(101 days)
The Ebony 0.014'' PTA Catheter is intended for dilatation of lesions in the iliac, femoral, popliteal, infra popliteal, renal and carotid arteries. This catheter is not for use in coronary or neuro-vasculature.
The Ebony® PTA 0.014'' Peripheral Dilatation Catheter is a standard Rapid Exchange (RX) PTA catheter with a semi-compliant inflatable balloon at the distal part and an atraumatic, tapered tip to aid in crossing the tight stenoses. The catheter is double lumen in the distal part, one lumen is used for inflation and deflation of the balloon, and the second lumen allows access to the distal part of the catheter for guide wire insertion (max. 0.014"). The maximum recommended guide wire diameter is 0.014". A luer lock fitting (Hub) allows the connection with an inflation device. The internal tubing of the balloon has two radio opaque markers to provide visual reference points for balloon positioning relative to the stenosis within the vessel. An hydrophilic coating solution is applied on the catheter body to improve the pushability of the catheter by reduction of the friction coefficient of the outer body. The balloon material expands to a known diameter at specific pressure defined in a compliance table supplied with the catheter. The device is available in balloon diameter of 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 7.0, 8.0 mm, and balloon lengths of 10, 15, 20, 25, 30, 35, 40, and 60 mm. It will be supplied sterile and is intended for one time use.
The provided text is a 510(k) Summary for a medical device (Ebony® PTA .014" RX Peripheral Dilatation Catheter). However, it does not contain any information about a study involving AI/ML directly related to clinical performance or human reader improvements. The "performance data" section exclusively refers to non-clinical tests and analyses of the physical device, not an AI model.
Therefore, I cannot fulfill the request as it pertains to a study proving the device meets acceptance criteria related to AI/ML performance, human reader improvement, or complex ground truth establishment. This document describes a traditional medical device submission, focusing on physical and biocompatibility properties.
The document covers:
- Acceptance Criteria for the physical device: These are defined by various non-clinical tests (e.g., balloon compliance, burst pressure, fatigue, bond strengths, dimensions, biocompatibility).
- Study Proving Device Meets Acceptance Criteria: This is broadly stated as "data collected from non-clinical tests and analyses."
- "Reported device performance": This is described in terms of a list of tests performed and is summarized as "The subject device...met all the predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, and test protocols."
Based on the provided text, here’s why I cannot answer the specific questions related to AI/ML studies:
- No AI/ML Component: The device described is a physical catheter, not an AI/ML algorithm or system.
- No Test Set/Ground Truth for AI: There's no mention of a test set of images or data that an AI would process, nor is there any discussion of establishing ground truth for such data (e.g., expert consensus, pathology).
- No Human Reader Study: There is no multi-reader multi-case (MRMC) study mentioned, no human performance metrics, and certainly no comparison of human readers with or without AI assistance.
- No Standalone AI Performance: Since there's no AI, there's no standalone AI performance to report.
- No Training Set: The concepts of training sets and how their ground truth is established are irrelevant to a physical device submission like this.
To directly address the prompt while acknowledging the content of the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Reported Device Performance (Summary from Document) |
|---|---|
| Biocompatibility | All materials are biocompatible based on testing results according to ISO 10993 (Parts 1, 2, 4, 5, 10, 11, 12), ASTM F756-00, and 21 CFR 58 (GLP). |
| Balloon Compliance | Tested, and the balloon material expands to a known diameter at specific pressures defined in a compliance table supplied with the catheter. |
| Balloon Burst Pressure | Tested. |
| Balloon Fatigue Endurance | Tested (repeated balloon inflation). |
| Balloon Inflation/Deflation Performance | Tested. |
| Bond Strengths | Tested. |
| Catheter Dimensions and Balloon Profile | Tested. |
| Catheter Body Minimum Burst Strength | Tested. |
| Device Preparation (Guide Wire and Introducer Compatibility) | Tested. |
| Overall Conclusion | The subject device met all the predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, and test protocols. |
Regarding the AI/ML specific questions (2-9):
The provided 510(k) summary does not contain any information related to an AI/ML component, a test set for AI, experts establishing ground truth for AI data, adjudication methods for AI performance, MRMC studies, standalone AI performance, type of ground truth for AI, training set size for AI, or how ground truth for an AI training set was established. The document explicitly focuses on the non-clinical, physical, and biological performance of a medical catheter.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).