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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™ 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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