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Intended for use by a qualified/trained doctor or technician on adult subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.

The Digital Radiography System (MobileApex 60E, MobileApex 60F, MobileApex 60G, MobileApex 60H) is comprised of a High Voltage Generator with a maximum power output of 63kW, the Digital Radiography System (MobileApex 60E, MobileApex 60F, MobileApex 60C, MobileApex 60H) can meet different exposure needs for varying positions and body mass. With the Digital Radiography System's (MobileApex 60E, MobileApex 60F, MobileApex 60G, MobileApex 60H) state-of-the-art design and powerful 63kW generator coupled with the Digital Detector (CareView 1500Cwe, CareView 750Cw, Mars1717X, Mars1417X, Luna 1012X) and Digital Radiography Operator Console, users can obtain clear images quickly and easily.

Based on the provided text, the device in question is a Digital Radiography System (MobileApex 60E, MobileApex 60F, MobileApex 60G, MobileApex 60H). The acceptance criteria and the study proving the device meets these criteria are focused on demonstrating substantial equivalence to a predicate device, the MX40 Mobile Digital X-ray System (K181874), rather than proving a specific, quantitative performance metric for a clinical application (like detection of a disease).

The documentation primarily discusses non-clinical performance tests related to electrical safety, electromagnetic compatibility, radiation protection, software validation, and usability. There is no mention of a clinical study to assess diagnostic performance (e.g., accuracy in detecting specific conditions).

Therefore, the following information is extracted and where information is not provided in the text, it is explicitly stated as "Not provided in the text."

Acceptance Criteria and Device Performance for Digital Radiography System

The acceptance criteria for this device are based on demonstrating substantial equivalence to a predicate device in terms of intended use, technological characteristics, and safety and effectiveness, primarily through compliance with recognized standards.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample size for test set: Not applicable/Not provided. The summary describes non-clinical engineering and performance testing against standards, not a clinical test set with patient data for diagnostic performance.
• Data provenance: Not applicable/Not provided. The testing described is type testing and verification against standards, not clinical data collection.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable/Not provided. Ground truth in a diagnostic sense (e.g., for disease detection) was not established as part of this submission's described testing, which is focused on technical performance and safety.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable/Not provided. No clinical test set requiring adjudication of ground truth is described.

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. An MRMC study was not done. This device is a mobile X-ray system, not an AI-powered diagnostic software.

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

• Not applicable. This is a hardware device (X-ray system), not a standalone algorithm.

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

• Not applicable for diagnostic performance. For the described non-clinical performance tests (e.g., electrical safety, radiation output), the "ground truth" is defined by the requirements and specifications of the relevant international and FDA performance standards (e.g., IEC 60601 series, 21 CFR 1020.30/31).

8. The sample size for the training set

• Not applicable/Not provided. This document describes a traditional medical device (X-ray system) and its non-clinical testing, not an AI/ML product that would require a training set.

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

• Not applicable/Not provided. (See point 8).

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Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.

The MX40 is comprised of a High Voltage Generator with a maximum power output of 50 kW, the MX40 can meet different exposure needs for varying positions and body mass. With the MX40's state-of-the-art design and powerful 50 kW generator coupled with the Varex PaxScan digital flat panel image receptor and E-COM Digital Radiography Operator Console (used on previously cleared devices K130883 and K143232), users can obtain clearer images quickly and easily. Our latest mobile X-ray system is based on the revolutionary MX family.

The provided text describes the MX40 Mobile Digital X-ray System and its substantial equivalence to a predicate device, the RadPRO Mobile 40KW. However, it does not contain information about acceptance criteria for device performance in terms of diagnostic accuracy or a clinical study proving the device meets specific acceptance criteria related to its diagnostic output.

Instead, the document focuses on:

• Regulatory Clearance: A 510(k) premarket notification for demonstrating substantial equivalence to a legally marketed predicate device.
• Device Description: Details about the MX40's components and features.
• Comparison to Predicate Device: A table detailing the technological and functional characteristics of the MX40 compared to the RadPRO Mobile 40KW.
• Non-Clinical Performance Testing: A list of international and FDA standards with which the device complies.
• Conclusion: The device is considered substantially equivalent to the predicate based on non-clinical tests and the use of previously cleared digital image panels and acquisition software.

Therefore, many of the requested details about acceptance criteria for diagnostic performance and a clinical study are not available in the provided text.

Here's a summary of what can be extracted:

Acceptance Criteria and Device Performance (based on regulatory substantial equivalence)

The acceptance criteria are implied by demonstrating substantial equivalence to the predicate device, the RadPRO Mobile 40KW (K161345). The device is deemed to meet these criteria by complying with relevant medical device standards and having comparable technical specifications.

Deviations/Improvements over Predicate:

• Generator Power Level: MX40: 50KW vs. Predicate: 40 KW
• mA Range: MX40: 10 - 630 mA vs. Predicate: 10 - 500 mA
• Exposure Time Range: MX40: 0.001 – 6.3 sec vs. Predicate: 0.001 - 10 sec
• mAs Range: MX40: 0.1 – 320 mAs vs. Predicate: 0.1 - 500 mAs
• X-Ray Tube: MX40: Toshiba E7843X vs. Predicate: (not specified, but implies a difference)
• Nominal Anode Input Power: MX40: Large Focus 50kW @ 6Hz, Small focus 22kW @ 60Hz vs. Predicate: (not specified)
• Imaging Panel: MX40 uses Varian 4336R, PAXSCAN 4336W (previously cleared K161459) vs. Predicate using Canon CXDI series (K133693, K131106). Both are previously cleared digital panels.
• Generator Type: MX40: Shenzhen Browiner vs. Predicate: Sedecal
• Collimator Model: MX40: Shenzhen Browiner Tech Co., Ltd Or Huestis 150MC vs. Predicate: Ralco R221 DHHS Manual Collimator

Regarding a study to prove the device meets acceptance criteria:

1. Sample size used for the test set and the data provenance: Not applicable. The submission is a 510(k) for substantial equivalence based on non-clinical performance and a comparison of technical specifications, not a clinical study on diagnostic performance.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth was established from expert readings for a diagnostic performance study.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No test set requiring adjudication was used for diagnostic performance.
4. 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 device is an X-ray system, not an AI-powered diagnostic tool.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an X-ray system, not an algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for this 510(k) clearance is the demonstrated compliance with engineering standards and performance characteristics of the device itself and its components, and its substantial equivalence to a predicate device.
7. The sample size for the training set: Not applicable. This device is an X-ray system, not a machine learning algorithm that requires a training set.
8. How the ground truth for the training set was established: Not applicable.

Summary of Non-Clinical Performance Testing:
The device undergone non-clinical performance testing for compliance with various international and FDA standards, including:

• ISO14971 (Risk Management)
• IEC60601-1 (Basic Safety and Essential Performance)
• IEC60601-1-2 (Electromagnetic Compatibility)
• EN 55032, EN 55024 (Electromagnetic Compatibility)
• IEC60601-1-3 (Radiation Protection)
• EN60601-1-6 (Usability)
• IEC60601-2-54 (X-Ray Equipment Specific Requirements)
• IEC62304 (Software Life-cycle Processes)
• ISO13485 (Quality Management)
• 21CFR 1020.30 (Diagnostic X-Ray systems and their major components)
• 21CFR 1020.31 (Radiographic equipment)

The submission leverages previous clearances for the digital image panel (K161459) and the image acquisition software (K130883 and K143232) to support the substantial equivalence claim.

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Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.

The Paragon 2 is a mobile x-ray unit that covers all the specific needs of any radiographic examination at the patient's bed, first aid, and emergency, orthopedics, pediatric, and operating theater. These battery or line operated units combine stand-alone feature for exposures with battery assisted motor drive. Any of the following digital x-ray acquisition panels are available: Toshiba's FDX4343RPW, FDX 3543RPW, or FDX2520RPW. Integration of the panels and the software with the mobile system was straightforward since the panels and software have already been cleared. (K130883) The device complies with the US Federal Safety Performance Standard and is UL listed. The Paragon 2 has a telescoping tubestand which enhances visibility while transporting the unit. The Paragon 2 employs the digital x-ray panels and software employed in our premarket notification K143232.

This document describes a 510(k) premarket notification for the Paragon 2, a mobile x-ray system, and states that no clinical study was required for its clearance. Therefore, the request for "acceptance criteria and the study that proves the device meets the acceptance criteria" cannot be fully addressed in the typical manner of a clinical trial.

Instead, the submission relies on bench and laboratory testing to demonstrate substantial equivalence to previously cleared predicate devices. The key aspects of the device's performance are evaluated against established safety and performance standards for x-ray equipment.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Since no specific numerical clinical acceptance criteria are defined in this document (due to the nature of the 510(k) submission for substantial equivalence based on bench testing), the "acceptance criteria" are implied by compliance with safety and performance standards, and the "reported device performance" is its demonstrated adherence to these standards and equivalence to predicate devices.

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