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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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The indications for use are applicable as previously presented for pReference TPS (K970464), such intracranial diseases as gliomas, neuromas, meningiomas, astroctyomas, arteriovenous malformations, and metastatic carcinomas.

The expanded indications for use are also applicable as previously presented for pReference Treatment System (K983793), including hepatic, pancreatic, retroperitoneal, paraspinal, skeletal, and prostatic tumors.

The software is used to electronically import CT images containing the target to be irradiated, to determine the precise location of the target with respect to implanted fiducials, to define and visualize treatment beam locations, and to visualize dose to the target and other structures.

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I apologize, but the provided text is a 510(k) premarket notification letter from the FDA regarding the "pReference IMRT Treatment Planning Module" and its indications for use. It primarily focuses on the regulatory approval and substantial equivalence to predicate devices.

The document does NOT contain information about specific acceptance criteria, a study proving the device meets those criteria, or the detailed methodology of such a study.

Therefore, I cannot provide the requested information in the format of a table of acceptance criteria and reported performance, nor can I answer questions about:

• Sample sizes (test, training) or data provenance
• Number of experts or their qualifications
• Adjudication methods
• MRMC comparative effectiveness study or effect size
• Standalone performance
• Type of ground truth used
• How ground truth for training was established

The letter only states that the device is "substantially equivalent" to legally marketed predicate devices for its stated indications for use. This means the FDA determined it performs as safely and effectively as existing, legally marketed devices, but it does not detail the specific performance metrics or studies that would typically be associated with defined acceptance criteria.

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• The indications for use are applicable as previously presented for pReference TPS (K970464), such intracranial diseases as gliomas, neuromas, meningiomas, astroctyomas, arteriovenous malformations, and metastatic carcinomas.
• The indications for use of pReference Treatment System are expanded to include lesions requiring extracranial stereotactic radiotherapy or radiosurgery. These include hepatic, pancreatic, retroperitoneal, paraspinal, skeletal, and prostatic tumors.
• The software is used to electronically import CT images containing the target to be irradiated, to determine the precise location of the target with respect to implanted fiducials, to define and visualize treatment beam locations, and to visualize dose to the target and other structures.

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The provided text does not contain information about acceptance criteria, device performance, study design, or ground truth establishment. This document is an FDA 510(k) clearance letter for the "pReference Treatment System," which is a treatment planning system. It outlines the device's indications for use and confirms its substantial equivalence to a predicate device.

Therefore, I cannot populate the requested information. The document focuses on regulatory clearance rather than a detailed performance study.

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The indications for use of pReference Treatment Planning Software 1.1 are such intracranial diseases as gliomas, neuromas, meningiomas, astrocytomas, arteriovenous malformations, and metastatic carcinomas.

The software is used to electronically import CT images containing the target to be irradiated, to determine the precise location of the target, to define and visualize treatment beam locations, and to visualize dose to the target and other structures.

Not Found

This is a 510(k) clearance letter and an Indications for Use statement for the "pReference Treatment Planning Software 1.1". These documents confirm the device's clearance for marketing based on substantial equivalence to a predicate device, but they do not contain information about acceptance criteria or specific study details proving the device meets those criteria, nor do they include performance metrics like those typically found in a clinical study report.

Therefore, I cannot extract the requested information from the provided text. To answer your questions, I would need a clinical study report, a validation report, or a similar performance evaluation document for the pReference Treatment Planning Software 1.1.

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Ask a specific question about this device