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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, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.

HF50-R High Frequency Special Radiography System can be applied in hospitals of different levels to meet the requirements of radiographic diagnosis. The system is complete, consisting of a 50kw generator, X-Ray tube assembly, collimator, tube mounting hardware, and an x-ray table. This product is applicable to clinical diagnostic radiography in all hospitals large or small. It has functions such as ionization chamber automatic exposure control (AEC), automatic radiography (APR), general radiography etc. It is applicable to the radiography of various parts of human body. It is a dedicated radiographic device for gastro-intestinal tract and the like. The technical characteristics parallels to that in the world in the late '90s of last century. It can also be used in scientific research and education of medical scientific research institutes and medical colleges. Power supply requirements: three phase: 380V, 50/60Hz; single phase: 220V, 50/60 Hz; fluctuation range for voltage: 10%; capacity: 55kVA. Environment requirements: temperature: 15-35C; relative humidity: 45-75%. Atmospheric pressure: 80.0kPa-106.0kPa.

The provided 510(k) summary for the AVANT Medical Systems Model HF-50R Computer Controlled X-Ray System (K052541) does not describe detailed acceptance criteria or a specific study proving the device meets performance criteria in the way a clinical study for a new AI/software device would.

This 510(k) is for a diagnostic X-ray system, which falls under a different regulatory pathway compared to, for example, an AI-powered diagnostic software. Instead of a specific study to prove diagnostic accuracy against ground truth, the submission focuses on demonstrating substantial equivalence to a predicate device based on technical characteristics, safety standards, and intended use.

Therefore, many of the requested categories (e.g., sample size for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth) are not applicable or explicitly mentioned in this type of submission for a conventional X-ray system.

However, I can extract the information relevant to the substantial equivalence claim.

Acceptance Criteria and Reported Device Performance

The acceptance criteria here are implicitly defined by demonstrating that the new device shares similar technical characteristics, intended use, and adherence to safety standards as the predicate device (Siemens Multix Stationary X-Ray System K001201). The "reported device performance" is the direct comparison of these characteristics.

Table of Acceptance Criteria (Implicit) and Reported Device Performance

Regarding the other requested information:

1. Sample size used for the test set and the data provenance: Not applicable or provided. The submission relies on technical comparisons and adherence to standards rather than a clinical "test set" of diagnostic images.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth in the context of diagnostic accuracy is not established for this type of device comparison.
3. Adjudication method for the test set: Not applicable.
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 is for an X-ray system, not an AI diagnostic tool.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to a substantial equivalence claim for an X-ray system. The "ground truth" here is compliance with technical specifications and safety standards, as well as the functionality of the predicate device.
7. The sample size for the training set: Not applicable. This device does not use an AI model with a training set.
8. How the ground truth for the training set was established: Not applicable.

Summary of the "Study" (Substantial Equivalence Demonstration):

The "study" in this context is the substantial equivalence comparison performed by AVANT Medical Systems.

• Methodology: The manufacturer compared the technical characteristics, intended use, and adherence to regulatory standards (21 CFR 1020.30, UL 2601, IEC 60601-1, EMC 60601-1-2) of their Model HF-50R Computer Controlled X-Ray System against a legally marketed predicate device, the Siemens Multix Stationary X-Ray System (K001201).
• Proof of Meeting Acceptance Criteria: The conclusion states: "After analyzing both bench and user testing data as well as external laboratory testing to applicable standards, it is the conclusion of Avant Medical Systems that the Model HF-50R Computer Controlled X-Ray System is as safe and effective as the predicate device, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate device."

In essence, for this type of device, meeting the "acceptance criteria" means demonstrating that it is functionally equivalent and equally as safe and effective as a previously cleared device, rather than proving novel diagnostic accuracy through clinical trials.

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