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The Gordon Large-Bore Curved Drainage Catheter is intended for abscess drainage.

The Nephrostomy Pigtail Drainage Catheter and Percutaneous Nephrostomy Set are intended for external urine drainage from the renal pelvis.

The Pigtail Drainage Catheter Needle Set is intended for percutaneous external drainage in multiple applications (e.g., nephrostomy, abscess drainage and other abdominal cavity drainage procedures).

The Multipurpose Drainage Catheters and Sets are intended for percutaneous drainage in a variety of drainage applications (e.g., nephrostomy, biliary and abscess), either by direct stick or Seldinger access technique.

The Gordon Large-Bore Curved Drainage Catheter is a drainage catheter that aspirates abscess cavity contents. The catheters are manufactured from radiopaque polyether-urethane material with hydrophilic coating on the surface of the catheter and are designed with six sideports at the distal curve. The catheters are available in diameters ranging from 16 to 22 French and in a length of 40 cm. The device includes flexible and rigid catheter introduction stiffening cannulas that aid in the placement of the catheter.

The Nephrostomy Pigtail Drainage Catheter is a drainage catheter used to drain urine from the kidney. The catheter is manufactured from radiopaque polyurethane tubing with a distal pigtail tip. The catheter is manufactured with six drainage sideports spaced within the pigtail curve. The catheter is available in a diameter of 8.3 French and in a length of 30 cm. The catheter is supplied with a Peel-Away straightener. The Percutaneous Nephrostomy Set is composed of the 8.3 Fr Nephrostomy Pigtail Drainage Catheter and several set components, including dilators, a wire guide, a Trocar needle, a Chiba needle, a connecting tube with a stopcock, and a fixation device.

The Pigtail Drainage Catheter Needle Set includes a drainage catheter used in multiple drainage applications, including nephrostomy, abscess drainage, and other abdominal cavity drainage procedures. The catheters are manufactured from radiopaque polyurethane tubing with a pigtail distal curve configuration. Four, six, or eight sideports are spaced evenly within the pigtail curve. The catheters are available in diameters of 5.0, 6.0, 7.0 and 8.3 French and in lengths of 15 or 25 cm. The Pigtail Drainage Catheter Needle Set is supplied with a Peel-Away straightener and a rigid stiffening cannula composed of a stainless steel needle, trocar stylet, and loading obturator.

The Multipurpose Drainage Catheters are used in a variety of drainage applications, e.g., nephrostomy, biliary, and abscess. There are 13 types of multipurpose drainage catheters and/or sets that fall into three different groups depending on the type of loop-locking mechanism, i.e., catheters without a locking mechanism, catheters with a Mac-Loc locking mechanism, and catheters with a Cook-Cope locking mechanism. Six product lines (Amplatz Universal Drainage Catheter and Set, Straight or Straight-Drain™ Drainage Catheter, Multipurpose Drainage Catheter, Universal Curved Drainage Catheters, Ring Biliary Duct Drainage Catheter, and Soft-Shaft Malecot Drainage Catheters) are designed without a locking mechanism. Four product lines (Multipurpose Drainage Catheter and Set, Dawson-Mueller Drainage Catheter and Set, Multipurpose Small Pigtail Drainage Catheter, and Biliary Drainage Catheters) are designed with a Mac-Loc® Locking Mechanism. Three product lines (Multipurpose Drainage Catheter, Biliary Drainage Catheter, and Cope Proximal Biliary Loop Catheter) are designed with a Cook-Cope or Luer lock Cook-Cope locking mechanism. The catheters are available in diameters ranging from 5.0 to 20.0 French and in lengths ranging from 15 to 60 cm. All catheters are manufactured from radiopaque polyether-urethane material. Most of the catheters are designed with distal curve configurations. The catheters may have a hydrophilic coating applied to their surface. The catheter size, number of sideports, distal tip configuration, and loop-locking mechanism are specific to the product type and drainage set specification. Many of these devices are supplied with a flexible and/or rigid stiffening cannula, as well as a catheter fixation device. The Multipurpose Drainage Set is composed of the Multipurpose Drainage Catheter and several set components, including a wire guide, dilator(s), a Neff percutaneous introducer set, and a connecting tube with a stopcock.

The provided text describes a 510(k) premarket notification for various drainage catheters. This document focuses on the substantial equivalence of new devices to existing predicate devices, rather than presenting a standalone study with specific performance metrics against pre-defined acceptance criteria for a novel device. Therefore, much of the requested information, particularly regarding a "study that proves the device meets the acceptance criteria" in the context of clinical performance, is not available.

The document outlines acceptance criteria in terms of various performance and biocompatibility tests conducted on the catheters to ensure reliable design and performance under specified design requirements. For all these tests, it is stated that "all pre-determined acceptance criteria were met." However, the specific quantitative acceptance criteria for each test and the detailed reported device performance against these criteria are not provided.

Here's a breakdown of the available and unavailable information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria and Reported Device Performance (as inferred from the document)

Note: The document explicitly states for physical and biocompatibility testing: "For these tests, all pre-determined acceptance criteria were met." However, the specific quantitative values for these criteria (e.g., "tensile strength of X N" or "flow rate of Y mL/hr") are not detailed in this submission. This is typical for a 510(k) where the focus is on demonstrating equivalence to predicates through adherence to recognized standards.

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

• Sample Size: Not specified for any of the performance or biocompatibility tests.
• Data Provenance: The tests were "conducted in accordance with applicable standards," which suggests they were performed internally by Cook Incorporated or by a contracted laboratory. The country of origin of the data is implicitly the USA (Cook Incorporated is based in Bloomington, IN, USA). The studies appear to be prospective in nature, in that they were conducted for the purpose of demonstrating equivalence for this submission.

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

• Not Applicable: This type of information is generally relevant for studies involving diagnostic accuracy or clinical judgment (e.g., reading medical images). The testing described here is primarily laboratory and bench testing of physical and biological properties. Experts were likely involved in developing the product and interpreting the results, but not in establishing a "ground truth" for a test set in the way you've described.

4. Adjudication Method for the Test Set

• Not Applicable: Adjudication methods (e.g., 2+1, 3+1) are used in clinical studies, particularly for diagnostic endpoints, to resolve disagreements among multiple expert readers. This document does not describe such a study.

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

• No: A MRMC comparative effectiveness study was not done. The document does not describe any studies involving human readers or AI assistance.

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

• No: This document describes medical devices (catheters), not an algorithm or AI system. Therefore, a standalone algorithm performance study is not applicable.

7. Type of Ground Truth Used

• Not Applicable (Clinical/Diagnostic Context): As mentioned above, the "ground truth" in the context of clinical diagnostic accuracy is not relevant here. For the performance and biocompatibility tests, the "ground truth" is established by the specifications of applicable ISO and USP standards. For instance, if a tensile test is performed, the "ground truth" is whether the material's tensile strength meets the specified minimum value as per the standard.

8. Sample Size for the Training Set

• Not Applicable: There is no "training set" as this is not an AI/ML device.

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

• Not Applicable: There is no "training set" as this is not an AI/ML device.

In summary, this 510(k) notification demonstrates substantial equivalence by comparing the technological characteristics of the new devices to predicate devices and by conducting various performance and biocompatibility bench tests in accordance with recognized standards, all of which "met the acceptance criteria." It does not involve complex clinical trials, expert adjudication, or AI performance studies that would require the specific details you've requested for those types of evaluations.

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Exodus Array Multipurpose Drainage Catheters are intended for percutaneous drainage of fluid or air in the chest, abdomen and pelvis, e.g., abscesses, cysts, pneumothoraces, and other general purpose drainage applications.

Exodus Nuance Nephrostomy Drainage Catheters are intended for percutaneous drainage of fluid collections in the urinary system.

Exodus Believe Biliary Drainage Catheters are intended for percutaneous drainage of the biliary tree.

The Exodus Drainage Catheter consists of a radiopaque polyurethane catheter. The distal end of the catheter is configured as a locking pigtail and is coated with GLYCE hydrophilic coating. Catheter markings are provided in centimeters on the shaft to indicate the distal tip. The Exodus Array Multipurpose Drainage Catheter (when applicable) and the Exodus Believe Biliary Catheter include a polymer marker to assist with catheter placement.

The proposed Exodus Drainage Catheters will include the following accessories: a metal cannula and a plastic cannula (all product offerings) and a 0.038" trocar needle (in multipurpose offerings only).

The provided text is a 510(k) Summary for the Exodus Drainage Catheters. This document details the substantial equivalence of new drainage catheters to previously marketed predicate devices. It focuses on device description, intended use, technological characteristics, and performance data to demonstrate safety and effectiveness.

However, it does not include the type of study that would typically generate acceptance criteria and performance metrics for a diagnostic AI device. The document describes physical and chemical performance tests for a physical medical device (catheter), not a digital or AI-based diagnostic tool.

Therefore, I cannot fulfill your request for specific acceptance criteria and study details related to an AI device's performance based on the provided text. The information required (e.g., sample sizes for test/training sets, ground truth establishment, expert qualifications, MRMC studies, standalone performance) is not available in this type of FDA submission for a catheter.

Here's how I would describe the current information, acknowledging its limitations for an AI device:

Based on the provided K152069 510(k) Summary for the Exodus Drainage Catheters, the device is a physical medical device (catheter), not an AI-based diagnostic tool. Therefore, the information requested regarding acceptance criteria and study details for an AI device's performance (such as sample sizes for test/training sets, ground truth establishment, expert qualifications, or MRMC studies) is not applicable or available in this document.

The document details performance testing for the physical attributes and biological compatibility of the catheter.

1. Table of Acceptance Criteria and Reported Device Performance (for a physical catheter):

The 510(k) summary lists the types of performance tests conducted for the Exodus Drainage Catheters to demonstrate substantial equivalence to a predicate device (K093392). While specific quantitative acceptance criteria and detailed reported performance values are not explicitly stated in this high-level summary, the document indicates that the results "demonstrate safety and effectiveness of the proposed device and substantial equivalence."

2. Sample size used for the test set and the data provenance: Not applicable. This summary describes physical testing of devices, not a study involving a "test set" of patient data for an AI algorithm.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth establishment for patient images/data is not relevant to the physical and biological testing of a catheter.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This is not a study involving reader adjudication of diagnostic output.

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 document pertains to a physical medical device (catheter) and does not describe an AI system's performance or human-AI interaction.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to this type of device and testing. The "ground truth" for catheter performance relates to established engineering standards, material specifications, and biological safety standards (e.g., ISO 10993-1).

8. The sample size for the training set: Not applicable. This is not an AI algorithm.

9. How the ground truth for the training set was established: Not applicable. This is not an AI algorithm.

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Multipurpose Drainage Catheters are intended for percutaneous drainage of fluid in the chest, abdomen and pelvis, e.g., abscesses, cysts, pneumothoraces, biliary, nephrostomy, urinary, pleural empyemas, lung abscess, and mediastinal collections.

The proposed Multipurpose Drainage Catheter consists of a flexible tube with an open distal tip, drainage holes and a lubricious surface. The distal end of the device has as a pigtail configuration. The proximal hub assembly of the device provides a Luer lock hub to allow the user to connect to a fluid collection device. Accessories include a Metal Stiffening Cannula and Plastic Stiffening Cannula and a Trocar.

This 510(k) summary (K111315) describes a Multipurpose Drainage Catheter. The document does not contain information about acceptance criteria or a study proving the device meets those criteria in the way typically expected for an AI/CAD/software device (e.g., performance metrics like sensitivity, specificity, AUC).

Instead, this submission focuses on demonstrating substantial equivalence to predicate devices. For a physical medical device like a catheter, "performance data" typically refers to engineering tests and biocompatibility, not clinical efficacy studies with specific performance metrics against a ground truth.

Here's how to interpret the available information in the context of your request:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria or report device performance in terms of clinical metrics (e.g., sensitivity, specificity, accuracy) because this is a physical medical device, not a diagnostic or AI-driven one.

The "performance data" mentioned in section H refers to:

• Results of performance testing: These would typically involve engineering tests to ensure the catheter meets design specifications related to strength, flexibility, flow rates, durability, etc. The document states these "demonstrate safety and effectiveness of the proposed device and substantial equivalence."
• Biocompatibility testing: Performed in accordance with ISO 10993-1, which "demonstrate the proposed device is acceptable for its intended use."

Table of Acceptance Criteria and Reported Device Performance (as applicable for this device type):

Other Information:

Given the nature of this physical medical device and the type of 510(k) submission, the following information is not applicable or not provided in the document:

2. Sample size used for the test set and the data provenance: Not applicable for engineering and biocompatibility testing. There isn't a "test set" of clinical cases in the way there would be for an AI device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for clinical interpretation is not relevant here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is not an AI/CAD/software device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this device would be its physical integrity, material properties, and biocompatibility, verified by engineering standards and lab tests.
8. The sample size for the training set: Not applicable (no training set for a physical device).
9. How the ground truth for the training set was established: Not applicable.

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Multipurpose Drainage Catheters are intended for percutaneous drainage of fluid or air from the chest, abdomen and pelvis, e.g., abscesses, cysts, pneumothoraces, biliary, nephrostomy, urinary, pleural empyemas, lung abscesses, and mediastinal collections.

Nephrostomy Drainage Catheters are intended for percutaneous drainage of fluid collections in the urinary system.

Biliary Drainage Catheters are intended for percutaneous drainage of the biliary tree.

The proposed percutaneous drainage catheter consists of a flexible tube with an open distal tip, drainage holes and a lubricious surface. The distal end of the device has either a pigtail or J-Tip configuration. Some catheter models have a radiopaque marker to aid the user in placement. The proximal hub assembly of the device provides a Luer lock hub to allow the user to connect to a fluid collection device. Accessories include a Metal Stiffening Cannula and Plastic Stiffening Cannula and some sets include an additional Trocar.

The provided text is a 510(k) summary for the NMI PDC II percutaneous drainage catheter and related FDA correspondence. It discusses the device's description, intended use, technological characteristics, and a conclusion of substantial equivalence to predicate devices based on performance data. However, this document does not contain the detailed information required to answer your specific questions about acceptance criteria for device performance, the study used to prove it, sample sizes, ground truth establishment, or expert involvement.

The document only states, "The proposed drainage catheters were tested and compared to predicate devices. Results of this testing demonstrate safety and effectiveness of the proposed device and substantial equivalence. Results of biocompatibility testing performed in accordance with ISO 10993-1 demonstrate the proposed device is acceptable for its intended use."

This is a general statement indicating that testing was performed, but it does not provide:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for the test set or data provenance. (The document does not mention data being "provenced" in terms of country of origin or retrospective/prospective nature regarding clinical performance data for the device itself, only biocompatibility.)
3. Number of experts used to establish ground truth or their qualifications.
4. Adjudication method for the test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size. (This device is a physical catheter, not an AI or diagnostic imaging device where MRMC studies are typically performed).
6. If a standalone (algorithm only) performance study was done. (Again, not applicable to a physical medical device like a catheter).
7. The type of ground truth used.
8. The sample size for the training set. (Not applicable as this is not an AI/algorithm-based device).
9. How the ground truth for the training set was established. (Not applicable).

In summary, the provided text does not contain the granular detail about performance criteria, study design, statistical analysis, or expert involvement that you are asking for. The 510(k) submission process for this type of device (a medical catheter) focuses on demonstrating substantial equivalence to a predicate device through engineering tests (e.g., mechanical performance, biocompatibility) rather than clinical performance metrics typically associated with diagnostic algorithms or AI.

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