(270 days)
The SpaceLabs Medical Cardiology Workstation is intended for use with the SpaceLabs Medical ECG Recorder to provide for the analysis of ambulatory ECG data. After the recording is made on the ECG Recorder. the Cardiology Workstation analyzes the ECG waveform data for the duration of the recording and produces a series of reports summarizing the overall activity on the recording and highlighting significant clinical events. The system provides for review of the automated analysis and for a qualified user to make editing changes to the automated results.
The Cardiology Workstation can also receive input from an analog-based cassette tape ambulatory recorder and an infrared serial link, as well as from the SpaceLabs PCMS monitoring network to provide for the collection. review, editing, printing and archiving of waveform data records.
The SpaceLabs Medical ECG Analysis System provides the means via a lightweight, portable recording device to ambulatory patient continuously continuously record electrocardioaraphic (ECG) data over a 24-hour period through a digital solid-state flash memory card for subsequent review and processing on an analysis workstation.
Workstation consists of a generally-available The Pentium® based personal computer system with an SVGA monitor, laser printer and keyboard, with optional mouse and CD-ROM drive, running Windows NT or Windows 95 and SpaceLabs Medical proprietary software. The Workstation is designed to accept input from a digital flash memory card, an analog cassette tape, or via an IR Serial Link to a portable recorder. The workstation also has the capability to interface via an Ethernet link with the SpaceLabs Medical Patient Care Management System (PCMS) to offer support for the collection, review, editing, archiving and printing of patient cardiac waveform data available from a clinical network.
Workstation software provides the capability for the processing of waveform data for display, editing, and analysis, the printing of reports, and the management of patient information. 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.
This 510(k) summary does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a study proving device performance. The summary focuses on demonstrating substantial equivalence to predicate devices rather than providing a comprehensive clinical or performance study breakdown.
Here's an analysis of what can be extracted and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance (as per 510(k) Summary) |
|---|---|
| Functional Requirements | "designed to ensure that the device meets all of its functional requirements" (General statement, no specific metrics provided) |
| Performance Specifications | "designed to ensure that the device meets all of its... performance specifications." (General statement, no specific metrics provided) |
| Clinical Output Data Requirements | "The ECG Analysis system meets the specified clinical output data requirements of the ANSI/AAMI EC38-1994 specification for ambulatory electrocardiography." (Specific standard cited, but no quantitative performance data, e.g., sensitivity, specificity, accuracy for specific ECG events, are given.) |
| Safety Tests | "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." (General statement, no specific test results or standards enumerated beyond "industry and safety standards.") |
Missing Information:
- Specific quantifiable acceptance criteria: The document refers to "functional requirements" and "performance specifications" but does not define what these are (e.g., minimum sensitivity, specificity, accuracy for arrhythmia detection, QRS detection accuracy, etc.).
- Quantifiable reported device performance data: The summary states the device meets requirements but doesn't provide the actual performance metrics (e.g., "98% sensitivity for VTAC detection," or "QRS detection accuracy of 99.5%"). It only references compliance with a standard (ANSI/AAMI EC38-1994) for clinical output data.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated. The summary mentions "Standard databases have been used for automated ECG algorithm verification testing." This suggests a test set was used, but its size is not provided.
- Data Provenance: "Standard databases" – details about the specific databases (e.g., name of database, country of origin, retrospective/prospective nature) are not provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not explicitly stated. While ground truth would have been established for the "standard databases," the 510(k) summary does not detail how many experts were involved or their qualifications for this process.
4. Adjudication Method for the Test Set
- Not explicitly stated. Given the use of "standard databases," the adjudication method would have been inherent to those databases, but the summary does not describe it.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No, this type of study is not mentioned. The summary focuses on the device's technical specifications and compliance with a standard, not on a comparison of human reader performance with and without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
- Yes, implied. The statement "Standard databases have been used for automated ECG algorithm verification testing" strongly suggests that the algorithm's performance was evaluated in a standalone manner against these databases. However, no specific standalone performance metrics (e.g., sensitivity, specificity, PPV, NPV for various ECG events) are reported.
7. The Type of Ground Truth Used
- Expert Consensus / Reference Standard: The use of "Standard databases" implies that a reference standard (likely expert-adjudicated annotations) was used to establish ground truth for the verification of the automated ECG algorithm. The exact nature (e.g., pure expert consensus, comparison to another gold standard) is not specified.
8. The Sample Size for the Training Set
- Not explicitly stated. The summary does not provide any information about the data used to train the ECG analysis algorithm. It only discusses the verification/test set.
9. How the Ground Truth for the Training Set Was Established
- Not explicitly stated. Since information on the training set itself is missing, how its ground truth was established is also not provided.
In summary, as typical for 510(k) summaries from this era (1997), the document provides high-level assurance of equivalence and adherence to standards rather than detailed reporting of clinical study design and quantifiable performance metrics that are common in more recent submissions. The focus is on demonstrating that the device is "as safe and effective as the predicate devices and raises no new issues."
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).