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The IMPEDE-FX Embolization Plug is indicated for use with the IMPEDE Embolization Plug to obstruct or reduce the rate of blood flow in the peripheral vasculature.

The IMPEDE-FX Embolization Plug is a permanent implant, pushable embolization device comprised of a porous, degradable polyurethane thermoset foam plug and a proximal platinumiridium alloy marker band. The foam plug is crimped into a secondary shape to allow delivery through a catheter to the target vessel using a guidewire. Upon deployment in the target vessel and exposure to an aqueous environment and body temperature, the plug will self-expand to its primary shape to embolize the target vessel. The IMPEDE-FX device may only be used in conjunction with the IMPEDE® Embolization Plug System to further enhance vessel occlusion or increase the length of occlusion within the target vessel. It is indicated to obstruct or reduce the rate of blood flow in the peripheral vasculature.

The IMPEDE-FX polyurethane foam undergoes slow oxidative degradation with the majority (> 90%) of the foam remaining at 30 days in a swine intravascular model. The amount of foam degradation was also assessed in vivo in 180-day rat subcutaneous implants and 26-week rabbit intramuscular implants. Analysis of the histology slides from both studies revealed near complete degradation of the polymer foam at the majority of the implant sites in each study.

The device is pre-loaded into an introducer sheath which is made of a PEEK tube bonded to a polycarbonate luer hub to facilitate the transfer of the device into the catheter. The device implant is categorized as a permanent implant, blood contacting device, and the introducer is categorized as an external communicating device, limited (

The provided document is a 510(k) summary for the IMPEDE-FX Embolization Plug. It describes the device, its indications for use, comparison with predicate devices, and performance data used to establish substantial equivalence.

Here's an analysis to answer your questions based on the provided text:

Acceptance Criteria and Device Performance Study

The document states: "Test results demonstrated that all acceptance criteria were met; therefore, the device conforms to established product specifications and intended use." However, specific quantitative acceptance criteria and their corresponding reported device performance values are not explicitly provided in a table format within this document.

The performance data section lists the types of tests conducted:

• New Performance Data for IMPEDE-FX:
  • Mechanical, Visual, and Characterization testing (Simulated use testing for Accessory Compatibility, Delivery Performance, Implantation Performance; Radial Force; Dimensional Inspection; Visual Inspection).
  • Animal Study (acute porcine large animal study for usability, performance, and vessel response).
• Leveraged Performance Data from Predicate IMPEDE device:
  • Biocompatibility testing (Cytotoxicity, Sensitization, Irritation, Genotoxicity, Hemocompatibility, Intramuscular Implantation, Materials Mediated Pyrogenicity, Systemic toxicity, Subchronic toxicity, Chronic toxicity).
  • Mechanical, Visual, and Characterization testing (Radiopacity, Particulate Testing, MRI Compatibility, Packaging/Sterilization, Material Characterization).
  • Animal Studies (30, 60, and 90-day porcine large animal study; 90-day standard subcutaneous rat study; 90 and 180-day custom (foam only) subcutaneous rat study; 4, 13, and 26-week intramuscular implant rabbit study).

Since the document does not provide a table of acceptance criteria with quantitative values and corresponding device performance, I cannot create one. It simply states that "all acceptance criteria were met."

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

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

   • Not explicitly provided. The document states that "all acceptance criteria were met," but does not list the specific criteria or the quantitative results.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Test Set Sample Size:
     • IMPEDE-FX (new data):
       • Animal study: "an acutely (i.e. 4 hour sacrifice) in a porcine large animal study." The exact number of animals is not specified.
     • IMPEDE (leveraged data):
       • Animal studies: "a number of animal studies including multiple animal species and implantation sites," specifically:
         • "30, 60, and 90-day porcine large animal study" (number of animals not specified).
         • "90 day standard subcutaneous rat study" (number of animals not specified).
         • "90 and 180-day custom (foam only) subcutaneous rat study" (number of animals not specified).
         • "4, 13, and 26-week intramuscular implant rabbit study" (number of animals not specified).
       • In vivo degradation: "in vivo in 180-day rat subcutaneous implants and 26-week rabbit intramuscular implants." The number of animals for these specific degradation assessments is not detailed.
   • Data Provenance: The studies are animal studies (porcine, rat, rabbit). The country of origin is not specified, but typically such studies supporting FDA submissions are conducted under GxP (e.g., GLP) guidelines, often in the US or accredited facilities internationally. The studies were prospective as they involved controlled animal experiments.

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)

   • Not applicable / Not specified. The studies described are primarily non-clinical performance evaluations involving mechanical testing and animal models, not human clinical trials requiring expert-established ground truth for diagnostic accuracy. The animal studies evaluate "usability, performance, and vessel response," likely assessed by veterinary pathologists and study investigators, but no specific number or qualifications of "experts" for establishing ground truth in a diagnostic sense are mentioned.

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

   • Not applicable / None specified. Adjudication methods like 2+1 or 3+1 are typically used in clinical trials, especially for endpoints or image interpretation where human readers' opinions need to be reconciled. Since this document focuses on non-clinical performance and animal studies, such a method would not be relevant.

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. An MRMC study is not mentioned. The device is a physical embolization plug, not an AI-powered diagnostic or assistive tool for human readers.

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

   • Not applicable. The device is a physical medical device, not an algorithm.

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

   • For the animal studies, the "ground truth" would be established through pathology (histology slides) for degradation assessment, and direct observation/measurements of "usability, performance, and vessel response" in the animal models, along with other objective measurements from the mechanical and characterization tests.

8. The sample size for the training set

   • Not applicable. This device is a physical embolization plug, not an AI/machine learning model that requires a training set.

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

   • Not applicable. See point 8.

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