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The Siemens MAMMOMAT series with OPDIMA option is intended for use in small field mammographic X-ray imaging (SFDM). Such small field imaging is used during stereotactic biopsy and diagnostic spot localization.

OPDIMA is a Small Field Digital Mammography (SFDM) system. It is marketed as an option to the Siemens MAMMOMAT Novation X-ray examination system. It provides spot imaging for diagnosis and stereotactic biopsy. OPDIMA features a small (49 x 85 mm²) CCD detector that converts the X-ray attenuation into an electronic pattern. The electronic pattern is read out, processed, and displayed on a high resolution monitor. The images may be post processed, printed, or transferred via DICOM network for multiple purposes.

The provided text is a 510(k) summary for the OPDIMA Digital Mammographic X-ray System. It focuses on demonstrating substantial equivalence to previously cleared devices, primarily due to a software and workstation upgrade (moving from UNIX to Windows). It does not contain information about specific acceptance criteria or a study proving the device meets those criteria, as it's a special 510(k) focused on a software change rather than initial device performance.

Therefore, I cannot fulfill most of your request from the provided text. The document does not describe the types of studies you've requested (e.g., standalone performance, MRMC comparative effectiveness, sample sizes for test/training sets, ground truth establishment, or expert details) because it's not a de novo submission or a traditional 510(k) for a new device requiring extensive clinical performance data for first-time market clearance.

However, I can extract the following limited information:

1. Table of Acceptance Criteria and Reported Device Performance:

This document does not present acceptance criteria or reported device performance in the format of a clinical study or a table demonstrating specific metrics against predetermined thresholds. It states that the "imaging characteristics" and "device dependent image processing remain unchanged" from the predicate devices.

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

Not specified in this document. This 510(k) is for a software upgrade, not a new imaging performance study.

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

Not applicable/specified in this document.

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

Not applicable/specified in this document.

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 MRMC study is mentioned. This device is a digital mammographic X-ray system, not an AI-assisted interpretation tool.

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

Not applicable/specified in this document. This device is a hardware system with associated software, not a standalone algorithm.

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

Not applicable/specified in this document.

8. The sample size for the training set:

Not applicable/specified in this document.

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

Not applicable/specified in this document.

Summary of what the document does provide concerning performance/equivalence:

• Claim of unchanged imaging characteristics: "The OPDIMA functionality, the technology characteristics of the system, with the new Windows based workstation remain unchanged for the imaging characteristics."
• Resolution: Maximum resolution (high res mode 2044 x 3584 pixel) with 20 lp/mm and with 13 lp/mm (normal res mode 1024 x 1792 pixel) remains unchanged.
• Image processing: Device dependent image processing remains unchanged.
• Predicate Devices: K003945 (OPDIMA Digital Mammographic X-ray system) and K071015 (OPDIMA Digital Mammographic x-ray system) are cited as predicates, implying that the performance of the current device is considered equivalent to these previously cleared devices.

This 510(k) essentially argues that changing the underlying operating system and workstation environment does not alter the fundamental imaging performance of the OPDIMA system, therefore extensive new clinical performance data is not required.

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The Siemens MAMMOMAT series with OPDIMA option is intended for use in small field mammographic X-ray imaging. Such small field imaging is used during stereo tactic biopsy and diagnostic spot localization.

OPDIMA is a Small Field Digital Mammography (SFDM) system. It is marketed as an option to the Siemens MAMMOMAT series X-ray examination systems. It provides spot imaging for diagnosis and stereo tactic biopsy. OPDIMA features a small (49 x 85 mm²) CCD detector that converts the X-ray attenuation into an electronic pattern. The electronic pattern is read out, processed and displayed at a high resolution monitor. The images may be post processed, printed or transferred via DICOM network for multiple purposes.

The provided text is a 510(k) summary for the OPDIMA Digital Mammographic X-ray System. It details the device's description, intended use, and substantial equivalence to a predicate device, but it does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The 510(k) K071015 primarily states that the updated OPDIMA with a Windows-based workstation is substantially equivalent to the previously cleared OPDIMA with a UNIX workstation (K003945). The justification for substantial equivalence is based on the hardware, control software, image processing, and intended use remaining the same, with only the graphical user interface and performance being improved due to a technology leap (moving to Windows from UNIX).

Therefore, I cannot populate the requested information from the provided text. The document is for a "software update" or "workstation update" to an existing device, and the focus is on maintaining equivalence rather than introducing a new device with new performance criteria to be met through a specific study.

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