(99 days)
PC1 Monitor - The Spacelabs Medical PC1 monitor is intended for use in any hospital environment as a bedside or central station patient monitor. The PC1 monitor is capable of displaying any of the patient parameters currently available through Spacelabs Medical.
Universal Clinical Workstation (UCW) - The Universal Clinical Workstation (UCW) is intended for use in any hospital environment as a bedside or central station patient monitor. The UCW is capable of displaying any of the patient parameters currently available through Spacelabs Medical.
PC Scout Monitor - The PC Scout is a lightweight, battery-powered or line powered monitor that is fully compatible and used in either bedside operation or in patient transport. The PC Scout is capable of displaying any of the patient parameters currently available through Spacelabs Medical.
General Spacelabs Medical PCIS Patient Monitor Intended Use Statement
Spacelabs Medical PCIS patient monitors passively display data generated from Spacelabs Medical patient parameter modules, Flexport interfaces, gas analyzers, and other SDLC based products. Spacelabs Medical PCIS patient monitors may also function as a generic display or computer terminal. As a generic display or terminal, the PCIS patient monitors allow networkbased applications to open windows and display information on other networked monitors.
PCIS patient monitors is intended to sound various alarm tones that are generated by the specific PCIS patient parameter modules. Each patient parameter module determines (a) when an alarm condition is violated; (b) the alarm priority (i.e. high, medium or low); (c) alarm limits; and (d) when to generate and terminate alarms. PCIS patient monitors are also capable of displaying alarm conditions on other monitors that are on the network through the Alarm Watch feature.
Spacelabs Medical PCIS patient monitors are designed to communicate with a variety of external devices such as display devices, network devices, serial devices, user input devices, audio system, local/remote recorders and Spacelabs Medical patient parameter modules.
In all applications, Spacelabs Medical PCIS patient monitors provide access to that data on the Spacelabs Medical network either via hardwire or wireless transmission .. Through this network, a patient's data may be displayed at the bedside monitor, central station or a clinical information system.
Spacelabs Medical PCIS patient monitors (code name "Viper") passively display data generated from Spacelabs Medical patient parameter modules, Flexport interfaces, gas analyzers, and other SDLC based products. Spacelabs Medical PCIS patient monitors may also function as a generic display or computer terminal. As a generic display or terminal, the PCIS patient monitors allow network- based applications to open windows and display information on other networked monitors.
The modifications to the Spacelabs Medical PCIS patient monitor design specified in this submission incorporate performance and functional enhancements. More specifically, different microcomputer processor hardware was incorporated into the modified design. In addition, the executive software has been changed to VxWorks, thereby requiring a significant change/conversion from the existing platform.
The provided document describes a 510(k) submission for modifications to the Spacelabs Medical PCIS Patient Monitors. This submission is primarily focused on demonstrating substantial equivalence to previously marketed devices rather than presenting a performance study with acceptance criteria against a defined ground truth for a new diagnostic or prognostic algorithm.
Therefore, many of the requested details related to acceptance criteria, study design, expert involvement, and ground truth establishment are not applicable to this type of regulatory submission. The document emphasizes safety and functional enhancements, a change in microcomputer processor hardware, and a software conversion (executive software changed to VxWorks).
Here's an analysis based on the information provided:
Description of Acceptance Criteria and the Study that Proves the Device Meets Acceptance Criteria
This 510(k) submission for the modified Spacelabs Medical PCIS Patient Monitors does not define specific performance-based acceptance criteria in the manner typically seen for diagnostic devices (e.g., sensitivity, specificity, AUC thresholds). Instead, the "acceptance criteria" are implicitly tied to demonstrating substantial equivalence to existing predicate devices and meeting general safety and performance expectations for patient monitors.
The "study" to prove the device meets these criteria is a technical and safety evaluation rather than a clinical effectiveness study.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Functional Equivalence (Display data from modules, act as generic display/terminal, support network applications, sound alarms, communicate with external devices, provide network access for patient data) | "Spacelabs Medical PCIS patient monitors passively display data generated from Spacelabs Medical patient parameter modules, Flexport interfaces, gas analyzers, and other SDLC based products." |
| "Spacelabs Medical PCIS patient monitors may also function as a generic display or computer terminal." | |
| "PCIS patient monitors is intended to sound various alarm tones that are generated by the specific PCIS patient parameter modules." | |
| "Spacelabs Medical PCIS patient monitors are designed to communicate with a variety of external devices..." | |
| "In all applications, Spacelabs Medical PCIS patient monitors provide access to that data on the Spacelabs Medical network..." | |
| The device is stated to incorporate "performance and functional enhancements." | |
| Technological Equivalence (Similar design, components, energy source to predicate devices) | "The design, components used in the modified Spacelabs Medical PCIS Patient Monitors, and energy source are similar to its predicate devices." |
| "More specifically, different microcomputer processor hardware was incorporated into the modified design. In addition, the executive software has been changed to VxWorks, thereby requiring a significant change/conversion from the existing platform." (Acknowledged difference, but justified as not raising new issues). | |
| Safety and Performance Compliance (Meeting functional requirements, performance specifications, and applicable industry/safety standards) | "The modified Spacelabs Medical PCIS Patient Monitors shall be subject to extensive safety and performance testing prior to release." |
| "Final testing for the system shall includes various performance tests designed to ensure that the device will meet all of its functional requirements and performance specifications." | |
| "Safety and standards testing are to be performed by third-party agencies to ensure the system complies with applicable industry and safety standards." | |
| Conclusion: "the modified Spacelabs Medical PCIS Patient Monitors are as safe and effective as the predicate devices and raises no new issues." |
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a test set with a specific sample size of patient data or cases. The "testing" mentioned refers to engineering and quality assurance verification and validation activities for the device's hardware and software, rather than a clinical performance study using patient data. Therefore, data provenance (country of origin, retrospective/prospective) is not applicable.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable as there is no mention of a test set requiring expert ground truth establishment in the context of clinical interpretation (e.g., image reading, diagnosis). The device is a patient monitor displaying data, not an AI/diagnostic algorithm interpreting data.
4. Adjudication Method for the Test Set
This information is not applicable for the same reasons as point 3.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not conducted or described. This type of study is relevant for AI-assisted diagnostic tools where human readers' performance with and without AI assistance is evaluated. The modified Spacelabs Medical PCIS Patient Monitor is a display and communication device, not an AI diagnostic aid requiring human interpretation of its output. Therefore, effect size of human improvement with AI assistance is not applicable.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
A standalone performance study in the context of an AI algorithm is not applicable. The device's "performance" is related to its ability to accurately display data, sound alarms, and communicate, which is verified through engineering tests, not an algorithm's diagnostic output.
7. Type of Ground Truth Used
The concept of "ground truth" as expert consensus, pathology, or outcomes data is not applicable here. The "ground truth" for this device would be the reference measurements from the patient parameter modules themselves and the validated functionality of the device's hardware and software against its design specifications and industry standards.
8. Sample Size for the Training Set
This information is not applicable. The device is a patient monitor with display and communication functions; it does not involve an AI model or algorithm that requires a training set of data. The software changes refer to the executive operating system (VxWorks) rather than a learning model.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as point 8.
§ 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.