Search Results

As a component of a cerebrospinal fluid shunt system, the SLD prevents over-drainage of CSF due to siphoning.

The SLD is a device that limits the siphoning effect caused by elevation of the ventricular catheter in relation to the distal catheter. It has the same intended use and design characteristics as the PS Medical Siphon Control Device (SCD). Both the Radionics SLD and the PS Medical SCD have an inlet and outlet port, as well as a flexible diaphragm which opens or closes as the result of a change in hydrostatic pressure.

This document, K962990, is a 510(k) premarket notification for a Class II medical device, the Radionics Siphon Limiting Device (SLD). It primarily focuses on demonstrating substantial equivalence to a predicate device, the PS Medical Siphon Control Device.

Crucially, this type of submission (a 510(k)) for a Class II device like this typically does not involve clinical studies or detailed performance metrics in the way a newer, novel device clearance or approval might. The purpose of a 510(k) is to show that the new device is as safe and effective as a legally marketed predicate device, often by demonstrating similar technological characteristics and intended use.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth is not present in this document. The document states "Performance Standard: None established under Section 514," which reinforces that there wasn't a specific performance standard or a requirement for a formal clinical trial with predefined acceptance criteria at the time of this submission.

Let's address each point based on the provided text, noting where the information is absent:

1. A table of acceptance criteria and the reported device performance

   • Not present in the document. The 510(k) focuses on substantial equivalence based on design and intended use, not on a formal study with performance metrics against acceptance criteria.

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Not applicable / Not present in the document. No specific test set data is described. The demonstration of safety and effectiveness relies on the comparison to the predicate device's established performance, rather than a new clinical study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

   • Not applicable / Not present in the document. No "test set" and corresponding ground truth establishment is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   • Not applicable / Not present in the document. No "test set" or adjudication process described.

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 / Not present in the document. This device is a mechanical component of a shunt system, not an AI-assisted diagnostic or therapeutic device. MRMC studies are irrelevant here.

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

   • Not applicable / Not present in the document. This is a mechanical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

   • Not applicable / Not present in the document. No specific ground truth for performance evaluation is mentioned for this 510(k). The "ground truth" for clearance is essentially the established safety and effectiveness of the predicate device.

8. The sample size for the training set

   • Not applicable / Not present in the document. This document does not describe a "training set" in the context of a statistical model or algorithm.

9. How the ground truth for the training set was established

   • Not applicable / Not present in the document. See point 8.

Summary based on the provided text:

The document states that the Radionics SLD "has the same intended use and design characteristics as the PS Medical Siphon Control Device (SCD)." It further notes that "Both the Radionics SLD and the PS Medical SCD have an inlet and outlet port, as well as a flexible diaphragm which opens or closes as the result of a change in hydrostatic pressure."

This indicates that the "study" proving the device meets acceptance criteria (though not explicitly defined as such) is essentially the demonstration of substantial equivalence to the predicate device through a comparison of:

• Intended Use: "As a component of a cerebrospinal fluid shunt system, the SLD prevents over-drainage of CSF due to siphoning." (Identical to predicate)
• Design Characteristics: Inlet, outlet port, flexible diaphragm, operation based on hydrostatic pressure changes. (Identical to predicate)
• Safety Information: The labeling includes proper use instructions, description, directions, and safety information to ensure safe and effective use when followed by a physician. This relies on the established safety profile of the predicate.

Therefore, the "acceptance criteria" here are met by the new device being sufficiently similar to a device already deemed safe and effective by the FDA. No new clinical trials or performance studies with defined quantitative acceptance thresholds are presented in this 510(k) summary.

Ask a specific question about this device