(10 days)
The NOMAD Pro X-ray System is intended to be used by trained dentists and dental technicians as an extraoral X-ray source for producing diagnostic X-ray images using intraoral image receptors. Its use is intended for both adult and pediatric subjects.
The NOMAD Pro X-ray System is indicated for use only by a trained and qualified dentist or dental technician for both adult and pediatric subjects as an extraoral diagnostic dental X-ray source to produce Xray images using intraoral image receptors.
NOMAD Pro is a handheld dental X-ray system that operates on 22.2 V DC supplied by a rechargeable Lithium Polymer battery pack enclosed in a Handset. The X-ray tubehead, X-ray controls, and power source are assembled into a single hand-held enclosure. The package includes a spare battery Handset, a Charging Cradle, an AC-to DC Power Supply, and a permanently attached Backscatter Shield.
Here's a breakdown of the acceptance criteria and study information for the NOMAD Pro Handheld X-ray System, based on the provided text:
Important Note: The provided text is a 510(k) Summary and FDA acceptance letter. It focuses on demonstrating substantial equivalence to predicate devices and does not contain details of a clinical study with acceptance criteria and a detailed performance report in the way a clinical trial report would. Instead, it relies on comparisons of technical specifications and performance against regulatory standards and existing devices to establish safety and effectiveness. Therefore, some sections you requested will be marked as "Not provided in text" or inferred from the regulatory context.
Acceptance Criteria and Reported Device Performance
The "acceptance criteria" for a 510(k) submission are generally met by demonstrating that the new device has the same intended use as a legally marketed predicate device and has similar technological characteristics, or if different, that these differences do not raise new questions of safety or effectiveness. The document effectively uses the predicate device as its benchmark for acceptable performance.
| Feature / Acceptance Criteria Category | Reported Device Performance (NOMAD Pro) |
|---|---|
| Intended Use | Extraoral X-ray source for diagnostic imaging using intraoral image receptors by trained dentists/dental technicians, for adult & pediatric subjects (Same as predicate) |
| Mechanical Characteristics | |
| Size (L x H x W) | 10.5"L x 12"H (including shield) x 5.25"W |
| Weight | 5.3 lbs |
| Source to skin distance | 21 cm |
| Cone diameter | 6 cm |
| User Interface | Up-down buttons for exposure time selection, with timer display. Also, user-selectable preset times with patient size, image-receptor type, and tooth selection icons on an LCD display. |
| Backscatter radiation protection | 6.75" dia. Pb-filled acrylic plastic scatter shield |
| Exposure switch | Trigger on Handset |
| Tubehead mounting | Handheld |
| Electrical Characteristics | |
| Energy Source | Rechargeable 22.2 V DC Lithium Polymer battery pack |
| Exposure Time | 0.02 – 1.00 seconds in 0.01 increments |
| Timer Accuracy | ±(10% + 1ms) |
| mA (current) | 2.5 mA fixed |
| kVp (voltage) | 60 kVp fixed |
| Waveform | Constant Potential (DC) |
| Duty Cycle | 1:60 |
| Electrical Safety Standards | IEC60601-1, EN60601-1 |
| EMI Standards | EN60601-1-2 |
| X-Ray Performance Standards | 21 CFR 1020.30, 1020.31, IEC60601-1-3, IEC60601-2-7 (Meets these standards) |
Study Details
The provided document describes a premarket notification (510(k)), which typically relies on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting results from a standalone clinical study that would establish specific performance metrics against pre-defined acceptance criteria. The "study" here is primarily a comparison and adherence to regulatory standards.
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Sample size used for the test set and the data provenance:
- Sample Size: Not applicable in the context of the provided 510(k) summary. This document does not describe a clinical "test set" of patient data in the sense of a diagnostic performance study. The evaluation is based on technical specifications, engineering tests demonstrating compliance with standards, and comparison to predicate devices.
- Data Provenance: Not applicable. The "data" here refers to the device's technical specifications and compliance with international and US standards, rather than patient data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as no "test set" with ground truth from experts is described in this regulatory submission. Expert evaluation would be part of the design and testing process internally, but not detailed as a separate component of the 510(k) summary for external review.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable as there is no described test set requiring expert adjudication.
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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:
- No MRMC study was done. This device is an X-ray source, not an AI-powered diagnostic tool, so reader improvement with AI assistance is not relevant to its function.
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If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm, but a physical X-ray device. Its standalone performance is assessed by meeting physical, electrical, and radiation safety standards, which were presumably tested by the manufacturer.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" here is adherence to established engineering, electrical, and radiation safety standards (e.g., IEC60601-1, EN60601-1-2, 21 CFR 1020.30, 1020.31) and demonstrating that its performance characteristics are comparable to legally marketed predicate devices. No clinical "ground truth" from patient data is described in this document.
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The sample size for the training set:
- Not applicable. This is not a machine learning or AI device that requires a training set.
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How the ground truth for the training set was established:
- Not applicable. There is no training set.
§ 872.1800 Extraoral source x-ray system.
(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.