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The Liver Access and Biopsy Sets are in obtaining liver histology samples via jugular vein approach in adult and pediatric populations. The devices are intended to be used in the following pediatric subgroups: infants, children, and adolescents.

The Liver Access and Biopsy Sets described in this submission are sets of various components that facilitate transjugular access to the liver for the purpose of taking tissue samples for biopsy. Each set includes a Quick-Core Biopsy Needle of a length sufficient to reach the liver from the patient's jugular vein, as well as a combination of a stiffening cannula and an introducer sheath (fitted with a Check-Flo valve adapter) that provides support for the biopsy needle. Other components that are included in some of these sets are a straight catheter, a curved angiographic catheter, an introducer set, and/or a dilator. Each component is individually packaged in an inner Tyvek pouch. All inner pouches for a given set configuration are packaged within an outer Tyvek pouch.

The Quick-Core Biopsy Needle consists of a stainless steel cutting cannula with a beveled point stylet that is activated by a plunger in the device's handle. The distal end of the needle is constructed of an inner stylet and a specimen notch that captures the tissue sample when the needle is fired. The Quick-Core Biopsy Needle is available in two sizes (18 gage and 19 gage) and in lengths of 48 and 60 cm. The combination of 14 gage stainless steel stiffening cannula and 7 Fr radiopaque sheath, available in lengths of 53.5 or 32.5 cm, provides access to the hepatic vein and support for the biopsy needle. Other available components include a 5 Fr straight Teflon catheter with a length of 39 or 62 cm; a 5 Fr curved angiographic catheter with a length of 80 cm made of radiopaque nylon and stainless steel braiding; a 9 Fr dilator made of polyethylene tubing with a length of 38 cm; and a Check-Flo Introducer Set consisting of an introducer made of radiopaque fluorinated polyethylene with a radiopaque band incorporated into its tip and a dilator made of polyethylene tubing.

The provided text is a 510(k) summary for the Cook, Inc. Liver Access and Biopsy Sets. It describes the device, its indications for use, comparison to a predicate device, and performance data. The device is intended for obtaining liver histology samples via the jugular vein approach in adult and pediatric populations.

Here's an analysis of the acceptance criteria and supporting studies based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria alongside reported device performance in the format requested for all tests. Instead, it describes various performance tests and states whether the acceptance criteria were met. For clinical performance, it discusses success rates and complication rates based on literature.

Here's a summary of the performance data, with explicit acceptance criteria often implied by "met the acceptance criteria" or "demonstrated that...":

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

For the physical and biocompatibility testing, specific sample sizes are not provided in this summary. The summary states "Testing performed demonstrated" or "Testing performed on the components" without giving specific n values for each test.

For the clinical evidence (literature search):

• Sample sizes:
  • Hoffer FA study (pediatric oncology): 44 patients (transjugular vs. percutaneous).
  • Behrens et al. study (comparison of subject and predicate devices): 233 patients total (141 for subject device, 92 for predicate device). Age ranges provided (e.g., 12 to 87 years for subject device group).
  • Other studies mentioned generally support use in populations ranging from 1 month to 94 years without specific new total numbers.
• Data Provenance: The clinical data is retrospective, derived from a systematic literature search of published journal articles from databases including Google Scholar, Embase, and PubMed. The studies cited are primarily from outside the immediate scope of this specific 510(k) submission, meaning the data origin for those studies could be various countries, and they are typically retrospective analyses of patient cohorts.

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

For the physical and biocompatibility testing, there is no mention of external human experts establishing ground truth. These tests likely rely on validated instruments, standardized protocols, and internal laboratory personnel performing analyses against defined specifications.

For the clinical evidence (literature review), the "ground truth" (e.g., liver histology diagnosis, complication assessment) was established within the scope of the original published studies. The 510(k) summary does not specify the number or qualifications of experts who established the ground truth in these external studies. However, for diagnostic studies like liver biopsies, expert pathologists typically establish histological diagnoses. Clinical outcomes would be determined by treating physicians and study investigators, who are generally board-certified specialists in hepatology, interventional radiology, or pediatric oncology, as suggested by the nature of the studies cited.

4. Adjudication Method for the Test Set

For the physical and biocompatibility testing, adjudication methods are not described. These tests generally involve objective measurements against pass/fail criteria.

For the clinical evidence, the adjudication methods for outcomes and diagnoses within the cited literature are not detailed in this 510(k) summary. Decisions like "success rate of obtaining a biopsy using the transjugular route was 100%" or "all biopsies yielded samples that were sufficient for diagnostic studies" imply expert review and consensus in the original research, but no specific X+Y style adjudication method is presented here.

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

No MRMC comparative effectiveness study involving human readers assisting with or without AI is mentioned. The device described is a physical medical instrument (biopsy sets), not an AI algorithm or an imaging CAD system that would typically be evaluated with MRMC studies. The clinical evidence focuses on the device's technical success and safety in obtaining biopsy samples, not on reader interpretation.

6. Standalone (Algorithm Only) Performance Study

This is not applicable as the device is a physical medical device (Liver Access and Biopsy Sets), not an algorithm or AI system.

7. Type of Ground Truth Used

For the physical and biocompatibility testing, the ground truth is based on engineering specifications, recognized industry standards (ISO, ASTM, JIS), and clinical requirements.

For the clinical evidence (literature review), the ground truth was derived from:

• Histology samples: Adequacy of samples and diagnostic results (pathology).
• Clinical outcomes data: Success of biopsy, occurrence and type of complications (e.g., bleeding, pain, major/minor complications, death), as assessed by clinicians and study investigators in the original research.

8. Sample Size for the Training Set

This concept is not applicable as the Liver Access and Biopsy Sets are physical medical devices, not an AI or machine learning model that requires a training set. The device design is based on engineering principles and preclinical testing, not on data training.

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

Not applicable, as there is no training set for this type of medical device.

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