(88 days)
The Stöckert Compact System is an integrated heart-lung machine consisting of pumps, monitoring, and control elements on a single chassis. It is indicated for speed controlled pumping through the cardiopulmonary bypass circuit for typical durations of six hours or less, left ventricular venting, cardiotomy suction, administration of cardioplegia solution, when used by a qualified perfusionist who is experienced in the operation of the SC System.
The SC System has been qualified only for durations appropriate to cardiopulmonary bypass procedures and has not been qualified through in vitro, in vivo, or clinical studies, for long term use as a bridge to transplant, pending recovery of the natural heart, or extracorporeal membrane oxygenation (ECMO) procedures.
The Stöckert Compact System is a modification of the Stöckert S3 System, which integrates its components into a single chassis. There is no change to the indications for use or the fundamental technological characteristics.
The provided document, K982014, describes a Special 510(k) for a device modification of the Stöckert Compact System (SC System). A Special 510(k) is used when a modification to a legally marketed device does not alter the fundamental technology or intended use, and therefore the determination of substantial equivalence relies heavily on the equivalence to the predicate device and the validation of the modifications according to design control procedures. This type of submission typically does not involve a traditional "study" in the sense of a clinical trial or performance study with acceptance criteria being met by reported device performance against a ground truth.
Instead, the "acceptance criteria" for a Special 510(k) are typically the demonstration that the modified device remains substantially equivalent to the predicate device in terms of intended use, technological characteristics, safety, and effectiveness. The "study" proving this usually involves design validation and verification activities.
Based on the provided text, here's an analysis against your requested information:
1. Table of acceptance criteria and the reported device performance
The document does not present a formal table of acceptance criteria with reported device performance in the manner requested for a new device submission. Instead, the "acceptance criteria" are implied by the nature of a Special 510(k) and the claim of substantial equivalence.
| Acceptance Criteria (Implied for Special 510(k)) | Reported Device Performance (as stated in the document) |
|---|---|
| Intended Use Equivalence: The modified device (SC System) must have the same intended use as the predicate device (Stöckert S3 System). | Met: "There is no change to the indications for use..." |
| Technological Characteristics Equivalence: The modified device must have fundamentally similar technological characteristics (design and operation) to the predicate. | Met: "...no change to... the fundamental technological characteristics." and "This determination is based on equivalence in intended use and technological characteristics (design and operation)." |
| Safety and Effectiveness Equivalence: Any differences between the modified and predicate device must not raise new issues of safety or effectiveness. | Met: Stöckert Instrumente GmbH "believes that any differences between the SC and S3 Systems are minor and raise no new issues of System safety or effectiveness." |
| Design Control Validation: System modifications must be validated according to Stöckert Instrumente Design Control procedures. | Met: "System modifications have been validated according to Stöckert Instrumente Design Control procedures, in compliance with the Quality Systems Regulations." |
2. Sample size used for the test set and the data provenance
The document does not mention a "test set" in the context of a performance study with a specific sample size. The validation performed focused on the modifications to the existing S3 system. There is no information about data provenance like country of origin or retrospective/prospective nature because it's not a performance study on a new clinical dataset.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No "test set" or "ground truth" was established by experts in the context of a new performance study. The validation relates to engineering and design control processes.
4. Adjudication method for the test set
Not applicable. There was no test set requiring adjudication in the context of a performance study.
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 device is a heart-lung machine, not an AI-powered diagnostic or assistive technology for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a heart-lung machine, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for this submission is the established safety and effectiveness of the predicate S3 System, and the demonstration that the modifications to create the SC System do not alter this. This is validated through design, engineering, and quality system procedures, not comparison to a clinical "ground truth" dataset.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, and therefore does not have a "training set."
9. How the ground truth for the training set was established
Not applicable. As above, this is not an AI/ML device.
§ 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).