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The Planmed Sophie Nuance Classic is a mammography x-ray system, which is intended to be used to produce radiographs of the human breast. The device can be equipped with accessories to fulfil different diagnostic needs. Spot mammography is only used in combination with stereotactic needle biopsy guidance.

The Planmed Sophie Nuance Classic is a conventional mammography x-ray system utilizing films and cassettes. This product is a modification of the previous devices Planmed Sophie and Planmed Sophie Classic, where the changes made are concentrated on the lower shelf construction (with easier assembly and better serviceability), a new Flex AEC system, more modern overall design and enhanced user friendliness. The modification also serves as a base to an easy upgradeability to full field digital imaging use in the future.

This document is a 510(k) summary for a mammographic x-ray system, the Planmed Sophie Nuance Classic. It establishes substantial equivalence to previously marketed predicate devices rather than providing information about specific acceptance criteria and a study proving a device meets them.

Therefore, the requested information elements related to acceptance criteria, device performance, study details (sample sizes, data provenance, expert qualifications, adjudication, MRMC, standalone performance), and ground truth establishment are not available in the provided text.

The document primarily focuses on:

• Device Identification: Trade name, common name, classification, regulation number.
• Manufacturer Information: Name, address, contact persons.
• Intended Use: To produce radiographs of the human breast, with accessories for different diagnostic needs.
• Product Description: A conventional mammography x-ray system utilizing films and cassettes, described as a modification of previous Sophie models with improvements in shelf construction, AEC system, design, and user-friendliness, and future upgradeability to digital.
• Substantial Equivalence: A list of predicate devices (Planmed Sophie models) to which the new device is considered substantially equivalent in design, composition, and function, concluding it is "as safe and effective as the predicate devices."
• FDA Correspondence: Official letter from the FDA confirming the substantial equivalence determination and outlining regulatory requirements.

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The Planmed Sophie and Planmed Sophie Classic are Mammographic X-ray Systems, which are intended to be used to produce radiographs of the human breast. The devices can be equipped with accessories to fulfil different diagnostic needs, as spot mammography and stereotactic breast needle biopsy.

Planmed Sophie and Sophie Classic (with Digispot and Cytoguide)

This document is a 510(k) premarket notification acceptance letter for the PlanMed Sophie and Sophie Classic Mammographic X-ray Systems. It does not contain the information requested about acceptance criteria and a study proving a device meets these criteria. This type of information would typically be found in a detailed submission document or a clinical study report, not in the FDA's acceptance letter which only states that the device is substantially equivalent to a legally marketed predicate device.

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The Planmed Sophie and Planmed Sophie Classic are Mammographic X-ray Systems, which are intended to be used to produce radiographs of the human breast. The devices can be equipped with accessories to fulfil different diagnostic needs.

Mammographic X-ray Systems

The provided text is a 510(k) FDA clearance letter for the "Planmed Sophie & Planmed Sophie Classic" mammographic x-ray systems. This document does not contain any information regarding acceptance criteria, device performance studies, or details about AI algorithms.

The letter primarily focuses on:

• Confirming that the device has been reviewed and determined to be substantially equivalent to legally marketed predicate devices.
• Outlining the regulatory class and product code.
• Advising the manufacturer on their responsibilities under the Federal Food, Drug, and Cosmetic Act, including general controls, registration, listing, good manufacturing practices, and labeling.
• Enclosing the "Indications For Use" statement for the device.

Therefore, I cannot extract the requested information from this document. To answer your questions, I would need a different type of document, such as a summary of safety and effectiveness, a clinical study report, or similar technical documentation submitted to the FDA for review.

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The Planmed Sophie and Planmed Sophie Classic are mammographic xray systems, which are intended to be used to produce radiographs of the breast. The devices can be equipped with accessories to fulfil different diagnostic needs.

Planmed Sophie and Sophie Classic Modification MAXVIEW Positioning System

The provided text is a 510(k) premarket notification letter from the FDA regarding a mammographic X-ray system. It does not contain any information about acceptance criteria or a study proving the device meets them. The letter merely states that the FDA has reviewed the notification and determined the device (Planmed Sophie and Sophie Classic Modification MAXVIEW Positioning System) is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided input. The document does not contain any of the requested information regarding:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and data provenance
3. Number of experts used to establish ground truth and their qualifications
4. Adjudication method
5. Multi-reader multi-case (MRMC) comparative effectiveness study results
6. Standalone performance study
7. 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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The Planmed Sophie and Planmed Sophie Classic are mammographic xray systems, which are intended to be used to produce radiographs of the breast. The devices can be equipped with accessories to fulfil different diagnostic needs.

Mammographic X-ray System Planmed Sophie and Sophie Classic Modification

This is an FDA clearance letter for a mammographic X-ray system, not a study report. It states that the device is substantially equivalent to legally marketed predicate devices.

Therefore, the document does not contain the information requested regarding acceptance criteria and the study that proves the device meets those criteria, such as device performance, sample sizes, ground truth establishment, or any details about multi-reader multi-case studies or standalone algorithm performance.

The document primarily focuses on:

• Device: Planmed Sophie and Planmed Sophie Classic Mammographic X-ray Systems (Modification).
• Regulatory Classification: Class II, 21 CFR 892.1710, Procode: 90 IZH.
• Date of Clearance: November 16, 1998.
• Indications for Use: To produce radiographs of the breast.

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