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Models for ventricular application:
The Integra Flow Regulating Valve Systems are implantable systems 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.

Models for lumbar application:
The Lumbar Integra Flow Regulating Valve Systems are implantable systems used in the treatment of patients with communicating hydrocephalus to shunt CSF from the lumbar subarachnoid region to the peritoneal cavity.

The Integra Flow Regulating Hydrocephalus Valve Systems are implantable devices for controlled cerebrospinal fluid (CSF) drainage from the ventricles to the peritoneal cavity or other appropriate drainage site such as the heart's right atrium (ventricular application) or from the lumbar subarachnoid region to the peritoneal cavity (lumbar application). Unlike conventional valves, these are variable resistance valves which maintain a drainage rate constant within the physiological range (for the specified populations and disorders) of intracranial pressure. The mechanism incorporates a safety pressure relief mode to prevent accidental intracranial hypertension.

The various models include two flow regulating ranges, two antechamber sizes, and various accessories allowing either a ventricular or a lumbar application. The two flow regulating ranges are:

Standard flow regulating: maintains a drainage rate close to the normal CSF secretion rate, around 20ml/hr (18-30ml/h).

Low flow regulating: maintains a lower drainage rate than OSV II Valve Systems, around 10ml/hr (8-17ml/h).

The systems are available in different configurations. A system generally consists of a ventricular or lumbar (proximal) catheter, a valve unit, and a drainage (distal) catheter. Some configurations contain an antechamber (standard or low profile) or a burr hole cap.

Various accessories are available for the implantation procedure or to be implanted in addition to the valves.

All products are sold sterilized, for single use only

The provided text is a 510(k) summary for the Integra OSV II Valve Systems. This document is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. It describes non-clinical performance and does not include an acceptance criteria table or a study proving device meeting clinical acceptance criteria based on human or expert evaluation.

Therefore, I cannot provide the requested information regarding acceptance criteria and studies proving the device meets those criteria, as that information is not present in the provided text. The document focuses on demonstrating substantial equivalence through non-clinical testing after a material change (epoxy glue), rather than presenting clinical performance data or acceptance criteria for such.

The document does include the following non-clinical testing information:

• Non-Clinical Tests Performed:

  • Load Testing (up to 15N (1.5kg))
  • Water Test (at 37℃ for 28 days)
  • Biocompatibility testing (Sensitization, Genotoxicity (Bacterial Reverse Mutation, In Vitro Chromosomal Aberration, Mouse Peripheral Blood Micronucleus), Pyrogen (Rabbit Pyrogen Study))
  • MR Conditional status testing (Radio Frequency Induced Heating Test, MR Image Artifacts, Magnetically Induced Displacement Force Test, Magnetically Induced Torque Test).

• Conclusion from Non-Clinical Data: The biocompatibility testing and design verification testing have verified that the change of glue has no impact on the product specifications, performance, and reliability. This testing supports the safety of the modified devices and demonstrates that they should perform as intended.

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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.

• Stage I (Low DP): 5-18 ml/hr flow rate (DP 30-120 mm H2O)
• Stage II (Flow Regulation): 18-30 ml/hr flow rate (DP 120-300 mm H2O)
• Stage III (Pressure Relief): Rapid flow for IVP normalization.
  (Note: These are design specifications/operational principles, not reported performance against acceptance criteria from a study for the modified device.) |

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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The Low Flow OSV II Hydrocephalus 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 Precision Flow OSV II and the modified Low Flow OSV II hydrocephalus valve systems are implantable devices for controlled cerebrospinal fluid drainage from the ventricles to the peritoneal cavity or other appropriate drainage site such as the heart's right atrium. 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.

This document describes a 510(k) premarket notification for the Low Flow OSV II Hydrocephalus Valve. The submission focuses on demonstrating substantial equivalence to a previously cleared device, the Precision Flow OSV II Hydrocephalus Valve, rather than presenting a de novo study with acceptance criteria and performance data in the context of AI/software.

Therefore, many of the requested categories related to AI/software performance studies, ground truth establishment, expert adjudication, and comparative effectiveness studies are not applicable to this document. The information provided is about a physical medical device.

However, I can extract the relevant information by interpreting "acceptance criteria" and "device performance" in the context of device modification and substantial equivalence.

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

• Performance testing reflects shelf life simulation and environmental conditions.
• Review of clinical experiences and published scientific literature supports the rationale for the additional flow regulation rate.
• "The modifications do not affect... new issues of safety and effectiveness." |
  | Effectiveness: Device is effective for intended use. | - Maintains controlled cerebrospinal fluid drainage from ventricles to peritoneal cavity or other appropriate drainage site.
• Variable resistance valve maintains a drainage rate constant within the physiological range of intracranial pressure.
• Designed to address needs of patients requiring a lower drainage rate.
• "no new issues of... effectiveness." |
  | Substantial Equivalence: Similar in function and intended use. | - Substantially equivalent to the unmodified OSV II (Precision flow OSV II) Hydrocephalus Valve (K971799).
• Design, materials of composition, and principle of operation remain the same as the predicate device.
• Modifications involve an additional flow regulation rate to provide lower drainage for specific patient needs. |
  | Biocompatibility: Materials are compatible with the body. | - (Implied, as materials of composition remain the same as the predicate device, which would have been assessed). |

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

This information is not provided. The document refers to "review of clinical experiences and of published scientific literature" but does not detail specific study designs, sample sizes, or data provenance. This is a 510(k) submission primarily relying on substantial equivalence to a predicate device and bench testing.

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. This is not a study requiring expert ground truth for a test set in the context of diagnostic or interpretive performance.

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 not an AI/software device.

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

Not applicable. This is not an AI/software device.

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

The "ground truth" for this device modification is largely based on:

• Predicate Device Performance: The established safety and effectiveness of the Precision Flow OSV II Hydrocephalus Valve (K971799) serves as the primary benchmark.
• Bench Testing: "Performance testing has been performed on The Low Flow OSV II Hydrocephalus Valve reflecting shelf life simulation and environmental conditions." This testing would verify the physical characteristics and flow rates.
• Clinical Literature/Experience: "A review of clinical experiences and of published scientific literature supports the rationale for this additional flow regulation rate which is designed to address the needs of patients who require a lower drainage rate." This implies that existing medical knowledge and clinical need define the appropriateness of a lower flow rate.

8. The sample size for the training set

Not applicable. This is not an AI/software device with a training set.

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

Not applicable. This is not an AI/software device.

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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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