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The [Trade Name] Fiducial Marker is intended to be implanted into the body to accurately visualize and constitute the reference frame for stereotactic body radiosurgery (SBRT) and radiotherapy target localization.

The [Trade Name] Fiducial Marker is a sterile, pyrogen free, single patient use, pyrolytic carbon coated zirconium oxide discrete marker incorporated into lyophilized glucan gel carrier that is visible on kV X-ray, CT, CBCT, mammography, ultrasound, and Magnetic Resonance Imaging (MRI).

The provided text is a 510(k) summary for a medical device called the "[Trade Name] Fiducial Marker." However, it does not contain the specific information required to answer questions 1 through 9 about acceptance criteria and the study that proves the device meets them.

The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices, addressing regulatory requirements like biocompatibility, visibility, MR safety, sterilization, and packaging/shelf-life. It mentions that "A Failure Modes and Effects Analysis (FMEA) was performed in order to assess the risks associated with the modifications introduced," and that "A biocompatibility, visibility, MR safety / compatibility and sterilization and packaging / shelf-life adoption evaluation confirmed that the modified device, [Trade Name] Fiducial Marker, was substantially equivalent to the predicate devices." This implies that some testing was done to ensure basic device functionality and safety, but it does not detail a study with the kind of acceptance criteria, test set, ground truth establishment, or multi-reader studies typically associated with validating an AI/ML-based medical device.

Therefore, based on the provided text, I cannot complete the table or answer the specific questions about acceptance criteria and performance studies. The document describes a traditional medical device (fiducial marker) clearance process, not one for an AI/ML-driven diagnostic or treatment planning system that would involve such performance metrics validated against a ground truth dataset and human expert comparisons.

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The Ball Fiducial Markers are intended to be implanted into the body to accurately visualize and constitute the reference frame for stereotactic radiosurgery and radiotherapy target localization. Specifically, they can be used in intracranial diseases such as gliomas, neuromas, meningiomas, astrocytomas, arteriovenous malformations, and metastatic carcinomas. Additionally, they can be used in the body for treating hepatic, pancreatic, retroperitoneal, paraspinal, skeletal, prostatic and breast tumors.

The Cosman Ball Fiducial Markers have similar physical and technical characteristics to the predicate devices.

The provided document is a 510(k) summary for the Cosman Ball Fiducial Markers. It states that the device is "substantially equivalent" to a predicate device (CIVCO MEDICAL SOLUTIONS, Fiducial Markers) and is "safe and effective for indicated intended use." However, it does not contain the specific information requested regarding acceptance criteria and a study proving those criteria are met.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets, training sets, or data provenance.
• Information on the number or qualifications of experts used for ground truth.
• Adjudication methods.
• Details of any Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or their effect sizes.
• Information on standalone algorithm performance.
• The type of ground truth used (e.g., pathology, outcomes data).
• How ground truth for any training set was established.

The document is a regulatory submission focused on demonstrating substantial equivalence to a previously cleared device, not a detailed performance study report. The core of its argument for safety and effectiveness is simply that it has similar physical and technical characteristics to the predicate device.

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The Fiducial Markers are intended to be implanted into the body to accurately visualize and constitute the reference frame for stereotactic radiosurgery and radiotherapy target localization. Specifically, they can be use in intracranial diseases as gliomas, neuromas, meningiomas, astroctyomas, arteriovenous malformations, and metastatic carcinomas. Additionally, they can be used in the body for treating hepatic, pancreatic, retroperitoneal, paraspinal, skeletal, prostatic and breast tumors.

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I am sorry, but based on the provided document, I cannot answer the question regarding the acceptance criteria and the study that proves the device meets them. This document is a 510(k) clearance letter from the FDA for "Fiducial Markers" and primarily focuses on the device's substantial equivalence to a predicate device and its indications for use. It does not contain information about specific acceptance criteria or the details of a study demonstrating performance against such criteria.

Ask a specific question about this device