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Nanova 2 Step Etch and Rinse Dental Adhesive is indicated for use in:

• All direct restorations
• All indirect restorations
• Intra-oral repairs
• Desensitizing/sealing of tooth structure
• Priming of enamel for orthodontic use

Nanova™ 2 Step Etch and Rinse Dental Adhesive is a methacrylate based, visible-light activated, dental adhesive, the same as the predicate. This device is available in bottle or unit dose packaging, the same as the predicate. Nanova™ 2 Step Etch and Rinse Dental Adhesive contains ethanol, methacrylate resins, photoinitiator, and inorganic filler material the same as the predicate.

When irradiated by light, the methacrylate functionalities of the resins and surface-treated fillers undergo, in conjunction with the photoinitiator system, a light-induced polymerization to form a hard sealant that is bonded to the prepared tooth structure.

The provided text describes the 510(k) summary for the "Nanova 2 Step Etch and Rinse Dental Adhesive". It focuses on establishing substantial equivalence to a predicate device through non-clinical performance testing and biocompatibility assessment, and explicitly states that no clinical performance data was conducted.

Therefore, the study design elements related to clinical trials, human reader performance, ground truth establishment for clinical data, or expert adjudication are not applicable to this submission.

Here's the breakdown of the information available in the document:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample size: Not specified. The document states "non-clinical performance testing conducted is shown in the table below," but does not provide specific sample sizes for each test.
• Data provenance: Not explicitly stated, but it refers to "non-clinical performance testing," implying laboratory-based testing rather than patient data.

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

• Not Applicable. No clinical test set or human-in-the-loop performance evaluation was conducted. Ground truth for non-clinical tests is established by laboratory measurements and adherence to specified standards.

4. Adjudication method for the test set:

• Not Applicable. No clinical test set or human adjudication was involved.

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. No MRMC study was performed as no clinical performance data was conducted. The device is a dental adhesive, not an AI-assisted diagnostic tool.

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

• Not Applicable (in the context of AI/algorithm performance). This device is a biomaterial (dental adhesive), not an algorithm. The non-clinical performance tests are standalone evaluations of the material's physical and mechanical properties.

7. The type of ground truth used:

• For non-clinical performance tests, the "ground truth" is based on established material testing standards (ISO 29022:2013, ISO 4049:2009) and internal specifications. These standards define the methodologies and expected outcomes for measuring the specific properties (e.g., bond strength, water sorption).

8. The sample size for the training set:

• Not Applicable. There is no "training set" 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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Nanova Sealant is indicated for use as a pit and fissure sealant

Not Found

This document is a 510(k) clearance letter for the Nanova™ Sealant, a pit and fissure sealant. It confirms that the device has been found substantially equivalent to a predicate device.

However, the provided text does NOT contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

The document is a regulatory communication from the FDA, and while it confirms the device can be legally marketed, it does not detail the technical performance studies that would typically be included in a 510(k) submission to demonstrate substantial equivalence. Such performance data would be in the original 510(k) submission (K171330), not in the clearance letter itself.

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

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Nanova Push-In Suture Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/ wrist, and elbow in the following procedures
Shoulder: Rotator Cuff Repair, Bankart Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Foot/Ankle: Lateral Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy
Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction.
Elbow: Biceps Tendon Reattachment; Tennis Elbow Repair, Ulnar or Radial collateral Ligament Reconstruction, Lateral Epicondylitis Repair

Nanova Screw-In Suture Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/ wrist, and elbow in the following procedures
Shoulder: Rotator Cuff Repair, Bankart Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Foot/Ankle: Lateral Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy
Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction.
Elbow: Biceps Tendon Reattachment; Tennis Elbow Repair, Ulnar or Radial collateral Ligament Reconstruction, Lateral Epicondylitis Repair

The NanovaTM Suture Anchor is comprised of two types: Screw-In and Push-In. Nanova™ Screw-In Suture Anchor is a cannulated, threaded, tapered anchor with integral eyelet for suturing soft tissue to bone. Nanova™ Push-In Suture Anchor is a cannulated anchor with integral evelet for suture soft tissue to bone. In addition the Push-In anchor can use a knotless technique by capturing suture. Suture anchors are preloaded with suture on a handled inserter with a hex driver. The device is made from a copolymer of absorbable 70-30 Poly-L/D-lactide (PLDLA) reinforced with hydroxyapatite. Nanoval Screw-In Suture Anchors are single use, prescription, long term implant, no drug.

The provided document is a 510(k) premarket notification for two medical devices: the Nanova Screw-in Suture Anchor and the Nanova Push-in Suture Anchor. This document focuses on demonstrating substantial equivalence to legally marketed predicate devices rather than proving the device meets specific acceptance criteria through a clinical study.

Therefore, many of the requested categories for acceptance criteria and study details are not applicable or not provided in this type of submission. The information below reflects what can be extracted from the document within the context of a 510(k) submission.

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

For a 510(k) submission, the "acceptance criteria" are generally based on demonstrating "similar performance" to the predicate devices through non-clinical testing. The document states that the mechanical and performance testing resulted in "similar mechanical and performance to the predicate." No specific numerical acceptance criteria or detailed device performance metrics (e.g., in a table with target values) are provided beyond this general statement.

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

• Sample Size for Test Set: This information is not provided in the document. The document mentions "non-clinical performance testing" which includes mechanical and performance testing, but the specific number of units tested is not disclosed.
• Data Provenance: The document does not specify the country of origin of the data or whether the testing was retrospective or prospective. Given it's non-clinical benchtop testing, these distinctions are less relevant than for clinical studies.

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 for this 510(k) submission. Ground truth establishment by experts (e.g., radiologists) is typically associated with clinical studies, especially those involving diagnostic devices or image interpretation. This submission focuses on the mechanical and biocompatibility properties of a physical implant (suture anchor), where "ground truth" would be determined by objective measurements and standardized testing protocols, not expert consensus on medical images or patient outcomes.

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

This information is not applicable for this 510(k) submission. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for subjective assessments or when multiple readers provide conflicting interpretations (e.g., in radiology studies). The non-clinical testing described involves objective mechanical measurements where adjudication by multiple experts is not relevant.

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 information is not applicable for this 510(k) submission. MRMC studies, especially those focusing on AI assistance, are relevant for diagnostic devices or software that assist human readers in interpreting medical data. The Nanova Suture Anchor is a physical surgical implant, not a diagnostic or AI-enabled device, so an MRMC study would not be performed for this product.

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

This information is not applicable for this 510(k) submission. "Standalone performance" refers to the performance of an algorithm or software operating independently without human intervention, which is relevant for AI-powered diagnostic tools. As mentioned, the Nanova Suture Anchor is a physical surgical implant.

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

For the non-clinical performance testing, the "ground truth" would be derived from objective measurements obtained through standardized laboratory testing methods and equipment (e.g., force gauges for pullout strength, torque wrenches for insertion torque, etc.). There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for these tests, as they are not clinical studies. The biocompatibility testing followed ISO 10993 standards, where "ground truth" is defined by the results meeting specific criteria or thresholds outlined in those standards.

8. The sample size for the training set

This information is not applicable for this 510(k) submission. "Training set" refers to data used to train machine learning algorithms. The Nanova Suture Anchor is a physical medical device, not an AI or software device that requires a training set.

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

This information is not applicable for this 510(k) submission, as there is no training set for a physical hardware device.

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Nanova™ Interference Screw is indicated for the fixation of soft tissue grafts during cruciate ligament reconstruction surgeries of the knee. The 7, 8 and 9mm x 23mm screws are also indicated for: medial and lateral collateral ligament repair of the knee, proximal bicep tenodesis in the shoulder and distal bicep tenodesis in the elbow.

Nanova™ Interference Screw is a cannulated, threaded, tapered fastener for use in interference fixation of soft tissue grafts or bone-tendon-bone grafts. The device is made from a copolymer of absorbable Poly-L/D-lactide (PLDLA) reinforced with hydroxyapatite. Nanova™ Interference Screws are single use, prescription, long term implant, no drug.

The provided document, a 510(k) premarket notification, describes the Nanova Interference Screw, a medical device. However, it does not contain information about acceptance criteria or a study designed to prove the device meets specific acceptance criteria in the context of an AI/ML medical device.

The document specifies that non-clinical performance testing was completed, comparing the device's mechanical and performance testing with a predicate device. It states, "Mechanical and performance testing was compared with the predicate, which resulted in similar mechanical and performance to the predicate (all testing passed)." It also mentions biocompatibility testing per ISO 10993 (all testing passed) and pyrogenicity testing (determined to be nonpyrogenic).

Crucially, under "Clinical Performance Testing," the document explicitly states: "Clinical performance data was not included."

Therefore, based on the provided text, I cannot answer the questions about acceptance criteria for AI/ML performance, study details, sample sizes for test/training sets, ground truth establishment, expert involvement, or MRMC studies. These elements are typically associated with the evaluation of AI/ML-driven medical devices, which this submission does not appear to be. This is a submission for a physical medical device (an interference screw) where substantial equivalence to existing devices is demonstrated through non-clinical testing.

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Vas-Q-Clip™ ligating clips are intended for use in procedures involving ligation of vessels or tissue structures. Surgeons should apply the appropriate size clip for the size of the vessel or tissue structure to be ligated such that the clip completely encompasses the vessel or tissue structure.

Nanova Biomaterials Inc.'s Vas-Q-Clip™ causes hemostasis through vessel ligation. The technological characteristics are the same as or equivalent to the predicate device. The non-absorbable polyacetal material used in the clips is the same as the predicate device and the clips are manufactured in a similar manner.

The clips are housed in a cartridge and package in a ridged plastic plaster with Tyvek coated lidding and is sold sterile. The method of sterilization is EtO with a SAL of 10-6. The blisters are fitted into a carton in which the clips are sold.

The Vas-O-Clip™ outer structure including legs, bosses, hook and latch mechanism, and hinge are the same as the Hem-o-lok® design (Shape and dimensions are the same for the corresponding sizes). The only difference is the inner closure feature designated as "teeth". Vas-Q-Clip™ triangular protrusions (teeth) are perpendicular to the vessel whereas the Hem-O-Lok teeth are parallel.

The provided document is a 510(k) summary for the Nanova Biomaterials Inc.'s Vas-Q-Clip. This document outlines the device's characteristics and its substantial equivalence to a predicate device, rather than describing a study to prove acceptance criteria for a new AI/imaging device. Therefore, much of the requested information regarding AI/imaging study methodology (such as expert adjudication, MRMC studies, training set details, and specific performance metrics) is not applicable or present in this document.

However, I can extract information related to the device's non-clinical performance testing and general acceptance criteria based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

The document lists "Tests performed on Vas-Q-Clip™" and their results, which can be interpreted as the device meeting predefined (though not explicitly stated numerical) acceptance criteria.

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

The document states, "Non-clinical testing was completed to assess its performance." It refers to "Internal Testing" for several mechanical properties (Migration Resistance, Vessel Occlusion, Application Force, Axial Pull-Off Force). However, no specific sample sizes or data provenance (country of origin, retrospective/prospective) are mentioned for these tests. The document does not describe imaging data or a test set in the conventional sense for AI.

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

Not applicable. This document describes non-clinical performance and biocompatibility testing for a medical device (ligating clip), not an AI/imaging device that requires expert ground truth for interpretation.

4. Adjudication method for the test set

Not applicable. There is no mention of adjudication, as this is not an imaging study requiring human interpretation.

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, and no MRMC study was performed.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used

For the non-clinical tests, the "ground truth" is defined by established laboratory testing procedures (e.g., USP standards for endotoxins and pyrogenicity, ISO standards for biocompatibility, and unspecified internal test methods for mechanical properties). The "Passed" results indicate adherence to the requirements of these test methods.

8. The sample size for the training set

Not applicable. This pertains to an AI/machine learning model, which is not the subject of this document.

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

Not applicable. This pertains to an AI/machine learning model, which is not the subject of this document.

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Nanova Universal Dental Composite is indicated for use in:

• · Direct anterior and posterior restorations (including occlusal surfaces)
• Core Build-ups
• · Splinting
• · Indirect restorations including inlays, onlays and veneers

Nanova™ Universal Dental Composite is a methacrylate based, visible-light activated, radiopaque, universal composite. This device is available in twist syringe and ampule packaging. Nanova™ Universal Dental Composite is available in a variety of tooth colored shades. Nanova"™ Universal Dental Composite contains methacrylate resins, photo-initiator, and inorganic filler material. Inorganic filler loading is approximately 77% by weight.

When irradiated by light, the methacrylate functionalities of the resins and surface-treated fillers undergo, in conjunction with the photo-initiator system, a light-induced polymerization to form a hard composite that is bonded to the tooth structure with a permanent dental adhesive.

Nanova™ Universal Dental Composite formulation is based off of several FDA approved commercially available universal dental composites. The formulation was modified to improve physical properties, such as flexural strength, and handling properties. As a result of the reformulation, a biocompatibility assessment was developed for Nanova™ Universal Dental Composite using standard risk assessment techniques and consideration of FDA & International Standards, including ISO 10993 Parts 5 and 10.

Here's a breakdown of the acceptance criteria and study information based on the provided document:

Acceptance Criteria and Device Performance

The document does not explicitly state numerical acceptance criteria with pass/fail thresholds for each test in a table format. Instead, it indicates that the device "Passed" each test, implying that it met the (unspecified) acceptance criteria for those tests. It also compares the device's performance to the predicate device in a qualitative manner for some properties.

Study Details

The provided document describes a non-clinical performance testing study.

• Sample size used for the test set and the data provenance: Not explicitly stated. The tests are benchtop assessments using standardized methods (ISO standards, ADA specifications). The provenance of the data is from Nanova Biomaterials, Inc.'s own testing. No specific country of origin for the data is mentioned beyond Nanova Biomaterials, Inc. being a US-based company. The study is retrospective in the sense that the data was collected prior to the 510(k) submission.

• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This was non-clinical benchtop testing, not involving human interpretation or ground truth establishment by experts in that sense.

• Adjudication method for the test set: Not applicable. This was non-clinical benchtop testing.

• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. The document explicitly states: "Clinical performance data was not included."

• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a material device, not an AI algorithm.

• The type of ground truth used: For the physical and mechanical properties, the "ground truth" or reference was established by the specified international standards (ISO 4049, ADA specification 27) and FDA guidance (UCM071576, UCM071631). For biocompatibility, the ground truth was based on ISO 10993 standards. The results (e.g., strength values, pass/fail for biocompatibility) are directly from laboratory measurements against these established standards.

• The sample size for the training set: Not applicable. This is not an AI/machine learning device. The product formulation was "modified to improve physical properties," which would involve research and development, but not a "training set" in the context of AI.

• How the ground truth for the training set was established: Not applicable. (See above).

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• Class III and V restorations o
• Restoration of minimally invasive cavity preparations (including small, non stress-bearing occlusal restorations)
• Base/liner under direct restorations .
• Repair of small defects in esthetic indirect restorations ●
• Pit and fissure sealant ●
• . Undercut blockout
• Repair of resin and acrylic temporary materials o

Nanova™ Flowable Dental Composite is a methacrylate based, low viscosity, visible-light activated, radiopaque, flowable composite. This device is available in syringe and ampule packaging. Nanova™ Flowable Dental Composite is available in a variety of tooth colored shades. Nanova™ Flowable Dental Composite contains methacrylate resins, photo-initiator, and inorganic filler material. Inorganic filler loading is approximately 60% by weight.

When irradiated by light, the methacrylate functionalities of the resins and surface-treated fillers undergo, in conjunction with the photo-initiator system, a light-induced polymerization to form a hard composite that is bonded to the tooth structure with a permanent dental adhesive.

Nanova™ Flowable Dental Composite formulation is based off of several FDA cleared commercially available flowable dental composites. The formulation was modified to improve physical properties, such as flexural strength, and handling properties. As a result of the reformulation, a biocompatibility assessment was developed for Nanova™ Flowable Dental Composite using standard risk assessment techniques and consideration of FDA & internationally recognized guidelines, including ISO 10993 Parts 3, 5, 6, 10 and 11.

The document describes the Nanova™ Flowable Dental Composite, a dental material. The acceptance criteria and supporting studies are detailed, primarily through comparison with a predicate device and non-clinical performance testing.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for "Nanova™ Flowable Dental Composite" are largely established by demonstrating its substantial equivalence to a legally marketed predicate device (Filtek Supreme Ultra Flowable Restorative K100235) and by meeting established international and ADA standards for dental materials.

Specific quantitative values for performance (e.g., exact flexural strength in MPa) are not provided in this summary, but the document confirms that the device meets or exceeds the standards or predicate device performance for these properties.

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

The document does not specify the sample sizes used for the individual non-clinical performance tests (e.g., number of specimens for flexural strength, depth of cure). It lists the types of tests performed.

The data provenance is from non-clinical benchtop testing performed by Nanova Biomaterials, Inc. and potentially external labs for GLP studies, but specific country of origin for all data is not explicitly stated. The submission is from Nanova Biomaterials, Inc. in Columbia, Missouri, USA. The studies are retrospective as they were conducted to support the 510(k) submission.

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

This information is not applicable as the studies are entirely non-clinical (benchtop and biocompatibility). There is no "ground truth" derived from expert consensus on patient data. The ground truth for performance is the specified standards (e.g., ISO, ADA) and comparison to the predicate device. For biocompatibility, it's defined by the ISO 10993 series.

4. Adjudication Method for the Test Set

This is not applicable as there is no human interpretation or subjective assessment of the test results that would require adjudication in the context of clinical or image-based studies. The results are quantitative measurements against established standards.

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 is not applicable. The device is a dental restorative material, not an AI-powered diagnostic or assistive tool. No MRMC study was performed.

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

This is not applicable. The device is a physical dental material, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for evaluating the Nanova™ Flowable Dental Composite is primarily:

• Established industry standards: ISO 4049:2009 (E) for properties like flexural strength, depth of cure, water sorption/solubility; ADA specification 27 for compressive strength.
• Comparison to a legally marketed predicate device: Filtek Supreme Ultra Flowable Restorative (K100235) for various technical and performance characteristics.
• Biocompatibility standards: ISO 10993 Parts 3, 5, 6, 10 and 11.

There is no pathology, outcomes data, or expert consensus on clinical cases described in this summary for establishing ground truth.

8. The Sample Size for the Training Set

This is not applicable. The device is a physical material, not a machine learning model, therefore there is no "training set."

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

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

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StarBright™ 5% Sodium Fluoride Varnish is a fluoride containing preparation for use as a cavity varnish and for the treatment of dentin hypersensitivity.

StarBright™ 5% Sodium Fluoride Varnish is a rosin based 5% sodium fluoride varnish. This device is available in tray form unit doses of 0.25 and 0.40 mL. Fluoride ions within StarBright™ 5% Sodium Fluoride Varnish may react with calcium and phosphate ions in saliva to form crystals in exposed dentin tubules, such as in exposed root surfaces, leading to protection by blocking external stimuli thereby reducing hypersensitivity.

The provided document is a 510(k) premarket notification for a medical device called "StarBright™ 5% Sodium Fluoride Varnish." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific acceptance criteria based on its performance against quantitative metrics in a clinical study.

Therefore, the document does not contain the information requested regarding acceptance criteria tables, sample sizes for test/training sets, expert ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, or detailed ground truth types.

Here's why the information is not present and what the document does contain:

• Type of Device: The device is a "Cavity Varnish" (Product Code: LBH), regulated as Class II. This is a dental material, not an AI/ML-based diagnostic or imaging device.
• Regulatory Pathway (510(k)): The 510(k) pathway for medical devices largely relies on showing that the new device is "substantially equivalent" to a legally marketed predicate device. This typically involves demonstrating similar technological characteristics, intended use, and performance, often through bench testing and biocompatibility. It does not generally require large-scale clinical trials or detailed performance metrics against ground truth, especially for a well-established device type like a fluoride varnish.
• Lack of AI/ML Component: The device is a chemical preparation. It does not involve any artificial intelligence, machine learning, image analysis, or diagnostic algorithms. Therefore, concepts like "test set," "training set," "ground truth experts," "adjudication," "MRMC study," and "standalone algorithm performance" are not applicable to this product.

What the document does include relevant to its regulatory pathway:

• Identified Predicate Devices: The submission identifies several predicate devices (e.g., Duraflor ®, 3M Vanish, Nupro Model 13016901, Enamelast) to which StarBright™ 5% Sodium Fluoride Varnish is considered substantially equivalent.
• Technological Characteristics and Intended Use: It states that the device has the same intended use (cavity varnish, treatment of dentin hypersensitivity) and similar technological characteristics (rosin-based 5% sodium fluoride varnish, paste formulation, unit dose packaging, applied with a brush) as the predicate devices.
• Non-clinical Performance Testing: It mentions that non-clinical performance testing (fluoride release, tubule occlusion, cytotoxicity, sensitization, irritation) was conducted to support substantial equivalence. The document states these tests "demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed predicate devices." This is the closest it comes to performance, but it's not quantitative "acceptance criteria" on a diagnostic metric.
• No Clinical Performance Testing: The document explicitly states, "Clinical performance data was not included." This further supports that the type of study design you're asking about (which often involves clinical endpoints or diagnostic accuracy) was not a requirement for this specific 510(k) submission.

In summary, as the input document describes a chemical dental product undergoing a 510(k) review based on substantial equivalence, the requested information pertaining to AI/ML device performance and clinical studies (e.g., MRMC, standalone algorithm performance, expert ground truth) is not applicable or present in this document.

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