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The UC-5000 Mobile X-Ray is intended for General Purpose Radiographic exams utilizing film, computed radiography, or direct digital flat panels. Not for mammography.

The UC-5000 Mobile X-Ray consists of an X-ray generator, continuously adjustable light beam collimator, mounting arm, exposure cord with exposure switch, and AC power cord. This is a high-frequency generator of updated design. Light Weight (no batteries) No Special Power Requirements (115/220 VAC Power Input) High Frequency 5.0 kW Generator with Closed loop regulation Digital Displays: kVp, mA, mAs & exposure time. Optionally available with the system is an FDA cleared digital panel and software combination.

The provided text describes a 510(k) premarket notification for a mobile X-ray system (UC-5000 Mobile X-Ray) and seeks to prove its substantial equivalence to a predicate device (PowerMax 1260 Portable X-Ray System). This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than proving absolute performance or clinical efficacy against specific disease outcomes.

Therefore, the "acceptance criteria" and "study" described are focused on proving substantial equivalence to the predicate device, not on meeting specific performance metrics for an AI algorithm or clinical diagnosis. The information provided is primarily related to the device's technical specifications and compliance with safety standards.

Let's address each point based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The "acceptance criteria" here are implicitly related to demonstrating that the UC-5000 is substantially equivalent to the predicate device (PowerMax 1260 Portable X-Ray System) in terms of safety and effectiveness, and that its technical specifications are comparable or improved within acceptable limits without raising new questions of safety or effectiveness.

2. Sample Size Used for the Test Set and the Data Provenance

• Sample Size: This submission does not involve a "test set" in the context of an AI algorithm or a clinical study with patient samples. The testing conducted was non-clinical bench testing, safety agency testing, and software validation. There is no mention of a traditional "test set" size as one would describe for an algorithm performance study.
• Data Provenance: Not applicable. The testing described is performance testing of the device hardware and software, not data collected from patients.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

• Not applicable. This is a 510(k) submission for an X-ray device, not an AI algorithm requiring expert ground truth for interpretation of medical images. The "ground truth" for this device's performance is its adherence to internal specifications and external safety/performance standards, verified through engineering tests.

4. Adjudication Method for the Test Set

• Not applicable. There is no test set requiring adjudication in this context.

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

• No. This submission is for an X-ray device, not an AI-assisted reading tool. Therefore, an MRMC study is not relevant and was not performed.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

• No. This is an X-ray device, not a standalone algorithm. While it mentions optional digital imaging components (panel and software), these are themselves FDA-cleared components (Viztek K152279) presumably validated separately. The focus here is on the X-ray generator and mobile system.

7. The Type of Ground Truth Used

• The "ground truth" for this device's substantial equivalence claim is multi-faceted:
  • Compliance with recognized electrical safety and performance standards: IEC 60601-1, IEC 60601-1-2, and 21 CFR 1020.30/1020.31.
  • Bench testing results: Measurements of kVp calibration, mA calibration, timer tests, mAs display, Half Value Layer, reproducibility, linearity, radiation leakage, collimator light illuminance and alignment, and X-ray field coverage.
  • Software validation: Ensuring the software functions as intended and meets design specifications.
  • Risk analysis: Identifying and mitigating potential hazards.
  • Comparison to the predicate device's established performance and safety.

8. The Sample Size for the Training Set

• Not applicable. This is a hardware device, not an AI algorithm trained on a dataset.

9. How the Ground Truth for the Training Set was Established

• Not applicable. As above, there is no training set for an AI algorithm in this context. The "ground truth" for the device's development and testing involved engineering specifications, design inputs, and regulatory standards.

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The Model PXS-710D X-Ray System is intended for General Purpose Podiatry Radiographic Applications.

Not Found

This 510(k) summary does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria for the Podiatry X-Ray System (Model PXS-710D).

The provided text is a standard FDA 510(k) clearance letter and an "Indications for Use" statement. It confirms the device's substantial equivalence to predicate devices but does not include clinical study data, performance metrics, ground truth establishment, or sample sizes related to the device's specific performance.

Therefore, I cannot provide the requested information based on the input text. The document focuses on regulatory clearance, not on the technical performance study details.

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The Model PowerMax 1260 Portable X-Ray System is intended for General Purpose Portable Radiographic Applications

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I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study details (sample size, data provenance, expert ground truth, adjudication method, MRMC study, standalone performance), or training set information. The document is an FDA 510(k) clearance letter for the "PowerMax 1260 Portable X-Ray System," primarily confirming its substantial equivalence to predicate devices and outlining regulatory requirements. It includes an "Indications for Use" form, but this does not provide the specific details you requested regarding performance studies.

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The Model PXS-810 Podiatry X-Ray System is intended for General Purpose Podiatry Radiographic Applications.

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This document is an FDA 510(k) clearance letter for an X-ray System, Podiatry (Model PXS-810). It states that the device is substantially equivalent to legally marketed predicate devices, but it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

Therefore, I cannot fulfill your request for that specific information from this document. The letter focuses on the regulatory clearance process and substantial equivalence, not on the detailed technical data or clinical study results that would typically include such details.

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The Model SR-115 Portable X-Ray System is intended for General Purpose Portable Radiographic Applications.

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I am sorry, but the provided text does not contain the detailed information about the acceptance criteria, device performance, or the specific study details that you requested. The document is a 510(k) clearance letter from the FDA for an "RC-115 Optional Remote Control (accessory to SR-115 Portable X-ray System)". It states that the device is substantially equivalent to legally marketed predicate devices.

The letter explicitly focuses on:

• Approval of marketing: It grants permission to market the device based on substantial equivalence.
• Regulatory classification: It identifies the device as Class II with product code IZL and regulation number 21 CFR 892.1720 (Mobile x-ray system).
• General regulatory requirements: It reminds the applicant about various FDA regulations they must comply with (registration, listing, labeling, good manufacturing practice, electronic product radiation control).
• Indications for Use: The portable X-ray system is intended for "General Purpose Portable Radiographic Applications."

It does not provide:

• A table of acceptance criteria or reported device performance.
• Details about specific studies, sample sizes, data provenance, or ground truth establishment.
• Information on expert reconciliation, MRMC studies, or standalone algorithm performance.

Therefore, I cannot fulfill your request for these specifics based on the input provided.

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The Model SR-115 Portable X-Ray System is intended for General Purpose Portable Radiographic Applications.

X-Ray System, Portable

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study related to device performance. The document is an FDA 510(k) clearance letter for the "Model SR-115 Portable X-Ray System," which states that the device is substantially equivalent to legally marketed predicate devices.

The letter primarily focuses on:

• Device identification: Trade/Device Name, Regulation Number, Regulation Name, Regulatory Class, Product Code, Date Received.
• Regulatory status: Substantial equivalence determination to predicate devices.
• Post-market requirements: General controls, additional controls for Class II/III devices, good manufacturing practices, labeling, electronic product radiation control provisions.
• Contact information: For specific advice and general information.
• Indications for Use: The Model SR-115 Portable X-Ray System is intended for General Purpose Portable Radiographic Applications.

There is no mention of:

1. A table of acceptance criteria or reported device performance.
2. Sample sizes or data provenance for any test sets.
3. Number or qualifications of experts for establishing ground truth.
4. Adjudication methods.
5. Multi-reader multi-case (MRMC) comparative effectiveness studies.
6. Standalone algorithm performance studies.
7. Type of ground truth used.
8. Sample size for a training set.
9. How ground truth for a training set was established.

This document is a regulatory approval, not a scientific study detailing performance metrics or clinical trial results. Therefore, I cannot fulfill your request for that specific information based on the text provided.

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The Model SR-130-D Digital Portable X-Ray System is The Model OR Too E Portable Radiographic Applications.

Not Found

This document is a 510(k) clearance letter for a Portable Digital X-Ray System. It does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The letter primarily:

• Confirms the FDA's review of the premarket notification.
• States that the device is substantially equivalent to legally marketed predicate devices.
• Outlines general regulatory requirements for the manufacturer.
• Provides contact information for further inquiries.
• Includes the "Indications For Use" statement.

Therefore, I cannot provide the requested information based on the input text.

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The Model SR-130 Portable X-Ray System is intended for General Purpose Portable Radiographic Applications.

Not Found

The provided text is a 510(k) clearance letter from the FDA for a portable X-ray system (SR-130). This type of letter does not contain details about acceptance criteria, device performance studies, or ground truth establishment.

The letter is a regulatory document stating that the device has been found substantially equivalent to a legally marketed predicate device, allowing it to be marketed. It focuses on regulatory compliance, classification, and general controls, rather than detailed performance study results.

Therefore, I cannot provide the requested information based on the input text. The document does not contain:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for test sets.
3. Number or qualifications of experts for ground truth.
4. Adjudication methods.
5. Information about MRMC comparative effectiveness studies or human reader improvement with AI.
6. Results from standalone algorithm performance studies.
7. The type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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