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The Subdural Drainage Catheter Kit is intended for drainage of extraventricular fluid collections, such as hygromas and chronic hematomas, into an external drainage system (such as the Suction Reservoir or the EDS or IDS Systems from Elekta) or an implanted catheter communicating with an appropriate drainage site. The patient's clinical pathology dictates whether the Subdural Drainage Catheter is connected to an internal or external drainage system.

The Subdural Drainage Catheter is intended for drainage of extraventricular fluid collections, such as hygromas and chronic hematomas, into an external drainage system, (such as the Suction Reservoir or the EDS or IDS Systems from Elekta) or an implanted catheter communicating with an appropriate drainage site (i.e., peritoneum).

The patient's clinical pathology dictates whether the Subdural Drainage Catheter is connected to an internal or external drainage system.

The catheter is manufactured from silicone elastomer (with barium sulfate) equivalent to those of other Cordis catheters and CNS fluid shunt systems and components. The distal catheter ends in a hollow, ovoid-shaped structure ("cage") with slit-like openings. For implantation, a stylet is passed through the proximal end of the catheter, and is pushed against the interior cage bottom. This elongates the cage and allows the catheter to be passed through a 5 mm diameter burr hole. When the distal tip is appropriately placed, the stylet is removed and the catheter tip returns to its cage-like appearance.

This document, K974726, describes the clearance of a medical device, the Elekta Subdural Drainage Catheter Kit, as substantially equivalent to existing predicate devices. It does not contain information about a study that establishes acceptance criteria for device performance in the way one would typically find for a new AI/software-as-a-medical-device (SaMD) product.

Therefore, many of the requested sections regarding acceptance criteria and performance studies, particularly those related to AI or a multi-reader multi-case (MRMC) comparative effectiveness study, cannot be extracted from this document.

Here's an analysis of the provided text based on your request:

Acceptance Criteria and Device Performance (Not applicable in the typical sense for SaMD)

This document is a 510(k) clearance, which means the device was found substantially equivalent to predicate devices already on the market. The "acceptance criteria" here are primarily about demonstrating equivalence in design, materials, manufacturing, indications for use, and biocompatibility, rather than meeting specific quantitative performance metrics against a clinical ground truth like an AI/SaMD product.

The document states:

• "The materials used to manufacture the Subdural Drainage Catheter have been subjected to biocompatibility testing. The tests reveal that the materials used are safe for their intended use." This is a key acceptance criterion for the materials, not the overall clinical performance for which you're likely asking.
• "The indications and contraindications of the Subdural Drainage Catheter Kit are equivalent to those of the predicate devices and their accessories."
• "The design, materials, manufacturing methods and specifications of the Subdural Drainage Catheter are similar to those of the predicate Cordis Ventricular Catheters and do not raise any new issues relating to safety and effectiveness for its intended use."

Thus, there isn't a table of specific performance acceptance criteria (e.g., sensitivity, specificity, accuracy) and reported device performance metrics in the context of a clinical study, as these are typically not required for a 510(k) clearance based on substantial equivalence for this type of hardware device.

Unable to Extract Information For:

The following information cannot be extracted from the provided text because the document pertains to the 510(k) clearance of a physical medical device (a catheter kit), not an AI/SaMD product or a clinical study evaluating its efficacy or performance against clinical endpoints.

1. A table of acceptance criteria and the reported device performance: As explained above, the "acceptance criteria" for a 510(k) for a physical device are about equivalence and safety of materials, not quantitative clinical performance metrics. There are no reported device performance metrics like sensitivity, specificity, or accuracy.
2. Sample size used for the test set and the data provenance: No clinical testing or test set is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable; no such ground truth establishment is described.
4. Adjudication method for the test set: Not applicable.
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 not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable; this is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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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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