(84 days)
The Stöckert Air Purge Control System detects air in the venous line and removes air from the venous bubble trap of the Synergy/ECC.O System tubing circuit that is intended to be used with the Stöckert S5 System.
The (integrated) S5 Stöckert is indicated for speed-controlled pumping of blood through the cardiopulmonary bypass circuit for durations of six (6) hours or less, left ventricular venting, cardiotomy suction, and administration of cardioplegia solution, when used by a qualified perfusionist who is experienced in the operation of the S5 System.
The modified Stöckert S5 System, like the parent S5 System, is a modular system consisting of a console, various pumps, monitors, displays, controls, and user interfaces.
The provided text describes the Stöckert Air Purge Control System, an upgrade to the Stöckert S5 System, and its substantial equivalence to a predicate device. However, it does not contain specific details about acceptance criteria, device performance, sample sizes for test sets (or training sets), data provenance, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.
The document primarily focuses on:
- Device Description: It's a modular system consisting of a console, various pumps, monitors, displays, controls, and user interfaces, with the Air Purge Control System detecting and removing air from the venous line.
- Intended Use: Detects air in the venous line and removes air from the venous bubble trap of the Synergy/ECC.O System tubing circuit, which is used with the Stöckert S5 System. The S5 System itself is for speed-controlled pumping of blood (cardiopulmonary bypass) for durations of six hours or less, left ventricular venting, cardiotomy suction, and cardioplegia administration by a qualified perfusionist.
- Substantial Equivalence: The modified system is considered substantially equivalent to the parent Stöckert S5 System and APC System based on intended use, indications for use, operational characteristics, and fundamental technological characteristics.
- Performance Testing (General Statement): "Testing of the modified Stöckert S5 System (hardware and software) has demonstrated that the System fulfills prospectively defined performance criteria and that the modified System meets user needs."
Given the limitations of the provided text, I cannot complete the requested tables and sections with specific numerical data or detailed methodologies. I can only report what is explicitly stated or can be inferred.
Here's an attempt to answer the questions based only on the provided input, highlighting where information is unavailable.
Acceptance Criteria and Device Performance Study
The provided document states that "Testing of the modified Stöckert S5 System (hardware and software) has demonstrated that the System fulfills prospectively defined performance criteria and that the modified System meets user needs." However, the document does not provide a table of these specific acceptance criteria or the reported device performance against them. It also does not detail a specific study proving this beyond this general statement.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Specified | Not Specified |
| (The document only states that the system "fulfills prospectively defined performance criteria".) | (The document only states that the system "meets user needs" but provides no specific metrics.) |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The document only refers to "Testing" in a general sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not specified.
4. Adjudication method for the test set
Not specified.
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 specified. The device is an "Air Purge Control System" which implies an automated function (detecting and removing air), rather than an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study in the traditional sense for diagnostic improvement is unlikely or not applicable.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done
While the system is described as detecting and removing air, implying an automated, standalone function, the document does not explicitly present a "standalone performance study" or specific metrics for such a study. It only states general performance criteria fulfillment.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not specified.
8. The sample size for the training set
Not specified.
9. How the ground truth for the training set was established
Not specified.
§ 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).