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The Pristina Serena Bright option provides the three-dimensional location of target lesions, using information obtained from stereotactic pairs of two-dimensional X-ray images acquired with Contrast Enhanced Spectral Mammography (CESM) under the same breast compression. This information provides guidance for a variety of minimally invasive or interventional procedures in the breast such as: vacuum assisted biopsy, core biopsy, pre-surgical localization (e.g. hookwire), and fine needle aspirations (FNA).
CESM-Biopsy application is indicated for patients with suspicious lesions only seen with certainty when imaged with a contrast agent or that do not have a definite correlate on mammography or ultrasound.

Pristina Serena Bright is a Biopsy System for Senographe Pristina. It is an additional software option that builds upon the Pristina Serena device (GE Healthcare Stereotaxy biopsy option for Senographe Pristina platform). Pristina Serena was cleared on May 14, 2018 (K173576).
Pristina Serena Bright enables biopsy medical application to be done using Contrast Enhanced Spectral Mammography images.
The Pristina Serena Bright add-on includes the following items: Software: A new software version for the Senographe Pristina platform which includes software to manage the Pristina Serena Bright option. Labeling for the CESM Biopsy Medical application.
Pristina Serena Bright option is compatible with previously installed Senographe Pristina systems. Pristina Serena Bright does not require any hardware modification on the Senographe Pristina platform. The hardware that was cleared on Pristina Serena (K173576) was also not modified.

The provided text describes the regulatory submission for GE Healthcare's "Pristina Serena Bright" and mentions substantial equivalence to predicate devices, but it does not contain the detailed acceptance criteria or a specific study proving the device meets those criteria with performance metrics, sample sizes for test sets, ground truth establishment, or MRMC study results as requested.

The document states that "Pristina Serena Bright has successfully completed required design control testing per GE Healthcare's quality management system." It also mentions "Non-Clinical Data – Biopsy accuracy testing: verification of the geometrical accuracy between the target lesion identified on the X-ray Stereo pair images and the actual position of the biopsy needle tip (or needle notch)." However, it does not provide the specific acceptance criteria for this accuracy (e.g., within X mm), nor the quantitative results of this testing.

Therefore, I cannot provide the complete answer to your request. I can only extract what is present in the document.

Based on the provided text, here's what can be gathered, and what is missing:

Missing Information:

• A table of specific acceptance criteria (e.g., accuracy must be X mm) and reported device performance against those criteria.
• Sample sizes used for the test set.
• Data provenance (country of origin, retrospective/prospective) for the test set.
• Number of experts used to establish ground truth for the test set.
• Qualifications of those experts.
• Adjudication method for the test set.
• Whether an MRMC comparative effectiveness study was done, and if so, the effect size.
• Specific quantitative results from the standalone performance (e.g., numerical accuracy metrics).
• The type of ground truth used (beyond "verification of the geometrical accuracy between the target lesion identified on the X-ray Stereo pair images and the actual position of the biopsy needle tip (or needle notch)").
• Sample size for the training set.
• How the ground truth for the training set was established.

Information Extracted (albeit limited):

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

   • Acceptance Criteria: Not explicitly stated in quantitative terms within the provided text. The document refers to "Biopsy accuracy testing" for "verification of the geometrical accuracy between the target lesion identified on the X-ray Stereo pair images and the actual position of the biopsy needle tip (or needle notch)."
   • Reported Device Performance: "The testing demonstrated that Pristina Serena Bright performs according to specifications and functions as intended." No specific performance metrics (e.g., mean accuracy, standard deviation) are provided.

2. Sample sized used for the test set and the data provenance: Not specified in the provided text. The testing is referred to as "Non-Clinical Data – Biopsy accuracy testing."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified in the provided text. The ground truth appears to be based on the physical position of a needle or target in a phantom/bench test, rather than human expert interpretation of images for ground truth.

4. Adjudication method for the test set: Not applicable based on the "Non-Clinical Data – Biopsy accuracy testing" described, which suggests a physical measurement validation rather than a reader study on images.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not indicated. The focus of the provided text is on demonstrating "substantial equivalence" of the device through technical and performance testing against a predicate, particularly in terms of image quality and biopsy accuracy, rather than clinical efficacy studies involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The "Biopsy accuracy testing" appears to be a standalone performance test of the system's ability to accurately guide a needle to a target, based on the stereotactic principles. However, specific metrics are not provided. The device provides "guidance for a variety of minimally invasive or interventional procedures," implying human involvement in the procedure, but the accuracy testing itself seems to be of the system's geometric capability.

7. The type of ground truth used:

   • For the "Biopsy accuracy testing": Ground truth was established by verifying "the geometrical accuracy between the target lesion identified on the X-ray Stereo pair images and the actual position of the biopsy needle tip (or needle notch)." This implies a physical, measurable ground truth (e.g., using a phantom or controlled setup).
   • For image quality and dose tests: Comparison to "SenoBright HD" images at similar dose levels.

8. The sample size for the training set: Not mentioned.

9. How the ground truth for the training set was established: Not mentioned.

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