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The NOMAD™ DENTAL 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 x-ray images using intraoral image receptors.

NOMAD™ Dental is a portable dental x-ray system that operates on 14.4 V DC supplied by a rechargeable NiCd battery pack. The x-ray tubehead, x-ray controls, and power source are assembled into a single handtubenoud, A ray controlage includes spare batteries, a battery charger, and a backscatter shield.

The provided text describes a 510(k) summary for the NOMAD™ Dental X-ray System, establishing its substantial equivalence to a predicate device (Portable HDX Intraoral X-ray system, K021378). The document focuses on regulatory approval based on comparison with existing technology rather than on detailed performance studies with acceptance criteria. Therefore, much of the requested information regarding specific acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment is not present in the provided text.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present specific acceptance criteria in a table format with corresponding reported device performance for clinical outcomes or image quality as would be expected for a detailed clinical study report. Instead, it compares the technical specifications of the NOMAD™ Dental X-ray System to its predicate device to argue for substantial equivalence. The "performance" mentioned relates to physical and electrical specifications meeting regulatory standards rather than clinical diagnostic performance.

Missing Information: There are no explicit acceptance criteria for clinical performance (e.g., diagnostic accuracy, image quality scores, etc.) and no reported device performance against such criteria. The "Conclusion" states: "The only significant technological difference, DC battery power versus AC line voltage, has no bearing on safety or effectiveness of the new device. Since the new device operates without an AC line voltage, it is substantially equivalent to the predicate device." This indicates the primary "proof" relies on demonstrating that the new power source does not negatively impact the established safety and effectiveness of the predicate device, which is usually demonstrated through bench testing and compliance with relevant standards.

2. Sample Size for Test Set and Data Provenance

Missing Information: The document does not describe a clinical test set, nor does it provide sample sizes or data provenance (e.g., country of origin, retrospective/prospective). The approval is based on a comparison of technical specifications and compliance with electrical and X-ray performance standards, not a clinical study involving a test dataset for diagnostic performance.

3. Number of Experts and Qualifications for Ground Truth

Missing Information: Since no clinical test set or diagnostic performance study is described, there is no mention of experts used to establish ground truth or their qualifications.

4. Adjudication Method

Missing Information: Not applicable, as no clinical test set requiring adjudication is described.

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

Missing Information: No MRMC study is mentioned. This approval is based on substantial equivalence to a predicate device through technical comparison and compliance with standards, not a study evaluating human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

Missing Information: This device is an X-ray system, not an AI algorithm. Therefore, "standalone (algorithm only)" performance is not applicable in this context. The document describes the performance of the hardware device itself.

7. Type of Ground Truth Used

Missing Information: No clinical ground truth (e.g., expert consensus, pathology, outcomes data) is mentioned as being used for the assessment described in the provided text. The "ground truth" implicitly referred to is the established safety and effectiveness of the existing predicate device and the adherence to relevant industry standards (e.g., 21 CFR, IEC standards).

8. Sample Size for Training Set

Missing Information: Not applicable. This document describes a physical X-ray device, not an AI model that requires a training set.

9. How Ground Truth for Training Set Was Established

Missing Information: Not applicable. This document describes a physical X-ray device, not an AI model.

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