(162 days)
The Spacelabs Pathfinder SL Holter Analyzer is intended to be used to analyze recordings of ambulatory electrocardiograms made on compatible Holter recorders. It is capable of detecting certain abnormal arrhythmias, and allows the operator to view and edit the ECG and the analysis results, and construct a report for physician use.
The Spacelabs Pathfinder SL Holter Analyzer is intended for use on adult patients only as a screening device to determine the need for clinical diagnosis and evaluation by polysomnography based on the patient's score. The ECG recording may be obtained at any location specified by a physician including home, hospital or clinic. Subjects screened for sleep apnea should have periods of sleep of at least 4 hours duration during which the ECG is predominantly sinus rhythm in nature.
Spacelabs Pathfinder SL Holter Analyzer (Pathfinder SL) is a software-only ECG analysis system for recording and analyzing up to 24 hours of 12 lead EGC or seven days of continuous 3 lead ambulatory ECG. Pathfinder SL is designed to operate on a Microsoft Windows® based personal computer (PC) platform, and contains provisions for networking. Pathfinder SL is compatible with Windows XP, Vista, or Windows 7 32-bit (ensure the latest service packs installed) operating systems.
Pathfinder SL is used in conjunction with Spacelabs Healthcare's Sentinel Cardiology Information Management System (Sentinel), and is sold only for use with Sentinel.
In conjunction with Sentinel, Pathfinder SL can acquire data from Spacelabs Holter recorders, analyze up to 12 channels of ECG data, providing classification, editing, and reporting of arrhythmia, ST segment, heart rate variability and pacer performance, and allows the operator to construct a report for physicians to use within their diagnosis of patients. Pathfinder SL is compatible with Lifecard CF, Lifecard 12, evo and Aria Holter Recorders.
ECG from pre-existing stored analyses created with the previous Spacelabs Healthcare Impresario or Pathfinder Holter analyzer systems can be analyzed from scratch using Pathfinder SL.
Pathfinder SL should be used by an operator trained in electrocardiography. A qualified medical practitioner should make any diagnosis.
Acceptance Criteria and Device Performance Study for Spacelabs Pathfinder SL Holter Analyzer
This analysis is based on the provided 510(k) Premarket Notification summary for the Spacelabs Pathfinder SL Holter Analyzer (K110001).
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Standard | Reported Device Performance |
|---|---|
| Internal requirements | "Test results indicated that the Pathfinder SL complies with its predetermined specification." |
| IEC 60601-2-47: 2001, Medical electrical equipment - Particular requirements for the safety including essential performance, of ambulatory electrocardiographic systems | "Test results indicated that the Pathfinder SL complies with... the applicable Standards." (Implicitly includes this standard, as it is listed as one of the applicable standards for performance testing). |
| ANSI/AAMI EC57: 1998, Testing and reporting performance results of cardiac rhythm and ST-segment measurement algorithms | "Test results indicated that the Pathfinder SL complies with... the applicable Standards." (Implicitly includes this standard, as it is listed as one of the applicable standards for performance testing). |
| ANSI/AAMI EC38: 1998, Ambulatory electrocardiographs | "Test results indicated that the Pathfinder SL complies with... the applicable Standards." (Implicitly includes this standard, as it is listed as one of the applicable standards for performance testing). |
| FDA guidance: The content of premarket submissions for software contained in medical devices, 11 May 05 | "Software device modifications made to the Pathfinder SL were designed and developed according to a robust software development process, and were rigorously verified and validated... Test results indicate that the Pathfinder SL complies with its predetermined specification." (Implicitly, adherence to FDA guidance is part of the robust development process and compliance). |
| FDA guidance: Off-the-shelf software use in medical devices, 09 Sep 99 | "Software device modifications made to the Pathfinder SL were designed and developed according to a robust software development process, and were rigorously verified and validated... Test results indicate that the Pathfinder SL complies with its predetermined specification." (Implicitly, adherence to FDA guidance is part of the robust development process and compliance). |
| FDA guidance: General principles of software validation; Final guidance for industry and FDA staff, 11 Jan 02 | "Software device modifications made to the Pathfinder SL were designed and developed according to a robust software development process, and were rigorously verified and validated... Test results indicate that the Pathfinder SL complies with its predetermined specification." (Implicitly, adherence to FDA guidance is part of the robust development process and compliance). |
| Safety and effectiveness as per intended use and labeling | "Verification and validation activities were conducted to establish the performance and safety characteristics of the software device modifications made to the Pathfinder SL. The results of these activities demonstrate that the Pathfinder SL is safe and effective when used in accordance with its intended use and labeling." This also forms the basis for the "Substantially Equivalent" determination. |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not explicitly state the sample size used for the performance test set.
- Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It only mentions "[acquiring] data from Spacelabs Holter recorders."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The 510(k) summary does not specify the number of experts used to establish ground truth for the test set, nor does it detail their qualifications. The device is intended to "allow the operator to view and edit the ECG and the analysis results, and construct a report for physician use," and that "A qualified medical practitioner should make any diagnosis." This implies human review, but the details of ground truth establishment for the test set are not provided.
4. Adjudication Method for the Test Set
The 510(k) summary does not describe the adjudication method used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The 510(k) summary does not mention or provide details of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. Therefore, no effect size of human readers improving with or without AI assistance is reported. The device is a "software-only ECG analysis system" used in conjunction with human operators and physicians for diagnosis.
6. Standalone Performance Study
Yes, a standalone performance study was done for the algorithm. The "Performance Testing" section states, "The Pathfinder SL was tested for performance in accordance with internal requirements and the applicable portions of the following Standards," and "Test results indicated that the Pathfinder SL complies with its predetermined specification and with the applicable Standards." This implies testing of the algorithm's performance independent of human-in-the-loop improvements, demonstrating its ability to detect arrhythmias and analyze ECG data.
7. Type of Ground Truth Used
The type of ground truth used for the performance testing is not explicitly stated beyond adherence to internal specifications and external standards (IEC 60601-2-47, ANSI/AAMI EC57, ANSI/AAMI EC38). These standards typically involve databases with expert-annotated arrhythmias or synthesized signals with known characteristics. However, the specific methodology for establishing ground truth as applied to this device's test set is not detailed.
8. Sample Size for the Training Set
The 510(k) summary does not state the sample size for the training set. It primarily focuses on the device's performance against established standards and internal specifications after development.
9. How the Ground Truth for the Training Set Was Established
The 510(k) summary does not describe how the ground truth for the training set was established. As this is a 510(k) submission, the emphasis is on demonstrating substantial equivalence to a predicate device and adherence to recognized standards, rather than the developmental details of a novel algorithm's training process.
§ 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).