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The 2430TCA Digital Flat Panel X-Ray Detector is indicated for digital imaging solution designed for a mammographic system. It is intended to replace film or screen based mammographic systems in screening mammography. Xmaru W is an integrated software solution indicated for use with the 2430TCA detector.

2430TCA is a digital mammography X-ray detector that is based on flat-panel technology. This mammographic image detector and processing unit consists of a CsI scintillator coupled to a TFT sensor. This device needs to be integrated with a mammographic imaging system. It can be utilized to capture and digitalize X-ray images for mammographic screening. The RAW files can be further processed as DICOM compatible image files by separate console SW, Xmaru W, for a mammographic screening. 2430TCA detector is connected to the viewing station via a LAN cable.

The provided text is a 510(k) summary for the Rayence 2430TCA with Xmaru W, a digital mammography system. While it discusses the device's characteristics and compares it to a predicate device (2430MCA with Xmaru W), it does NOT contain detailed information about acceptance criteria for an AI/software component, nor a specific study proving it meets such criteria in terms of AI performance.

The document primarily focuses on demonstrating substantial equivalence of the detector (2430TCA) to its predicate (2430MCA) based on physical characteristics, imaging performance (MTF, DQE, NPS), and human expert review of images. It also mentions general software (Xmaru W) but doesn't detail any AI functionality or its validation.

Therefore,Based on the provided FDA 510(k) summary, I cannot provide the requested information about acceptance criteria and a study proving an AI component of the device meets those criteria.

The document discusses the substantial equivalence of a Full-Field Digital Mammography System (including a detector and image processing software). It focuses on the hardware (2430TCA detector) and its image quality parameters (MTF, DQE, NPS) compared to a predicate device. While it mentions "Xmaru W is an integrated software solution," it does not describe any specific AI or machine learning functionality within this software, nor does it discuss validation studies for such a component.

The "Summary of Performance Testing" section describes:

• Human expert review of plain radiographic images from the 2430TCA and 2430MCA, concluding "overall, better image quality of the same anatomical position in the separate patients" for 2430TCA.
• Non-clinical tests (MTF, DQE, NPS) performed on the detector, not an AI algorithm.

Therefore, many of the specific points you've asked for (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set details) are not present in this document because it is focused on the performance of a digital X-ray detector and its fundamental image quality, not an AI algorithm.

If this device were to have an AI component for advanced image analysis (e.g., CADe for lesion detection), that information would typically be in a separate section detailing the AI's performance validation, often with a different set of acceptance criteria and study designs that align with the specific AI function (e.g., sensitivity, specificity, FROC analysis, reader studies). This document does not suggest the presence or validation of such an AI component for diagnostic aid.

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Performa Stereo is intended to be used for breast biopsy or lesion marking with the base mammographic system Performa with stereo adapter.

Performa Stereo is a breast biopsy and lesion marking system in connection with the Performa mammographic system (#K981641). The Performa stereo is especially developed for fine needle aspiration (FNA), core biopsy, vacuum assisted biopsy and lesion marking. The Performa Stereo system consists of a biopsy unit with a needle guide and a breast support table, an adapter unit for making ±15° angles, and a film marker unit. A mechanical docking interface is used for connecting the Performa Stereo's stereo adapter and the biopsy unit together. There are no electrical connections between the biopsy unit and Performa.

The adapter unit is identical to adapter used in the case of Alpha Stereo 4 and Delta 16. The needle guide is a Cytoguide biopsy unit which is the same than used in the case of Delta 32.

In an examination two X-ray images are taken at angles of +15° and -15° degree of the region of interest in the breast. The image capturing will be made by 18x24 cm film cassette and the needle targeting driving will be made with the motorized Cytoguide needle guide unit which are the main functions of the biopsy unit. After making two individual stereotactic X-ray exposures to one film, the corresponding two images are shown side by side on the film reader unit. The user then marks the target point with a cursor on each image. Based on the marking the xyzcoordinates of target are calculated by the film marker unit. The needle holder is then automatically positioned, taking into account the coordinate information and the needle length selected. The tip of the needle, which is then inserted into the holder with correct bushings can now be used to penetrate the lesion area.

The provided document is a 510(k) premarket notification for a medical device called "Performa Stereo." This document primarily focuses on establishing substantial equivalence to predicate devices and does not contain detailed information about a study proving specific acceptance criteria for the device itself.

Here's a breakdown of the information that can be extracted and what is missing:

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

Missing. The document does not provide a table of acceptance criteria or reported device performance metrics. It focuses on the function and design of the device and its equivalence to previously approved devices.

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

Missing. There is no mention of a test set, sample size, or data provenance. The submission describes the device's mechanism and its intended use, rather than presenting results from a clinical or performance study.

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)

Missing. Since no specific test set or study is described, there is no information about experts or ground truth establishment.

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

Missing. No test set or adjudication method is described.

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

Missing. The Performa Stereo is a mechanical system for breast biopsy and lesion marking, not an AI-powered diagnostic tool. Therefore, an MRMC study related to AI assistance is not applicable and not mentioned.

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

Missing. As the device is a physical, mechanical system, there is no "algorithm only" performance to evaluate in this context.

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

Missing. No study or ground truth is described.

8. The sample size for the training set

Missing. This device is a mechanical system, not an AI model, so there is no concept of a "training set" in the context of this submission.

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

Missing. Not applicable, as there is no training set for this type of device.

Summary of available information:

The document serves as a 510(k) summary for the "Performa Stereo" system, a breast biopsy and lesion marking system. Its purpose is to demonstrate substantial equivalence to previously marketed devices (Alpha Stereo 4, GE Stereotix 2, Siemens Mammomat 3000 Stereo). The submission describes the device's components and functionality, emphasizing its mechanical aspects and integration with the Performa mammographic system. It does not include performance data from a clinical study, acceptance criteria, or ground truth establishment as it's not a diagnostic AI device or a device requiring specific performance metrics beyond functional equivalence in this submission.

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