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K Number
K040021
Device Name
SHUNTCHECK (PROMETHEUS 1)
Manufacturer
SAMUEL NEFF M.D.
Date Cleared
2004-11-02

(301 days)

Product Code
JXG
Regulation Number
882.5550
Type
Traditional
Panel
NE
Reference & Predicate Devices
N/A
Predicate For
K080168
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

ShuntCheck is indicated for the detection of flow in implanted silastic cerebrospinal Shuid (CSF) shunts. ShuntCheck must be used by a qualified neurosurgeon according to instructions. ShuntCheck cannot, alone diagnose CSF shunt function or malfunction. The clinical diagnosis of CSF shunt function or malfunction, incorporating the flow information from ShuntCheck, should be made only by a qualified neurosurgeon.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the detailed information needed to describe the acceptance criteria and the study that proves the device meets them. The document is a 510(k) clearance letter for a device called "ShuntCheck," indicating that the FDA has determined it is substantially equivalent to legally marketed predicate devices.

While it mentions the indications for use, it does not include:

  • A table of acceptance criteria and reported device performance.
  • Details about sample sizes, data provenance, or the number and qualifications of experts for ground truth.
  • Information on adjudication methods.
  • Any mention of multi-reader multi-case (MRMC) studies or standalone algorithm performance.
  • The type of ground truth used in studies.
  • Sample size and ground truth establishment for a training set (which would be relevant for devices involving AI/ML, but less so for a 2004 device like ShuntCheck which likely relies on physical principles).

Therefore, I cannot fulfill your request based on the given text.

§ 882.5550 Central nervous system fluid shunt and components.

(a)
Identification. A central nervous system fluid shunt is a device or combination of devices used to divert fluid from the brain or other part of the central nervous system to an internal delivery site or an external receptacle for the purpose of relieving elevated intracranial pressure or fluid volume (e.g., due to hydrocephalus). Components of a central nervous system shunt include catheters, valved catheters, valves, connectors, and other accessory components intended to facilitate use of the shunt or evaluation of a patient with a shunt.(b)
Classification. Class II (performance standards).