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The XABO Catheters are used for cerebrospinal fluid (CSF) shunting.

The XABO Catheters are manufactured using barium sulfate fillcone elastomer and are impregnated with clindamycin hydrochloride and rifampicin designed to be released over time from the exterior and inner lumen surface once implanted.

The XABO Ventricular Catheters will be offered in 18 cm in length with an inner diameter of 1.2 mm and an outer diameter of 2.5 mm. Lengths are marked in 1 cm intervals starting from the catheter tip, thus enabling the surgeon to qauge the depth of penetration of the catheter into the lateral ventricle. The proximal end of the catheter has 16 flow holes around the catheter circumference.

Components supplied with the XABO Ventricular Catheter include a pre-loaded stainless steel stylet and depending on the confiquration may contain a deflector.

The XABO Peritoneal Catheters measure 60 cm or 120 cm in length, 1.2 mm in inner diameter, and 2.5 mm in outer diameter. There are no length markers or wall slits on the tip is open ended. The catheter may be trimmed to the proper length.

The XABO Catheters are 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 miniNAV valve, and the Miethke Shunt System (DSV, connectors, and reservoirs) cleared by FDA (K192266/K190174/K161853/K141687/K110206/K030698/K011030).

The provided text focuses on the 510(k) premarket notification for the XABO Ventricular Catheter, XABO Peritoneal Catheter, and XABO Catheter Set. It primarily addresses the substantial equivalence of these devices to existing predicate devices. While it mentions performance bench testing and specific tests performed, it does not explicitly state specific acceptance criteria values or detailed study results that would allow for a complete fill of the requested table.

The document indicates that the devices were tested against "performance specifications" and that the results "confirm that the XABO Catheters meet performance specifications." However, the exact numerical or qualitative specifications themselves are not provided.

Therefore, the following information is extracted directly from the provided text, and where information is not explicitly stated, it is noted as "Not explicitly stated in the provided text."

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated in the provided text. The phrase "All testing was performed on the worst-case final finished device" could imply a limited number of samples, but a specific number is not given.
• Data Provenance: The studies are described as "Performance bench testing" and "Biocompatibility testing," suggesting laboratory-based testing, not human-patient data. The country of origin of the data is not specified. It is laboratory research, not retrospective or prospective patient data.

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

• Not applicable as the testing described is bench testing and biocompatibility, not studies requiring expert interpretation of clinical data for ground truth.

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

• Not applicable for the types of tests described (bench testing, biocompatibility).

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, an MRMC comparative effectiveness study was not done. The submission focuses on device equivalence through bench and biocompatibility testing, not AI-assisted human reading.

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

• Not applicable. This device is a physical medical device (catheter), not an algorithm or AI system.

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

• For performance bench testing, the "ground truth" would be the pre-defined engineering specifications and standards (e.g., ISO 7197) that the device must meet.
• For biocompatibility testing, the "ground truth" is compliance with international standards (ISO 1099-1) and FDA guidance, ensuring that the device's biological interactions are within acceptable limits.

8. The sample size for the training set

• Not applicable. 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. This is not an AI/machine learning device that requires a training set and ground truth establishment.

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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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The M.blue Adjustable Shunt System is used for cerebrospinal fluid (CSF) shunting.

M.blue is an adjustable valve that combines an adjustable gravitational unit and a fixed differential pressure unit. The M.blue valve can be set for a range of pressures and is offered in four pressure level settings. The M.blue valve is comprised of a titanium housing enclosed by a thin titanium membrane with a curved wave profile design. The gravitational unit of the M.blue valve contains a tantalum weight, leaf spring and ball mechanically controlled by internal magnets. The differential pressure unit (ball-in-cone) of the M.blue valve contains a sapphire ball and titanium spring.

Manual devices are available to locate, verify the pressure setting and to set or change the pressure pre and postoperatively. These manual accessories are for external use by the Healthcare provider.

The M.blue valve will be distributed by itself or in combination with the proGAV 2.0 valve. The M.blue valve includes the same legally marketed accessories that are available with the Miethke Shunt Systems.

The provided document describes the K192266 submission for the M.blue Adjustable Shunt System. This document focuses on the device's performance criteria and its substantial equivalence to a predicate device, rather than the performance of an AI/ML device or a medical imaging device. Therefore, many of the requested categories for AI/ML study descriptions are not applicable.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the M.blue Adjustable Shunt System are based on various performance tests demonstrating its safety and efficacy, often by showing it performs substantially equivalent to the predicate device.

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

The document does not explicitly state numerical sample sizes for each test listed. It generally refers to "samples" passing the acceptance criteria. The data provenance (country of origin, retrospective/prospective) is not mentioned, but these are likely laboratory or bench tests conducted by the manufacturer.

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

Not applicable. This is a device performance and biocompatibility study, not an AI/ML study requiring expert ground truth for image interpretation or diagnosis. The "ground truth" here is objective physical or chemical measurement against established standards.

4. Adjudication Method for the Test Set

Not applicable. There's no subjective assessment requiring adjudication in these device performance tests.

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

No, an MRMC comparative effectiveness study was not done. This device is a medical implant, not an AI-assisted 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 algorithm. The performance tests are for the physical device itself.

7. The Type of Ground Truth Used

The ground truth used for these tests are:

• Established engineering standards and physical properties: e.g., pressure-flow characteristics, mechanical strength, resistance to leakage, bursting pressure, radiopacity.
• Biological and chemical standards: e.g., cytotoxicity assays against ISO standards (ISO-10993).
• MRI safety standards: as per ASTM guidelines.
• Manufacturer's declarations: for certain performance characteristics mentioned in the Instructions for Use.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" as this is not an AI/ML product.

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

Not applicable. There is no "training set."

Summary of Device and Study:

The K192266 submission describes the M.blue Adjustable Shunt System, a medical device for cerebrospinal fluid shunting. The core of the submission is to demonstrate its substantial equivalence to a legally marketed predicate device (Aesculap Miethke proSA Adjustable Shunt System K161853) and a reference device (Miethke Shunt System miniNAV Valve K110206).

The acceptance criteria are based on various physical and biological performance tests, as detailed in the table above. These tests cover aspects like radiopacity, resistance to leakage, pressure-flow performance, mechanical integrity (dynamic break strength, bursting pressure), long-term stability, and MRI compatibility. The device's components were also subjected to biocompatibility testing, specifically cytotoxicity, demonstrating the absence of cytotoxic potential.

The studies conducted are primarily bench testing (in vitro) and biocompatibility assessments. The document states that "All samples met predefined acceptance criteria and the proposed devices passed design verification test activities," concluding that the device "performs as intended and is substantially equivalent to the predicate device." The "performance data is provided in support of the substantial equivalence determination." This implies that the 'study' is a series of verification and validation tests aligned with relevant standards (e.g., EN ISO 7197:2009 for shunt safety and performance, and ISO-10993 for biocompatibility).

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The Miethke Shunt System GAV 2.0 and SA 2.0 are used for cerebrospinal fluid (CSF) shunting.

The Aesculap Miethke Shunt System is used in the treatment of hydrocephalus. Components of the Miethke Shunt System can include the GAV (Gravity Assisted Valve) 2.0 valve and SA (SHUNTASSISTANT) 2.0 valve.

The GAV 2.0 is a posture dependent, fixed gravitational valve that combines a differential pressure unit and gravitational unit. This combination allows an automatic adjustment of the opening pressure according to the patient's different body position and is used to control overdrainage. The housing of the GAV 2.0 valve is manufactured from titanium. The GAV 2.0 valve is available in three models, each model is offered in six pressure level settings in various accessory configurations. The GAV 2.0 valve is available as a single device as well as with various Miethke shunt system accessories such as catheters, connectors, deflectors and reservoirs.

The SA 2.0 valve is a posture dependent gravitational valve and is used to control overdrainage. The SA 2.0 is designed for use in combination with an adjustable or non-adjustable differential pressure valve to add increased resistance to the shunt system as a patient changes position. housing of the SA 2.0 valve is manufactured from titanium. The SA 2.0 valve is available in three models, each model is offered in six pressure level settings in various accessory configurations. The SA 2.0 valve is available as a single device as well as with the proGAV 2.0 valve and various Miethke shunt system accessories such as catheters, connectors, deflectors and reservoirs.

This document is a 510(k) summary for the Miethke Shunt System GAV 2.0 and SA 2.0 Valves, which is a cerebrospinal fluid (CSF) shunting device. This type of device regulates the flow of CSF to treat hydrocephalus.

Based on the provided information, the device is a shunt system, not an AI/ML powered device. As such, concepts like "acceptance criteria for an AI/ML powered device," "sample sized used for the test set," "number of experts used to establish the ground truth," "adjudication method," "multi reader multi case (MRMC) comparative effectiveness study," "standalone performance," "type of ground truth," "sample size for the training set," and "how the ground truth for the training set was established" are not applicable in this context.

The acceptance criteria and study that proves the device meets the acceptance criteria are related to the physical performance and safety of the shunt system.

Here's the information extracted from the document regarding the acceptance criteria and performance of the device:

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

The document summarizes that "All samples met predefined acceptance criteria and the proposed devices passed design verification test activities." It does not provide a specific table of quantitative acceptance criteria values for each test, but rather lists the types of tests performed and attests to a "Pass" result for all of them.

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

The document states, "All samples met predefined acceptance criteria and the proposed devices passed design verification test activities." However, it does not specify the sample size used for these performance tests. The data provenance (e.g., country of origin, retrospective or prospective) is not stated, but given it's a device manufactured by Aesculap, Inc. in Center Valley, Pennsylvania, the testing was likely conducted in a controlled lab environment, not on patient data directly.

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

This concept is not applicable for a physical device performance test. The "ground truth" for a medical device like a shunt is its compliance with established engineering standards and its physical performance characteristics, measured in controlled laboratory settings, not established by human experts in the way an AI algorithm's output might be.

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

Not applicable. This is a term used in validating expert assessments for AI/ML models. For a physical device, the "adjudication" is typically adherence to predefined test protocols and measurement verification.

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 relevant to AI/ML software. This document is for a physical medical device.

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

Not applicable. This is a physical device, not an algorithm. Its performance is inherently "standalone" in mechanical terms, meaning it functions without human intervention once implanted, but its pre-market testing is bench testing.

7. The type of ground truth used:

The ground truth for the device's performance is established by physical measurements and adherence to international and national standards for medical device safety and performance, specifically ISO 7197:2006 and various ASTM F standards for MRI compatibility.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device that requires a training set.

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