(129 days)
The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.
Physiological parameters that may be monitored include ECG with arrhythmia detection, respiration, invasive and noninvasive blood pressure, temperature, oxygen saturation (SpO2) and cardiac output. Acquired data may then be communicated to an information network for display, recording, editing and analysis.
The Spacelabs Multi-parameter Module provides monitoring capability for the following parameters: ECG with arrhythmia detection, respiration, invasive and noninvasive blood pressure, temperature, oxygen saturation (SpO2) and cardiac output. It is a "plug-in" module that is used in conjunction with a Spacelabs Monitoring Station such as the Model 91387.
The patient is connected to the Spacelabs Multi-parameter Module via parameter-specific cables/sensors which provide the monitor with the patient's physiological data. The physiological data for each active parameter is accumulated by the Spacelabs Multi-parameter Module, and sent to the monitor which performs any necessary analysis and provides both waveform data and numeric values for display on the monitor screen. The monitor provides the display and printing capabilities for the care provider.
Setting of alarm limits, enabling or disabling alarm monitoring, and definition of alarm responses are determined on a parameter-byparameter basis, and can be defined by the user for each parameter. In general, alarm limits can be set to provide the user with both audible and visible indications of the alarm condition. Each parameter provides a hierarchy of menu structures and keys that are activated through controls of the monitor by touching the monitor screen.
Each parameter provides the capability to output recordings of selected information to a variety of recording devices. Recordings are available using the Spacelabs Monitor internal printer, network printers, and the Intesys Clinical Suite Print Manager Model 91881. Recordings can be automatically generated by each of the parameter's alarm managers or manually generated.
The Spacelabs Multi-parameter Module utilizes the same technology for each parameter as utilized by the predicate device.
Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and the study proving the device meets them:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria Category | Reported Device Performance | Comments |
|---|---|---|
| Sterilization & Shelf-Life | Not applicable | Device is not sterilized or sterilizable by the user. Software modifications did not affect accessories that are. |
| Biocompatibility | Not applicable | Device is not intended for direct or indirect patient contact. Software modifications did not affect accessories that are. |
| Software Testing | Complies with predetermined specifications | Designed and developed according to a robust software development process; rigorously verified and validated. Complies with FDA guidance for software in medical devices. |
| Electrical Safety & Electromagnetic Compatibility | Not applicable | Software modifications did not affect these aspects; no hardware modifications were made. |
| Performance Testing - Bench | Performance equal to or better than the predicate device | Tested in accordance with ANSI/AAMI EC57: 1998 / (R) 2003, in addition to software verification and validation. |
| Performance Testing - Animal | Not applicable | Not necessary to demonstrate safety and effectiveness. |
| Performance Testing - Clinical | Not applicable | Not necessary to demonstrate safety and effectiveness. |
2. Sample size used for the test set and the data provenance:
- The document does not specify a numerical sample size for a dedicated "test set" in the context of clinical or large-scale data evaluation.
- The performance testing primarily focuses on software verification and validation and bench testing against a standard (ANSI/AAMI EC57: 1998 / (R) 2003) and comparison to a predicate device. This suggests internal testing and adherence to engineering standards rather than external data-driven validation.
- Data provenance is not explicitly mentioned as no clinical or animal performance testing was deemed necessary. The evaluation seems to be based on engineering benchmarks and comparisons to the predicate device's established performance.
3. 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):
- This information is not provided in the submission. Given that clinical and animal testing were deemed not applicable, and the focus was on software and bench testing, expert review for ground truth on patient data (such as for arrhythmia detection accuracy) is not described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not provided. As clinical and animal testing were not performed, and no external expert review of patient cases is described, an adjudication method for a test set is not detailed.
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 MRMC comparative effectiveness study was performed or described. The device is a multi-parameter module that includes arrhythmia detection, which is typically an algorithmic function, not a human-in-the-loop AI assistance tool that would necessitate an MRMC study. The comparison is between the modified device and its predicate, based on technical performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in essence. The "Software Testing" and "Performance Testing - Bench" sections evaluate the device's inherent performance. The arrhythmia detection component would inherently be a standalone algorithmic function within the module. The document states:
- "Test results indicate that the Spacelabs Multi-parameter Module complies with its predetermined specification." (Software Testing)
- "Test results demonstrate performance equal to or better than the predicate device." (Performance Testing - Bench, which includes testing in accordance with ANSI/AAMI EC57 for ECG/arrhythmia).
- These statements imply that the algorithm's performance was evaluated in isolation to ensure it met its defined specifications and performed comparably to the predicate device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the software and bench testing, the "ground truth" would be the expected output or reference standard defined by the product's specifications and the requirements of standards like ANSI/AAMI EC57. For instance, in arrhythmia detection, this would involve synthetic ECG signals with known arrhythmias, or recorded physiological data where arrhythmias have been definitively identified by established methods (though specifics of how this ground truth was established for the test data are not detailed in this summary). The comparison to the predicate device also implies its established performance serves as a benchmark for "ground truth."
8. The sample size for the training set:
- This information is not provided. The submission details modifications to an existing device rather than the development of a novel algorithm that would typically involve a distinct "training set." The software development process mentioned implies iterative testing and refinement, but specifics of data used for internal training are not disclosed.
9. How the ground truth for the training set was established:
- As a "training set" is not explicitly mentioned, the method for establishing its ground truth is not described. For an algorithmic component like arrhythmia detection, initial development (training) would likely involve a combination of expert-annotated ECG waveforms (synthetic or recorded) and adherence to physiological principles. However, the 510(k) focuses on the modifications' verification and validation against existing standards and the predicate, not the original algorithm's development.
§ 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.