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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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Intended 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.

Spectrum® VentriClear™ II Ventricular Drainage Catheter Set includes a silicone 2.8 mm (9 Fr.) ventricular catheter available in a 33 cm length with numbered markings and 16 sideports. VentriClear™ II is impregnated with minocycline and rifampin. This device is supplied sterile and is intended for one-time use.

The provided document describes a Special 510(k) Premarket Notification for a medical device (Spectrum® VentriClear™ II Ventricular Drainage Catheter). This type of submission is for modifications to a legally marketed device and primarily focuses on demonstrating substantial equivalence to a predicate device through performance testing. It is not an AI/ML device, and therefore the requested information such as MRMC studies, effect size of human readers with AI assistance, or standalone algorithm performance, and training set details are not applicable to this submission.

Here's a breakdown of the acceptance criteria and study information that is relevant and available in the document:

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

The document does not explicitly state quantitative acceptance criteria with specific threshold values for each test. Instead, it refers to the tests generally assuring "reliable design and performance" and conforming to "requirements necessary for its use." The performance results are described in a qualitative manner.

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

The document does not specify the sample sizes used for any of the described tests (HPLC, Tensile, Liquid Leakage, Burst Pressure, Biocompatibility, Gravity Flow Rate). The data provenance is also not specified, but given that these are physical performance tests of a manufactured medical device, they would typically be conducted in a laboratory setting by the manufacturer (Cook Incorporated) rather than involving human patient data from a specific geographical origin. These tests are prospective in nature, as they are conducted on newly manufactured or modified devices.

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), not an AI/ML diagnostic tool requiring expert interpretation for ground truth establishment. The "ground truth" for its performance is determined by physical and chemical testing against engineering specifications and industry standards.

4. Adjudication method for the test set

Not applicable, as ground truth is not established through expert consensus or interpretation. The performance is assessed against predefined physical/chemical standards.

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-assisted diagnostic device.

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

Not applicable. This is not an AI/ML algorithm.

7. The type of ground truth used

The "ground truth" for the performance of this device is established through:

• Engineering Specifications and Standardized Test Methods: Each test (HPLC, Tensile, Leakage, Burst Pressure, Flow Rate, Biocompatibility) would have pre-defined acceptance criteria based on established engineering principles, material science, and relevant industry standards for medical devices of this type.
• Predicate Device Performance: The primary method of demonstrating "substantial equivalence" is by showing that the modified device performs comparably to the legally marketed predicate device (Cook Spectrum® Ventricular Drainage Catheter Set - K011812) in terms of these physical and chemical properties.

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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The SPECTRUM® Ventricular Catheter is intended 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 device will be supplied sterile and is intended for one-time use.

The SPECTRUM® Ventricular Catheter is a 9 Fr catheter nominally 33 cm in length. The catheter has a closed-end configuration with nominally 16 sideports, and has markings at 1 cm increments to aid in determining depth of placement. The SPECTRUM® Ventricular Catheter is impregnated with an antimicrobial combination of minocycline and rifampin which may reduce the risk of catheter related infection during use. Based on HPCC analysis, the average amount of minocycline on the catheter is approximately 5 mg (159 Φg/cm), and the average amount of rifampin on the catheter is approximately 4 mg (116 @g/cm). Components supplied with the SPECTRUM® Ventricular Catheter include a pre-loaded stainless steel stylet, a stainless steel tunneling trocar, and proximal fittings, which are included to facilitate placement and use of the Ventricular Catheter.

The SPECTRUM® Ventricular Catheter is a medical device intended for short-term external drainage of fluid from the ventricular cavity of the brain to relieve elevated intracranial pressure or fluid volume. The information provided outlines the device's characteristics, intended use, and the studies conducted to demonstrate its substantial equivalence to predicate devices and ensure its safety and efficacy.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

The provided text does not explicitly state numerical acceptance criteria in a typical "Pass/Fail" format. Instead, it describes various tests and a clinical study designed to demonstrate that the SPECTRUM® Ventricular Catheter performs as intended and is as safe and effective as predicate devices. The "reported device performance" is essentially the successful completion of these tests and the favorable outcomes of the clinical study.

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 Clinical Study:
  • SPECTRUM® Ventricular Catheter group: 149 patients were followed up.
  • Standard non-coated catheter group (control): 139 patients were followed up.
• Data Provenance: The clinical study was described as a "prospective, randomized, multicenter clinical trial." The country of origin is not explicitly stated, but the submission is to the U.S. FDA, implying the study was conducted under appropriate regulatory guidelines, likely within the U.S. or internationally with standards acceptable to the FDA.

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)

The document does not specify the number of experts or their qualifications for establishing the ground truth related to the clinical study's outcome (catheter-related infection). The "ground truth" for infection would typically be established by clinical diagnosis, laboratory tests, and potentially microbiological culture results, which would be interpreted by healthcare professionals (physicians, microbiologists). There is no mention of an independent panel of experts reviewing cases in the context of adjudication for ground truth.

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

The document does not describe a specific adjudication method (like 2+1 or 3+1) for the clinical study's outcomes. Clinical study endpoints, such as catheter-related infection, are typically diagnosed by treating physicians and confirmed by laboratory results, rather than relying on an adjudication panel in the context of device performance claims unless there's a specific nuanced diagnostic challenge. It's presumed that the diagnoses were made by the clinical staff involved in the multicenter trial.

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 MRMC comparative effectiveness study was done as this device is a physical medical device (catheter), not an AI-powered diagnostic or assistive technology. Therefore, the concept of human readers improving with AI assistance is not applicable here.

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

This question is not applicable. The SPECTRUM® Ventricular Catheter is a physical medical device, not an algorithm or AI system.

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

For the clinical study, the ground truth was based on outcomes data, specifically the "incidence of catheter-related infection." This would involve clinical diagnosis of infection, potentially supported by laboratory findings (e.g., cerebrospinal fluid analysis, culture results), and clinical follow-up of patients.

For the other non-clinical tests (biocompatibility, physical performance, antimicrobial efficacy), the ground truth was based on established laboratory and test standards defined for each specific test (e.g., ASTM standards for physical tests, ISO standards for biocompatibility, specific microbiological testing protocols).

8. The sample size for the training set

This question is not applicable. This is a physical medical device, not a machine learning model, so there is no concept of a "training set."

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

This question is not applicable for the same reason as point 8.

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