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The hydrocephalus accessories are intended for use with Codman's Hydrocephalus Shunt Systems.

The Codman-Medos Connector is for use in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid (CSF) is indicated.

The Type A Fixation and Joining Connector is indicated for use in the joining and fixation of 1.2 rite Type P. Pixation and coming with nonabsorbable sutures in a surgical application.

The Type B Fixation and Joining Connector is indicated for use in the joining and fixation of 0.8 me rype b fixation and obling to 1.2 mm nominal I.D. silicone rubber tubing, and min fromman f.D. Billions fulls of the version in a surgical applical application.

The Ventriculostomy Reservoir Set is indicated for use to gain access to the cerebral ventricles or other intracranial cavities for the purpose of diagnostic studies or therapeutic drug administration with or without a shunting device. When used with the shunting device, the ventriculostomy reservoir is also indicated for use as the proximal fluid pathway.

The ACCU-FLO Three Way Connector can be utilized as a component in systems designed to The ACCO-FLO Three Way Ochniction our be unities into the right atium of the heart or the shunt cereorospinal had from the lateral vonthologime and fixation of approximately 1.3 mm peritoneal cavity, providing they are used in the joining aurrical application pentioneal cavily, providing they are about in the John's and surgical application.

The ACCU-FLO Connectors can be utilized as a component in systems designed to shunt The AOOO+ LO Ochhoolors our be anticles into the right atrium of the heart or the peritoneal cerebrospiral not from the joining and fixation of approximately 1.3 mm nominal I.D. silicone rubber tubing with nonabsorbable sutures in a surgical application.

The Cerebral Catheter-Reservoir is indicated for use as a component of a shunting system to The Gerebral Vatheter-1000Non in Indication for see and cavities for the purpose of diagnostic studies, therapeutic drug administration, or the diversion of fluid.

The In-Line Shunt Filter is indicated for use to filter particles that are larger than approximately The in Line Gham Mis suspected and when shunting is the procedure of choice in the treatment of hydrocephalus.

The hydrocephalus accessories consist of connectors, reservoirs, and a filter. The connectors are made of stainless steel or plastic and are used in the joining and fixation of silicone rubber tubing. The reservoirs are made of silicone, stainless steel, and/or plastic and are used for the purpose of diagnostic studies or therapeutic drug administration. The filter is made of stainless steel and silicone and is used to filter particles.

This submission describes a collection of Central Nervous System Fluid Shunt and Components, including various connectors, reservoirs, and a shunt filter.

Here's an analysis of the acceptance criteria and study data provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document focuses on the Magnetic Resonance (MR) safety of the devices. The acceptance criteria are implicit in adhering to established ASTM standards for MR safety. The reported performance demonstrates that the devices meet these standards.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: The document does not specify the exact number of units or individual components tested for each ASTM standard. It simply states "Bench testing was performed according to the following MRI standards: ASTM F 2052, ASTM F 2213, ASTM F 2119, and ASTM F 2182." and that "The devices that are made of silicone and plastic were evaluated and determined to be MR Safe". However, given the nature of MR safety testing for medical devices, it typically involves a representative sample of each unique device type, material, and configuration that could potentially interact with the MR environment.
• Data Provenance: The study is a retrospective bench-top study. The data provenance is internal to the manufacturer ("Bench testing was performed..."). There is no indication of country of origin of the data beyond the manufacturer's location (Raynham, MA, USA).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not provided in the document. For MR safety testing, ground truth is established by objective measurements based on scientific principles and standardized test methods (ASTM standards) rather than expert consensus. The experts involved would typically be engineers or technicians with expertise in magnetic resonance and materials science who conduct the tests and interpret the results according to the specified ASTM protocols.

4. Adjudication Method for the Test Set:

This information is not applicable/not provided for this type of bench testing. Adjudication methods like 2+1 or 3+1 are used in clinical studies where human readers interpret data (e.g., radiology images) and disagreement among readers needs resolution. Here, the "ground truth" is determined by direct physical measurements against established standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This submission is for a medical device (hydrocephalus shunt components) and their MR safety, not an AI or imaging diagnostic tool that would involve human readers or comparative effectiveness studies with AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This is not an algorithm or software device.

7. The Type of Ground Truth Used:

The ground truth used is based on objective physical measurements and adherence to internationally recognized ASTM standards for Magnetic Resonance safety (ASTM F 2052, ASTM F 2213, ASTM F 2119, ASTM F 2182, and ASTM F 2503). These standards define acceptable limits for device interaction with MR fields (e.g., heating, force, torque, artifacts).

8. The Sample Size for the Training Set:

Not applicable. This submission describes a physical medical device. There is no concept of a "training set" as would be found in machine learning or AI development. The device design and materials are based on established engineering principles and prior knowledge.

9. How the Ground Truth for the Training Set was Established:

Not applicable. As stated above, there is no training set for a physical medical device like this in the context of MR safety testing. The "ground truth" for the device's characteristics and safety (before testing) is established through its design specifications, material properties, and manufacturing processes, which are then validated through bench testing.

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The SiphonGuard™ CSF Control Device is a component of hydrocephalus shunt systems designed to shunt CSF from the lateral ventricles of the brain into the peritoneal cavity or right atrium of the heart.

The SiphonGuard™ CSF Control Device is designed to reduce the potential hazards of excessive lowering of intraventricular pressure (with respect to atmospheric pressure) when a patient is in an upright position.

The SiphonGuard™ CSF Control Device is a siphon control device that is designed with two internal passages. The primary passage is a ruby ball-in-seat valve design that opens and closes depending on the CSF flow rate. The secondary passage is a longer spiral passage that remains permanently open but effectively slows the progress of the CSF through the device. The device has two basic modes of operation:

• Normal CSF Flow Conditions: Maiority of the CSF flows through the ruby ball-in-seat valve and exits directly out of the distal port of the SiphonGuard™ CSF Control Device. The remaining CSF travels through a spiral passage that surrounds the primary passage, and reioins the fluid that passes through the primary passage, distal to the ball-in-seat valve.
• Excessive CSF Flow Conditions: Ball-in-seat valve closes and the entire volume of CSF is forced through the longer spiral passage, effectively slowing the rate at which CSF is shunted from the brain. Once the CSF flow rate is reduced. the ruby ball separates from the valve seat, reopening the primary passage, and returning the SiphonGuard™ CSF Control Device to normal CSF flow conditions.

As long as CSF continues to be shunted from the ventricles, flow through the secondary passage never stops, regardless of patient position. The rigid device shell prevents inadvertent closure of the device by externally applied pressure.

The provided document describes the SiphonGuard™ CSF Control Device, a component of hydrocephalus shunt systems. The information primarily focuses on establishing substantial equivalence to existing devices rather than presenting a standalone study with detailed acceptance criteria and performance metrics in the way a diagnostic AI device would.

Here's an analysis based on the provided text, addressing your questions where possible:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states "Performance: Pressure-flow test results showed that the SiphonGuard™ CSF Control Device is substantially equivalent to the Delta® Valve antisiphon component and the Transguard™ antisiphon device in reducing CSF flow rate." This implies that the acceptance criteria for performance were met by demonstrating equivalence to established predicate devices in pressure-flow characteristics that are relevant to reducing CSF flow rate. Specific quantitative thresholds for pressure or flow rate are not provided in this summary.

2. Sample Size Used for the Test Set and Data Provenance

This document does not describe a test set or data provenance in the context of a clinical study for performance evaluation. The "pressure-flow test results" mentioned are likely bench testing (laboratory-based) to compare the device's physical properties to predicate devices. Information regarding human patient data, its origin, or whether it was retrospective or prospective is not available in this summary.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not applicable and not provided. The device is a medical device (antisiphon component) and its performance evaluation for FDA clearance (510(k)) focuses on engineering design, materials, and substantial equivalence to existing devices, not on diagnostic accuracy requiring expert ground truth in the context of imaging or clinical decision-making. The "ground truth" here would be established by the physical laws of fluid dynamics and established engineering standards for such devices.

4. Adjudication Method for the Test Set

This information is not applicable and not provided for the same reasons as point 3.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study was not conducted and is not applicable to this type of device and its 510(k) submission. This is a physical device, not an AI or diagnostic algorithm that human readers would interact with.

6. Standalone Performance Study (Algorithm Only)

A standalone performance study in the context of an "algorithm only (without human-in-the-loop performance)" was not conducted and is not applicable. This is a physical medical device, not a software algorithm. The "performance" described relates to its physical function in controlling CSF flow.

7. Type of Ground Truth Used

The "ground truth" for this device's evaluation is primarily based on engineering and physical performance metrics (e.g., pressure-flow characteristics) as measured in a lab setting, comparing it to well-established predicate devices. It is not based on expert consensus, pathology, or outcomes data in the way a diagnostic device would be. The overarching ground truth is that the device "reduces the potential hazards of excessive lowering of intraventricular pressure" as demonstrated by its substantial equivalence to other devices proven to do so.

8. Sample Size for the Training Set

This information is not applicable and not provided. There is no "training set" in the context of machine learning or AI as this is a physical medical device.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable and not provided for the same reasons as point 8.

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