(30 days)
The Hologic Digital StereoLoc II is an optional accessory for the Selenia full field digital mammography system. It is designed to allow the accurate location of lesions in the breast in three dimensions, using information extracted from stereotactic pairs of twodimensional images. It is intended to provide guidance for interventional purposes (such as biopsy, pre-surgical localization or treatment devices).
The Digital StereoLoc II is an optional accessory to the Selenia Full Field Digital Mammography System. It is attached to the Selenia to perform stereotactic biopsies and is composed of the following elements:
- The Biopsy Unit or Stage used for patient compression and vertical mounting of the . biopsy needle.
- The SmartWindow control module for X and Y-axis motion control and Z-axis . positioning guidance.
- DSM computer workstation and software for stereotactic targeting. .
The breast is compressed between the compression paddle and the carbon fiber breast platform of the biopsy unit. The biopsy unit has its own manual compression mechanism that is independent of the Selenia FFDM compression device. There are two compression knobs; one at each side of the biopsy unit. The Smart Window control module gets the Cartesian coordinates (X, Y, Z) of the target from the DSM workstation. - X and Y motion is motorized. Controlled by the operator via the SmartWindow. .
- . Z-axis motion is manual and controlled by the operator.
Although the provided text doesn't contain a detailed study with acceptance criteria and reported device performance in a tabular format, nor does it include information on sample sizes, ground truth establishment, or specific study designs (like MRMC or standalone), I can extract the relevant information regarding the device's assessment and general conclusions.
Here's a summary based on the provided 510(k) summary:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or a table of performance metrics. Instead, it relies on a qualitative assessment of substantial equivalence to predicate devices and compliance with relevant standards.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document.
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)
This information is not provided in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
This information is not provided in the document. The filing focuses on the device's function as an accessory for guidance during interventional procedures, not on AI-assisted diagnostic improvement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided in the document. The device is described as an accessory that provides guidance for human operators during interventional procedures.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided in the document.
8. The sample size for the training set
This information is not provided in the document.
9. How the ground truth for the training set was established
This information is not provided in the document.
Summary of Device Assessment from the Provided K071542 Document:
The 510(k) summary for the Hologic Digital StereoLoc II primarily establishes substantial equivalence to predicate devices rather than proving performance against specific quantitative acceptance criteria through a dedicated study.
Study that Proves the Device Meets the Acceptance Criteria:
The "Summary of Testing" section indicates:
- The Digital StereoLoc II System was tested by UL to IEC 60601-1 Medical Electrical Equipment Standards. This implies an assessment of electrical safety and essential performance, not clinical accuracy or diagnostic performance.
- The DSM Workstation complies with ACR/NEMA Digital Imaging Communications in Medicine version 3.0. This refers to adherence to DICOM standards for image communication.
- Hologic performs design control verification and validation tests under 21 CFR Part 820 (Quality System Regulation).
The core of the submission for demonstrating safety and effectiveness relies on:
- Comparison With Predicate Devices: The Digital StereoLoc II is stated to be "substantially equivalent" to:
- Conclusion: "The Digital StereoLoc II principles of operation, clinical effectiveness, design, construction and materials are similar to existing marketed devices. This system poses no additional risk."
Therefore, the "proof" is based on demonstrating that the device is functionally and operationally similar to existing legally marketed devices, rather than a new clinical study with specific performance metrics against a defined ground truth. The FDA's letter confirms a "substantial equivalence" determination.
§ 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.