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X-Ray Film Development

SRX-701 Film Processor

The provided text is a 510(k) clearance letter from the FDA for the Konica SRX 701 Automatic X-ray Film Processor. It does not contain any information about acceptance criteria, device performance studies, or AI/algorithm-related details.

This device is an X-ray film processor, which is a physical piece of equipment for developing X-ray film, not a software algorithm or an AI-powered diagnostic device. Therefore, the questions regarding ground truth, expert consensus, sample size for training sets, or comparative effectiveness studies with AI assistance are not applicable to this particular device.

To directly answer your request based on the provided text, while acknowledging its limitations:

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

• Information Not Available: The document is a clearance letter, not a study report. It does not contain acceptance criteria or reported device performance metrics. Its purpose is to state that the device is "substantially equivalent" to legally marketed predicate devices.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Information Not Available: No such information is present as this is not a study report for an AI/diagnostic algorithm.

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)

• Information Not Available: Not applicable to an X-ray film processor.

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

• Information Not Available: 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

• Information Not Available: Not applicable, as this is an X-ray film processor, not an AI-assisted diagnostic device.

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

• Information Not Available: Not applicable.

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

• Information Not Available: Not applicable.

8. The sample size for the training set

• Information Not Available: Not applicable.

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

• Information Not Available: Not applicable.

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A device containing X-ray film for use in diagnostic imaging procedures.

A device containing X-ray film

This document is a 510(k) clearance letter from the FDA for a Konica Mammography Cassette, Models CM and CM DS-7. It primarily states that the device is substantially equivalent to legally marketed predicate devices and can be marketed subject to general controls.

The provided text does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or human-in-the-loop performance. Therefore, I cannot fulfill the request for a table of acceptance criteria and device performance, nor can I provide details on the specific study components mentioned in your request.

The 510(k) letter confirms that the device is cleared for "A device containing X-ray film for use in diagnostic imaging procedures." but it does not delve into the detailed performance metrics or study designs that led to that clearance.

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Accessory to a cassette to convert X-Ray energy into light energy.

Not Found

The provided text is a 510(k) clearance letter from the FDA for "Konica Intensifying Screens MD100 and MM150." This type of document declares substantial equivalence to a predicate device and does not contain information about acceptance criteria or specific study details as would be found in a clinical study report or a premarket approval (PMA) application.

Therefore, I cannot extract the requested information regarding acceptance criteria and study details from the provided text. The document is a regulatory approval, not a scientific study report.

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Ask a specific question about this device