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The Precision Flow OSV II is an implantable system used in the treatment of patients with hydrocephalus, to shunt CSF from the ventricles to the peritoneal cavity or other appropriate drainage site such as the heart's right atrium.

The Orbis Sigma Valve and the Precision Flow OSV IT are both variable resistance valves that manuain a drainage rate close to the rate of CSF secretion (~ 20 ml/h) within the physiological range of intracranial pressure. The mechanism incorporates a safety pressure relief mode to prevent accidental intracranial hypertension. The principle of operation consists of a flow restricting diaphragm, a seat, and a notched pln. The diaphragm, held between two polysulfone parts of the casing, reacts to variations in pressure. A synthetic ruby seat is inserted into the center of the diaphragm. The clearance between the seat aperture and the notched synthetic ruby nin varies depending on seat movements along the pin as pressure varies. Precision Flow OSV II and Orbis Sigma Valve are characterized by the same three stages of operation, that are defined below : Stage / - Low Differential Pressure (DP), Stage II - Flow Regulation, Stage III - Pressure Rellef Mode.

This document, K971799, is a 510(k) premarket notification for the Precision Flow OSV II, a Central Nervous System (CNS) Fluid Shunt System. The primary method used to demonstrate safety and effectiveness, and thus meet acceptance criteria, is through substantial equivalence to a predicate device, the Cordis Orbis Sigma Valve.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The core "acceptance criteria" are the performance specifications of the predicate device, which the Precision Flow OSV II claims to replicate. The study described focuses on demonstrating that the new device's performance is identical to the predicate device.

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

This submission does not describe a clinical study with a "test set" in the sense of a new patient cohort for the Precision Flow OSV II. Instead, it relies on the established performance of its predicate, the Orbis Sigma Valve.

• Sample Size for Test Set: Not applicable. The "test" is a comparison to the established specifications of the predicate device, not an independent clinical trial on a new set of patients for the Precision Flow OSV II.
• Data Provenance: The hydrodynamic specifications and operating principles are derived from the Orbis Sigma Valve. The document references a clinical study and use over more than seven years validating the concept for the Orbis Sigma Valve (Sainte Rose, Hooven MD, Hirsch JF: A new approach in the treatment of hydrocephalus. J Neurosurg. 86:213-226, 1987). This suggests retrospective data from clinical use of the predicate, likely from various international locations where the device was marketed.

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

• Number of Experts: Not explicitly stated for establishing "ground truth" for the new device.
• Qualifications of Experts: The "concept of the flow regulation linked to the OSV hydrodynamic specifications has been developed by Pr C. Sainte Rose M.D." This indicates that the initial specifications were developed by a medical professional. For the 510(k) submission, FDA reviewers (Celia M. Witten, Ph.D., M.D., Director, Division of General and Restorative Devices, Office of Device Evaluation) acted as experts in reviewing the claim of substantial equivalence.

4. Adjudication Method for the Test Set

Not applicable, as there was no "test set" requiring adjudication in the context of a new clinical study for the Precision Flow OSV II. The device's performance is asserted as identical to, and therefore meeting the established performance of, its predicate.

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

No, an MRMC comparative effectiveness study was not done. This device is a physical medical implant (shunt), not an imaging or diagnostic AI tool that would typically involve a multi-reader study. The evaluation focuses on physical and hydrodynamic equivalence.

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

Not applicable. This device is a physical CNS shunt system and does not involve an algorithm or AI.

7. The Type of Ground Truth Used

• The "ground truth" for the predicate device's performance was established through:
  • Expert Consensus/Development: The concept developed by Pr C. Sainte Rose M.D.
  • Clinical Studies and Use: "Validated by clinical studies and use over more than seven years" (for the predicate Orbis Sigma Valve). This implies outcomes data from a real-world patient population.
• For the Precision Flow OSV II, the ground truth is that its design, materials, manufacturing methods, and performance specifications are identical/equivalent to this established predicate.

8. The Sample Size for the Training Set

Not applicable. There is no training set in the context of machine learning or AI, as this is a physical medical device. The "training" for its design and performance would be the extensive research, development, and clinical validation conducted for its predicate device over several years.

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

Not applicable, as there is no "training set" in the AI sense. The "ground truth" for the predicate device's efficacy and performance, which forms the basis for demonstrating equivalence for the Precision Flow OSV II, was established through a combination of:

• Expert Design and Theoretical Principles: Pr C. Sainte Rose M.D.'s development of the flow regulation concept and hydrodynamic specifications.
• Clinical Validation: "Clinical studies and use over more than seven years" for the predicate Orbis Sigma Valve, which would have involved patient outcomes data to confirm the device's intended therapeutic effect and performance in vivo.

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The Cordis Cyst Puncture Catheter Kit is intended to facilitate puncturing thick-walled or mobile intracranial cysts, allowing insertion of a ventricular catheter for cyst drainage.

The Cordis Cyst Puncture Catheter kit consists of a ventricular catheter with enlarged holes whose distal tip has been modification allows the sharpended stylet to be inserted through and locked into the distal tip. This facilitates cyst puncture. The kit also includes sharp- and blunt-ended stylets to facilitate catheter placement. The catheter is manufactured from silicone elastomer made radiopaque with barium sulfate.

This is a 510(k) premarket notification for a medical device (Cordis Cyst Puncture Catheter Kit) submitted in 1996. The provided text is a summary of safety and effectiveness, which primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific performance acceptance criteria through a dedicated study.

In the context of 510(k) submissions from this era, a "study that proves the device meets the acceptance criteria" as you've described for AI/software devices is not typically conducted or summarized in this manner. Instead, the focus is on showing similarity in design, materials, manufacturing, and intended use to legally marketed predicate devices, and that these similarities do not raise new questions of safety or effectiveness.

Therefore, many of the specific questions you asked are not directly applicable or answerable from the provided text for this type of medical device submission. However, I can extract information related to what is present and explain why other information is absent.

Here's a breakdown of what can be inferred or stated based on the provided document:

Acceptance Criteria and Reported Device Performance

The document does not specify formal, quantitative "acceptance criteria" for performance in the way a modern AI/software device would. The core "acceptance" is that the device is substantially equivalent to predicate devices. This means that its design, materials, manufacturing methods, and intended use are similar enough not to raise new questions of safety or effectiveness.

Unanswerable or Not Applicable Questions (Based on the Provided Text)

The following questions cannot be answered from the provided text because they pertain to clinical or performance studies typically conducted for devices requiring more extensive proof of safety and effectiveness (e.g., PMA devices, or modern AI/software devices) or for which specific data is not detailed in a Summary of Safety and Effectiveness for a 510(k).

2. Sample size used for the test set and the data provenance: Not applicable. No "test set" in the context of controlled clinical trials or AI evaluation is described. The submission relies on substantial equivalence to predicate devices, which generally means no new clinical data demonstrating performance in a "test set" is required for the 510(k) pathway.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment for a test set is described.

4. Adjudication method for the test set: Not applicable. No test set adjudication is 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. This is a medical device (catheter kit), not an AI/software device. No MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a hardware medical device, not an AI algorithm.

7. The type of ground truth used: Not applicable in the conventional sense of clinical trials. The "ground truth" for a 510(k) is that the predicate devices are safe and effective, and the new device is sufficiently similar.

8. The sample size for the training set: Not applicable. This is a hardware medical device, not a machine learning model.

9. How the ground truth for the training set was established: Not applicable. This is a hardware medical device.

In summary: The provided document is a 510(k) summary focusing on demonstrating substantial equivalence to predicate devices. It relies on comparisons of design, materials, and intended use, rather than presenting clinical study data with defined acceptance criteria and performance metrics typical of more rigorous clinical trials for novel devices or AI/software. The "proof" of meeting "acceptance criteria" (which are implicit substantial equivalence) is the argument that the device is "similar to predicate devices and does not raise any new issues relating to safety and effectiveness for their intended use."

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