(147 days)
The Stöckert S5 System is intended to be used during cardiopulmonary bypass surgery lasting six (6) hours or less.
The Stöckert S5 System, like the parent S3 System, is a modular system consisting of a console, various pumps, monitors, displays, controls, and user interfaces.
This document describes the Stöckert S5 System, a heart-lung machine intended for use during cardiopulmonary bypass surgery. However, the provided text does not contain the detailed acceptance criteria or a study proving the device meets specific performance metrics in the format requested.
The document states: "Testing of the Stöckert S5 System demonstrated that the System fulfills prospectively defined performance criteria and included electrical safety, electromagnetic compatibility, software validation, and functional testing." This is a general statement of testing, but it does not provide the specific criteria or the results of those tests in a quantifiable manner.
Therefore, I cannot populate the table or answer most of the questions as the information is not present in the provided text.
Here's a breakdown of what can be inferred or what is explicitly missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (e.g., Specificity, Sensitivity, Accuracy, Precision, AUC, etc.) | Reported Device Performance |
|---|---|
| N/A (Not specified in the provided text) | N/A (Not specified in the provided text) |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The text only mentions "prospectively defined performance criteria" but doesn't detail the data used for the testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device is a heart-lung machine, not an imaging or diagnostic device requiring expert interpretation for ground truth. The "ground truth" for such devices typically relates to engineering specifications and functional safety.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. See point 3.
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. This is not an AI-assisted diagnostic or imaging device. It's a medical device for cardiopulmonary bypass.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This question is usually for diagnostic algorithms. For a mechanical device, performance is inherently "standalone" in its function, but the question's context implies AI. The device itself is a standalone system without an "algorithm only" performance that would be separated from human interaction in the way diagnostic AI is typically evaluated.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Implied Engineering and Safety Standards: For a heart-lung machine, the "ground truth" for performance testing would be adherence to established engineering specifications, electrical safety standards (e.g., IEC 60601-1), electromagnetic compatibility standards (e.g., IEC 60601-1-2), and verified software functionality according to design specifications. The document mentions "electrical safety, electromagnetic compatibility, software validation, and functional testing," which align with this type of ground truth.
8. The sample size for the training set:
- Not applicable. This device is a physical medical device, not a machine learning model that requires a "training set."
9. How the ground truth for the training set was established:
- Not applicable. See point 8.
In summary, the provided 510(k) summary focuses on establishing substantial equivalence to a predicate device (Stöckert S3 System) based on intended use, indications for use, operational characteristics, and fundamental technological characteristics. While it mentions performance testing, it does not elaborate on the specific acceptance criteria or detailed results of those tests in the way requested for a performance study.
§ 870.4220 Cardiopulmonary bypass heart-lung machine console.
(a)
Identification. A cardiopulmonary bypass heart-lung machine console is a device that consists of a control panel and the electrical power and control circuitry for a heart-lung machine. The console is designed to interface with the basic units used in a gas exchange system, including the pumps, oxygenator, and heat exchanger.(b)
Classification. Class II (performance standards).