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K Number
K964814
Device Name
BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER
Manufacturer
BIPORE, INC.
Date Cleared
1997-05-07

(159 days)

Product Code
DYB
Regulation Number
870.1340
Type
Traditional
Panel
CV
Reference & Predicate Devices
K924607
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Bipore AccuFlex™ Percutanous Sheath Introducer is designed to be used for the percutaneous introductionn of various devices into arteries and/or veins for diagnostic and therapeutic procedures.

Device Description

The Bipore AccuFlex™ Percutaneous Sheath Introducer is a wire-reinforced flexible tube with an integral side port/hemostasis valve at the proximal end.

AI/ML Overview

The provided text describes a medical device, the Bipore AccuFlex™ Percutaneous Sheath Introducer, and summarizes its safety and effectiveness for a 510(k) submission. However, the document does not contain the specific information required to complete your request regarding acceptance criteria and performance studies for an AI/ML powered device.

The Bipore AccuFlex™ is a physical medical device (a sheath introducer), not an AI/ML powered device. The "Safety and Performance" section lists general potential complications for this type of product, and the "Conclusion" states that safety and effectiveness are based on "technological characteristics, and mechanical tests." This indicates a traditional medical device approval process, likely involving engineering bench tests and possibly animal or human clinical studies to assess its physical properties and safety during use, rather than a performance study comparing an algorithm's output to ground truth.

Therefore, I cannot extract the following information because it is not present in the provided text:

  1. A table of acceptance criteria and the reported device performance: The document mentions "mechanical tests" but does not detail their specific acceptance criteria or the quantitative results.
  2. Sample size used for the test set and the data provenance: Not applicable as it's not a data-driven device.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
  4. Adjudication method for the test set: Not applicable.
  5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
  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: Not applicable.
  8. The sample size for the training set: Not applicable.
  9. How the ground truth for the training set was established: Not applicable.

To answer your prompt, you would need a document describing the validation of an AI/ML model, not a traditional medical device like the Bipore AccuFlex™ Percutaneous Sheath Introducer.

§ 870.1340 Catheter introducer.

(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).