(77 days)
The Prelude® Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures.
The Prelude® Sheath Introducer consists of a sheath introducer with compatible vessel dilator that snaps securely into the sheath introducer hub. The sheath is equipped with a side arm terminating in a 3-way stopcock. The sheath hub contains an integral hemostasis valve and a suture ring. The subject sheath introducer has a radiopaque marker tip. The device is marketed with and without an appropriately sized guide wire.
The document provided is a 510(k) Pre-market Notification Summary for a medical device (Prelude® Sheath Introducer), not a study analyzing the performance of an AI/ML powered device. Therefore, it does not contain information related to AI/ML device performance, acceptance criteria for such a device, sample sizes, ground truth establishment, or expert involvement as requested.
The document indicates that the device is a physical medical device (Vessel Dilator for Percutaneous Catheterization) and the 510(k) submission is for a minor change to an existing predicate device (specifically, "The only change that was made was to the radiopaque marker tip material.").
The "Acceptance Criteria" and "Study" described in the document are related to the physical and biological safety and performance of the medical device itself, not to a diagnostic or analytical algorithm.
Here's an attempt to extract relevant information, acknowledging that it pertains to a physical device and not an AI/ML algorithm:
1. Table of acceptance criteria and the reported device performance:
| Type of Test/Criterion | Specific Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Design Verification | Tortuous path test | Met pre-determined acceptance criteria for safety and efficacy. | Successfully completed. |
| Force at break | Met pre-determined acceptance criteria for safety and efficacy. | Successfully completed. | |
| Radiopacity | Met pre-determined acceptance criteria for safety and efficacy. | Successfully completed. (Note: This was the very aspect that was changed and tested). | |
| Tip insertion/peel back | Met pre-determined acceptance criteria for safety and efficacy. | Successfully completed. | |
| Dilator drag | Met pre-determined acceptance criteria for safety and efficacy. | Successfully completed. | |
| Stiffness | Met pre-determined acceptance criteria for safety and efficacy. | Successfully completed. | |
| Biocompatibility | Cytotoxicity | Met pre-determined acceptance criteria for safety and efficacy based on ISO 10993-5 (Tests for in vitro cytotoxicity) and FDA guidance. | Successfully completed. |
| Sensitization | Met pre-determined acceptance criteria for safety and efficacy based on ISO 10993-10 (Tests for irritation and skin sensitization) and FDA guidance. | Successfully completed. | |
| Irritation | Met pre-determined acceptance criteria for safety and efficacy based on ISO 10993-10 (Tests for irritation and delayed type hypersensitivity) and FDA guidance. | Successfully completed. | |
| Acute Systemic Toxicity | Met pre-determined acceptance criteria for safety and efficacy based on ISO 10993-11 (Tests for systemic toxicity) and FDA guidance. | Successfully completed. | |
| Pyrogenicity | Met pre-determined acceptance criteria for safety and efficacy based on United States Pharmacopeia 33, National Formulary 28, 2010 Pyrogen Test and FDA guidance. | Successfully completed. | |
| Genotoxicity | Met pre-determined acceptance criteria for safety and efficacy based on ISO 10993-3 (Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity) and FDA guidance. | Successfully completed. | |
| Hemolysis | Met pre-determined acceptance criteria for safety and efficacy based on ISO 10993-4 (Selection of tests for interaction with blood) and ASTM F756-08:2008 (Standard Practice for Assessment of Hemolytic Properties of Materials) and FDA guidance. | Successfully completed. | |
| Thrombogenicity | Met pre-determined acceptance criteria for safety and efficacy based on ISO 10993-4 (Selection of tests for interaction with blood) and FDA guidance. | Successfully completed. | |
| Complement Activation | Met pre-determined acceptance criteria for safety and efficacy based on ISO 10993-4 (Selection of tests for interaction with blood) and FDA guidance. | Successfully completed. | |
| Chemical Characterization | Met pre-determined acceptance criteria for safety and efficacy based on ISO 10993-1 (Evaluation and Testing within a risk management process) and FDA guidance (Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices, May 1, 1995). | Successfully completed. | |
| Sterilization | Routine Control of Sterilization Process | Met requirements of ANSI/AAMI/ISO 11135-1:2007 (Sterilization of health care products - routine control of a sterilization process for medical devices). | Successfully completed. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not specify sample sizes for each test. The tests are general performance and biocompatibility tests for a physical medical device. Data provenance (country of origin, retrospective/prospective) is not applicable or specified for these types of engineering and biological tests, which are typically performed in a laboratory setting by the manufacturer.
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):
This is not applicable to a physical device performance and biocompatibility study. "Ground truth" in the context of expert consensus is relevant for diagnostic accuracy studies, typically involving human interpretation of medical images or data. For this device, "ground truth" refers to established scientific principles, regulatory standards (like ISO and ASTM), and pre-defined pass/fail criteria for physical and biological properties.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. Adjudication methods like '2+1' or '3+1' are used for resolving disagreements among multiple human readers in diagnostic accuracy studies. For physical device testing, results are typically objective measurements against engineering specifications and biological standards.
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. This document describes the safety and performance testing for a physical medical device (sheath introducer), not an AI/ML-powered diagnostic tool. Therefore, MRMC studies and AI assistance are not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the device's performance is based on established international standards (ISO, AAMI, ASTM, USP) and FDA guidance documents for medical device testing. These standards define the methodologies and acceptance criteria for various physical, chemical, and biological properties.
8. The sample size for the training set:
Not applicable. There is no AI/ML algorithm involved, so no "training set."
9. How the ground truth for the training set was established:
Not applicable. There is no AI/ML algorithm involved, so no "training set" or ground truth establishment for it.
§ 870.1310 Vessel dilator for percutaneous catheterization.
(a)
Identification. A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.(b)
Classification. Class II (performance standards).