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The Handheld 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 dental X-ray source to produce X-ray images using intraoral image receptors.

These are hand-held portable battery operated x-ray generators for dental purposes. The Portable Dental X-Ray is an X radiation controlled emissions generator system, i.e., once put into service, is intended to be moved from one location to another by a person, used together with appropriate capture devices to generate intraoral radiological images for dental assessment, diagnosis and treatment. This equipment has exposure programs that can be applied to a variety of patients and has predefined exposure parameters depending on the type of patient. The operator is free to change these parameters depending on the situation. The equipment's human-machine interface consists of a control panel located on the top of the equipment, a local trigger button and a remote trigger (hard wired). The triggers are "dead-man" triggers, meaning they release and interrupt the exposure. The Portable Dental X-Ray was designed to be used in adult and children patients by trained dentists and dental technicians to produce X-ray images for diagnosis. The Portable Dental X-Ray is indicated for the production of intraoral medical images of teeth, mandible and oral structures; it assists in the diagnosis of diseases, planning of surgical treatment and monitoring. It is exclusively for dental use, and must be used and handled by qualified and trained health professionals according to the User Manual.

The provided text is an FDA 510(k) summary for a portable dental X-ray system. It focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a study proving the device meets those criteria, particularly in the context of an AI/algorithm-based medical device.

Therefore, many of the requested details about acceptance criteria, study design for AI evaluation (sample size, data provenance, expert ground truth, adjudication, MRMC, standalone performance, training set details), are not present in this document.

The document primarily covers non-clinical testing for safety, EMC, and basic performance of the X-ray system itself, not an AI algorithm.

However, based on the information provided, here's what can be extracted and what information is missing:

Information Present in the Document (Related to Device Performance Testing, Not AI):

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

  • The document primarily lists performance characteristics of the device and compares them to a predicate, rather than defining "acceptance criteria" in a quantitative, pass/fail sense for an AI.
  • For the X-ray device itself, non-clinical tests were performed.
  • Accepted Performance (device characteristics vs. predicate):
    • Indications for Use: Same as predicate.
    • Models: Proposed device has two (60 kV 2.5 mA, 65 kV 2.5 mA); predicate has one (60 kV 2.5 mA). "ALMOST IDENTICAL"
    • Timer Range: Proposed device 0.01 to 1 sec (0.01 sec steps); predicate 0.02-1.00 sec (0.01 sec steps). "Slightly greater range of steps."
    • Duty Cycle: Both 1:60. "SAME"
    • Waveform: Both DC. "SAME"
    • mA: Both 2.5 mA fixed. "SAME"
    • Where Used: Both Dental offices. "SAME"
    • Operating Temp. Range: Proposed device +10°C to +35°C; predicate -5°C to +40°C.
    • Supply Voltage (for battery charging): Proposed device 100-240 V~, 50-60 Hz; predicate 110/120V or 220/240V. "SAME (Charger is UL listed)"
    • Battery: Proposed device Rechargeable Lithium-ion, 21.6V - 2.50Ah; predicate Rechargeable Lithium-ion, 22.2V; 1.7 A-hr.
    • Electrical Safety Standards: Both ANSI/AAMI ES60601-1: A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012, etc. "SAME"
    • EMC: Both IEC60601-1-2 Ed. 4. "SAME"
    • X-Ray Performance: Both 21 CFR 1020.30, 1020.31; IEC 60601-1-3; IEC 60601-2-65. "SAME"

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

  • Not applicable as this is not an AI/algorithm dataset evaluation.
  • However, for the non-clinical bench testing: "Bench Testing was performed to confirm compliance with the FDA Radiation Safety requirements of the Code of Federal Regulations including: accuracy and reproducibility specifications (kV, ma, time) and aluminum equivalence." The sample size for these bench tests (e.g., number of exposures, equipment tested) is not specified.

• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

  • For the X-ray device itself, "Image Evaluation: Using a digital image receptor (cleared in K230732) images were acquired and were found to be of diagnostic quality for dental applications." This implies a qualitative assessment by an unnamed expert or group. The ground truth for "diagnostic quality" is not explicitly defined (e.g., against a gold standard).
  • For radiation safety, compliance was against regulatory standards (CFR).

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

  • Not applicable as this is not an AI/algorithm that requires a training set.

Information NOT Present in the Document (and likely not relevant to this specific 510(k) as it's for an X-ray generator, not an AI/CADe system):

• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable for an X-ray generator submission.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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: Not applicable.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• 8. The sample size for the training set: Not applicable as this is not an AI/algorithm driven device.

In summary: The provided FDA 510(k) summary is for a Portable Dental X-Ray generator, not an AI-powered diagnostic device. Therefore, the detailed requirements for AI acceptance criteria and study designs are not addressed in this document. The document focuses on demonstrating the substantial equivalence of the X-ray generator's basic performance, safety, and electromagnetic compatibility to a legally marketed predicate device.

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