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The SiphonX® gravitational anti-siphon device is designed to control the siphon effect during the treatment of hydrocephalus by shunting Cerebrospinal Fluid CSF).

The SiphonX® Gravitational Anti-sibhon Device is a siphon requlating accessory device used in the treatment of hydrocephalus. SiphonX® Gravitational Anti-siphon Device is an implantable, single-use device. The SiphonX® Gravitational Anti-siphon Device consists of a plastic housing with integral inflow and outflow channels that are separated by a conical valve seat. The housing contains a weight ball that rests upon a smaller, orifice-sealing ball. The device contains two silicone seals. Gravitational effect is provided by a weight ball which pushes on the valve sealing ball, under the effect of gravity, as the device transitions from a horizontal to a vertical position. The cerebrospinal fluid (CSF) flows in through the inlet connector, past the orifice-sealing ball and flows out by way of the outlet connector when the fluid pressure is greater than the sum of the pressure exerted by the weight ball and the operating pressure of the valve. When the SiphonX® Gravitational Anti-siphon Device is in a horizontal position, no resistance to the flow is provided by the weight ball and orifice-sealing ball thereby allowing CSF to flow freely as regulated by the upstream shunt. On the contrary, when the SiphonX® Gravitational Antisiphon Device is in a vertical position, maximum CSF resistance is applied as the weight ball presses on the orifice-sealing ball. The CSF is directed towards the orifice-sealing ball creating an opposing force to that which is generated by the weight ball. Upon sufficient CSF flow and combined valve pressure and Gravitational Anti-siphon Device pressure, CSF is able to push up the orifice-sealing ball and weight ball and flow through the outlet channel and connector. The device will be distributed by itself or in combination with the Polaris® and Sophy® Pressure Adiustable valves and valve kits.

The provided document is a 510(k) summary for the SiphonX® Gravitational Anti-siphon Device. It describes the device, its intended use, and the testing conducted to demonstrate its safety and efficacy.

Here's an analysis of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document mentions that functional tests were conducted, but it does not explicitly state specific acceptance criteria values or detailed reported device performance metrics in a readily quantifiable format within this summary. It broadly states that:

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

The document states: "The SiphonX® Gravitational Anti-siphon Device was subjected to laboratory testing to demonstrate device safety and efficacy."

• Sample Size for Test Set: Not explicitly stated. The text refers to "laboratory testing" and "functional tests" but does not provide the number of devices or units tested.
• Data Provenance: The testing appears to be prospective laboratory testing conducted by the manufacturer, Sophysa SA, located in France. The standards referenced (ISO/FDIS 7197:2006(E) and ASTM F 647) are international and US national standards, respectively, suggesting universally applicable test methods rather than specific country-of-origin patient data.

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

This information is not provided in the document. The testing described is functional and biological testing against standards, not a clinical study involving expert interpretation of patient data. Therefore, the concept of "ground truth established by experts" as typically understood in studies involving images or diagnoses (e.g., radiologists) does not apply here.

4. Adjudication Method for the Test Set

This information is not applicable/provided. Since the testing conducted was functional and biological laboratory testing against predefined standards, there would be no need for an adjudication method as seen in clinical studies with human assessors.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not conducted according to this 510(k) summary. The document describes laboratory testing, not a clinical study involving human readers or patient cases to assess the improvement with AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable as the device is a mechanical medical device (a shunt accessory), not an AI algorithm. Therefore, "standalone algorithm performance" is not a relevant concept for this device.

7. The Type of Ground Truth Used

The ground truth for the functional and biocompatibility testing was established by international and national standards (ISO/FDIS 7197:2006(E), ASTM F 647, and ISO 10993-1). The device's performance was compared against the requirements and specifications outlined in these standards.

8. The Sample Size for the Training Set

This information is not applicable/provided. The SiphonX® Gravitational Anti-siphon Device is a physical medical device, not an AI or machine learning model. Therefore, there is no "training set" in the context of an algorithm. The device design would have been developed through engineering processes, but not "trained" on data.

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

This information is not applicable/provided for the same reason as point 8.

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