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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 Equi-Flow™ Valve and Shunt Systems are used in the treatment of patients with hydrocephalus. The device is designed to shunt cerebrospinal fluid from the ventricles of the brain to an appropriate drainage site, such as the atrium of the heart or the peritoneal cavity.

The Equi-Flow™ Valve is indicated in patients where excessive reduction of intraventricular pressure or volume may be caused by the siphoning effect of hydrostatic pressure in the Distal Catheter of the shunt system.

The Integra NeuroSciences Equi-Flow™ Valve is a multi-function membrane valve incorporating a normally open Siphon Limiting Device, occluders, and integrant valving connectors. It is used in treatment of patients with hydrocephalus when shunting cerebrospinal fluid (CSF) from ventricles of the brain. It incorporates a central reservoir for pumping and injection, proximal and distal occluders, and a fully flexible profile.

The Siphon Limiting Device limits the siphon effect in the shunt system by closing when exposed to a negative Hydrostatic pressure (often caused by the patient sitting or standing).

The Equi-Flow Valve incorporates a central reservoir for pumping and injection, proximal and distal occluders, and a fully flexible profile. The Equi-Flow Valve design includes a flat silicone membrane, which provides resistance to CSF flow. The flat silicone membrane seats on a conical polypropylene base which is integral to the Siphon Limiting Device. This base is integral to a rigid outlet port. The design allows for accurate and precise regulation of CSF flow due to its structural integrity. The flat silicone membrane also prevents retrograde flow of CSF. The Equi-Flow valve is available in two sizes: Regular and Small. Both sizes are available in five pressure/flow characteristics ranges: Low/Low, Low, Low/Medium, Medium and High.

The provided text describes the Equi-Flow™ Valve and Shunt System, but it does not contain information about acceptance criteria or a study proving the device meets those criteria.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting performance data from a specific study against acceptance criteria.

Here's a breakdown of why the requested information cannot be extracted from the provided text:

1. Table of acceptance criteria and reported device performance: This information is not present. The document mentions that the device "has been tested for pressure/flow, leakage, antireflux, catheter elongation and bending, and markings visual inspection," but it does not provide what the acceptance criteria were for these tests or the specific results achieved.

2. Sample size used for the test set and data provenance: No specific test set or study with corresponding sample sizes or data provenance (country of origin, retrospective/prospective) is described.

3. Number of experts used to establish ground truth and qualifications: Not applicable, as no study generating ground truth is detailed.

4. Adjudication method: Not applicable, as no study requiring adjudication is detailed.

5. Multi-reader multi-case (MRMC) comparative effectiveness study: No such study is mentioned or referenced.

6. Standalone (algorithm-only) performance: Not applicable, as this is a physical medical device, not an AI algorithm.

7. Type of ground truth used: Not applicable, as no study generating ground truth is detailed.

8. Sample size for the training set: Not applicable, as this is a physical medical device, not an AI algorithm requiring a training set.

9. How ground truth for the training set was established: Not applicable, as this is a physical medical device.

Conclusion from the provided text:

The submission for the Equi-Flow™ Valve and Shunt System relies on demonstrating substantial equivalence to existing, legally marketed predicate devices (Equi-Flow™ Valve and Shunt System and Contour-Flex Valve and Shunt System), rather than a new standalone performance study against specific acceptance criteria. The document explicitly states: "The modified Equi-Flow™ Valve and Shunt System is substantially equivalent to the unmodified Equi-Flow Valve and Shunt System and Contour-Flex Valve and Shunt System. The modifications do not affect the intended use, the fundamental scientific technology of the device, and do not raise new issues of safety and effectiveness."

Therefore, based solely on the provided text, it is not possible to fill out the requested table or answer the other questions about acceptance criteria and a specific study proving device performance. The "Safety" section briefly lists tests performed (pressure/flow, leakage, antireflux, etc.) but does not provide quantitative acceptance criteria or results.

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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 Integra NeuroSciences Burr Hole Valve and Shunt System is used in treatment of patients with hydrocephalus. The Burr Hole Valve is a component of a system designed to shunt cerebrospinal fluid from the ventricles of the brain to an appropriate drainage site such as the atrium of the heart or to the peritoneal cavity.

The Integra NeuroSciences Burr Hole Valve incorporates a membrane valve with integral connectors and domed reservoir to fit into a formal burr hole. It is used in treatment of patients with hydrocephalus when shunting cerebrospinal fluid (CSF) from ventricles of the brain. The Burr Hole design includes a flat silicone membrane, which provides resistance to CSF flow. The silicone membrane scats on a conical polypropylene base. This base is int4egral to a rigid outlet port. The design allows for accurate and precise regulation of CSF flow due to its structural integrity. The flat silicone membrane also prevents retrograde flow of CSF. The Burr Hole valve is available in two sizes designed to fit a 12mm or 16mm formal burr Both sizes are available in three (3) pressure/Now characteristics ranges: low, hole. medium, and high.

The provided text describes a 510(k) summary for the Integra NeuroSciences Burr Hole Valve and Shunt System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study. Therefore, much of the requested information regarding study design, sample sizes, ground truth establishment, expert qualifications, and comparative effectiveness studies is not applicable or available in this document.

Here's an analysis based on the provided text, addressing the points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" for the device's performance in the context of clinical efficacy or diagnostic accuracy. Instead, it details that the device was tested for various physical and functional properties. The "reported device performance" are the results of these tests, which were deemed satisfactory by the manufacturer and accepted by the FDA for substantial equivalence.

Explanation: For a 510(k) submission concerning a device like a shunt system, the "acceptance criteria" are implied by the performance characteristics of predicate devices and consensus standards for medical devices. The manufacturer's goal is to demonstrate that their new device performs at least as well as and is as safe and effective as the predicate device. The text states "The Burr Hole Valve and Shunts have been tested for pressure/flow, leakage, catheter elongation and bending, markings visual inspection, pull testing and radiopacity," and concludes that the modified device is "substantially equivalent" and "do not raise new issues of safety and effectiveness." This implicitly means the results of these tests met the necessary standards for safety and function.

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

The document does not provide details about the sample size for the test set or the data provenance (country of origin, retrospective/prospective) for the physical and functional tests described. The tests mentioned (pressure/flow, leakage, etc.) are bench-top or mechanical tests, not clinical studies involving patients or human expert analysis of data.

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

Not applicable. The "test set" in this context refers to the manufactured devices undergoing engineering and functional verification, not clinical data requiring expert interpretation.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical data or imaging that required expert adjudication. The tests were objective measurements of physical properties.

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 device is a hydrocephalus shunt system, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study or AI component is mentioned.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the physical and functional tests was based on engineering specifications and established performance standards for hydrocephalus shunt systems. For example, a leakage test would have a "ground truth" of "no leakage" or "leakage within acceptable predefined limits."

8. The Sample Size for the Training Set

Not applicable. There is no AI or machine learning component mentioned that would require a training set.

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

Not applicable. As there is no training set for an algorithm, there is no corresponding ground truth establishment method for it.

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The Integra NeuroSciences Contour-Flex Valve and Shunt System is used in treatment of patients with hydrocephalus. It is a component of a system designed to shunt cerebrospinal fluid from the ventricles of the brain to an appropriate drainage site such as the atrium of the heart or to the peritoneal cavity.

The Integra NeuroSciences Contour-Flex™ Valve is a multi-function membrane valve with occluders and integral connectors. It is used in treatment of patients with hydrocephalus when shunting cerebrospinal fluid (CSF) from ventricles of the bram. It incorporates a central reservoir for pumping and injection, proximal and distal occluders, and a fully flexible profile. The Contour-Flex Valve design includes a flat siliconc membrane, which provides resistance to CSF flow. The flat silicone membrane seats on a conical polypropylene base. This base is integral to a rigid outlet port. The design allows for accurate and precise regulation of CSF flow due to its structural integrity. The flat silicone membrane also prevents retrograde flow of CSF. The Contour-Flex valve is available in two s izes: R egular a nd S mall. B oth s izes a re a vailable in 3 pressure/flow c haracteristics ranges: low, medium, and high

This document (K033698) describes a 510(k) premarket notification for the Contour-Flex™ Valve and Shunt System, a medical device used in the treatment of hydrocephalus. The focus of this submission is on demonstrating substantial equivalence to a previously cleared device, rather than a clinical study evaluating novel performance against specific acceptance criteria in a clinical setting.

Therefore, many of the requested elements for a study that proves the device meets acceptance criteria are not directly applicable or available in this document. The "study" described here is primarily a series of engineering and performance tests to ensure the modified device functions similarly to its predicate.

Here's the information extracted from the provided text, addressing the points where possible:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified in the provided text. The document refers to "systems" and individual "components" being tested but does not give specific numbers for how many units were subjected to each test.
• Data Provenance: The tests are described as engineering/performance tests conducted on the device itself.
  • Country of Origin: Integra NeuroSciences Implants SA is located in Sophia Antipolis Cedex, France. It's highly probable the testing was conducted at their facilities or by contracted labs, likely in Europe.
  • Retrospective or Prospective: These are prospective tests performed on the manufactured device components to verify design specifications.

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

• Not Applicable. For these engineering performance tests, "ground truth" is established by adherence to predefined engineering specifications and validated test methods, not by expert clinical review of test results in the same way it would be for a diagnostic AI device.

4. Adjudication Method for the Test Set

• Not Applicable. Adjudication methods like 2+1 or 3+1 typically apply to clinical studies where multiple human readers assess cases and a consensus is needed for ground truth. For these performance tests, the outcome is typically pass/fail based on objective measurements against criteria.

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

• No. This document describes a 510(k) submission for a physical medical device (hydrocephalus shunt system), not a diagnostic AI algorithm. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance was not conducted or reported here.

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

• No. This is not an AI algorithm.

7. The Type of Ground Truth Used

• Engineering Specifications and Performance Standards: The "ground truth" for these tests is the pre-defined engineering specification or performance standard (e.g., a specific pressure/flow rate, acceptable leakage level, visual appearance criteria) that the device must meet.

8. The Sample Size for the Training Set

• Not Applicable. This is not an AI algorithm, so there is no "training set."

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

• Not Applicable. There is no training set for an AI algorithm. The design and performance specifications would have been established through engineering design processes, previous device iterations (like the predicate device), industry standards, and regulatory requirements.

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The External Drainage Sets are intended for cerebrospinal fluid (CSF) drainage, sampling and collection.

The External Drainage Set is designed for cerebrospinal fluid (CSF) drainage, sampling and collection. The system connects to a ventricular or lumbar catheter via a Luer connection to a patient line.

The graduated cylinder of the External Drainage Set is attached to an IV pole and may be moved up and down to change positioning of the graduated cylinder by using the Velcro straps. CSF can be collected and measured in the graduated cylinder and subsequently emptied to the drainage bag by opening the stopcock placed in-line between the graduated cylinder and the drainage bag.

A hydrophobic vent filter is included in the graduated cylinder cap of the External Drainage Set. This vent filter allows air to enter the graduated cylinder to facilitate drainage from the graduated cylinder to the drainage bag while protecting the system from contamination.

The provided text describes a 510(k) summary for an "External Drainage Set" and its substantial equivalence to a previously cleared device. It does not contain information about acceptance criteria, detailed device performance studies, sample sizes, expert involvement, or any of the other specific study design elements typically associated with demonstrating performance for a medical device that might use AI or require extensive clinical validation.

Here's why and what information can be extracted:

• 510(k) summaries primarily focus on demonstrating substantial equivalence to a predicate device. This means showing that the new device is as safe and effective as a legally marketed device and doesn't raise new questions of safety or effectiveness. They are not typically elaborate clinical study reports.
• The device in question ("External Drainage Set") appears to be a physical medical instrument for CSF drainage. The context does not suggest it uses AI or complex algorithms.

Given this, I can only fill in the table and address certain prompts based on what is available in the provided document. Many fields will be marked as "Not Applicable/Not Provided" because the document does not contain that type of information.

Acceptance Criteria and Device Performance

• Bonded components must have adequate tensile strength.
• Must withstand pressure and prevent leakage.
• Must effectively drain CSF.
• Must maintain package integrity.
• Needleless sampling sites must reduce needlestick injuries and exposure to infected fluids (in compliance with Needlestick Safety and Prevention Act).
• Must not raise new issues of safety. | - The External Drainage Set is provided sterile.
• The External Drainage Set has been tested for tensile strength of bonded components.
• The External Drainage Set has been tested for pressure and leakage.
• The External Drainage Set has been tested for drainage.
• The External Drainage Set has been tested for package integrity.
• The needleless sampling sites were designed to reduce needlestick injuries and subsequent exposure to infected fluids in compliance with the Needlestick Safety and Prevention Act, H.R.5178.
• "The modifications do not affect... do not raise new issues of safety and effectiveness." (Implies meeting safety criteria by virtue of equivalence to predicate) |
  | Effectiveness (Intended Use) | - Must be able to perform cerebrospinal fluid (CSF) drainage.
• Must be able to perform CSF sampling.
• Must be able to perform CSF collection.
• Must be substantially equivalent in function and intended use to the predicate device (K910853).
• Must not raise new issues of effectiveness. | - "The External Drainage Set is designed for cerebrospinal fluid (CSF) drainage, sampling and collection."
• "CSF can be collected and measured in the graduated cylinder..."
• "A hydrophobic vent filter... allows air to enter the graduated cylinder to facilitate drainage..."
• "The External Drainage Set is substantially equivalent in function and intended use to the Unmodified External Drainage Set which has been cleared to market under Premarket Notification 510(k) K910853."
• "The modifications do not affect the intended use, the fundamental scientific technology of the device, and do not raise new issues of safety and effectiveness." (Implies meeting effectiveness criteria by virtue of equivalence to predicate) |
  | Material/Design Specifications | - Connects to ventricular or lumbar catheter via Luer connection.
• Graduated cylinder attached to IV pole, movable with Velcro straps.
• Stopcock between graduated cylinder and drainage bag.
• Hydrophobic vent filter in graduated cylinder cap. | - "The system connects to a ventricular or lumbar catheter via a Luer connection to a patient line."
• "The graduated cylinder of the External Drainage Set is attached to an IV pole and may be moved up and down to change positioning of the graduated cylinder by using the Velcro straps."
• "CSF can be collected and measured in the graduated cylinder and subsequently emptied to the drainage bag by opening the stopcock placed in-line between the graduated cylinder and the drainage bag."
• "A hydrophobic vent filter is included in the graduated cylinder cap..." |

Study Information

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

   • Sample Size: Not Applicable/Not Provided. The document mentions tests for tensile strength, pressure and leakage, drainage, and package integrity, but does not specify the sample sizes for these engineering or bench tests. It does not describe a clinical test set.
   • Data Provenance: Not Applicable/Not Provided. The tests described appear to be bench tests rather than clinical data from specific countries or populations. The manufacturer is based in France with an authorized agent in the US.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not Applicable/Not Provided. The document describes engineering/performance tests, not a study requiring expert-established ground truth from, for example, image interpretation or clinical diagnosis.

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

   • Not Applicable/Not Provided. This is not a study design involving adjudication.

4. 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:

   • No. A MRMC comparative effectiveness study was not performed. This device is a physical drainage set and does not involve human readers or AI.

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

   • No. A standalone algorithm performance study was not performed. This device does not incorporate an algorithm or AI.

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

   • The "ground truth" for the tests mentioned (tensile strength, pressure, leakage, drainage, package integrity) would be based on engineering specifications and established test methods for material and device performance, rather than clinical consensus or outcomes data. For needle-stick prevention, the "ground truth" would be compliance with the specified Act.

7. The sample size for the training set:

   • Not Applicable/Not Provided. This device does not involve a "training set" in the context of machine learning.

8. How the ground truth for the training set was established:

   • Not Applicable/Not Provided. This device does not involve a training set.

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