(50 days)
The intended uses of the Biopsy Digit are mammographic procedures requiring stereotactic guidance, such as fine needle aspiration, needle biopsy and guide wire placement. The intended uses are identical to those of the predicate device.
The Biopsy-Digit device uses two stereo images taken by a digital solid state camera to determine the location of a lesion in three dimensions. Once the coordinates of the lesion are determined by the Biopsy-Digit they are used to position a needle holder such that when the physician inserts the needle or guide-wire, the tip will be precisely positioned at the pre-determined coordinates.
The provided text does not contain specific acceptance criteria or a detailed study proving the device meets them. It describes the device's function, intended use, and substantial equivalence to a predicate device, but lacks the quantitative performance data needed to populate the requested table and answer several questions about a performance study.
Therefore, many of the requested fields will state "Not available in the provided text."
Here's a breakdown based on the available information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not available | Not available |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size (Test Set): Not available in the provided text.
- Data Provenance: Not available in the provided text.
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)
- Number of Experts: Not available in the provided text.
- Qualifications of Experts: Not available in the provided text.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not available in the provided text. The document focuses on the mechanical and functional equivalence of the device, not on diagnostic performance where adjudication would be relevant.
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
- MRMC Study: Not available in the provided text. The device is a stereotactic guidance system, not an AI-powered image analysis tool that would typically be evaluated in an MRMC study for reader improvement.
- Effect Size: Not applicable, as no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study: Not available in the provided text. The device is described as a system that facilitates a physician's procedure, implying human-in-the-loop operation, rather than a standalone AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: Not available in the provided text. The submission focuses on the mechanical accuracy of the device in determining lesion location and guiding a needle, rather than a diagnostic outcome where "ground truth" (e.g., pathology) would typically be established for diagnostic accuracy.
8. The sample size for the training set
- Sample Size (Training Set): Not applicable. The device described appears to be a mechanical device based on "human binocular vision" principles, rather than a machine learning model that requires a training set.
9. How the ground truth for the training set was established
- Ground Truth Establishment (Training Set): Not applicable, as the device does not appear to be a machine learning model requiring a training set.
§ 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.