(24 days)
The TraxyLoc™-1 System is a near-real time, image-guided accessory to mammography equipment designed to stabilize a patient's breast and assist a qualified physician in performing a pre-surgical, stereotactic needle localization procedure to target one or more mammographically previously discovered abnormalities for subsequent biopsy or other procedures.
The TraxyLoc™-1 System is designed for, pre-surgical use in a stereotactic needle localization procedure to target mammographically previously discovered breast abnormalities. The device provides breast stabilization and needle guidance for accurate placement of localization needles at positions of suspected abnormalities in the breast.
The device is intended for appropriately trained and qualified physicians, radiologists, and radiology/medical technicians who have previously performed manual and/or stereotactic needle localizations procedures.
The TraxyLoc™-1 System stabilizes the breast in a compression unit which is attached to the mammography equipment. After obtaining two images sterentactically (horizontal and vertical images) the previously identified breast artifact is identified and located on the Overlay Grids. The view orientation and artifact location data is then entered into the Traxalign™ software and the system settings for performing a needle localization are obtained. The localization needle is southings to personally holder. The needle holder is then placed onto the guidance frame as per the software directions. The needle is inserted into the breast as per a typical manual needle localization procedure. At least one confirmatory mammography image should be taken to ensure the position of the needle.
Here's a breakdown of the acceptance criteria and study information for the TraxyLoc™-1 System, based on the provided text:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Device performs as intended. | All testing demonstrated satisfactory performance of the device. |
| Image quality of breast artifact. | Equivalent to current standards. |
| Breast stabilizer comfort. | Compresses the breast comfortably. |
| Breast stabilizer impact on image quality. | Does not impact image quality. |
| Breast stabilizer stability during procedure. | Does not uncompress during the procedure. |
| Software accuracy of needle placement. | +/- 1mm. Note: This accuracy is dependent upon accurate user data input, needle straightness, breast density, and user attention to needle assembly positioning. At least one and sometimes a pair of post needle localization confirmatory X-ray images are required as part of standard practice. |
Study Details
The provided text describes bench testing, not a clinical study involving human subjects or experts establishing ground truth for a test set in the traditional sense of medical image analysis.
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Sample size used for the test set and the data provenance: Not applicable. The text mentions "bench testing," which typically refers to laboratory testing of the device's components and functionality under controlled conditions. It does not refer to a test set of patient data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No human expert review of "test set" data is described. The acceptance criteria focus on physical and software performance rather than diagnostic accuracy against a ground truth established by experts.
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Adjudication method for the test set: Not applicable. No adjudication process is described as there isn't a test set requiring expert review.
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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, an MRMC study was not done. The device is an accessory to mammography equipment for stereotactic needle localization, not an AI-powered diagnostic tool for interpreting images. The focus is on the device's mechanical and software performance in guiding needle placement, not on improving human reader performance in interpreting images.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The "software accuracy of the needle placement is +/-1mm" suggests a standalone assessment of the software's geometric calculation capability. However, the note explicitly states its dependence on user input and actions, indicating it's not a fully automated, standalone device for performing the localization without human interaction. It's a guidance system.
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The type of ground truth used:
- For image quality, the ground truth appears to be "current standards," which likely refers to established industry or regulatory benchmarks for mammographic image quality.
- For breast stabilizer performance (comfort, impact on image quality, stability), the ground truth would be ergonomic assessment and physical stability testing.
- For software accuracy of needle placement, the ground truth would be precise measurements in a controlled bench setting, verifying the calculated coordinates against known physical targets.
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The sample size for the training set: Not applicable. The text describes bench testing for device performance, not the training of a machine learning model.
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How the ground truth for the training set was established: Not applicable, as there is no mention of a training set for a machine learning model.
§ 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.