(226 days)
The Smart Finder is intended to be used for mammographic procedures requiring stereotactic guidance, such as fine needle aspiration, needle biopsy and guide wire placement.
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This document, K203509, is a 510(k) clearance letter for a mammographic x-ray system called "SMART FINDER." It primarily covers the administrative aspects of the device's clearance for marketing. It does not contain information regarding detailed acceptance criteria, study methodologies, performance metrics (such as sensitivity, specificity, AUC), sample sizes for test or training sets, expert qualifications, or ground truth establishment relevant to an AI/CAD device.
The "SMART FINDER" device, as described, is intended for "mammographic procedures requiring stereotactic guidance, such as fine needle aspiration, needle biopsy and guide wire placement." This suggests it's a hardware device used for image-guided procedures, not an AI or CAD software that analyzes images for diagnostic aid.
Therefore,Based on the provided text, I cannot provide the requested information about device acceptance criteria and the study proving it meets them. The document is a 510(k) clearance letter for a medical device called "SMART FINDER," which is described as a "mammographic x-ray system" used for stereotactic guidance in procedures like fine needle aspiration and biopsy.
This document does NOT contain the following information:
- A table of acceptance criteria and reported device performance: This letter is an administrative clearance, not a technical report on performance.
- Sample sizes used for the test set and data provenance: No study details are provided.
- Number of experts used to establish ground truth and their qualifications: No study details are provided.
- Adjudication method for the test set: No study details are provided.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size: No study details are provided.
- If a standalone (algorithm only) performance study was done: No study details are provided.
- The type of ground truth used: No study details are provided.
- The sample size for the training set: No study details are provided.
- How the ground truth for the training set was established: No study details are provided.
The document indicates that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for 510(k) clearance. However, the details of the studies and data used to demonstrate this substantial equivalence are not included in this administrative letter.
§ 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.