(90 days)
Senographe Stereo is an optional accessory for the Senographe DS full field digital system. It is designed to allow the accurate location of lesions in the breast in three dimensions, using information extracted from steroetactic pairs of two-dimensional images. It is intended to provide guidance for interventional purposes (such as biopsy, pre-surgical localization, or treatment devices).
Senographe Stereo is an option of Senographe DS composed of the following elements:
- A stereotactic positioner .
- Display and stereo positioning software of the Senographe DS .
- A lateral arm for the lateral approach procedures .
- A vertical adapter for vertical approach procedures using a vacuum assisted . device
The Senographe Stereo is an optional accessory for the Senographe DS full field digital system, designed to accurately locate breast lesions in three dimensions using stereotactic pairs of 2D images. It provides guidance for interventional purposes like biopsy and presurgical localization.
1. Acceptance Criteria and Reported Device Performance:
The provided document does not explicitly state numerical acceptance criteria with corresponding reported device performance values. It mentions that "Three kinds of tests have been performed to verify the Senographe Stereo: Functional test, Application accuracy test, IQ Stereo test results." and that "These tests prove the safety and effectiveness of Senographe Stereo." However, the specific metrics or thresholds used for acceptance are not detailed.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the sample size used for the test sets (Functional test, Application accuracy test, IQ Stereo test results) nor the data provenance (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
The document does not provide information on the number of experts used or their qualifications for establishing ground truth for any of the mentioned tests.
4. Adjudication Method for the Test Set:
The document does not describe any adjudication method used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
The document does not mention any multi-reader multi-case (MRMC) comparative effectiveness study, nor does it provide an effect size for human reader improvement with AI assistance. The device is a stereotactic localization system, not an AI-powered diagnostic tool in the sense of image interpretation assistance.
6. Standalone Performance Study:
The information primarily describes the device's functional and accuracy tests, which inherently measure the standalone performance of the algorithm and system in a technical sense (e.g., coordinates calculation, needle positioning). However, it does not explicitly label a study as a "standalone performance study" with specific diagnostic metrics (e.g., sensitivity, specificity) against a human interpreter.
7. Type of Ground Truth Used:
The document does not explicitly state the type of ground truth used for the mentioned tests. For an "Application accuracy test" and "IQ Stereo test results," it's highly likely that a phantom with known, precisely defined target locations would be used as ground truth for evaluating the system's ability to accurately determine X, Y, and Z coordinates. Functional tests would likely involve verifying proper operation of mechanical and software components.
8. Sample Size for the Training Set:
The document does not provide any information regarding a training set or its sample size. This type of device (stereotactic localization) relies on geometric principles and precise engineering, rather than machine learning models that require extensive training data.
9. How the Ground Truth for the Training Set Was Established:
As no training set is mentioned or implied for this type of device, there is no information on how its ground truth might have been established.
§ 892.1710 Mammographic x-ray system.
(a)
Identification. A mammographic x-ray system is a device intended to be used to produce radiographs of the breast. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.