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The Cleveland Multiport Ventricular Catheter Set is indicated for gaining access to the ventricles of the brain for the removal of cerebrospinal fluid (CSF) or for injecting Cytarabine.

The Cleveland Multiport Ventricular Catheter contains a main or central lumen for the insertion stylet which is surrounded by four minor lumens (equally spaced) that contain the microcatheters. The catheter includes a ribbed distal tip, a housing for locking the insertion stylet, and proximal male Luer fittings at the end of each micro-catheter. The ribbed distal tip of the main catheter allows the micro-catheters to retract into the main catheter, by stretching the catheter when the insertion stylet is fully inserted and locked. This stretched state allows the catheter tip outside diameter to reduce slightly for atraumatic insertion into the ventricles of the brain. Once the insertion stylet is removed the catheter tip returns to its relaxed state (larger outside diameter) and the micro-catheters deploy. The enlarged tip aids in backflow prevention during injection of fluids. The distal Luer fittings allow for connectivity to a standard syringe or infusion pumps for removal of CSF and/or infusion. The biocompatible metal insertion stylet provides temporary rigidity to the distal portion of the device during catheter insertion and is removed after placement. The Cleveland Multiport Ventricular Catheter has no software, power sources, or radiation emitting components.

The provided text describes a 510(k) premarket notification for a medical device called the "Cleveland Multiport Ventricular Catheter Set." This submission is to demonstrate that the new device is substantially equivalent to legally marketed predicate devices. The document refers to various tests performed to support this claim, but it does not describe an AI/ML powered device, an acceptance criteria table with reported device performance in the context of AI/ML, nor does it include information about sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment for AI/ML models.

The information provided relates to the physical and functional aspects of a traditional medical device (a catheter) and its comparison to existing catheters. Therefore, most of the requested fields are not applicable to the given text.

Here's an attempt to answer the applicable parts of your request based on the provided text, while explicitly stating when information is not available or not applicable:

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

The document lists various performance tests and their results, indicating that the device "passed" and "results demonstrate the Cleveland Multiport Ventricular Catheter is substantially equivalent to the predicate devices." The specific quantitative acceptance criteria are generally implied rather than explicitly stated as numerical thresholds in this summary, but the results confirm compliance.

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The SmartFlow™ Flex Ventricular Catheter is intended for injection of Cytarabine or removal of CSF from the ventricles during intracranial procedures. The device is not intended for implant. This device is intended for "single patient use only."

The Catheter has a stepped distal tip with a 30 cm removable rigid ceramic stylet protecting the fluid lumen while providing rigidity to the distal portion of the device. The stylet is removed after insertion to the desired point. Soft tubing protects the lumen in the center portion and at the distal end where it terminates. The fluid containing central lumen is manufactured from PEEK tubing.

The Catheter will be marketed in the following sizes:
Ventricular Catheter .008 x 7.5mm tip
Ventricular Catheter .008 x 15mm tip
Ventricular Cathcter .021 x 7.5mm tip
Ventricular Catheter .021 x 15mm tip

Each unit will provide for an approximate 23 inch tubing extension.

The provided document is a 510(k) summary for a medical device (MRII MR Compatible Ventricular Catheter) and focuses on demonstrating substantial equivalence to a predicate device, rather than providing a study proving performance against specific acceptance criteria for a new AI/software device.

Therefore, the information required to populate most sections of the table and answer the subsequent questions is not present in the provided text, as this document describes a traditional medical device submission, not an AI/software device.

However, I can extract information related to the device's technical specifications and the Performance Testing – Bench section, which acts as the "study" proving the device meets certain operational criteria.

Here's a breakdown of what can be extracted based on the provided text:

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

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

• Sample Size: Not explicitly stated for each test, but phrases like "All samples" and "All Bone Anchors" suggest that specific, likely small, batches of devices/components were tested. The exact number of units per test is not provided.
• Data Provenance: The studies are described as "Bench testing" performed by "MRII, Inc." This indicates the data is from in-vitro (lab/bench) testing of the physical device, not patient data. No country of origin for data is specified beyond the company's location (Irvine, CA, USA). It's prospective in the sense that the tests were conducted specifically for this submission.

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 a traditional device submission focused on physical and material properties, not an AI/software device requiring expert ground truth for classification or detection tasks. The "ground truth" for these tests is based on objective physical measurements and adherence to engineering specifications.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation or subjective assessments, often for AI performance evaluation. The tests described here are objective bench tests.

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, and no MRMC study was performed.

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. The device's "performance" is its physical function, not an algorithm's output.

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

The "ground truth" for the performance tests is derived from:

• Pre-defined engineering specifications and limits (e.g., specific flow rates, pressure limits, force thresholds).
• Comparative performance against the legally marketed predicate device.
• Objective physical measurements (e.g., fluid volume, pressure, force, visual inspection for damage/leaks).
• Compliance with recognized standards (e.g., ISO 10993 for biocompatibility, ANSI/AAMI/ISO 11137-2 for sterility).

8. The sample size for the training set

Not applicable. This is not an AI/software device and does not involve training data.

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

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

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Codman BACTISEAL™ Barium Striped Catheters are intended for use in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid (CSF) is indicated.

Codman BACTISEAL™ Barium Striped Catheters are manufactured from barium striped silicone which is impregnated with Clindamycin Hydrochloride and Rifampicin. BACTISEAL™ catheters have been shown in laboratory studies to reduce the colonization of gram positive bacteria on the tubing surface.

The provided text describes a 510(k) submission for the Codman BACTISEAL™ Barium Striped Catheters. The substantial equivalence was based on performance and in-vitro testing. It does not contain information about a study that would produce acceptance criteria and device performance in the way described in the prompt (e.g., using a test set, ground truth, expert opinions, or MRMC studies). The provided document is a regulatory submission for substantial equivalence.

Therefore, many of the requested fields cannot be extracted directly from this document.

However, I will extract what is available and indicate when information is not present.

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

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

• Sample size for test set: Not specified.
• Data provenance: Not specified (presumably from laboratory studies, but country and retrospective/prospective status are not mentioned).

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 as this document refers to physical and in-vitro performance testing, not studies requiring expert ground truth in a clinical or diagnostic image analysis context.

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

• Not applicable (see point 3).

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

• No. This type of study (MRMC for AI assistance) was not done, as the device is a physical catheter, not an AI diagnostic tool.

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

• No. This is not an algorithm, but a physical medical device.

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

• For the physical and in-vitro testing, the "ground truth" would be the established performance metrics and specifications for the predicate devices and general standards for medical devices (e.g., material strength, antibacterial efficacy measurements in lab conditions). The document highlights "laboratory studies" for antibacterial properties.

8. The sample size for the training set

• Not applicable, as this is not an AI/machine learning device that requires a training set.

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

• Not applicable (see point 8).

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For injection of material into, or removal of material from, the mendou over I or any intracranial procedures. This device is not intended for implant. This device is ETO sterilized and intended for one time use only.

Bresagen Catheter, Model CS-3000

I'm sorry, but this document does not contain the information requested. The document is a 510(k) clearance letter from the FDA for a medical device (Bresagen Catheter) and does not include details about acceptance criteria, study designs, sample sizes, expert qualifications, or ground truth establishment. It primarily focuses on the regulatory clearance process and the device's intended use.

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The Miethke Shunt System is intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneum.

The ventricular catheter is a part of the Miethke Shunt System. It is used to gain access to the cavities of the brain for removal of excess CSF.

The provided text is a 510(k) Summary of Safety and Effectiveness for the Miethke Shunt System. It describes the device, its intended use, and claims substantial equivalence to previously cleared devices. However, the document explicitly states, "No performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices. The new Miethke Shunt System conforms to applicable ASTM and ISO standards."

This crucial statement indicates that

1. No specific acceptance criteria based on performance metrics (e.g., sensitivity, specificity, accuracy) were required or defined for this device in the context of this 510(k) submission. The regulatory pathway here is substantial equivalence, meaning the device is compared to existing legally marketed devices, not assessed against novel performance benchmarks derived from clinical studies.
2. No study proving the device meets performance-based acceptance criteria is presented. The "performance data" section only mentions conformity to ASTM and ISO standards, which are related to manufacturing, materials, and mechanical aspects, not clinical efficacy or diagnostic accuracy.

Therefore, many of the requested items cannot be answered from the provided text because they pertain to a type of performance study (e.g., comparative effectiveness, standalone algorithm performance, clinical validation with ground truth) that was not conducted or required for this 510(k) clearance based on substantial equivalence.

Here's an attempt to fill in as much as possible based on the given information, with explanations for what cannot be answered:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Not applicable / Not provided. No specific test set for evaluating device performance against clinical outcomes or diagnostic accuracy was used or reported in this 510(k) summary. The clearance was based on substantial equivalence to existing devices and conformity to design/manufacturing standards.

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

• Not applicable / Not provided. No test set requiring ground truth establishment by experts was part of this submission for performance evaluation.

4. Adjudication method for the test set

• Not applicable / Not provided. No test set requiring adjudication was part of this submission. The regulatory pathway focused on technical and design equivalence.

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 cerebrospinal fluid shunt system, not an AI-assisted diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human performance with and without AI assistance is irrelevant and was not 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 (shunt system), not an algorithm or AI system. Therefore, standalone algorithm performance is irrelevant and was not assessed.

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

• Not applicable. No clinical ground truth was established for a performance study in this 510(k) submission. The basis for clearance was a comparison of device characteristics and intended use to predicate devices, and conformity to relevant engineering standards.

8. The sample size for the training set

• Not applicable / Not provided. There is no mention of a training set as this is not an AI/ML device.

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

• Not applicable / Not provided. Not relevant for this type of device.

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The use of the ACT II MP Monitoring System by a qualified neurosurgeon is indicated when direct measurement of intracranial pressure in patients is required and when the patient may require CSF drainage in the course of their care or when data from a second parameter may be deemed useful in optimum patient management.

The ICP monitor uses a bolt anchored in the skull. The bolt holds an air-column catheter with a flaccid bladder on the distal end. The proximal end of the catheter is attached to a pressure transducer placed in the distal end of a standard cable. The cable can be attached directly to any patient monitor. The ICP monitoring technology is based on Boyle's law. The bladder volume changes to accommodate PTV =P2V2 The pressure in the bladder, catheter and transducer thereby mirrors that of ICP. The air required to activate the bladder is introduced into the bladder when a piston on the proximal end of the catheter is joined to a cylinder on the transducer housing. The bladder air is replaced once per shift by removing and replacing the transducer housing on the piston.

A probe guide is incorporated into the cap placed on the bolt at the factory and into the cap that accompanies the drainage catheter. The guides direct the path of a probe inserted through the cap/bolt. The guide tube does not enter the brain but stops just above the drill hole. Both caps provide a compression fitting that secures and seals the probe to the cap.

The catheter is a single lumen catheter. A preloaded stylet is used for catheter insertion and placement. A luer connector is provided to connect the catheter to a standard CSF collection system.

The bolt provides an access port through which a ventricular catheter can be introduced if drainage is needed. Should drainage of CSF be indicated, the top cap of the bolt is removed and the ACT II Ventricular Catheter is inserted into a ventricle. Once the catheter is in place, a preinstalled elastomeric sleeve and compression cap are moved down the catheter to the bolt. The cap compresses the sleeve against the bolt and catheter anchors the catheter in place.

Here's a breakdown of the acceptance criteria and study information for the ACT II MP ICP Monitoring System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text does not specify a sample size for a test set or the data provenance (e.g., country of origin, retrospective/prospective) for a clinical study related to this specific modification (the MP version).

The text mentions:

• "Animal test data of the subject device vs. a ventricular catheter shows the device faithfully follows the ventricular pressure and waveform and that the bolt is securely anchored in the skull." This implies animal testing was conducted.
• "Laboratory testing has shown that the ACT II MP ICP Monitoring System... are safe in the following areas: Mechanical integrity; Biocompatibility." This refers to laboratory tests, not human clinical trials.

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

This information is not provided in the document. The study described is primarily animal and laboratory testing, not a human clinical trial where expert-established ground truth would be relevant in the same way (e.g., for diagnostic accuracy).

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of the described animal and laboratory testing, an adjudication method like 2+1 or 3+1 (typically used in human reader studies for diagnostic accuracy) would not be applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A multi-reader multi-case (MRMC) comparative effectiveness study was not mentioned or described in the provided text. The device is a medical monitoring system, not an AI diagnostic tool primarily aimed at improving human reader performance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This is not applicable as the device described is a physical intracranial pressure monitoring system and associated components, not a software algorithm.

7. Type of Ground Truth Used

Based on the text, the ground truth for the performance evaluation comes from:

• Physiological measurements in animal models (e.g., actual ventricular pressure and waveform).
• Laboratory test results (e.g., mechanical integrity tests, biocompatibility tests against ISO standards).
• Consensus standards (AAMI performance standards for accuracy).

8. Sample Size for the Training Set

This is not applicable. The device is a physical medical device, not an AI/ML algorithm that requires a training set.

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

This is not applicable for the same reason as above (not an AI/ML algorithm).

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For the Aspiration or Irrigation of fluids during Intracranial procedures. This device is not intended for implant

Aspiration/Irrigation Catheter

The provided document is a 510(k) clearance letter from the FDA for an "Aspiration/Irrigation Catheter." This type of document does not contain details about acceptance criteria or a study proving the device meets them.

The 510(k) process is primarily a premarket notification demonstrating that a device is "substantially equivalent" to a legally marketed predicate device. It typically relies on comparisons to existing devices and performance data that may or may not include rigorous clinical studies with specific acceptance criteria as you've described.

Therefore, I cannot provide the requested information based on the given text. The document refers to the device being substantially equivalent to prior predicate devices, which means its safety and effectiveness are deemed similar to those already on the market. It doesn't detail performance metrics or studies in the way you've outlined.

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The Innervision Ventricular Catheter with BioGlide is designed to be used with the Neuropen endoscope or other compatible Medtronic PS Medical endoscope when the physician desires direct vision from the tip of a ventricular catheter during its placement. Direct vision facilitates placement of the catheter tip at a specific intraventricular location. The catheter is designed to be used as the proximal component of a CSF-Flow Control Shunt for use in shunting cerebrospinal fluid from the ventricles of the brain into the right atrium of the heart or to the peritoneal cavity.

The Medtronic PS Medical Innervision Ventricular Catheter with BioGlide is manufactured of translucent silicone elastomer w/barium impregnated stripe. The catheter incorporates a BioGlide surface modification on the interior and exterior of the catheter. The catheter incorporates a slit tip.

This document is a 510(k) summary for the Medtronic PS Medical Innervision Ventricular Catheter with BioGlide. It is a premarket notification for a medical device seeking clearance from the U.S. Food and Drug Administration (FDA) based on substantial equivalence to predicate devices. As such, it does not describe a clinical study in the way a traditional clinical effectiveness study would for a novel device or drug.

Therefore, many of the typical acceptance criteria and study details (like sample size for test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance with metrics like AUC or sensitivity/specificity, and training set details) are not applicable in this context.

Here's a breakdown of the available information in relation to your request:

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

The document describes the device's characteristics and compares them to predicate devices to establish "substantial equivalence." The "acceptance criteria" for a 510(k) submission are primarily about demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is achieved through a comparison of:

2. Sample size used for the test set and the data provenance:

• Not Applicable. This is a 510(k) submission based on substantial equivalence to existing predicate devices, not a clinical trial with a "test set" of patients in the traditional sense. The "test" here is the comparison of the device's characteristics to those of already approved devices.

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

• Not Applicable. "Ground truth" in this context is the safety and effectiveness of the predicate devices, which have already been established by the FDA. The submission relies on the existing regulatory clearance of those devices.

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

• Not Applicable. There is no "test set" requiring adjudication in a clinical trial sense. The FDA's review process involves evaluation by regulatory experts.

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 physical catheter, not an AI or imaging diagnostic tool. Therefore, MRMC studies or AI assistance are irrelevant.

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

• Not Applicable. As above, this is a physical medical device, not an algorithm.

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

• The "ground truth" for this type of submission is the established safety and efficacy profiles of the predicate devices as previously determined by the FDA. The new device is asserted to be "substantially equivalent" to these already cleared devices, meaning it does not raise new questions of safety and effectiveness.

8. The sample size for the training set:

• Not Applicable. There is no "training set" for a device like this in the context of a 510(k). The device's design and materials are based on established engineering principles and prior device experience, not machine learning training data.

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

• Not Applicable. See point 8.

In summary:

This document is a regulatory submission for device clearance, not a report of a clinical efficacy study. The "study" proving the device met acceptance criteria is the comparison presented in the document itself, demonstrating that the Innervision Ventricular Catheter with BioGlide shares the same technological characteristics, intended use, and therefore the same safety and effectiveness as its predicate devices, which were already cleared by the FDA.

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