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510(k) Data Aggregation
(254 days)
Albany, New York 12207
Re: K170423
Trade/Device Name: DentureID Microchip Regulation Number: 21 CFR 880.6300
Implantable Radiofrequency Transponder System for Patient Identification and Health Information (21 CFR 880.6300
Implantable Radiofrequency Transponder System for O Patient Identification and Health Information (21 CFR 880.6300
Radiofrequency
Transponder System for
Patient Identification and
Health Information (21
CFR 880.6300
Radiofrequency
Transponder System for
Patient Identification and
Health Information (21
CFR 880.6300
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
| Test Description | Standard | Acceptance Criteria (Implied by Result) | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | |||
| Cytotoxicity | ISO 10993-5:2009 | Non-cytotoxic (score '0') | The test article scored '0' at 24, 48, and 72 ± 4 hours and is considered non-cytotoxic under the conditions of this test. |
| Irritation | ISO 10993-10:2010 | Mean test and control scores of extract dermal observations less than 1.0 | The differences in the mean test and control scores of the extract dermal observations were less than 1.0, indicating that the requirements of the ISO Intracutaneous Reactivity Test have been met by the test article. |
| Sensitization | ISO 10993-10:2010 | No sensitization response greater than '0' for test article extracts | None of the negative control animals challenged with the control vehicles were observed with a sensitization response greater than '0'. None of the animals challenged with the test article extracts were observed with a sensitization response greater than '0'. The normal saline extract of the test material had a sensitization response of '0' under valid test conditions. The sesame oil extract of the test material had a sensitization response of '0' under valid test conditions. Under the conditions of this protocol, the test article did not elicit a sensitization response. |
| Chemical Characterization of Materials (Leachate) | Proprietary standards of Nelson Laboratories and ChemTech Ford Laboratories | Potential toxicity from leaching of harmful chemicals is not significant | The incremental substances found in the study are presented and compared to toxicity standards for the respective materials. As a result of the study, we feel that the potential toxicity from leaching of harmful chemicals from the DentureID RFID tag is not significant. |
| Information Security Procedures | Not specified | Passed | Passed |
| Software Validation | Not specified | Passed | Passed |
| Migration Testing of Implanted Transponder | Not specified | Passed | Passed |
| Performance Testing of Implanted Transponder | Not specified | Passed | Passed |
| Electromagnetic Compatibility (EMC) | |||
| Radiated Emissions | EN 55011:2009 | Pass | Pass |
| Electrostatic Discharge Immunity | EN 61000-4-2:2008 | Pass | Pass |
| Radiated Electromagnetic Field Immunity | EN 61000-4-3:2010 | Pass | Pass |
| Magnetic Field Immunity | EN 61000-4-8:2009 | Pass | Pass |
| Data Integrity (during EMC) | Not specified | No loss or corruption of data, latency, or throughput | No loss or corruption of the data, latency or through-put, which was coordinated with the electromagnetic compatibility (EMC) performance of the microchip, scanner and wireless data link. |
| Magnetic Resonance Imaging Compatibility (MRI) | |||
| Magnetic Field Interactions at 3-Tesla | ASTM F2052-15 | No additional risk or hazard to a patient in the 3-Tesla MRI environment or less with regard to torque (qualitative measurement of 0) | The qualitatively measured torque at 3-Tesla for the DentureID was 0, no torque. As such, this device will not present an additional risk or hazard to a patient in the 3-Tesla MRI environment or less with regard to torque. |
| MRI-related heating, 1.5-Tesla and 3-Tesla | ASTM F2182-11a | Maximum temperature rise matches background (e.g., 1.5°C at 1.5T, 1.9°C at 3T) | 1.5-Tesla demonstrated a maximum of 1.5°C temperature rise and the 3-T system demonstrated a 1.9°C rise. Both of these temperature rises matched the maximum background temperature rise. In conclusion, MRI 1.5 and 3 do not induce significant heating to DentureID Microchip. |
| Artifacts at 3-Tesla | ASTM F2119-07 (Reapproved 2013) | Localized signal voids corresponding to device size and shape; maximum artifact size around 10-mm relative to device size. | The artifacts that appeared on the MR images were shown as localized signal voids (i.e., signal loss) that corresponded to the size and shape of this device. The gradient echo pulse sequence produced larger artifacts than the T1-weighted, spin echo pulse sequence for the device. The maximum artifact size (i.e., as seen on the gradient echo pulse sequence) extends approximately 10-mm relative to the size and shape of this device. |
| Effects of MRI at 1.5-Tesla and 3-Tesla on Function | Not specified (Internal investigation protocol) | 100% pre and post-exposure performance | DentureID Microchips performed 100% pre and post exposures. |
| Simulated Wear (Denture Cleaning) | Not specified (Internal protocol based on 5-year simulated wear with cleaning medium/brush) | No impact on device performance; clear self-cure dental acrylic not affected | The clear self-cure dental acrylic placed over the DentureID Microchip was not affected by the scrubbing action. Therefore, cleaning dentures will not impact the performance of DentureID Microchip. |
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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