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510(k) Data Aggregation
(72 days)
ASCOM CLINICALCONNEX CARDIOMAX
The intended use of the Ascom ClinicalConneX Cardiomax (Cardiomax) is to provide an interface with clinical systems to forward information associated to the particular event to the designated display device(s). For medical, near real time alarms, the Ascom Cardiomax is intended to serve as a parallel, redundant, forwarding mechanism to inform healthcare professionals of particular medical related events. Ascom Cardiomax does not alter the behavior of the primary medical devices and associated alarm annunciations. The display device provides a visual, and/or audio and/or vibrating mechanism upon receipt of the alert. The Ascom Cardiomax is intended for use as a secondary alarm. It does not replace the primary alarm function on the monitor.
The Ascom (US), Inc. (Ascom) ClinicalConneX | Cardiomax (Cardiomax) is an on-site messaging integration solution which forwards patient monitor status and alarm information to the user via display devices provided by Ascom or third-party mobile device companies. Users receive interactive, time-critical information from patient monitoring devices directly via their display devices as voice, text, alarms or data. The Ascom Cardiomax allows users to be aware of their patients' status and alarm conditions when they are away from the patient and patient monitoring system. The Ascom Cardiomax connects to the information sources through wired ethernet connections which are part of the customer's infrastructure. The Ascom Cardiomax software acquires patient data from patient monitoring devices. The user configures the Ascom Cardiomax to determine which information, including alarm notifications, is delivered to which users. The Ascom Cardiomax then formats the data for wireless delivery to the display devices. All messaging activities are recorded in the Ascom Communications Server providing real-time activity logging for audit trail records and reporting. The Ascom Cardiomax hardware consists of small, embedded network appliances, and application-specific software. The Ascom Cardiomax delivers near real-time text messaging alerts and information to text-capable display devices. Ascom provides a wireless communications system platform on which the Ascom Cardiomax may operate: DECT (Digital Enhanced Cordless Telecommunications) technology. The Ascom Cardiomax, combined with an Ascom wireless communication system, is part of an Ascom end-to-end solution designed to provide all the components necessary to optimize work flow, including display devices, gateways and device management.
The Ascom ClinicalConneX Cardiomax is an on-site messaging integration solution that forwards patient monitor status and alarm information to users via display devices.
Here's an analysis of the acceptance criteria and supporting study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Software Testing | Develop and design software according to a robust software development process, and rigorously verify and validate it. | "Test results indicated that the Ascom Cardiomax complies with its predetermined specifications." |
| Electrical Safety | Comply with applicable electrical safety standards. | "Test results indicated that the Ascom Cardiomax complies with its predetermined specifications and with the applicable standards." |
| Electromagnetic Compatibility (EMC) | Comply with applicable EMC standards. | "Test results indicated that the Ascom Cardiomax complies with its predetermined specifications and with the applicable standards." |
| Performance Testing - Bench | Comply with predetermined specifications and applicable standards for overall performance. | "Test results indicated that the Ascom Cardiomax complies with its predetermined specifications." |
| Substantial Equivalence | Demonstrate substantial equivalence to the predicate device (Spacelabs Medical Clinical Event Interface (CEI), Model 91847, K062278). The device should employ the same or similar technological characteristics. | "The Ascom Cardiomax employs the same or similar technological characteristics as the predicate device." |
| "Based upon a comparison with predicate devices and testing results, the Ascom Cardiomax is substantially equivalent to the predicate device." The FDA later issued a letter confirming substantial equivalence. | ||
| Sterilization & Shelf-Life | (Not Applicable) The device is not provided sterile and has no shelf-life. | "The Ascom Cardiomax is not provided sterile and is not intended to be sterilized by the user. Additionally, the Ascom Cardiomax does not have a shelf-life. Therefore, this section is not applicable." |
| Biocompatibility | (Not Applicable) The device does not directly or indirectly contact the patient. | "The Ascom Cardiomax does not directly or indirectly contact the patient. Therefore, this section is not applicable." |
| Intended Use | Provide an interface with clinical systems to forward information associated with particular events to designated display devices. For medical, near real-time alarms, serve as a parallel, redundant, forwarding mechanism to inform healthcare professionals. Does not alter primary medical device behavior. Display device provides visual, audio, and/or vibrating alert. Intended as a secondary alarm, not a replacement for the primary alarm function on the monitor. | The device description and "Indications for Use" statement align with the intended functions. The performance testing (bench and software) would implicitly validate that the device performs these functions as specified, though specific metrics for successful information forwarding or alert delivery are not presented in this summary. |
2. Sample size used for the test set and the data provenance
The provided 510(k) summary does not specify a sample size for a test set in the context of clinical or data-driven validation. The performance testing described focuses on engineering and system-level validation (software, electrical safety, EMC, bench performance). Given the nature of the device (a middleware for forwarding alerts), a "test set" in the sense of clinical data cases (e.g., medical images or patient records) is not directly applicable in the way it would be for a diagnostic AI device.
The provenance of data is not applicable as this is a communication and alert forwarding system, not a device that processes clinical data for diagnosis or prognosis.
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 communication system, not a diagnostic tool that requires expert-established ground truth from clinical data.
4. Adjudication method for the test set
Not applicable for the same reasons as above.
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, an MRMC study was not done. This device is not an AI-assisted diagnostic tool for human readers; it is a system for forwarding alerts.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is essentially a "standalone" algorithm/system in its function of acquiring, formatting, and forwarding data. The "Performance Testing - Bench" and "Software Testing" sections describe the standalone performance validation, indicating that the system meets its predetermined specifications. However, this is not a "standalone performance" in the context of diagnostic accuracy but rather functional performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the various tests conducted (Software, Electrical Safety, EMC, Bench Performance), the "ground truth" would be established by the predetermined specifications and applicable engineering/safety standards. For example, for software, the ground truth is adherence to the functional requirements defined in the software development process. For electrical safety, the ground truth is compliance with specified safety standards. This is not clinical ground truth.
8. The sample size for the training set
Not applicable. This device is not an AI/ML model that undergoes a "training" phase with a dataset. It is a communications middleware that follows programmed logic.
9. How the ground truth for the training set was established
Not applicable for the same reasons as above.
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