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This device is intended for implantation over either right or left frontal horn, in conjunction with a ventricles for the purpose of diagnostic studies, therapeutic drug access to the cord/or diversion of cerebrospinal fluid.

Accura Elite Gravity Compensating Reservoir

The provided document is a 510(k) premarket notification letter from the FDA for a device called "Acura Elite Gravity Compensating Reservoir." This letter indicates that the device has been found substantially equivalent to a predicate device and can be marketed.

However, the letter does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth, or an AI algorithm. This document is a regulatory approval letter, not a scientific study report or clinical trial summary.

Therefore, it is impossible to extract the requested information from the provided text.

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The Universal Shunt System is intended for use as the principle pressure-regulating component of a cerebrospinal fluid shunt assembly, used in the treatment of hydrocephalus.

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I am sorry, but the provided text does not contain the information requested in your prompt. The document is a clearance letter from the FDA for a device called "Phoenix Universal Shunt System" and primarily discusses regulatory matters, product classification, and general marketing stipulations.

It does not include any details about:

1. Acceptance criteria or reported device performance
2. Sample sizes for test sets or their data provenance
3. Number or qualifications of experts for ground truth
4. Adjudication methods
5. Multi-reader, multi-case (MRMC) comparative effectiveness studies
6. Standalone algorithm performance studies
7. Type of ground truth used
8. Sample size for training sets
9. How ground truth for training sets was established

Therefore, I cannot provide the requested table or answer the specific questions based on the input text.

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The Accura Elite Shunt System is intended for use as the principle of a cerebrospinal fluid shunt assembly, used in the treatment of hydrocephalus.

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This document is an FDA 510(k) clearance letter for the Accura Elite Shunt System, a Central Nervous System Fluid Shunt and Components. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The letter primarily states that the device has been found substantially equivalent to a legally marketed predicate device and can therefore be marketed.

Therefore, I cannot provide the requested information.

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• The Perf (Ommaya Style) Reservoir is intended as a means of gaining access to the cerebral ventricles by hypodermic puncture. It may be used for ventricular drainage.
• The Perf (Ommaya Style) Reservoir may be used to access the ventricles for the administration of chemotherapeutic agents and/or radioisotopes.

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This document is a 510(k) premarket notification letter from the FDA to Phoenix Biomedical Corporation regarding their "Perf (Ommaya Style) Reservoir." It is a regulatory approval document and does not contain information about acceptance criteria, device performance, or study details.

Therefore, I cannot provide the requested information from the provided text. The document outlines the FDA's decision that the device is substantially equivalent to legally marketed predicate devices and is thus cleared for marketing, subject to general controls provisions of the Act.

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This device is intended as the principle pressure regulating component of a CSF shunt assembly, used regulabing compt of hydrocephalus.

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I am sorry but this document does not contain the answer to your question. The document is a 510(k) premarket notification letter from the FDA regarding the "Diamond II Valve" and does not include details about acceptance criteria, device performance studies, or related information.

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The software changes described in this submission enable the DICOMIT Dicom Image Manager - with 3D-visualization software module to store in memory, multiple sequential ultrasound images when using a standard ultrasound transducer during any standard ultrasound scanning procedure. These images can then be rendered as a 3D image that can be displayed and manipulated in "windows" on the monitor.

This 510(k) summary does not contain the information required to answer your request. It describes a software module for 3D visualization of ultrasound images but does not include details on acceptance criteria, study design, performance metrics, ground truth establishment, or sample sizes for testing or training. The document primarily focuses on identifying the device, its manufacturer, and predicate devices.

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This device is intended for use as the principle regulating component of a CSF ITOW and pressure regaremently, used in the treatment of hydrocephalus.

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This document is a 510(k) clearance letter from the FDA for a medical device called the "CRX DIAMOND VALVE." It confirms that the device is substantially equivalent to a legally marketed predicate device.

However, the provided text does not contain any information regarding acceptance criteria or a study that proves the device meets specific performance criteria.

Therefore, I cannot provide the requested information in a table or answer the specific questions about sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. This type of information is typically found in the 510(k) submission itself, not in the clearance letter.

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