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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.

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The intended use of the device Giotto Class is to produce digital images suitable for screening and diagnostic examination of the breast for detection of breast cancer.

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This is an FDA 510(k) clearance letter for a Full-Field Digital Mammography (FFDM) system called "Giotto Class." The provided document does not contain the acceptance criteria for a device, nor does it describe a study that proves the device meets specific performance criteria.

The letter confirms that the FDA has determined the "Giotto Class" device is "substantially equivalent" to legally marketed predicate devices for the indicated use of producing digital images suitable for screening and diagnostic examination of the breast for detection of breast cancer. Substantial equivalence is the pathway for clearance, meaning the device performs as safely and effectively as an already legally marketed device, but it does not require a demonstration against specific, quantitative performance criteria as would be found in a clinical trial report.

Therefore, I cannot provide the requested information from the given text. The document is solely a regulatory clearance for market access based on substantial equivalence.

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