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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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