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The indications for use of ACCULOC Breast Localization System (formerly MAMMOLOC) are lesions requiring extracranial stereotactic radiotherapy or radiosurgery to the breast.

The software is used to determine the precise location of the target with respect to implanted fiducials.

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The input provided is a 510(k) clearance letter from the FDA for a medical device called the "ACCULOC Breast Localization System (formerly MAMMOLOC)".

Based on the content of the provided document, no information about acceptance criteria or a study that proves the device meets those criteria is available.

The document is primarily an FDA clearance letter confirming that the device is substantially equivalent to a legally marketed predicate device. It outlines:

• The trade/device name.
• Regulation number and name.
• Regulatory class.
• The date of the review and receipt.
• General controls provisions of the Act that apply.
• Contact information for FDA offices.
• Indications for Use for the device.

There is no mention of:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number or qualifications of experts for ground truth establishment.
4. Adjudication methods.
5. MRMC comparative effectiveness studies or effect sizes.
6. Standalone algorithm performance.
7. Type of ground truth used (e.g., pathology, outcomes data).
8. Sample size for a training set.
9. How ground truth for a training set was established.

This type of information is typically found in a clinical study report or a premarket submission (510(k) or PMA) summary, which is not included in the provided FDA clearance letter. The letter itself does not contain the detailed technical or clinical performance data.

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