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DentureID Microchip is intended to enable access to secure patient identification and device information when used with complete dentures, partial dentures and other removable oral appliances.

DentureID Microchip enables access to secure patent identification and device information when used with removable oral appliances. The microchip is permanently embedded into a denture and is a digital link to owner contact information and information about the denture in the event that a repair or replacement is needed. All of the information is controlled on the secure DentureID.com website by the denture owner and dental professional. The DentureID Microchip can be read by any NFC compatible Android Smart Phone (after downloading the DentureID.com App from Google Play) and holding the phone against the microchip. The information on the DentureID.com website may be modified at any time by the patient or dental professional by entering a username and password. The information that is on the website will appear on the smart phone when reading the DentureID Microchip. DentureID Microchips are classified as RFID ISO 14443 which use NFC (near-field-communication). DentureID Microchips are designed to be read by ISO 14443 NFC-compliant smart phones with DentureID App installed. DentureID Microchips are encased in a medical-grade epoxy resin. The size is 1.5mm X 6 mm in diameter. They are inserted into the buccal flange of a denture and completely covered with self-cure repair resin. The DentureID Microchip does not directly contact the patient.

This document describes the non-clinical performance testing of the DentureID Microchip.

1. Table of Acceptance Criteria and Reported Device Performance

Study Information:

The provided document describes non-clinical performance testing to demonstrate the substantial equivalence of the DentureID Microchip to its predicate devices. It does not detail a clinical study involving human readers or a training set in the context of typical AI device evaluation.

Here's a breakdown of the available information:

2. Sample Sizes and Data Provenance for Test Set:

• Cytotoxicity, Irritation, Sensitization: These tests involve biological samples (e.g., cell cultures, animals). The document doesn't specify the exact number of samples/animals used but refers to the standards (ISO 10993-5, ISO 10993-10) which define such sample sizes. The data provenance is implied to be laboratory testing in facilities adhering to these standards, likely in the US given the FDA submission. These are retrospective tests conducted on device materials.
• Chemical Characterization: Not specified, but involved proprietary standards of Nelson Laboratories and ChemTech Ford Laboratories. Retrospective laboratory testing.
• EMC Testing: Not specified for the number of devices tested, but it's laboratory testing of the DentureID Microchips. Retrospective.
• MRI Compatibility: Not specified for the number of devices tested, but it's laboratory testing of DentureID Microchips to ASTM standards. Retrospective.
• Simulated Wear: Not specified for the number of DentureID Microchips installed in dentures, but it's a non-clinical performance test over a 5-year simulation. Retrospective.

3. Number of Experts and their Qualifications for Ground Truth:

• This information is not applicable in the context of this non-clinical performance testing. The "ground truth" for these tests is established by adhering to recognized international standards (ISO, ASTM, EN) and laboratory protocols, with results interpreted by qualified laboratory personnel (e.g., toxicologists, engineers) who execute these specific tests.

4. Adjudication Method for the Test Set:

• Not applicable. These are objective, quantitative and qualitative laboratory tests against defined scientific and engineering standards, not subjective interpretations requiring adjudication by experts.

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

• No, an MRMC comparative effectiveness study was NOT done. This document focuses on the technical and safety performance of the device itself (hardware and its interaction with a smartphone app), not on the diagnostic or interpretative ability of human readers or AI in a clinical setting. Therefore, there is no effect size of how much human readers improve with AI vs. without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance):

• Yes, in essence, standalone performance testing was done for the core function of the microchip. The various tests (Biocompatibility, EMC, MRI Compatibility, Simulated Wear, Migration Testing, Performance Testing of Implanted Transponder) evaluate the physical and functional characteristics of the DentureID Microchip itself, independent of a human interpreting its output. The "algorithm" here is the RFID chip's ability to respond with its serial number and the smartphone app's ability to retrieve information from a database. "Performance Testing of Implanted Transponder" is a direct measure of this standalone function.

7. Type of Ground Truth Used:

• The ground truth for this non-clinical testing is based on:
  • Standardized test methods and protocols: Defined by international standards (ISO, ASTM, EN) and proprietary laboratory standards.
  • Objective measurements and observations: E.g., cytotoxicity scores, temperature rises, torque measurements, pass/fail criteria for EMC.
  • Chemical analysis: For leachate testing.

8. Sample Size for the Training Set:

• Not applicable. This device (DentureID Microchip) is a passive RFID transponder and its associated database/app. It does not employ machine learning or AI models that require a "training set" in the conventional sense for image analysis or diagnostic tasks. Its function is to communicate a serial number, which then links to pre-entered data on a website.

9. How Ground Truth for Training Set Was Established:

• Not applicable, as there is no training set for an AI/ML model for this device. The information stored on the DentureID.com website, which is retrieved by the microchip's serial number, is entered by a dental lab or dentist. This user-provided information serves as the "ground truth" for the data it's designed to return, but it's not a training set for an algorithm.

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Nobilplast Denture Resin is intended for the fabrication of partial or full removable dentures, as well as occlusal splints and night quards.

Nobilplast Denture Resin is a polyamide (nylon) resin available in pink and white colors. The resin granules are packaged in injectable aluminum cartridges or sold in a bulk container where users can fill empty aluminum cartridges that are sold separately.

The FDA 510(k) summary for Nobilplast Denture Resin is a submission for substantial equivalence based on comparison to legally marketed predicate devices. The document does not describe a clinical study in the typical sense (e.g., a multi-reader, multi-case study with human-in-the-loop performance or standalone algorithm performance). Instead, it relies on bench testing and a comparison of material properties and indications for use to existing predicate devices.

Therefore, many of the requested details about acceptance criteria, study design, ground truth establishment, and expert involvement are not applicable in this context. The document focuses on demonstrating that the new device is as safe and effective as the predicate devices based on material characteristics and standard tests.

Here is an attempt to address the prompts based on the provided document, noting where information is not applicable (N/A) for this type of submission:

Acceptance Criteria and Device Performance for Nobilplast Denture Resin

The acceptance criteria for Nobilplast Denture Resin are implicitly based on demonstrating that its material properties and performance characteristics are substantially equivalent to its primary predicate device, FLEXSTAR V, and other reference devices (TCS Unbreakable, DENTSOLL Rezen NF, and Valplast). This is achieved through a series of bench tests and a comparison of intended use and material composition.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission based on direct comparison rather than a device with specific quantifiable "performance" in a diagnostic or assistive capacity, the acceptance criteria are framed as "similarity" or "comparability" to established predicate devices. The "reported device performance" is how Nobilplast Denture Resin's measured properties compare to those of the predicate.

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

• Sample Size for Test Set: The document does not specify a "sample size" in terms of cases or images for testing an AI device. Instead, it refers to the number of samples used for various bench tests of the material properties. These are standard material science tests, and the sample sizes would be defined by the specific ASTM/ISO standards referenced (e.g., a certain number of specimens for tensile strength, impact, etc.). The document does not provide these detailed sample counts.
• Data Provenance: The data provenance is from laboratory bench testing of the Nobilplast Denture Resin material, as well as biological testing. This is not clinical data derived from patients or images. It is prospective testing performed on the manufactured material. The country of origin for the data is not explicitly stated, but the company is based in the USA.

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

N/A. This is a material testing submission, not an AI or diagnostic device submission requiring expert human interpretation of data for ground truth. The "ground truth" here is the measured physical and chemical properties of the material, verified through standardized testing protocols (ASTM, ISO).

4. Adjudication Method for the Test Set

N/A. No human adjudication is involved for material properties testing.

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

N/A. This type of study is for diagnostic or assistive devices involving human readers interpreting cases. Nobilplast Denture Resin is a material for fabricating dentures.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

N/A. This is not an algorithm or software device.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established through:

• Standardized Bench Testing: Direct measurement of material properties (e.g., density, melting point, hardness, tensile strength, flexural properties, impact strength, sorption & solubility) according to internationally recognized ASTM and ISO standards.
• Biocompatibility Testing: Evaluation of biological response as suggested by FDA Guidance (Cytotoxicity, Irritation, Sensitization tests).
• Comparison to Predicate Devices: The established and legally marketed performance and safety profiles of the predicate devices (FLEXSTAR V, TCS Unbreakable, DENTSOLL Rezen NF, Valplast) serve as a de facto "ground truth" for substantial equivalence.

8. The Sample Size for the Training Set

N/A. There is no training set as this is not a machine learning or AI device.

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

N/A. Not applicable.

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CMP's Flex-Star V is used for the fabrication of partial or full removable dentures, as well as occusal splints and night guards. It is to be used only by professional dental practitioners who make or repair dentures for patients

Flex-Star V is used for the fabrication of partial or full removable dentures, as well as occusal splints and night guards.

Here's an analysis of the provided text regarding acceptance criteria and study information:

Based on the provided document, which is a 510(k) premarket notification letter from the FDA, the device in question is a "Denture Relining, Repairing, or Rebasing Resin" called "Flex-Star V."

This type of FDA correspondence, specifically a 510(k) clearance, does not typically contain detailed information about specific acceptance criteria or the study data that "proves" the device meets those criteria in the way a clinical trial report would. Instead, a 510(k) submission generally relies on demonstrating "substantial equivalence" to a legally marketed predicate device. This means showing that the new device has the same intended use and technological characteristics as a predicate device, or different technological characteristics that do not raise new questions of safety and effectiveness.

Therefore, the requested information elements related to detailed study design, sample sizes, expert qualifications, and specific performance metrics cannot be found within this FDA clearance letter.

However, I can extract what limited information is available and explain why other requested details are absent:

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

Explanation: In a 510(k), specific numerical performance criteria and their corresponding results are generally not published in the clearance letter itself. Instead, the FDA reviews the manufacturer's submission which would have contained this data, demonstrating that the Flex-Star V performs as safely and effectively as a legally marketed predicate device. The letter states the device is "substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices."

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

• Sample Size for Test Set: Not specified in this document.
• Data Provenance (country of origin, retrospective/prospective): Not specified in this document.

Explanation: The letter does not detail the specific studies performed for the 510(k) submission, let alone the sample sizes or provenance of the data used in those studies.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

Explanation: This information would be specific to clinical or performance testing, which is not detailed in this FDA clearance letter.

4. Adjudication method for the test set:

• Adjudication Method: Not specified.

Explanation: Similar to the above, this pertains to study design not present in this document.

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:

• MRMC Study: No, this device is a dental resin, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human readers improving with AI is irrelevant and was not conducted.

Explanation: This category doesn't apply to a denture repair/rebase resin.

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

• Standalone Performance Study: No, this device is a material, not an algorithm.

Explanation: This category doesn't apply to a denture repair/rebase resin.

7. The type of ground truth used:

• Type of Ground Truth: For a dental material, "ground truth" would typically relate to established physical, chemical, and biological performance standards (e.g., strength, water absorption, biocompatibility, bond strength to other materials, wear resistance) rather than expert consensus on images or pathology. This would be established through laboratory testing (e.g., ISO standards for dental materials) and potentially non-clinical in vitro/in vivo studies.

Explanation: The relevant "ground truth" for a dental resin would be its adherence to material science specifications and biocompatibility, not clinical outcomes in the same way a diagnostic device would. These would be assessed through lab tests.

8. The sample size for the training set:

• Sample Size for Training Set: Not applicable in the context of this type of device and 510(k) submission.

Explanation: "Training set" implies machine learning or AI, which is not relevant for a dental resin.

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

• How Ground Truth for Training Set was Established: Not applicable.

Explanation: This question is not applicable to the device described.

In summary: The provided document is an FDA 510(k) clearance letter for a medical device (a dental resin). It confirms that the device is "substantially equivalent" to predicate devices, allowing it to be marketed. However, it does not contain the detailed study protocols, acceptance criteria, or performance data that would be found in a comprehensive study report for a diagnostic AI or imaging device. The questions posed are largely designed for diagnostic/AI devices, not for a material such as a dental resin.

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CMP' IMPAK denture relining, repairing/rebasing liquid resin is indicated for relining a denture surface which contains tissue, for repairing a fractured denture, or forming a new denture base.

Not Found

This document is a 510(k) clearance letter from the FDA for a dental device. It does not contain information about acceptance criteria, device performance, study designs, sample sizes, expert qualifications, or ground truth establishment. This type of information is typically found in the 510(k) summary or in the actual premarket notification submission, but not in the clearance letter itself.

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