(203 days)
Use of the Heartport Endovenous Drainage Cannula is indicated for patients undergoing endovascular cardiopulmonary bypass. The Heartport Endovenous Drainage Cannula serves to drain non-oxygenated blood for cardiopulmonary bypass during cardiac surgery.
Not Found
This document describes a 510(k) summary for the Heartport Endovenous Drainage Cannula, a medical device. The information provided is for regulatory submission and focuses on demonstrating equivalence to predicate devices rather than a detailed performance study with acceptance criteria in the typical sense of algorithm-based studies.
Here's an analysis based on the provided text, addressing your points where possible, and noting where information is not available due to the nature of the document:
1. Table of Acceptance Criteria and Reported Device Performance
Given this is a 510(k) summary for a physical medical device (cannula) and not an AI/software device, the "acceptance criteria" and "reported device performance" are framed around demonstrating equivalence to existing devices, primarily regarding mechanical function (flow rates).
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Achieves comparable flow rates to predicate devices. | "Performance testing has demonstrated that the Heartport Endovenous Drainage Cannula provides comparable flow rates to the identified predicate devices." |
| Functions safely. | "Performance testing has demonstrated that the Heartport Endovenous Drainage Cannula will function safely..." |
| Functions efficaciously for its intended use. | "... and efficaciously, while meeting the anticipated clinical requirements for the intended use." |
| No significant difference from identified predicates (except coating). | "The Heartport Endovenous Drainage Cannula is not significantly different from the identified predicates. The only difference is the addition of a surface coating to enhance lubricity during insertion of the cannula." |
2. Sample Size Used for the Test Set and the Data Provenance
This information is not provided in the summary. The document mentions "Performance testing" but does not detail the size or nature of the test set, nor the provenance of any data. Given it's a physical device, testing would likely involve benchtop or in-vitro experiments rather than a clinical dataset in the AI sense.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable/not provided. For a physical device demonstrating comparable flow rates, "ground truth" would be established by objective measurements rather than expert consensus on diagnostic images.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
This information is not applicable/not provided. Adjudication methods are typically used in studies involving subjective interpretations (e.g., radiologists reviewing images), which is not the nature of the testing described for this physical device.
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
This information is not applicable. This is a physical medical device, not an AI/software product, so an MRMC study is irrelevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth, for the performance testing mentioned, would likely be objective physical measurements (e.g., actual flow rates in ml/min) compared to established values or measurements from the predicate devices. This is implied by the statement "provides comparable flow rates."
8. The Sample Size for the Training Set
This information is not applicable. There is no "training set" in the context of this 510(k) summary for a physical medical device. Device design and development follow different methodologies than AI model training.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. As there is no training set for an AI model, this question is not relevant.
In summary: The provided text is a 510(k) summary for a physical medical device. It focuses on demonstrating substantial equivalence to predicate devices, primarily through "performance testing" to show comparable flow rates and overall safety and efficacy. The concepts of acceptance criteria, ground truth, expert review, sample sizes, and study methodologies common in AI/software device submissions are largely not applicable or not detailed in this type of regulatory document for a physical product.
§ 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.
(a)
Identification. A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.(b)
Classification. Class II (performance standards).