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The OSV II® Low Flow Low Pro Valve 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 proposed OSV II Low Flow Low Pro Valve (OSV II LFLP) and the currently marketed Integra NPH Low Flow Valve System (NPH Valve) are implantable hydrocephalus valve systems for shunting controlled cerebrospinal fluid (CSF) drainage from the ventricles to the peritoneal cavity or other appropriate drainage site such as the heart's right atrium. Unlike conventional valves, these valves are variable resistance valves which maintain a drainage rate constant within the physiological range for the specified populations and disorders of intracranial pressure. These valves were designed to maintain a lower drainage rate than that of normal CSF production (approximately 20 ml/hr), and are intended to accommodate the needs of patients requiring a drainage rate between 8-17 ml/hr. The proposed OSV II LFLP Valve is designed to maintain the same lower drainage rate of 8-17 ml/hr, but with a smaller overall height and diameter to accommodate the needs of patients requiring a smaller valve.

The proposed OSV II Low Flow Low Pro Valve (OSV II LFLP) is similar to the currently marketed Integra NPH Low Flow Valve. The proposed valve is designed to maintain the same lower drainage rate of 8-17 ml/hr, but with a smaller overall height and diameter to accommodate patients requiring a smaller valve. The modifications include a reduction in the silicone boot (external envelope) and replacement of the needle stop.

The proposed OSV II LFLP Valve System is available in different configurations in order to accommodate the needs of the patient. A system typically consists of a valve unit, a ventricular (proximal) catheter, and a drainage (distal) catheter. Depending on the configuration, the ventricular catheter is fully radiopaque length markings at 2cm intervals from the tip, or, with a barium stripe and non radiopaque length markers every 1cm. Connectors are designed for use with 1.1 to 1.4 mm inner diameter silicone elastomer tubing.

The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for a medical device (OSV II® Low Flow Low Pro Valve) seeking substantial equivalence to a predicate device. It describes the device, its indications for use, and a comparison to predicate devices, but it does not include any performance data, clinical study results, or specific acceptance criteria for performance metrics.

Therefore, I cannot provide the requested table or answer the questions related to studies, sample sizes, ground truth, or expert involvement. The document primarily focuses on establishing substantial equivalence based on design and material similarities to previously cleared devices.

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Both the OSV II Lumbar Valve System and the OSV II Low Flow Lumbar Valve System are indicated as implantable systems used in the treatment of patients with communicating hydrocephalus to shunt CSF from the lumbar subarachnoid region to the peritoneal cavity.

The OSV II® Lumbar Valve System (OSV II Valve) and the OSV II® Low Flow Lumbar Valve System (OSV II Low Flow Valve) are implantable devices for controlled cerebrospinal fluid drainage (CSF) from the lumbar subarachnoid region to the peritoneal cavity. Unlike conventional valves, they are variable resistance valves which maintain a drainage rate constant within the physiological range (for the specified populations and disorders) of intracranial pressure. They maintain a drainage rate around 20ml/hr for OSV II Valves and around 10ml/hr for OSV II Low Flow Valves.

The OSV II Lumbar Valve System and OSV II Low Flow Lumbar Valve System are provided with accessories including a 14G tuohy needle, a F5 lumbar catheter, a guidewire, a luer lock connector and a F8-F5 stepdown connector, which are required for using the valves in a lumbar approach. The designs of the accessories are identical to the accessories currently provided with the Integra H-V Lumbar Valve System.

Here's an analysis based on the provided text, outlining the acceptance criteria and the study details:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not contain explicit acceptance criteria in the form of a table or specific quantitative benchmarks set for the OSV II Lumbar Valve System and OSV II Low Flow Lumbar Valve System in a clinical study for this 510(k) submission.

Instead, the submission for these devices relies on demonstrating substantial equivalence to previously cleared predicate devices. The performance specifications are stated as being "the same as the predicate valves" because the new devices are designed the same as existing ventricular approach valves but adapted for a lumbo-peritoneal approach.

However, the operating principles define specific flow rate ranges at different differential pressures. These could be considered intrinsic performance specifications verified during manufacturing.

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

The document explicitly states: "…supported by the clinical evidence included in this 510(k)…". However, it does not provide details on the sample size used for a specific clinical "test set" in this 510(k) submission. The submission primarily relies on demonstrating substantial equivalence to existing devices.

The text does not specify the country of origin of any data, if clinical data were used, nor whether it was retrospective or prospective.

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 given text. The submission focuses on device design, materials, and equivalence to predicates, not on a clinical study that would require expert-established ground truth.

4. Adjudication Method for the Test Set

This information is not provided in the given text, as no detailed clinical study with an adjudication method is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size

No, an MRMC comparative effectiveness study was not done. This 510(k) submission is for an implantable medical device (CSF shunt valves), not for an AI or diagnostic imaging device that typically undergoes MRMC studies to evaluate human reader performance with and without AI assistance.

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

This is not applicable to the device described. The OSV II Lumbar Valve System and OSV II Low Flow Lumbar Valve System are physical implantable medical devices, not algorithms or AI systems. Therefore, a "standalone algorithm performance" evaluation would not be relevant.

7. The Type of Ground Truth Used

The primary "ground truth" for this 510(k) submission appears to be the established performance and safety profiles of the legally marketed predicate devices. The new devices are being cleared based on their substantial equivalence (same design, materials, principle of operation, and performance specifications) to these existing predicate devices (K971799, K081773, K042192 for the valves, and K944595 for the accessories).

Direct clinical outcomes data for the new devices for this specific 510(k) seem to be a supportive element rather than the primary ground truth for novel performance.

8. The Sample Size for the Training Set

This information is not applicable as the devices are physical medical devices, not algorithms requiring a training set.

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

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

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The 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 OSV II is designed to shunt cerebrospinal fluid (CSF) from the ventricles of the brain to an appropriate drainage site, such as the atrium of the heart or the peritoneal cavity. Unlike conventional valves, it is a variable resistance valve which maintains a drainage rate constant within the physiological range (for the specified populations and disorders) of intracranial pressure.

The principle of operation consists of a flow restricting diaphragm, a seat, and a notched pin. 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. As pressure varies, the clearance between the seat and the pin increases or decreases depending on seat movement along the pin.

The provided text describes a 510(k) summary for the OSVII Hydrocephalus Valve. It does not contain information related to a study with acceptance criteria and device performance in the format requested, particularly for AI/ML-based device evaluation. The document focuses on demonstrating substantial equivalence to a previously cleared device (OSV II, K911799) based on design, principle of operation, intended use, materials, and manufacturing process.

The "Safety and Effectiveness" section does not report numerical performance metrics or acceptance criteria in the way that would typically be seen for a new performance claim. Instead, it makes qualitative statements about safety and effectiveness and focuses on the impact of a connector modification.

Below is an attempt to structure the available information, noting where the requested details are not present in the provided text.

Acceptance Criteria and Study for OSVII Hydrocephalus Valve

Summary: The OSVII Hydrocephalus Valve 510(k) submission primarily relies on demonstrating substantial equivalence to a previously cleared predicate device rather than presenting a performance study against specific acceptance criteria with numerical outcomes. The "Safety and Effectiveness" section addresses product attributes and the impact of a minor modification but does not provide quantitative performance metrics or acceptance criteria as typically found in studies for AI/ML devices or new performance claims.

1. Table of Acceptance Criteria and Reported Device Performance

As the provided text focuses on substantial equivalence rather than a detailed performance study with defined acceptance criteria and numerical results for the modified device, a table in the requested format cannot be fully generated. The "Safety and Effectiveness" section provides qualitative statements.

2. Sample size used for the test set and the data provenance: Not explicitly stated. The document refers to "test methods" and "testing" related to the connector modification, implying physical and functional tests were conducted, but does not specify sample sizes or data provenance (e.g., country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The submission focuses on device characteristics and substantial equivalence, not on expert-adjudicated ground truth for a diagnostic task.

4. Adjudication method (e.g., 2+1, 3+1, none) 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 a medical device (hydrocephalus valve), not an AI/ML diagnostic or assistive tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of diagnostic "ground truth." The "ground truth" for this device would relate to its physical and functional performance specifications (e.g., flow rate, pressure regulation, material integrity, sterility) typically established through engineering and biological testing.

8. The sample size for the training set: Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable.

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