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SprintRay Apex Flex is an alternative to traditional thermoplastic material used for the fabrication and repair of partial dentures. It is intended exclusively for professional dental work.

SprintRay Apex Flex is a photo-polymeric methacrylate/acrylate resin material used in conjunction with a 3D printer and a scanned 3D image in a dental office to fabricate partial dentures by 3D printing layer upon layer of the composite material. The product is available in two shades: Light Pink and Standard Pink.

SprintRay Apex Flex resin is intended exclusively for professional dental work. Fabrication of dental prosthetics with SprintRay Apex Flex resin requires computer-aided design and CAD/CAM manufacturing system that includes the following components not part of the device: Apex Flex file created in an optical impression system, 3D printer, and curing light equipment.

Apex Flex resin is designed to meet appropriate ISO standards for flexibility and sorption, to withstand prolonged use in the oral cavity. It is delivered non-sterile, and instructions on curing, and cleaning the final device prior to providing it to a patient are provided in the device indication for use document.

The provided document is an FDA 510(k) clearance letter and supporting summary for a dental resin product, SprintRay Apex Flex. This document does not describe an AI/ML-enabled medical device or a study involving human readers and AI assistance for diagnostic purposes. Instead, it details the substantial equivalence of a new dental material (resin) to existing predicate devices based on physical, chemical, and biocompatibility properties.

Therefore, many of the requested elements pertaining to AI/ML device studies (e.g., test set data provenance, expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance, training set details) are not applicable to this document.

However, I can extract the acceptance criteria and performance data for the material properties of the SprintRay Apex Flex device as presented in the document.

Analysis of Acceptance Criteria and Device Performance for SprintRay Apex Flex

The "acceptance criteria" for this device are implicitly derived from the performance of the predicate and reference devices, and conformance to industry consensus standards like ISO 20795-1. The SprintRay Apex Flex is demonstrated to be substantially equivalent to these devices by meeting comparable performance metrics.

1. Table of Acceptance Criteria and Reported Device Performance

The document presents a comparison of the SprintRay Apex Flex (Subject Device) against its primary predicate (Flex-Star V), secondary predicate (TCS® Unbreakable), and a reference device (SprintRay NightGuard Flex). The "acceptance criteria" are not explicitly stated as numerical thresholds but are implied by the measured values of the predicate devices, particularly the Flex-Star V as the primary predicate. The subject device must show comparable or improved performance without raising new safety or effectiveness concerns.

Summary of Device Performance: SprintRay Apex Flex demonstrates comparable or in some cases superior physical properties (e.g., flexural modulus, lower water sorption) compared to the predicate and reference devices, while meeting biocompatibility and other standard requirements.

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

The document does not specify a "test set" in the context of an AI/ML model for diagnostic performance. The "testing" refers to bench testing of material properties.

• Sample Size: The exact number of samples tested for each material property (e.g., flexural strength, sorption) is not provided. The results are reported with mean values and standard deviations, implying multiple samples were tested for each property as per ISO standards.
• Data Provenance: The data is generated from bench testing of the manufactured SprintRay Apex Flex resin. The "country of origin" for this data would be the location where these laboratory tests were conducted, which is not specified in the document but is typically part of the manufacturer's internal testing process. The nature of the data is prospective in the sense that the manufacturer specifically produced and tested samples of the Apex Flex resin for this 510(k) submission.

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

This question is not applicable as the document describes a material and its physical properties, not an AI/ML diagnostic device requiring expert interpretation for ground truth. The "ground truth" for material properties is established by standardized test methods (e.g., ISO 20795-1) and measurement equipment, not by human experts.

4. Adjudication Method for the Test Set

Not applicable. As the "test set" refers to material samples undergoing physical and chemical tests, there is no need for adjudicating human interpretations.

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 document pertains to a dental material, not an AI-assisted diagnostic device.

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

Not applicable. This question refers to AI algorithm performance.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on standardized laboratory measurements of physical, mechanical, and chemical properties (e.g., flexural strength, water sorption) as defined by ISO consensus standards (specifically ISO 20795-1 and ISO 10993-1/7405 for biocompatibility). There is no "expert consensus" or "pathology" in the context of a diagnostic outcome.

8. The Sample Size for the Training Set

Not applicable. As this is a material, there is no "training set" in the context of machine learning. The device itself is manufactured, and its properties are measured.

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

Not applicable. There is no "training set" for this type of device.

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SprintRay Digital Temp is a light-curable resin indicated for the fabrication of individual and fixed temporary full single crowns, temporary partial crowns, and temporary bridges. The material is an alternative to traditional restorative dental material.

SprintRay Digital Temp is a photo-polymer methacrylate resin material used in conjunction with a 3D printer and a scanned 3D image in a dental office to build dental prosthetics by 3D printing layer of the composite material. SprintRay Digital Temp resin is offered in various shades such as Bleach, A1, A2 and B1. Digital Temp is an alternative to traditional dental prosthesis material that is intended exclusively for professional dental work.

SprintRay Digital Temp resin is intended exclusively for professional dental work. Fabrication of dental prosthetics with SprintRay Digital Temp resin requires computer-aided design and CAD/CAM manufacturing system that includes the following components not part of the device: Digital Temp file created in an optical impression system, 3D printer, and curing light equipment.

Digital Temp resin is designed to meet appropriate ISO standards for flexibility and sorption, to withstand prolonged use in the oral cavity. It is delivered nonsterile, and instructions on curing, and cleaning the final device prior to providing it to a patient are provided in the device indication for use document.

The provided text is a 510(k) summary for SprintRay Digital Temp, a light-curable resin used for fabricating temporary dental restorations. It does not contain information on acceptance criteria or studies proving that a device meets such criteria for an AI/ML-based medical device.

Instead, it focuses on the substantial equivalence of the Digital Temp resin to a predicate device based on:

1. Intended Use/Indications for Use: Both are for temporary dental restorations.
2. Technological Characteristics: Both are light-cured acrylate resins used with 3D printers and scanned 3D images.
3. Performance Data: Biocompatibility testing and bench testing based on ISO 10477 were performed, and the resin "functioned as intended."

Therefore, I cannot extract the requested information about acceptance criteria and the study proving an AI/ML device's performance, as the document describes a material (resin) and not an AI/ML algorithm.

The questions you've asked (e.g., sample size for test/training sets, expert ground truth establishment, MRMC studies) are highly relevant to AI/ML device evaluations but are not addressed in this material-focused 510(k) summary.

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SprintRay Crown HT is a light-curable polymerizable resin intended to be used for the fabrication of; individual and fixed definitive full single crowns; definitive partial crowns in anterior and posterior area, individual and fixed single veneers; artificial teeth for dental prostheses, which are used for removable definitive full dentures; and individual and removable monolithic full and partial dentures in dental offices and laboratories. The material is an alternative to traditional restorative dental material.

SprintRay Crown HT is a photo-polymer methacrylate resin material used in conjunction with a 3D printer and a scanned 3D image in a dental office to build dental prosthetics by 3D printing layer upon layer of the composite material. SprintRay Crown HT resin is offered in various shades such as Bleach. A1, A2, A3, and B1. Crown HT is an alternative to traditional dental prosthesis material that is intended exclusively for professional dental work.

SprintRay Crown HT resin is intended exclusively for professional dental work. Fabrication of dental prosthetics with SprintRay Crown HT resin requires computer-aided design and CAD/CAM manufacturing system that includes the following components not part of the device: Crown HT file created in an optical impression system, 3D printer, and curing light equipment.

Crown HT resin is designed to meet appropriate ISO standards for flexibility and sorption, to withstand prolonged use in the oral cavity. It is delivered non-sterile, and instructions on curing, and cleaning the final device prior to providing it to a patient are provided in the device instruction for use (IFU) document.

The provided text describes the 510(k) summary for SprintRay Inc.'s "Crown HT" dental resin. It includes acceptance criteria for the device based on performance testing but does not describe a study involving human readers, ground truth consensus, or AI assistance for diagnostic purposes. The device being discussed is a material for fabricating dental prosthetics, not a diagnostic imaging AI system.

Therefore, many of the requested elements (e.g., sample size for test set, number of experts for ground truth, MRMC study, effect size of human reader improvement with AI, type of ground truth for AI, training set size for AI, ground truth establishment for AI training) are not applicable to this submission.

However, I can extract the relevant acceptance criteria and performance data for the material properties of the Crown HT resin, as well as information about the studies conducted to prove these properties.

Here's the information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by the requirement to perform testing based on ISO standards and to show comparable or better performance than the predicate device.

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SprintRay OnX Tough is a tooth shade ceramic-hybrid resin used for the fabrication of hybrid denture prosthetics, implant-supported denture prosthetics, monolithic full and partial removable dentures, and preformed denture teeth to be used in a denture.

OnX Tough resin consists of a curable dental acrylate resin that is manufactured in a dental office based on a 3D scanned image of a patient's teeth. The acrylate resin material is designed to be used in conjunction with a scanned 3D image, and 3D printer assembly, to locally manufacture out a dental appliance based on the clinician's judgment of patient need.

Fabrication of dental prosthetics with OnX Tough resin requires computer-aided design and CAD/CAM manufacturing system that includes the following components not part of the device: oral casting impression, digital denture file created in an optical impression system, 3D printer, and curing light equipment.

The material is an alternative to traditional dental prostheses material. OnX Tough resin is intended exclusively for professional dental work.

OnX Tough resin is designed to meet appropriate ISO standards for flexibility and sorption, to withstand prolonged use in the oral cavity. It is delivered non-sterile, and instructions are provided on cleaning the material prior to providing it to a patient. Curing is performed with a UV lamp. The appliance is then cleaned, trimmed, and verified to fit in the dental office before the patient leaves.

Here's an analysis of the provided text regarding the acceptance criteria and study for the SprintRay OnX Tough device.

It's important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices, not typically on a standalone clinical study demonstrating the device's diagnostic performance against a "ground truth" established by experts, as would be common for AI/ML devices. Therefore, many of the requested points from your prompt (like sample size for test sets, expert qualifications, MRMC studies, standalone algorithm performance, training set details) are not applicable in this context as this is a dental material, not an AI/ML diagnostic device.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The device, OnX Tough, was tested against industry consensus standards, primarily ISO 20795-1 and ISO 20795-2, which set the acceptance criteria for denture base polymers. Biocompatibility testing was also conducted according to ISO 10993-1, among others.

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

The document does not specify the exact sample sizes (e.g., number of test specimens for each mechanical test) used for the bench testing. This information is typically detailed in the full test reports, not usually in the 510(k) summary. Given this is a material properties verification, the "data provenance" is typically laboratory testing results, not patient data from a specific country or collected retrospectively/prospectively.

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

Not Applicable. This is a material science and biocompatibility assessment, not a diagnostic device relying on expert interpretation of results to establish ground truth for a clinical condition. The "ground truth" for these tests is the quantitative measurement against established physical/chemical standards.

4. Adjudication Method for the Test Set

Not Applicable. As above, this is laboratory bench testing against objective criteria, not a clinical study requiring adjudication of expert interpretations.

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

Not Applicable. This is a dental material, not an AI-assisted diagnostic tool. Therefore, MRMC studies evaluating human reader improvement with or without AI assistance are irrelevant to this device.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

Not Applicable. This is a physical dental material, not an algorithm or software. Its performance is evaluated through material property testing and biocompatibility.

7. Type of Ground Truth Used

The "ground truth" used for this device is based on established international standards for physical, mechanical, and chemical properties of dental materials (ISO 20795 series) and biocompatibility standards (ISO 10993 series). These are objective, quantitative benchmarks, not subjective expert consensus, pathology, or outcomes data in the sense of a diagnostic medical device.

8. Sample Size for the Training Set

Not Applicable. This is a manufactured dental resin, not a machine learning model that requires a training set. The development of the resin would involve material science research and iterative formulation, not data training in the context of AI.

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

Not Applicable. As explained above, there is no "training set" in the context of an AI/ML algorithm for this device. The material's formulation and properties are developed through chemical engineering and material science principles, with validation against performance specifications derived from ISO standards.

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SprintRay Digital Crown is a light-curable polymerizable resin intended to be used for the fabrication of; individual and fixed definitive full single crowns; definitive partial crowns in anterior and posterior area, individual and fixed single veneers; artificial teeth for dental prostheses, which are used for removable definitive full dentures; and individual and removable monolithic full and partial dentures in dental offices and laboratories. The material is an alternative to traditional restorative dental material.

SprintRay Digital Crown resin consists of a curable dental acrylate resin that is manufactured in a dental office based on a 3D scanned image of a patient's teeth. The acrylate resin material is designed to be used in conjunction with a scanned 3D image, and 3D printer assembly, to locally manufacture out a dental appliance based on the clinician's judgment of patient need.

Fabrication of dental prosthetics with SprintRay Digital Crown resin requires computer-aided design and CAD/CAM manufacturing system that includes the following components not part of the device: oral casting impression, digital crown file created in an optical impression system, 3D printer, and curing light equipment. SprintRay Digital Crown Resin is intended exclusively for professional dental work. Digital Crown Resin is offered in following shades/colors: Bleach, A1, B1.

The device is manufactured via additive manufacturing process using a 3D printer with 405 nm wavelength, 50 m print layer thickness, and light energy of 28.8 mW/cm².

Digital Crown resin is designed to meet appropriate ISO standards for flexibility and sorption, to withstand prolonged use in the oral cavity. It is delivered nonsterile, and instructions are provided on cleaning the material prior to providing it to a patient. Curing is performed with a UV lamp. The appliance is then cleaned, trimmed, and verified to fit in the dental office before the patient leaves.

The provided document is a 510(k) Summary for the SprintRay Digital Crown resin. It describes the device, its intended use, technological characteristics, and performance data to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the provided information concerning acceptance criteria and study details:

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

The document does not explicitly present a table of acceptance criteria with corresponding performance values. Instead, it states that "In all instances, Digital Crown resin functioned as intended and the outcomes were as expected" for the various bench tests. It also indicates that the device met ISO standards.

However, the "Comparison of Technology Characteristics" table implicitly conveys acceptance criteria by listing the standards that both the predicate and the subject device adhere to, and then stating "Similar" for the reported performance.

Here's a reconstructed table based on the provided information, focusing on the standards and the conclusion of compliance:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the sample size used for the test set or the data provenance for any of the performance studies (biocompatibility or bench testing). It only refers to "a battery of testing" and "additional bench testing."

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)

This information is not applicable and therefore not provided in the document. The device is a material (resin) for fabricating dental prosthetics, and its performance is evaluated through objective physical, chemical, and biological tests, not through expert assessment of diagnostic accuracy or interpretation of images. Therefore, there's no "ground truth" to be established by experts in the context of diagnostic performance.

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

This information is not applicable and therefore not provided. Adjudication methods are typically used in clinical studies involving interpretation of medical data (e.g., radiology reads) where discrepancies between assessors need to be resolved to establish ground truth. As this document describes the bench testing of a material, clinical adjudication is irrelevant.

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

This type of study is not applicable to this device. An MRMC study is relevant for AI-powered diagnostic devices that influence human interpretation. The SprintRay Digital Crown is a material for manufacturing dental prosthetics, not an AI diagnostic tool.

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

This information is not applicable. The device is a material, not an algorithm. The performance tests described (biocompatibility and bench testing) evaluate the intrinsic properties of the material and the fabricated dental appliance, not an algorithm's performance.

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

For the biocompatibility and bench testing, the "ground truth" is established by adherence to internationally recognized standards (ISO standards) and scientific test methodologies. For example, flexural strength is measured according to specific protocols outlined in ISO 10477 and ISO 4049, and the result is compared against the requirements specified in those standards. The outcomes of these tests inherently serve as their own "ground truth" concerning the material's properties according to those standards.

8. The sample size for the training set

This information is not applicable as the device is a material and not a machine learning model. There is no concept of a "training set" for the material itself.

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

This information is not applicable (see point 8).

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The SprintRay High Impact Denture Base resin is a light-curable polymerizable resin intended to be used for the fabrication and repair, of full and partial removable dentures and baseplates. The material is an alternative to traditional denture base material.

Fabrication of dental prosthetics with High Impact Denture Base resin requires computer-aided design and manufacturing system that includes the following components not part of the device: oral casting impression, digital denture base file created in an optical impression system, 3D printer, and curing light equipment.

The High Impact Denture Base consists of a curable dental acrylate resin that is designed to be used in conjunction with a scanned 3D image of a patient's teeth, and 3D printer assembly, to locally manufacture out a dental appliance in dental offices based on the clinician's judgment of patient need.

High Impact Denture Base Resin is intended exclusively for professional dental work. SprintRay High Impact Denture Base Resin is offered in following shades/colors:

• Light Pink .
• Original Pink ●
• . Light Meharry
• Original Meharry .
• . Dark Meharry

High Impact Denture Base is designed to meet appropriate ISO standards for flexibility, sorption, and solubility to withstand prolonged use in the oral cavity. It is delivered non-sterile, and instructions are provided on cleaning the material prior to providing it to a patient. Curing is performed with a UV lamp. The appliance is then cleaned, trimmed, and verified to fit in the dental office before the patient leaves.

The provided text describes the regulatory clearance for a dental resin, not an AI/ML powered device. Therefore, it does not contain the information requested in the prompt regarding acceptance criteria and a study that proves the device meets those criteria for an AI/ML device.

However, based on the information provided for the SprintRay High Impact Denture Base, I can extract information related to its performance and equivalence to a predicate device. This information pertains to the physical and biocompatibility characteristics of the resin, not AI/ML performance.

Here's a summary of the performance data and equivalence to predicate devices, as presented in the document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly derived from the industry consensus standard ISO 20795-1 and the biocompatibility testing standards. The reported device performance indicates that the SprintRay High Impact Denture Base functioned as intended and the outcomes were as expected against these standards.

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

• The document does not explicitly state sample sizes for each specific test (e.g., number of samples for flexural strength). It broadly states that "High Impact Denture Base was tested for conformity with the industry consensus standard ISO 20795-1." These standards typically specify sample sizes for their respective tests.
• Data provenance is not provided (e.g., country of origin, retrospective or prospective). The tests are laboratory-based bench and biocompatibility tests, not clinical studies involving patient data.

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

• Not applicable. The "ground truth" for this device is based on established scientific and engineering standards (ISO standards) and laboratory test results, not expert consensus on medical images or clinical outcomes.

4. Adjudication method for the test set:

• Not applicable. This concept is relevant for studies involving human interpretation or clinical data, which is not the case here.

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/ML powered device.

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

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

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

• The "ground truth" is defined by the performance specifications and methodologies outlined in recognized international standards for dental materials (e.g., ISO 20795-1 for physical properties, ISO 10993 for biocompatibility).

8. The sample size for the training set:

• Not applicable. This is not an AI/ML powered device, so there is no "training set."

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

• Not applicable. As above, there is no "training set" for this type of device.

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SprintRay Denture Base resin is a light-curable polymerizable resin intended to be used for the fabrication and repair, of full and partial removable dentures and baseplates. The material is an alternative to traditional denture base material.

Fabrication of dental prosthetics with SprintRay Denture Base resin requires computer-aided design and manufacturing system that includes the following components not part of the device: oral casting impression, digital denture base file created in an optical impression system, 3D printer, and curing light equipment.

SprintRay Denture Base consists of a curable dental acrylate resin that is designed to be used in conjunction with a scanned 3D image of a patient's teeth, and 3D printer assembly, to locally manufacture out a dental appliance in dental offices based on the clinician's judgment of patient need.

SprintRay Denture Base resin is intended exclusively for professional dental work. SprintRay Denture Base resin is offered in following shades/colors:

• Light Pink
• Original Pink
• Light Meharry
• Original Meharry
• Extra Light Pink
• Medium Pink
• Dark Pink
• Dark Meharry
• Deep Dark Meharry

SprintRay Denture Base is designed to meet appropriate ISO standards for flexibility, sorption, and solubility to withstand prolonged use in the oral cavity. It is delivered non-sterile, and instructions are provided on cleaning the material prior to providing it to a patient. Curing is performed with a UV lamp. The appliance is then cleaned, trimmed, and verified to fit in the dental office before the patient leaves.

The SprintRay Denture Base is a light-curable polymerizable resin used for the fabrication and repair of full and partial removable dentures and baseplates. The 510(k) summary provides details on the performance data, primarily bench testing, to demonstrate substantial equivalence to the predicate device, Dentca Denture Base (K143033).

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for SprintRay Denture Base are based on conformity with the industry consensus standard ISO 20795-1 for dental base polymers, as well as biocompatibility standards. The reported performance indicates that the device met these criteria.

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

The document does not explicitly state the sample sizes used for the biocompatibility or bench testing. It refers to "battery of testing" for both categories. The provenance of the data is implicit as part of a regulatory submission to the FDA, suggesting the tests were conducted by or for SprintRay Inc. The document does not specify the country of origin of the data or whether it was retrospective or prospective, but for bench and biocompatibility testing of a material, these distinctions are generally less relevant than for clinical studies involving patient data.

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

This information is not provided in the document. For bench chemistry and physical property testing, "ground truth" is typically established by certified laboratory equipment and validated test methods, not human expert consensus, so this question is not directly applicable in the usual sense for this type of device.

4. Adjudication method for the test set

Not applicable, as the performance testing described is primarily objective laboratory testing against established standards, not interpretation by human experts.

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. The SprintRay Denture Base is a dental material, not an AI-powered diagnostic or assistive device for human readers. No MRMC study or AI assistance is mentioned or relevant to this device's performance testing.

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

Not applicable. This device is a material, not an algorithm.

7. The type of ground truth used

For biocompatibility testing, the ground truth is established by the accepted biological responses and safety profiles defined in international standards (ISO 10993-1 and ISO 7405) for medical devices.

For bench testing, the ground truth is established by the specified material properties and performance requirements outlined in the industry consensus standard ISO 20795-1 for dental base polymers. The results of physical and chemical tests are compared against the limits and ranges defined by this standard.

8. The sample size for the training set

Not applicable. This device is a material, not a machine learning model, and therefore does not have a "training set" in the context of AI or similar algorithms.

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

Not applicable, as there is no training set for this device.

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The SprintRay NightGuard Flex is indicated for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints and repositioners.

The NightGuard Flex is intended to be used for the manufacture of orthodontic and dental appliances in a clinical setting by trained dental professionals.

The NightGuard Flex is indicated for use in the fabrication of orthodontic and dental appliances such as mouthquards, nightquards, splints and repositioners.

The NightGuard Flex consists of a curable dental acrylate resin that is manufactured in a dental office based on a 3D scanned image of a patient's teeth. The acrylate resin material is designed to be used in conjunction with a scanned 3D image, and 3D printer assembly, to locally manufacture out a dental appliance based on the clinician's judgment of patient need.

NightGuard Flex is designed to meet appropriate ISO standards for flexibility, sorption and tensile strength to withstand prolonged use in the oral cavity. It is delivered non-sterile and instructions are provided on cleaning the material prior to providing it to a patient. Curing is performed with a UV lamp. The appliance is then cleaned, trimmed and verified to fit in the dental office before the patient leaves.

This is a 510(k) summary for the SprintRay NightGuard Flex, a dental acrylate resin used for 3D printing orthodontic and dental appliances. The summary focuses on demonstrating substantial equivalence to a predicate device (KeySprint's KeySplint Soft, K183598).

Based on the provided text, here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a direct table with specific numerical acceptance criteria and corresponding reported performance values for each test. Instead, it states that the NightGuard Flex "meet predefined acceptance criteria" without specifying those criteria.

2. Sample Size for the Test Set and Data Provenance

The document does not explicitly state the sample size used for the bench testing or the provenance of any data (e.g., country of origin, retrospective/prospective). It only mentions "samples of the NightGuard Flex" and "dental appliance fabricated from NightGuard Flex."

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

This information is not applicable as the study described is bench testing of physical material properties, not a clinical study involving expert interpretation or ground truth establishment in a diagnostic context.

4. Adjudication Method for the Test Set

This information is not applicable as the study described is bench testing of physical material properties. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for interpretation disagreements among experts.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document describes bench testing of material properties, not a study involving human readers or AI assistance.

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

No, a standalone (algorithm only) performance study was not done. This device is a dental material, not an algorithm or AI software.

7. The Type of Ground Truth Used

The ground truth for the bench testing was based on predefined acceptance criteria derived from "appropriate ISO standards for flexibility, sorption and tensile strength." These standards set the benchmarks for the physical and chemical properties of the material.

8. The Sample Size for the Training Set

This information is not applicable. The device is a dental material, not an AI/ML algorithm that requires a training set.

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

This information is not applicable as there is no training set for this type of device.

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