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510(k) Data Aggregation
(58 days)
TuxDeluxe (Size 1 6100B, Size 2 6101B)
Dental Sensors, models Tuxdeluxe, 6100B-Size 1, and 6101B-Size 2 are intended to collect dental x-ray photons and convert them into electronic impulses that may be stored, viewed, and manipulated for diagnostic use by dentists. This device must only be used in hospital environments, clinics or dental offices by trained and qualified dental personnel, and not used in the oxygen rich environment. This device is suitable for providing dental radiography imaging for both adult and pediatric patients.
This Intraoral Digital Imaging Sensor employs CMOS (Complementary Metal-Oxide-Semiconductor), protective optical fiber and scintillator. This sensor was developed to obtain a high-quality x-ray image from the human mouth and its structures. The acquisition process is made by positioning the sensor inside the mouth, behind the structure you want to perform the exam. The structure must be exposed to an x-ray dose using an external source. Once exposed, the sensor performs a conversion of the x-ray photons into a digital signal and transfers it to a computer through USB connection (Universal Serial Bus). The x-ray generator (an integral part of a complete dental x-ray system) is not part of the device. Device sensor sizes: Size 1: 24.1 x 36.2 x 5.9mm Size 2: 30.5 x 42.8 x 5.7mm. The I/O sensor is compatible with the following cleared software: Xray Vision / XV Capture (XV Web) / Curve / Sota. This software must be purchased separately by the end user.
The provided document is a 510(k) Premarket Notification from the FDA for the Tuxdeluxe Intraoral Dental Digital Imaging Sensor. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed acceptance criteria study for an AI/CAD system. Therefore, I cannot generate the specific information requested about acceptance criteria and a study proving a device meets them in the context of an AI/CAD system.
The document discusses the physical characteristics and general performance of the dental sensor, comparing it to an already cleared predicate device (NanoPix). The "study" mentioned for this device is primarily non-clinical testing to ensure safety, EMC, biocompatibility, and general performance, and an image quality analysis by a dentist. There is no mention of an AI algorithm or a comparative effectiveness study involving human readers with and without AI assistance.
Here's how to break down why the requested information cannot be fully provided based on the document:
- The Device: The Tuxdeluxe is a dental imaging sensor (hardware), not an AI/CAD software or system. It collects X-ray photons and converts them into electronic impulses for viewing. It does not perform diagnostic algorithms or AI-driven analysis.
- The Goal of the Submission: The 510(k) submission aims to prove "substantial equivalence" to a predicate device. This is a common regulatory pathway for medical devices that are similar in technology and intended use to devices already on the market. It does not require a full clinical trial to prove efficacy in the same way a novel drug or a high-risk AI algorithm might.
- "Acceptance Criteria" for this device: For this hardware device, acceptance criteria revolve around technical specifications (pixel size, line pairs/mm, DQE, operating temperature, etc.), safety standards (IEC 60601-1, EMC, usability), and basic image quality deemed suitable for diagnostic use by a qualified professional. They are not about the performance of an AI algorithm (e.g., sensitivity, specificity for detecting a disease).
However, I can extract the relevant information that is present and explain why other requested information is absent:
Acceptance Criteria and Device Performance (Based on "Comparison with predicate device" and "Non-clinical Testing")
| Acceptance Criteria Category | Specific Criteria/Metric | Reported Device Performance (Tuxdeluxe) |
|---|---|---|
| Preamble/General Equivalence | Device is safe, effective, and performs well as or better than predicate. | Demonstrated through non-clinical tests and comparison to predicate. |
| Indications for Use | Intended to collect dental x-ray photons and convert to electronic impulses for diagnostic use by dentists. | SAME as predicate (6100B-Size 1, 6101B-Size 2), suitable for adult and pediatric patients in hospital/clinic/dental offices by trained personnel. |
| Operating Environment | Where Used | Clinics, hospitals, dental offices (SAME as predicate) |
| Temperature Range | 10°C to 30°C (Predicate) | +5°C to +35°C (Greater operating temperature range than predicate) |
| Electrical | Supply Voltage | +5 Vdc (USB) (SAME as predicate) |
| Imaging Technology | Technology | CMOS (SAME as predicate) |
| Image Depth | Contrast | 12 bits (SAME as predicate) |
| Grayscale Levels | Gray Level | 4096 (SAME as predicate) |
| Resolution (Fineness of Detail) | Pixel Size | 14 μm (Predicate: 20 μm) - Better resolution |
| Number of pixels | Size 1: 1404 x 2104; Size 2: 1852 x 2574 (Predicate: Size 1: 1000 x 1500; Size 2: 1300 x 1800) - More pixels/higher resolution | |
| Line pairs/mm | 35 Line pairs/mm (Predicate: 16 Line pairs/mm) - Significantly better | |
| Image Quality (Modulation Transfer Function) | MTF | 0.095 at 12.5lp/mm (Predicate: 0.1 at 12.5lp/mm) - Essentially the same |
| Image Quality (Detective Quantum Efficiency) | DQE @ RQA5 | >65% @ 0 lp/mm (Predicate: >61.3% @ 0 lp/mm) - Slightly better |
| Physical Dimensions | Active Sensor Area | Size 1: 24.1 x 36.2 mm; Size 2: 30.5 x 42.8 mm (Predicate: Size 1: 25 x 38.5 mm; Size 2: 31 x 40 mm) - Similar |
| Compatibility | Imaging Software (Cleared) | Compatibility verified with XrayVision K983111, XVCapture/XVWeb K983111, Curve K110139, Sota K210682. |
| Connectivity | Target Computer System Type | Windows with USB (SAME as predicate) |
| Connection type | USB 2 or 3 (SAME as predicate) | |
| Cable Length | Cable Length | 2 or 3 m (6 ft or 9 ft) (Predicate: 10 ft.) - Similar |
| Patient Protection | Single Use Patient Protective Barrier, FDA cleared | SAME as predicate. (Not supplied by manufacturer, but required for use). |
| Safety Testing | Electrical, mechanical, environmental safety | Successful testing to IEC 60601-1:2005 (and amendments), EN 60601-1:2006+A1:2013+A12:2014. |
| Electromagnetic Compatibility (EMC) | EMC | Successful testing to IEC 60601-1-2 Ed4.0 (2014) / EN 60601-1-2 Ed4.0 (2015). |
| Usability | Usability | Successful testing to IEC 60601-1-6:2010 + A1:2013 / EN 60601-1-6:2010 +A1:2015. |
| Ingress Protection (IP) | Degrees of protection IP68 | Successful testing to IEC 60529: 2013 / NF EN 60529: 1992 + A1: 2000 + A2: 2014. |
| Biocompatibility | Patient contact material safety | Relies on FDA cleared barrier sheath (K160232), not supplied by manufacturer. |
| Risk Management | Risk Analysis | Conducted, "All test results were satisfactory." |
| Cybersecurity | Cybersecurity concerns addressed | Addressed via labeling, referencing "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" guidance. |
| Image Quality (Clinical Review) | Image quality is acceptable for intended use | USA Board Certified Dentist reviewed images and concluded they are of good quality, clinically acceptable, and suitable for intended use. |
Information Not Applicable or Not Provided in the Document (due to the nature of the device and submission type):
- Sample size used for the test set and the data provenance: This refers to the number of images/cases used in a study evaluating a diagnostic algorithm. For this hardware device, there wasn't a "test set" of images in that sense for an algorithmic performance evaluation. The "image quality analysis" by the dentist is mentioned, but the number of images reviewed or their provenance is not specified.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Ground truth establishment (often by multiple experts) is for diagnostic algorithm studies. Here, a "USA Board Certified Dentist" reviewed images for general clinical acceptability, but not to establish ground truth for an AI system.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for this type of hardware device submission.
- 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 a hardware device, not an AI/CAD system designed to assist human readers. The document explicitly states "Clinical testing is not required for a finding of substantial equivalence."
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no diagnostic algorithm in this device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable as there's no diagnostic algorithm performance being evaluated against a ground truth. The "image quality analysis" by a single dentist is simply to confirm the images produced are acceptable.
- The sample size for the training set: Not applicable. This is a hardware device, not a machine learning model requiring a training set.
- How the ground truth for the training set was established: Not applicable for the same reason as above.
In summary, the provided document describes the regulatory approval of a dental imaging hardware device based on substantial equivalence to an existing predicate. It does not provide details about an AI/CAD system's acceptance criteria or performance study, as such studies would be required for AI-driven diagnostic software.
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