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The Gel-Block Embolization Pledgets are intended for use in embolization of hypervascularized tumors and arteriovenous malformations (AVMs).

The Gel-Block Embolization Pledgets are an embolic device consisting of two radially-compressed gelatin pledgets that can be delivered through a catheter system. The pledgets are stored individually within a transparent delivery assembly that has a luer lock on the proximal end and a vented cap on the distal end. The luer lock allows for attachment to syringes for flushing, while the vented cap allows the flushing to occur without pledget evacuation from the delivery assembly. After flushing, the vented cap is removed to expose a threaded luer that connects to the hub of an in-place delivery catheter. The Gel-Block Embolization Pledgets consist of the following components: Two gelatin pledgets, in individual delivery assemblies; One syringe for pledget delivery.

This document describes the acceptance criteria and the study conducted for the Gel-Block Embolization Pledgets (K113266). However, it's important to note that this 510(k) summary does not present acceptance criteria and performance data in a typical, quantitative format often seen for diagnostic or AI-driven medical devices. Instead, it describes a series of studies designed to demonstrate substantial equivalence to predicate devices.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document doesn't explicitly state quantitative "acceptance criteria" for performance metrics like sensitivity, specificity, or accuracy, which are common for AI/diagnostic devices. Instead, the acceptance criteria are implicitly defined by the successful completion of various tests and the demonstration of substantial equivalence to predicate devices. The "reported device performance" refers to the qualitative successful outcome of these tests.

Note: The acceptance criteria here are largely qualitative – evidence of functional performance, biocompatibility, and embolic efficacy and safety equivalent to predicate devices, without introducing new safety or performance concerns.

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

• Sample Size for Test Set:
  • GLP Animal Study: 9 test animals (adult female sheep) and 4 control animals (adult female sheep).
  • In vitro/Bench Testing: Sample sizes for swelling capability, pepsin digestibility, flushing capability, deliverability, formaldehyde residuals, and biocompatibility tests are not specified in this summary.
• Data Provenance: The animal study was conducted as a "GLP animal study," indicating it was a prospective study following Good Laboratory Practice (GLP) guidelines. The country of origin is not specified but implicitly within the regulatory framework for FDA submission.

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

• Animal Study Ground Truth: The ground truth for embolic effect in the animal study was established through angiography and/or histopathology. The number of experts interpreting these results and their specific qualifications (e.g., veterinary pathologists, radiologists) are not specified in this summary.

4. Adjudication Method for the Test Set

• Animal Study Adjudication: The document does not specify a formal adjudication method (e.g., 2+1, 3+1 consensus) for the angiography or histopathology results in the animal study. The statement "Angiography and/or histopathology confirmed..." implies an assessment by qualified personnel, but details on consensus or adjudication are absent.

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

• No, an MRMC comparative effectiveness study was NOT done. This type of study is typically for evaluating the impact of a diagnostic aid (like AI) on human performance. The Gel-Block Embolization Pledgets is a therapeutic device, not a diagnostic one. The study focused on demonstrating the device's inherent safety and effectiveness, and substantial equivalence to existing devices.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Yes, a standalone study was done. The animal study and the various bench and biocompatibility tests represent "standalone" evaluations of the device itself, independent of human interpretation or assistance in the way an AI algorithm would be evaluated. The device's performance was directly measured or observed.

7. The Type of Ground Truth Used

• Animal Study: The primary ground truth for the animal study was histopathology and angiography. This represents direct observation of the physiological effect of the embolization (e.g., renal infarct) and the presence/absence of blood flow.
• Bench/Biocompatibility Tests: The ground truth for these tests would be defined by the specific measurement standards and protocols of each test (e.g., standardized methods for measuring swelling, digestibility, or cell viability).

8. The Sample Size for the Training Set

• Not Applicable. This device is a physical medical implant, not an AI algorithm. Therefore, there is no "training set" in the context of machine learning. The design and development of the device would involve engineering, material science, and preclinical testing, but not machine learning training.

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

• Not Applicable. As there is no training set for an AI algorithm, this question is not relevant to the Gel-Block Embolization Pledgets device.

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