Search Results

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.

Ask a specific question about this device

The Pristina Serena 3D option provides the three-dimensional location of target lesions, using information obtained from Digital Breast Tomosynthesis (DBT) images. 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.q. hookwire), and fine needle aspirations (FNA).

Pristina Serena 3D is DBT Biopsy System for Senographe Pristina. It is an additional 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 3D enables biopsy medical application to be done using Digital Breast Tomosynthesis (DBT) images.

The Pristina Serena 3D add-on includes the following items: Software: A new software version for the Senographe Pristina platform which includes software to manage the Pristina Serena 3D option. Labeling for the Biopsy DBT (3D) Medical application. Pristina Serena 3D option is compatible with previously installed Senographe Pristina systems. Pristina Serena 3D does not require any hardware modification on the Senographe Pristina platform. The hardware that was cleared on Pristina Serena 3D (K173576) was also not modified.

The Pristina Serena 3D device is designed to provide three-dimensional localization of target lesions using Digital Breast Tomosynthesis (DBT) images to guide minimally invasive breast procedures.

Here's an analysis of the acceptance criteria and the studies that prove the device meets these criteria:

1. Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state a table of quantifiable acceptance criteria with corresponding performance metrics like sensitivity, specificity, or accuracy for lesion detection or biopsy targeting. Instead, the "Determination of Substantial Equivalence" section emphasizes the device's conformance to standards, successful verification/validation testing, and demonstrated performance according to specifications.

However, based on the technology description and comparison with reference devices, the key performance criteria for a biopsy guidance system generally revolve around accuracy of lesion localization and image quality.

• "Both 3D localization features calculate a three dimensional location for percutaneous placement for biopsy, pre-surgical localization or treatment devices." (referring to the predicate and reference devices, implying similar performance)
• "same stated accuracy" (when comparing with Hologic's Affirm) |
  | Image Quality for Biopsy Procedures | -"Since Pristina Serena 3D option uses the Image chain of the Senographe Pristina platform, the image quality of images during the biopsy procedure is equivalent to that of standard screening/diagnostic images of Senographe Pristina 3D."
• "Non-Clinical Data - Image Quality and Dose test that demonstrates that images acquired with Pristina Serena 3D are of same quality as images acquired with Senographe Pristina at similar dose levels." |
  | Dose Management | -"a single DBT acquisition allows for both confirming appropriate breast positioning and for lesion targeting (as opposed to a Stereotaxy procedure that requires three X-ray acquisitions: one scout image plus a stereotaxic pair). This translates into dose reduction to patient."
• "uses a single AOP mode available when acquiring biopsy images. This AOP mode provides the same parameters as the Senographe Pristina 3D AOP mode called "STD+" (P130020/S003 3D STD+ on Senographe Pristina 3D submission)." |
  | Mechanical Accuracy/Precision of Biopsy Device Holder | -"motorized and takes into account the geometry of the biopsy needles, so when the biopsy device holder is in place, the user introduces the needle in the breast until reaching the mechanical stop of the biopsy device holder..." |
  | Usability/Functionality | -"Pristina Serena 3D Design and Usability Validation Report which contains evidence of validation of claims and performance bench testing"
• "allows two different needle approaches for Biopsy: vertical and horizontal" |
  | Safety and Compliance | -"successfully completed required design control testing per GE Healthcare's quality management system."
  -"designed and will be manufactured under the Quality System Regulations of 21CFR 820 and ISO 13485." |

2. Sample Size for the Test Set and Data Provenance

The document does not specify a distinct "test set" in terms of clinical images or patient data with a defined sample size for evaluating the device's diagnostic or interventional accuracy. The evaluation appears to be based on non-clinical data, engineering bench performance testing, and design/usability validation.

• "Non-Clinical Data - Image Quality and Dose test": No sample size or data provenance (e.g., country of origin, retrospective/prospective) is provided for this test. It focuses on demonstrating equivalent image quality and dose to the predicate.
• "Pristina Serena 3D Design and Usability Validation Report": No sample size for user studies or specific details on data provenance are provided. This likely involved internal validation testing.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Since specific clinical test sets are not detailed in the summary, information regarding the number of experts, their qualifications, or how they established ground truth for these tests is not provided. The assessment appears to rely on simulated use testing and technical performance specifications rather than clinical reads.

4. Adjudication Method for the Test Set

As there is no described clinical "test set" involving expert interpretation, an adjudication method (such as 2+1 or 3+1) is not applicable or described in this document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study that demonstrates how much human readers improve with AI vs. without AI assistance was not mentioned in the provided 510(k) summary. This device is an accessory for biopsy guidance and not an independent AI-powered diagnostic tool for image interpretation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)

The device acts as a guidance system. Its primary function is to accurately calculate 3D coordinates for a biopsy. The technology description focuses on the system's ability to determine 3D location and guide the biopsy needle, not an algorithm that performs standalone interpretation. Therefore, a standalone performance evaluation in the typical sense of an AI diagnostic algorithm is not discussed. The device's "performance" is inherently linked to its interaction with the imaging platform and the biopsy accessories.

7. Type of Ground Truth Used

Based on the documentation, the "ground truth" for evaluating the targeting accuracy in the non-clinical and bench testing would likely be phantom measurements or simulated lesion placements with known coordinates. For image quality, the ground truth would be established through technical image quality metrics and comparison to established standards for the predicate device. For usability, the ground truth would come from user feedback and task completion analysis. Clinical outcomes data are not mentioned as being used for these specific tests.

8. Sample Size for the Training Set

The document does not describe the specific underlying algorithms or models that would require a "training set" in the context of machine learning. The device is described as using principles of DBT image analysis to determine 3D locations. If any internal algorithms that contribute to coordinate calculations or image processing were developed using data, the sample size of such a training set is not disclosed.

9. How the Ground Truth for the Training Set Was Established

As no "training set" for a machine learning model is explicitly mentioned or described, the method for establishing its ground truth is not provided. The device functionality appears to be based on established physics and geometric principles of imaging and targeting rather than a data-driven learning approach from a large labeled dataset.

Ask a specific question about this device

The Pristina Serena option provides the three-dimensional locations, using information obtained from stereotactic pairs of two-dimensional X-ray images. 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).

Pristina Serena is a hardware and software add-on to the Senographe Pristina mammography platform (cleared in K162268).
Pristina Serena uses the Stereotaxy principle to determine the three-dimensional (3D) location (X, Y and Z coordinates) of a region of interest in the breast (such as a suspicious lesion).
The stereotaxy biopsy process uses a stereo pair of +/-15° angulated 2D low-dose X-ray images of the compressed breast. The user identifies the point of interest in each image of the stereo pair, Pristina Serena computes the three dimensions coordinates (X,Y,Z) of the user-specified location in the stereo pair.
Pristina Serena uses the target lesion 3D coordinates and information on the geometry of the biopsy device to compute the position of a biopsy device holder that will allow intervention in the breast at the targeted position (biopsy of sample tissue or placement of a hookwire for guidance of surgical interventions).
The Pristina Serena add-on includes the following items:
Hardware: a Biopsy Positioner (BP) the main hardware component of the Pristina Serena option. It can be mounted on the Senographe Pristina in lieu of the Imaging Bucky. The purpose of the BP is to allows breast positioning and mechanical guidance to the target lesion for Biopsy medical application; dedicated breast compression paddles for Biopsy application; mechanical adaptors: pieces of hardware to allow mounting of several kind of biopsy devices on the Biopsy positioner arm.
Software: A new software version for the Senographe Pristina platform which includes software to manage the Pristina Serena option. Labeling for the Biopsy Medical application.
Pristina Serena option is compatible with previously installed Senographe Pristina systems. Pristina Serena does not require any hardware modification on the Senographe Pristina platform.

Here's an analysis of the provided text to extract information about the acceptance criteria and the study proving the device meets them, specifically for the GE Healthcare Pristina Serena.

It's important to note that the provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than a full clinical trial report or a detailed performance validation study. Therefore, some information, particularly regarding specifics of human reader studies (MRMC), detailed ground truth methodologies for large datasets, and training set information, may not be explicitly present or fully elaborated upon as one might find in a peer-reviewed publication or a more comprehensive FDA submission. The focus here is on bench performance testing for accuracy and engineering validation for safety and proper function.

Acceptance Criteria and Device Performance for Pristina Serena (K173576)

The primary acceptance criteria mentioned for the Pristina Serena are related to its biopsy accuracy and image quality/dose performance, demonstrating equivalence to its predicate device (Senographe Stereo) and reference predicate (Senographe Pristina).

1. Table of Acceptance Criteria and Reported Device Performance

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

The text does not specify numerical sample sizes for the "biopsy accuracy testing" or "image quality and dose performance testing."

Regarding data provenance:

• The tests described ("engineering bench performance testing") are laboratory-based and simulation-based.
• The device is manufactured by GE Healthcare in France (283 RUE DE LA MINIERE, 78530 BUC - FRANCE).
• The nature of the testing implies these are prospective bench tests performed during device development and validation.
• The data used for these engineering tests would typically be generated in a controlled lab environment rather than being retrospective patient data from a specific country, as these are tests of the device's technical specifications.

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

For the engineering bench tests described (biopsy accuracy, image quality/dose), the concept of "experts establishing ground truth for a test set" in the context of human interpretation of medical images (like for an AI algorithm's diagnostic performance) is not directly applicable.

• Ground truth for biopsy accuracy: This would be established by precise metrology and physical measurements of the needle tip's position relative to a target in a phantom using the device. This is a technical measurement, not an expert interpretation.
• Ground truth for image quality/dose: This would be established by physical measurements (e.g., dose meters) and standardized image quality metrics (e.g., contrast, spatial resolution) using phantoms, not by human experts.

Therefore, the text does not mention human experts for establishing ground truth for these specific performance tests.

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

Given that the performance evaluation relies on "engineering bench performance testing" and technical measurements/verification, adjudication methods as typically used in human reader studies (like 2+1 or 3+1 consensus for ambiguous cases) are not applicable or mentioned in this context. The determination of accuracy and image quality is based on objective, quantifiable metrics following established engineering protocols.

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 comparative effectiveness study is mentioned in this 510(k) summary. The Pristina Serena device is a stereotactic biopsy guidance system, not an AI-assisted diagnostic tool for image interpretation. Its function is to guide physical interventions, not to interpret images for diagnosis alongside human readers. Therefore, there is no discussion of human reader improvement with or without AI assistance.

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

This device is not an AI algorithm for image interpretation. It's a hardware and software add-on that uses stereotaxy principles to calculate 3D coordinates based on user-identified points in 2D images.

• The "standalone" performance here refers to the system's ability to accurately calculate the 3D coordinates and guide the biopsy device. This was addressed by the "Biopsy accuracy testing."
• The user is "human-in-the-loop" by identifying the initial point of interest in the images, but the calculation itself is algorithmic/systemic. The tests confirm the accuracy of the system's output (3D coordinates and guidance).

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

For the "Biopsy accuracy testing":

• The ground truth is established by physical measurement of the actual position of the biopsy needle tip (or needle notch) relative to a known target in a phantom. This is a highly precise engineering measurement.
• It is not based on expert consensus, pathology, or outcomes data, as those are typically used for diagnostic or prognostic AI systems evaluated on patient data.

For "Image quality and dose performance testing":

• The ground truth is established by physical measurements using phantoms and adherence to established image quality metrics.

8. The sample size for the training set

The text does not mention a training set sample size. This is expected because the Pristina Serena is a stereotactic guidance system, not a machine learning or deep learning AI model that requires a vast training dataset of medical images. Its core function is based on principles of geometry and X-ray physics to calculate 3D coordinates from 2D images.

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

As no training set (in the context of machine learning) is mentioned or implied for this device, the question of how its ground truth was established is not applicable. The device's operation relies on established physical and mathematical principles, which do not typically involve a "training" phase with ground-truth labels in the way AI/ML algorithms do. The development involved traditional software development lifecycle testing, verification, and validation against engineering specifications.

Ask a specific question about this device