ II is indicated for temporization of provisional prosthesis or restorative provisional crowns, bridges, inlays, and on lays).

UltraTemp™ REZ II temporary resin cement is a low viscosity, temporary luting/filling material featuring a hydrophilic resin-based formula which is recommended for the retention of provisional restorations of provisional prosthesis. UltraTemp REZ II temporary resin cement may also be used for temporary restorative procedures (i.e. provisional crowns, bridges, inlays, and on lays). It is available in Fast Set (1 to 2 minutes) and Regular Set (2 to 3 minutes).

The provided text is a 510(k) Premarket Notification for a dental cement named UltraTemp Rez II. It describes the device, its intended use, and compares it to a predicate device (UltraTemp REZ). The document focuses on demonstrating substantial equivalence based on technological characteristics, rather than presenting a study of a device, especially not a device using AI, that would typically involve acceptance criteria related to classification performance metrics (like sensitivity, specificity, accuracy, etc.), expert adjudication, or MRMC studies.

Therefore, many of the requested items in your prompt are not applicable to the content of this document. This document is a regulatory submission for a dental material, not an AI/software device requiring performance validation in the way your prompt describes.

However, I can extract the information that is present and explain why other information is absent given the nature of the document.

Information Applicable to This Document:

1. A table of acceptance criteria and the reported device performance:
   The document does not explicitly state "acceptance criteria" in the context of classification task performance (e.g., sensitivity, specificity thresholds). Instead, it presents a comparison table (Table 5-1) showing various characteristics of the proposed device (UltraTemp REZ II) against its predicate device (UltraTemp REZ). The "reported device performance" are the physical properties and analytical tests conducted to demonstrate equivalence.

Information Not Applicable or Not Provided in This Document:

2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): This document does not describe a clinical "test set" in the context of an AI/algorithm evaluation. The "studies" mentioned are laboratory tests of physical and chemical properties of the dental cement. Specific sample sizes for each physical/chemical test are not provided, nor is the data provenance in terms of country or retrospective/prospective nature, as these are typically conducted in a laboratory setting for material characterization.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in the context of this material, relates to the measured physical and chemical properties, not a diagnostic classification established by experts.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as there's no diagnostic test set requiring human 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 is a dental cement, not an AI-powered diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a dental cement, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device would be defined by the established physical and chemical standards for dental cements (e.g., ISO standards for film thickness, radio-opacity, mechanical strength). The document refers to internal procedures and ISO standards for these measurements.

8. The sample size for the training set: Not applicable. This is a material, not a learning algorithm.

9. How the ground truth for the training set was established: Not applicable.

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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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ChlorCid, ChlorCid V and ChlorCid Surf are used for irrigating, instrumentation and debriding of root canal preparations.

The ChlorCid family of products are aqueous solutions of 3% sodium hypochlorite used for endodontic procedures. When desired, ChlorCid V is a more viscous solution for enhanced flow control and lubrication, and ChlorCid Surf includes a surfactant which assists in the product's ability to penetrate in tight canal spaces.

This document is a 510(k) premarket notification for dental devices (ChlorCid, ChlorCid V, ChlorCid Surf), which are root canal cleansers. It asserts substantial equivalence to predicate devices, and therefore, does not contain details of an AI/ML-based device or a comparative effectiveness study involving AI assistance.

The document describes material properties, such as concentration, pH, viscosity, and wettability, and "simulated root canal" and "extracted molars" tests to demonstrate performance of the device. It focuses on chemical and physical properties and their functional relevance, rather than diagnostic accuracy or human-AI interaction.

Therefore, I cannot provide the information requested in your prompt as it pertains to AI/ML device acceptance criteria and study designs (e.g., sample sizes for test and training sets, expert ground truth establishment, MRMC studies, standalone performance, etc.). The provided document is for a traditional medical device (chemical solution) and its substantial equivalence filing, not a software as a medical device (SaMD) or an AI-enabled 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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