(459 days)
Use of the KION Anesthesia Workstation is indicated in order to allow for the provision of anesthesia to the neonatal to adult patient populations in all ventilation modes except for Volume Control in the Circle System, where it is not intended for use on neonates. It is intended to be used in an environment where patient care is provided by Healthcare professionals, trained in the administration of anesthesia, when the professional determines that a device is required to assist the breathing of a patient undergoing anesthesia. The device can be used to administer anesthesia while controlling the entire ventilation for patients without any ability to breath, as well as supporting patients with reduced ability to breath.
The KION Anesthesia Workstation - Extended Modes Functionality, adds primarily new functions for Pressure Support and Non-rebreathing to the already cleared KION Anesthesia Workstation with Pressure Control Functionality.
The provided text is related to a 510(k) summary for the KION Anesthesia Workstation - Extended Modes Functionality. This document, like many 510(k) submissions for medical devices, focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and expert-adjudicated ground truth data typically found in AI/ML device submissions.
Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment cannot be extracted from the provided text because it describes a traditional medical device submission, not an AI/ML diagnostic system. The document does not describe a study involving algorithms, human readers, or performance metrics like sensitivity, specificity, or AUC against a ground truth dataset in the way an AI/ML device would.
Here's an analysis based on the information that is present:
Acceptance Criteria and Device Performance
The concept of "acceptance criteria" in this document is related to demonstrating substantial equivalence to legally marketed predicate devices, rather than meeting specific quantifiable performance metrics against a clinical ground truth as would be seen for an AI/ML device. The device's "performance" is assessed in terms of its clinical performance being "equivalent" to the predicate devices.
| Acceptance Criteria (Implied by Substantial Equivalence and Device Description) | Reported Device Performance |
|---|---|
| Deliver operator set concentrations of oxygen and anesthesia gases. | Not explicitly quantified, but implied by substantial equivalence. |
| Deliver controlled breaths to the patient with constant or decelerating flow. | Not explicitly quantified, but implied by substantial equivalence. |
| Allow for provision of manual ventilation. | Not explicitly quantified, but implied by substantial equivalence. |
| Allow for provision of spontaneous ventilation. | Not explicitly quantified, but implied by substantial equivalence. |
| Intended for use on neonatal to adult patient populations (with exceptions). | Stated in Intended Use and Device Description. |
| Equivalent clinical performance to predicate devices. | Stated: "results show that the KION anesthesia Workstation. Extended Modes functionality has the equivalent clinical performance." |
| Functional equivalence for Pressure Support and Non-rebreathing modes. | "adds primarily new functions for Pressure Support and Non-rebreathing to the already cleared KION Anesthesia Workstation" |
Study Details
The document describes a 510(k) submission for the KION Anesthesia Workstation - Extended Modes Functionality, claiming substantial equivalence to predicate devices. It does not describe a clinical study in the typical sense of evaluating diagnostic performance with a test set, ground truth, or human-AI comparison.
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. The document does not describe a "test set" for performance evaluation in the context of an AI/ML device. The comparison is against predicate devices based on technological characteristics and intended use.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. There is no mention of establishing ground truth by experts for a test set. This is a traditional medical device submission.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 an anesthesia workstation, not an AI-assisted diagnostic tool for human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithmic diagnostic device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this submission is implicitly the established safety and effectiveness of the legally marketed predicate devices, against which equivalence is claimed.
- The sample size for the training set: Not applicable. This is not an AI/ML device requiring a training set.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided text concerns a traditional 510(k) submission for an anesthesia workstation, focusing on demonstrating substantial equivalence to predicate devices based on design, intended use, and technological characteristics. It does not provide the type of performance study details requested for an AI/ML diagnostic or assistive device.
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.