(341 days)
The SpaceLabs Medical Multi-Disclosure Workstation is intended for use with the SpaceLabs PCMS monitoring network to provide for the collection, review, editing, printing and archiving of waveform data records (full disclosure and strips), 12-lead ECG diagnostic reports, and alarm recordings collected by monitors on the network.
Indications for Use:
- Data Access Provides the user with the means to collect multiple patient data directly from a hardwired or telemetry Patient Care Management System (PCMS) monitoring network.
- Data Storage Allows the user to retain up to 48 patient waveforms for up to 48 hours.
- Data Display - Allows the user to pull data from storage or during continuous monitoring by patient and parameter.
- Data Editing Provides the user with the means to edit 12-lead ECG waveform data and interpretation text from SpaceLabs Medical 12-lead modules connected to the Patient Care Management System (PCMS) monitoring network.
- Data Printing Allows the user to print time annotated waveforms and patient data on paper for review or archive history.
The SpaceLabs Medical Multi-Disclosure Workstation is a personal computer accessory with an Ethernet link to the SpaceLabs Medical PCMS network. The Workstation is a software application for a generally available Pentium® based computer system with an SVGA monitor, laser printer and keyboard, with optional mouse and CD-ROM drive, running Windows NT. The SpaceLabs Medical proprietary software consists of modules for monitoring census information on the PCMS network, collecting waveform, 12-lead and alarm data from the network, processing waveform data for display, printing reports, and managing patient information. The system provides full-disclosure waveform data, which provides a means to review continuous waveform data from a patient for one or more channels of data. Strips or disclosure print-outs of the data may be reviewed on-screen, printed, or saved for archival purposes and later side-by-side comparisons of previously stored data. The user may select from a variety of viewing and printing formats.
The provided text describes the SpaceLabs Medical Multi-Disclosure Workstation, an accessory to the SpaceLabs Medical PCMS network. The document is a 510(k) submission to the FDA, indicating it focuses on demonstrating substantial equivalence to predicate devices rather than proving novel performance.
Here's an analysis of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission primarily focuses on demonstrating substantial equivalence to predicate devices, rather than establishing specific, quantitative acceptance criteria for its own performance in a medical diagnosis context. The "performance" described is largely functional equivalence.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Equivalence to Predicate Devices: | The SpaceLabs Medical Multi-Disclosure Workstation provides support for the collection, review, editing, archiving, and printing of patient waveform data available from the PCMS network. It is stated to be "substantially equivalent to workstations currently marketed by Hewlett-Packard Company and Marquette Electronics, Inc." |
| - Collection of waveform data | Collects waveform, 12-lead, and alarm data from the network. |
| - Review of waveform data | Provides full-disclosure waveform data for review, on-screen. |
| - Editing of waveform data | Provides means to edit 12-lead ECG waveform data and interpretation text. |
| - Archival of waveform data | Saves data for archival purposes and later side-by-side comparisons. Allows printing for archive history. |
| - Printing of waveform data | Prints strips or disclosure print-outs. Allows printing of time annotated waveforms and patient data on paper. |
| - Data Storage | Allows the user to retain up to 48 patient waveforms for up to 48 hours. |
| - Data Display | Allows the user to pull data from storage or during continuous monitoring by patient and parameter, with a variety of viewing and printing formats. |
| Safety and Regulatory Compliance: | "The SpaceLabs Medical Multi-Disclosure Workstation has been subject to extensive safety and performance testing prior to release. Final testing for the system includes various performance tests designed to ensure that the device meets all of its functional requirements and performance specifications. Safety tests have further been performed by the various manufacturers of the required hardware components to ensure the system complies to applicable industry and safety standards." The FDA also states it "assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices" |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a test set sample size in terms of patient data or cases. The "testing" mentioned refers to functional and performance tests of the device itself and its compliance with standards, rather than a clinical study evaluating its diagnostic accuracy or impact on patient care using a specific dataset.
The data provenance (country of origin, retrospective/prospective) related to a specific test set is not mentioned, as such a test set for clinical performance is not detailed.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided. The document does not describe a clinical study where expert ground truth would be established for a test set.
4. Adjudication Method for the Test Set
This information is not provided. No clinical test set requiring adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No MRMC study is mentioned. The submission is focused on demonstrating substantial equivalence, not on comparing human reader performance with and without AI assistance. The device is a workstation for data management, not an AI diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the loop performance) Was Done
No "standalone" algorithm performance study is described in the context of an AI or diagnostic algorithm. The device itself is a "software application" that processes and displays data, but it explicitly states: "the SpaceLabs Medical Workstation does not support non-network applications and provides no analysis of physiological data." This suggests it does not contain a standalone diagnostic algorithm.
7. The Type of Ground Truth Used
The document does not describe the use of ground truth in the context of diagnostic performance (e.g., expert consensus, pathology, outcomes data). The "performance tests" mentioned are about the device's functional requirements and specifications.
8. The Sample Size for the Training Set
This information is not provided. The device is a workstation for data management and display; it is not described as an AI system that undergoes training on a dataset.
9. How the Ground Truth for the Training Set Was Established
This information is not provided, as the device is not described as an AI system requiring a training set with established ground truth.
§ 870.2450 Medical cathode-ray tube display.
(a)
Identification. A medical cathode-ray tube display is a device designed primarily to display selected biological signals. This device often incorporates special display features unique to a specific biological signal.(b)
Classification. Class II (performance standards).