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The Diagnostic PRO, VXR-16, and VXR-16 DOSIMETRY PRO x-ray film digitizers are intended for producing digital copies of medical x-ray films.

The x-ray film digitizer is an electronic device that converts analog x-ray films into digital data. The maximum film width is 14".

This 510(k) summary (K993599) does not appear to contain the level of detail requested for a comprehensive study description and acceptance criteria. The document focuses on establishing substantial equivalence to a predicate device (MedScan 12) rather than providing extensive performance data from a specific study.

However, based on the provided text, here's what can be extracted and inferred regarding the "acceptance criteria" through the lens of substantial equivalence, and the "study" demonstrating this equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" in this 510(k) is tied directly to the performance of the predicate device, MedScan 12. The underlying assumption is that if the new devices (Diagnostic PRO, VXR-16, and VXR-16 DOSIMETRY PRO) perform comparably to the predicate device, they meet the necessary safety and effectiveness standards. The document states: "Technical differences between the devices and the predicate raise no new issues of safety and effectiveness." This implies that the current devices meet the same performance standards as the MedScan 12.

Without specific quantitative performance metrics listed for the predicate or the new devices in this summary, a direct table of numerical "acceptance criteria" and "reported device performance" is not available. However, based on general expectations for X-ray film digitizers, the acceptance criteria would implicitly revolve around:

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

The 510(k) summary does not provide information on a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective). The primary "study" presented here is a comparison to a predicate device, not an independent clinical or technical performance study with a defined test set. The claim relies on the established safety and effectiveness of the existing MedScan 12.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. The summary does not describe a study involving human expert review to establish ground truth. The basis of equivalence is technical comparison to a predicate device already on the market.

4. Adjudication Method

Not applicable. There is no mention of adjudication methods as no human expert review or formal "test set" evaluation is described in this summary for the purpose of establishing a new ground truth.

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

No. The K993599 summary does not describe an MRMC comparative effectiveness study, either with or without AI assistance. The devices are film digitizers, not AI-powered diagnostic tools. There is no mention of human readers or AI in the context of improving diagnostic accuracy.

6. Standalone Performance Study

The summary does not present a standalone (algorithm only) performance study with quantitative metrics. The "study" described is the assertion of substantial equivalence to a predicate device based on technical similarities and the absence of new safety/effectiveness concerns. The emphasis is on the digitizer's ability to convert analog films to digital data, implicitly assuming the digital output is faithful to the original film.

7. Type of Ground Truth Used

Not applicable in the typical sense of a diagnostic algorithm. For a film digitizer, the "ground truth" would implicitly be the physical X-ray film itself. The performance evaluation, if there were one detailed here, would relate to how accurately the digital representation matches the analog film. However, this 510(k) simply states that "Technical differences between the devices and the predicate raise no new issues of safety and effectiveness," indicating an assumption of equivalent fidelity without explicitly defining or evaluating a "ground truth" for the new devices.

8. Sample Size for the Training Set

Not applicable. The devices are film digitizers, not machine learning or AI algorithms that require a "training set."

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

Not applicable. As the devices are not AI or machine learning based, there is no training set or ground truth establishment method for it.

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