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The Bone Anchor is intended to be used with commercially available stereotactic systems for intracranial and neurosurgical procedures which require accurate positioning of compatible small surgical instruments or accessories in the cranium, brain, or nervous systems. It is designed to provide short-term fixation and positioning of compatible neurosurgical instruments or accessories under image-guidance.

The Bone Anchor is a single-use device for temporary short-term fixation of surgical tools or accessories during a single surgical procedure. The Bone Anchor may be used during image-guided or MR interventional procedures. This device is not intended to create a seal or barrier from potential infection and has not been tested for long-term (>24 hours) use. The Bone Anchor components are listed below along with their function:

• Bone Anchor (Skull Device) A device that is inserted into the Skull that is used . to hold an instrument or accessory in place after is it inserted to the desired position. Part of the Skull Fixation Device protrudes from the Skull.
• Bone Anchor Driver (Driver) An optional device used to position the Skull . Fixation Device into the skull.
• Bone Anchor Silicone Seal A device within the Bone Anchor which is . compressed against the inserted instrument or accessory when the Cap is tightened, thereby holding the instrument or accessory in place.
• Bone Anchor Cap A device which connects to the Bone Anchor and, when . tightened, compresses the Silicone Seal against the inserted instrument or accessory.
• . Bone Anchor Cover - An optional device which is placed over the Cap when inserting a flexible instrument or other accessory and can be locked into place on the Cap to secure the accessory.

The provided text is a 510(k) summary for the ClearPoint Neuro Bone Anchor, which focuses on demonstrating substantial equivalence to predicate devices rather than presenting a standalone study with specific acceptance criteria and detailed performance metrics. Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC study, ground truth for training set) are not available in this document.

However, based on the information provided, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes performance testing for the Bone Anchor and mentions testing for the predicate and reference devices. However, it does not explicitly
state specific acceptance criteria or provide quantitative performance results (e.g., exact load values, push force values, or targeting error measurements) for the Bone Anchor, only noting that "meets all test specifications" for demonstrating substantial equivalence.

Note: The document states that the subject device "meets all test specifications" and performs "as well as the predicate device" but does not provide the numerical values for these specifications or the device's performance against them. Similarly, for the predicate Microtable, it lists "Dimensional Stability" and "Load Testing" but no specifics. For the reference device, it lists the same tests as the subject device.

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

The document does not specify the sample size used for the described performance testing. The provenance of the data (e.g., country of origin, retrospective or prospective) is also not mentioned.

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

Not applicable. The document describes engineering and mechanical performance testing, not a study involving human experts establishing ground truth for clinical data.

4. Adjudication Method for the Test Set

Not applicable. This is not a clinical study involving human assessment of data.

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

No, an MRMC comparative effectiveness study was not done. The document focuses on bench testing and comparison to predicate devices, not on human reader performance with or without AI assistance.

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

Not applicable. This device is a mechanical medical instrument, not an AI algorithm.

7. The Type of Ground Truth Used

For the performance testing mentioned (Load, Push Force, Insertion Force, Retention Force, Removal Force, Driver Pull Force Testing), the "ground truth" would be established by the engineering and mechanical testing standards and methodologies used to evaluate the device's physical properties and functionality. It is not based on expert consensus, pathology, or outcomes data in a clinical sense.

8. The Sample Size for the Training Set

Not applicable. This device is a mechanical instrument and does not involve AI/ML requiring a training set.

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

Not applicable. As noted above, there is no training set for this type of device.

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The Bactiseal Catheters are indicated for use in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid (CSF) is indicated.

The Bactiseal Barium Striped Catheters are indicated for use in the treatment of hydrocephalus as a component of a shunt system when draining of cerebrospinal fluid (CSF) is indicated.

The Bactiseal Endoscopic Ventricular Catheter is designed for use in the treatment of hydrocephalus when shunting cerebrospinal fluid (CSF) from the ventricles of the brain.

The Bactiseal Catheters, Bactiseal Barium Striped Catheters and Bactiseal Endoscopic Ventricular Catheter include a ventricular and/or distal (peritoneal) drainage catheter that are used as part of a CSF shunting system to treat hydrocephalus. Both catheters are attached to the valve portion of a shunting system, which is then implanted in the patient's brain. The ventricular catheter diverts the excessive CSF from the ventricles of the brain through the valve. After passing through the valve, the excessive CSF is drained through the distal (peritoneal) drainage catheter into another part of the body, such as the peritoneal cavity, where it is reabsorbed into the bloodstream. The catheters are subjected to a treatment process by which the silicone is impregnated with two antimicrobials, rifampicin and clindamycin hydrochloride. Bactiseal silicone catheters have been shown in laboratory studies to reduce the colonization of gram-positive bacteria on the tubing surface. The catheters contain barium sulfate for radiopacity and have tantalum "dots" incorporated onto the silicone tubing to aid in positioning of the catheter. The Bactiseal Catheters and Bactiseal Endoscopic Ventricular Catheter are made of radiopaque silicone tubing, and the Bactiseal Barium Striped Catheters are made of clear silicone tubing with radiopaque striping. The Bactiseal Endoscopic Ventricular Catheter has a slit in the tip of the ventricular catheter in order for the catheter to be placed with the use of an endoscope.

This document is a 510(k) summary for modifications made to existing Bactiseal Catheters, Bactiseal Barium Striped Catheters, and Bactiseal Endoscopic Ventricular Catheters. The modifications primarily involve updates to MRI labeling and a change in the supplier of clindamycin hydrochloride.

Therefore, the submission focuses on demonstrating that these modifications do not introduce new questions of safety or effectiveness, rather than proving the initial efficacy of an entirely new device. This means that a conventional study with specific acceptance criteria, test sets, expert adjudication, and detailed ground truth establishment as typically seen for entirely new AI/CADe devices, is not applicable in this context. The document relies on bench testing and an equivalency assessment to the predicate devices.

Here's a breakdown of the requested information based on the provided text, with significant portions noted as "Not applicable" due to the nature of this 510(k) submission:

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

Explanation of Implied Acceptance Criteria: The document states that the testing "utilized well-established methods, including those from FDA consensus standards." For a "Pass" result in such tests, the device must meet the specific criteria outlined in those standards. For drug equivalency and effectiveness, the stated goal is to confirm the new supplier's clindamycin hydrochloride is "equivalent" and "continues to meet the same drug specifications" and efficacy. The biocompatibility assessment "determined that the introduction of the new supplier for clindamycin hydrochloride does not introduce any new issues."

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 for Test Set: Not specified. The document indicates "All testing was performed on production equivalent devices," but the number of devices or units tested for each benchmark is not provided.
• Data Provenance: Not applicable in the context of clinical data. The tests are benchtop performance tests. The specific labs or countries where these bench tests were conducted 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. This submission concerns bench testing and equivalency assessment of device modifications, not clinical performance requiring expert-established ground truth.

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

• Not applicable. This submission concerns bench testing and equivalency assessment of device modifications, not clinical performance requiring adjudication.

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/CADe device.

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

• Not applicable. This is not an AI/CADe device.

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

• Not applicable in the conventional sense. The "ground truth" for the bench tests would be the established scientific and engineering principles, and the specifications of the predicate device/original drug, against which the modified device's performance is compared. For example, the ground truth for MRI safety is defined by the ASTM standards.

8. The sample size for the training set

• Not applicable. This is not an AI/CADe device, and no training set is mentioned or implied for its development or evaluation.

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

• Not applicable. As there is no training set, there is no ground truth to establish for it.

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Draining and monitoring of CSF flow from the lateral ventricles or lumbar subarachnoid space is indicated in selected patients to:

1. Reduce ICP, e.g., pre-, intra- or postoperative.
2. Monitor CSF chemistry, cytology, and physiology.
3. Provide temporary CSF drainage in patients with infected cerebrospinal fluid shunts.
   Monitoring of ICP is indicated in selected patients with:
4. Severe head injury.
5. Subarachnoid hemorrhage graded III, IV or V preoperatively.
6. Reyes syndrome or similar encephalopathies.
7. Hydrocephalus.
8. Intracranial hemorrhage.
9. Miscellaneous problems when drainage is to be used as a therapeutic maneuver.
   Monitoring can also be used to evaluate the status pre- and postoperatively for space-occupying lesions.

The Exacta External Drainage and Monitoring System (EDMS) is provided as a complete closed system for the drainage and monitoring of cerebrospinal fluid (CSF) flow from the lateral ventricles or the lumbar subarachnoid space. The system is offered in various kit configurations for various clinical applications.
The Exacta EDMS product family is comprised of a single use drainage system, a reusable blue pole clamp and a laser level accessory. The single use drainage assembly is comprised of a patient line, main system stopcock, graduated cylinder and drainage bag. The single use drainage assembly is mounted on the reusable blue pole clamp. The reusable blue pole clamp secures the system to an I.V. pole and includes the system pressure scale and holds an optional laser level accessory. The optional laser level accessory assists the user in leveling the single use drainage system to the patient's Foramen of Monro or lumbar catheter exit site.

This document is a 510(k) summary for the Medtronic Exacta External Drainage and Monitoring System (EDMS). The submission focuses on changes to a laser level accessory and does not involve AI. Therefore, several requested sections, especially those related to AI model evaluation, are not applicable.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria provided are qualitative (e.g., "met the acceptance criteria") rather than quantitative thresholds.

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

The document does not specify the sample size for the test set used in the bench testing. It only states that the testing was performed, but not how many units were tested.

• Data Provenance: The tests were "design verification bench testing," implying they were conducted in a lab setting by the manufacturer, Medtronic, Inc., located in Irvine, California, USA. The data is retrospective in the sense that it was collected as part of the device development and submission process.

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

Not applicable. The testing described is bench testing of physical device characteristics (mechanical, laser performance, electrical safety) against established engineering and safety standards, not against clinical ground truth requiring expert consensus.

4. Adjudication Method for the Test Set

Not applicable. This was bench testing against engineering specifications, not a clinical study requiring expert adjudication of results.

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 submission is for an External Drainage and Monitoring System and its laser level accessory. It is a physical medical device, not an AI-powered 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. This device is not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the bench testing was defined by engineering specifications and international standards for mechanical strength, beam uniformity, laser accuracy, laser safety (IEC/EN 60825-1:2014), electrical safety (IEC 60601-1:2005 + AMD1:2012), and EMC (IEC 60601-1-2:2014 / EN 60601-1-2:2015).

8. The Sample Size for the Training Set

Not applicable. This device does not use a training set as it is not an AI/machine learning product.

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

Not applicable.

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The catheter is used for cerebrospinal fluid (CSF) shunting.

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

The ventricular catheter will be offered in lengths of 18 cm or 25 cm with an inner diameter of 1.2 mm and an outer diameter of 2.5 mm. The ventricular catheter contains five stripe depth markers at 3, 5, 7, 10 and 13 cm from the catheter tip. The ventricular catheter is manufactured using barium sulfate filled silicone elastomer.

The purpose of this submission is to seek clearance for modifications to the ventricular catheter which is part of the Miethke Shunt System (K020728). This submission proposes the following modification:

• adding stripe depth markers at 4, 6, 8, 9, 11 and 12 cm and point markers at 1 cm intervals on both sides of the tubing starting at 3.5 cm to 12.5 cm from the catheter tip.

The ventricular catheter is designed to articulate with existing Miethke Shunt Systems, such as the M.blue Adjustable Shunt System, Miethke Shunt System GAV 2.0 and SA 2.0 Valves, proGAV 2.0 Adjustable Shunt System, proSA Progammable Shunt System, Miethke Shunt System miniNAV valve, Miethke Shunt System Gravity Assisted Valve (GAV), and the Miethke Shunt System (DSV, ShuntAssistant, paedi-GAV, connectors, and reservoirs) cleared by FDA (K192266/K190174/K161853/K141687/K120559/K110206/K103003/K062009/K031303/ K030698/K011030).

The provided text is a 510(k) summary for the Miethke Ventricular Catheter, which addresses a modification to an existing device rather than a new AI-powered diagnostic tool. Therefore, much of the requested information regarding AI study design, such as MRMC comparative effectiveness, standalone performance, training set details, and expert ground truth establishment, is not applicable to this document.

However, I can extract information related to the acceptance criteria and the study performed for this specific device, as it pertains to the physical catheter modification.

Here's the relevant information:

1. Table of acceptance criteria and the reported device performance:

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

• Sample Size: Not explicitly stated. The document mentions "All samples" in relation to meeting acceptance criteria, implying a test set was used, but the exact number is not provided.
• Data Provenance: Not explicitly stated, but it is implied to be from non-clinical laboratory performance testing.

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

• Not Applicable. This device is a physical medical device (catheter) and the testing performed relates to its physical properties (radiopacity) rather than diagnostic accuracy requiring expert interpretation for ground truth.

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

• Not Applicable. As mentioned above, this testing does not involve human interpretation or adjudication in the context of diagnostic accuracy.

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 physical medical device, not an AI-powered diagnostic tool.

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 AI-powered diagnostic tool.

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

• For the radiopacity testing, the "ground truth" would be established by the physical measurements and standards defined in the ASTM F 640-12 standard test methods. This is an objective measurement rather than a subjective interpretation requiring expert consensus or pathology.

8. The sample size for the training set:

• Not Applicable. This is a physical medical device; there is no "training set" in the context of an AI algorithm.

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

• Not Applicable. There is no training set for this type of device.

Study Details:

• Study performed: Non-clinical laboratory performance testing.
• Standard used: ASTM F 640-12 standard test methods for determining radiopacity for Medical Use.
• Purpose: To demonstrate that the modification (additional depth markers) to the ventricular catheter maintains its intended performance, particularly regarding radiopacity, and is substantially equivalent to the predicate device.

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Draining CSF and monitoring CSF flow from the lateral ventricles or lumbar subarachnoid space is indicated in selected patients to:

• 1. Reduce intracranial pressure (ICP), e.g. pre-, intra- or postoperative.
• 2. Monitor CSF chemistry, cytology and physiology.
• 3. Provide temporary CSF drainage in patients with infected cerebrospinal fluid shunts.

The monitoring of the intracranial pressure (ICP) is indicated in selected patients with:

• 1. Severe head injury
• 2. Subarachnoid hemorrhage graded III, IV or V preoperatively
• 3. Reye's syndrome or similar encephalopathies
• 4. Hydrocephalus
• 5. Intracranial hemorrhage
• 6. Miscellaneous problems when drainage is to be used as a therapeutic maneuver.

Monitoring can also be used to evaluate the status pre- and postoperative for space-occupying lesions.

The Medtronic External Drainage and Monitoring System EDMS is provided as a complete closed system for the drainage and monitoring of cerebrospinal fluid (CSF) flow from the lateral ventricles or the lumbar subarachnoid space. The system is offered in various kit configurations for various clinical applications. The EDMS Drainage Assembly is supplied pre-assembled, sterile and non-pyrogenic in a double wrap package system. A drainage bag with braided cord is also included with each EDMS kit.
The EDMS and components are intended for single (one time) use only and is not designed or intended to be re-used, re-processed, or re-sterilized. Some of the basic features include the following:

• . a patient line stopcock with latex-free injection site and non-distensible patient connection line:
• a graduated chamber and hanging bracket for I.V. pole suspension; ●
• a drainage bag connection line with two slide clamps and latex-free injection site;
• a removable vented drainage bag with approximate volumetric graduations and drainage port; ●
• pressure scale tape.

The provided text does not describe an AI medical device. It pertains to the Medtronic External Drainage and Monitoring System (EDMS), which is a physical device for draining and monitoring cerebrospinal fluid. Therefore, the questions related to AI device performance metrics, such as ground truth establishment with experts, MRMC studies, or standalone algorithm performance, are not applicable.

However, I can extract information related to the acceptance criteria and the study that proves the device meets those criteria for the Medtronic EDMS.

Acceptance Criteria and Performance for Medtronic External Drainage and Monitoring System (EDMS)

The Medtronic EDMS underwent bench testing to demonstrate its safety and effectiveness, particularly addressing changes made to the disposable drainage bag.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• The text does not specify the exact sample size for each bench test conducted.
• The tests were bench tests (laboratory-based testing of the physical device or its components). Data provenance is internal to the manufacturer's testing facility.

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

• This question is not applicable as the study involved bench testing of a physical medical device, not an AI algorithm requiring expert ground truth for image or data interpretation.

4. Adjudication method for the test set:

• This question is not applicable as there was no expert review or adjudication process for bench testing a physical device.

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:

• This question is not applicable as the device is not an AI-assisted diagnostic or interpretive tool.

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

• This question is not applicable as the device is not a standalone algorithm.

7. The type of ground truth used:

• The ground truth for the bench tests was based on engineering specifications and established test methods designed to verify the physical properties and functionality of the device components (e.g., verifying volumetric graduations, absence of leaks, strength of seals).

8. The sample size for the training set:

• This question is not applicable as this is not an AI device that requires a training set.

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

• This question is not applicable as this is not an AI device that requires a training set.

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Draining and monitoring of CSF flow from the lateral ventricles or lumbar subarachnoid space is indicated in selected patients to:

1. Reduce intracranial pressure (ICP), e.g., pre-, intra- or postoperative;
2. Monitor CSF chemistry, cytology, and physiology;
3. Provide temporary CSF drainage in patients with infected cerebrospinal fluid shunts.
   Monitoring of intracranial pressure (ICP) is indicated in selected patients with:
4. Severe head injury
5. Subarachnoid hemorrhage graded III, IV. or V preoperatively
6. Reyes syndrome or similar encephalopathies
7. Hydrocephalus
8. Intracranial hemorrhage
9. Miscellaneous problems when drainage is to be used as a therapeutic maneuver.
   Monitoring can also be used to evaluate the status pre- and postoperatively for space-occupying lesions.

The Becker External Drainage and Monitoring System (Becker EDMS) provides the physician with a complete closed system for:

1. Draining cerebrospinal fluid (CSF) from the lateral ventricles of the brain or the lumbar subarachnoid space.
2. Monitoring CSF pressure and flow rate from the lateral ventricles of the brain and the lumbar subarachnoid space.
   The Becker EDMS consists of a nondistensible blue or green striped (proximal end) patient connection line, patient line stopcock, mounting panel/main system section, two latex-free injection sites and a removable drainage bag with approximate volumetric graduations and microbial barrier air vent.
   The main system section located on the mounting panel includes:
3. Mounting bracket for height adjustment of system
4. Optional self-adjusting cord with lock for adjustment of system height
5. Main system stopcock with optional transducer attachment location
6. Sliding, graduated, 50 cc drip chamber with drip former and conical bottom, and locking bracket
7. Two drainage line slide clamps for flow monitoring and sampling
8. Drainage bag connection line
9. Needleless Injection Site (Interlink or Smartsite)
10. Instructions for Use
    The system does not contain any latex components.

Here's an analysis of the acceptance criteria and supporting study for the Becker External Drainage and Monitoring System, based on the provided FDA 510(k) summary:

This device is not an AI/ML device, so many of the requested fields are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size for each specific bench test. However, the testing was conducted as part of the design verification process for a modified component (the disposable drainage bag) within the Becker EDMS. The data provenance is from bench testing, which is a controlled laboratory environment, not derived from human patients or specific geographical regions.

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

This information is not applicable as the studies were bench tests evaluating physical properties and functional performance against engineering specifications, not clinical outcomes requiring expert interpretation of medical data.

4. Adjudication Method for the Test Set

This information is not applicable as the studies were bench tests against predetermined engineering specifications, not studies involving subjective interpretation of data that would require an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is a physical medical device, not an AI-assisted diagnostic or therapeutic tool for which such studies are typically performed.

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

This information is not applicable. This is a physical medical device, not an algorithm or software.

7. The Type of Ground Truth Used

The "ground truth" for the bench tests was based on engineering specifications and design requirements for the physical properties and functional performance of the modified drainage bag.

8. The Sample Size for the Training Set

This information is not applicable. As this is a physical medical device and not an AI/ML system, there is no "training set."

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

This information is not applicable. There is no training set for this type of device.

Summary of the Study Proving Device Meets Acceptance Criteria:

The device is the "Becker External Drainage and Monitoring System" (Becker EDMS), with specific modifications to its disposable drainage bag component. The study proving the device meets acceptance criteria was a series of "Performance Data - Bench" tests.

The modifications to the disposable bag primarily involved changes in its design (approximate volume capacity of 600ml with approximate volumetric markings in 50mL increments, an inlet port, an outlet port, and a hydrophobic/anti-microbial vent).

The performance testing was conducted in accordance with a risk assessment of these changes, which determined that dimensional verification and design verification testing of the bag were necessary. The specific tests performed included:

• Visual and Dimensional Inspection: To ensure the printed graduations met volumetric capacity.
• Leakage of Drainage Bag: To confirm the bag could withstand inversion without leaking.
• Flow Initiation Pressure: To record the pressure at which fluid flow begins.
• Drainage Bag Seal Weld: To ensure the bag's seals were intact and leak-free.
• Tensile Strength of Drainage Bag Inlet Port: To evaluate the durability of the connection point.

The results of all these bench tests showed that the Becker EDMS device met the specified acceptance criteria for each test. Based on these successful results, the manufacturer concluded that the changes introduced by the modified disposable bag do not raise new questions of safety and effectiveness, thus supporting the substantial equivalence to the predicate device (Medtronic PS Medical Becker External Drainage and Monitoring System, K984053).

No animal or clinical testing was deemed necessary for these specific modifications, as the determination of substantial equivalence was based solely on the design verification bench testing.

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The EKOS Ultrasound EVD System is intended to be used with dimensionally compatible devices for draining cerebrospinal fluid (CSF) as a means of reducing intracranial pressure and CSF volume.

Not Found

This is a 510(k) premarket notification for the EKOS Ultrasound EVD System, which is a ventricular catheter. The document does not describe the acceptance criteria or a study proving the device meets those criteria. It is a regulatory letter from the FDA confirming substantial equivalence to legally marketed predicate devices and outlining general controls and regulations.

Therefore, I cannot provide the requested information from the provided text.

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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 VentriClear® Ventricular Drainage Catheter Set with Cook® Spectrum® Antibiotic Impregnation and the VentriClear® II Ventricular Drainage Catheter have been designed for obtaining access to a ventricular cavity of the brain for short-term use to externally drain fluid for the purpose of relieving elevated intracranial pressure or fluid volume.

The VentriClear® Ventricular Drainage Catheter Set with Cook® Spectrum® Antibiotic Impregnation consists of a VentriClear® Ventricular Drainage catheter and other components that are used to facilitate the procedure. The VentriClear® Ventricular Drainage Catheter is a 9 French catheter designed with a radiopaque tip which aids in radiographic recognition and has a closed-end configuration with 16 standard and 16 small sideports. The VentriClear® Ventricular Drainage Catheter has markings at 1 cm increments to aid in determining depth and ease of placement and is 33 cm in length. The VentriClear® Ventricular Drainage Catheter consists of silicone elastomer impregnated with the antimicrobial agents minocycline and rifampin.

The VentriClear® II Ventricular Drainage Catheter consists of a VentriClear® II Ventricular Drainage catheter and other components that are used to facilitate the procedure. The VentriClear® II Ventricular Drainage Catheter is a 9 French catheter designed with a radiopaque tip which aids in radiographic recognition and has a closedend configuration with 16 sideports. The VentriClear® II Ventricular Drainage Catheter has markings at 1 cm increments, starting at the 3 cm mark and extending to 33 cm, to aid in determining depth and ease of placement and is 33 cm in length. The VentriClear® II Ventricular Drainage Catheter consists of silicone elastomer impregnated with the antimicrobial agents minocycline and rifampin.

The provided text describes Cook Incorporated's VentriClear Ventricular Drainage Catheter Set with Cook Spectrum Antibiotic Impregnation and VentriClear II Ventricular Drainage Catheter. This document is a 510(k) premarket notification to the FDA, asserting substantial equivalence to previously marketed predicate devices.

However, this document does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of device performance metrics such as sensitivity, specificity, accuracy, or any other quantifiable performance indicators.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices (Spectrum® Ventricular Catheter K011812 and VentriClear® II Ventricular Drainage Catheter Set K071640) by comparing device characteristics and indications for use. The only difference noted is the addition of a contraindication for use in pregnant women for both the VentriClear and VentriClear II catheters.

Therefore, I cannot provide the requested information in the format of a table of acceptance criteria and reported device performance, nor can I elaborate on sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as this type of information is not present in the provided text.

The document explicitly states under "Nonclinical Testing": "There were no device changes, so no additional testing was required to support the determination of substantial equivalence to the predicate devices." This further confirms that a new performance study to establish acceptance criteria was not conducted or reported in this submission.

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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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