(43 days)
The EWC: ECG Cable and Leadwire Systems are reusable electrode cable systems used to transmit signals from patient electrodes (not supplied by EWC) to various electrocardiograph recorders/monitors (not supplied by EWC) for both diagnostic and monitoring purposes. The EWC: ECG Cable and Leadwire Systems are limited by the indications for use of the connected monitoring or diagnostic equipment. Such equipment is commonly located in hospitals, doctor's offices, emergency vehicles, as well as in home use.
The EWC: ECG Cable and Leadwire Systems are reuseable electrode cables designed to transmit signals from the patient electrode (not supplied by EWC) to various electrocardiograph recorders/monitors (not supplied by EWC) for both diagnostic and monitoring purposes. This device is common to both the industry and to most medical establishments. The EWC Cable and Leadwire Systems is offered in various configurations of cable types (3, 5, 7 and 10 lead versions), various lead styles (length, color, etc.) and various electrode connector configurations (snaps, grippers and pins).
Here's an analysis of the provided text regarding the acceptance criteria and study for the EWC: ECG Cable and Leadwire Systems:
Acceptance Criteria and Study Details for EWC: ECG Cable and Leadwire Systems
The provided document describes the 510(k) submission for the EWC: ECG Cable and Leadwire Systems, demonstrating substantial equivalence to a predicate device. The information primarily focuses on compliance with established standards and comparison to a legally marketed device rather than a traditional clinical study with detailed performance metrics against specific quantitative acceptance criteria.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the regulatory standards and the performance of the predicate device. The reported device performance is qualitative, stating compliance and comparability.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Compliance with 21 CFR Part 898 (Performance Standard for Electrode Lead-wire and Patient Cables) | "The EWC: ECG Cable and Leadwire Systems was tested to the requirements of 21 CFR 898 and shown to comply with the performance standard." |
| Performance comparable to Tronomed Patient Cable and Lead Wire Systems (predicate device) | "Simulated use testing was also completed on both the predicate device cable and leadwire system and compared against the same tests conducted on the EWC: ECG Cable and Leadwire Systems and no significant difference in performance could be observed." "it is felt that the EWC: Cable and Leadwire Systems performs as expected and compares well, in terms of overall performance to the selected Tronomed device (predicate device)." |
| Adherence to relevant tests within ANSI/AAMI EC53-1995 (voluntary standard) | "a number of the test identified in the standard were performed, as necessary to evaluate the overall cable design and utility." |
Note: The document does not provide specific quantitative thresholds for acceptance (e.g., signal-to-noise ratio, impedance values, durability cycles) or quantitative performance data. The "performance" is reported as compliance and equivalence.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not explicitly state the sample size for the "simulated use testing" or other engineering/design tests. It refers to "the predicate device cable and leadwire system" and "the EWC: ECG Cable and Leadwire Systems," implying at least one unit of each configuration tested.
- Data Provenance: The testing was conducted by EWC itself ("Test Summary and Conclusion" from EWC). The provenance is therefore internal company testing. The country of origin for the data is implicitly the manufacturing location (Waupun, WI, USA) or the submitter's location (Pewaukee, WI, USA). The study is retrospective in the sense that it evaluates a developed product against existing standards and a predicate device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
N/A. This scenario does not involve establishing ground truth from expert consensus in the way a diagnostic AI study would. The performance is assessed against technical standards and comparison to a predicate device, not against clinical expert interpretations.
4. Adjudication Method for the Test Set
N/A. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where expert consensus is needed to resolve discrepancies in ground truth labeling. This type of testing involves engineering and performance comparisons.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. These studies are common for evaluating diagnostic AI systems and their impact on human reader performance. This submission is for a medical device (cables and leadwires) and focuses on engineering performance and substantial equivalence.
6. Standalone Performance Study (Algorithm Only)
Yes, in a way. The "Test Summary and Conclusion" describes testing of the EWC: ECG Cable and Leadwire Systems itself against the requirements of 21 CFR 898 and compared to the predicate device. While not an "algorithm" in the AI sense, this is a standalone performance evaluation of the device as a product. The human element would be in connecting and using the cables, but the core "performance" being evaluated is the physical and electrical characteristics of the cable system.
7. Type of Ground Truth Used
The "ground truth" for this device's evaluation is primarily:
- Regulatory Standards: Specifically, 21 CFR Part 898.
- Performance of a Predicate Device: The Tronomed Patient Cable and Lead Wire Systems.
- Voluntary Industry Standards: Relevant tests from ANSI/AAMI EC53-1995.
This is not a ground truth derived from expert consensus, pathology, or outcomes data in a clinical trial sense. It's a technical and regulatory "ground truth."
8. Sample Size for the Training Set
N/A. This is not an AI/machine learning device. Therefore, there is no "training set." The device is a physical product, and its design and manufacturing are based on engineering principles and regulatory requirements, not data-driven learning.
9. How the Ground Truth for the Training Set Was Established
N/A. As there is no training set for an AI model, this question is not applicable.
§ 870.2900 Patient transducer and electrode cable (including connector).
(a)
Identification. A patient transducer and electrode cable (including connector) is an electrical conductor used to transmit signals from, or power or excitation signals to, patient-connected electrodes or transducers.(b)
Classification. Class II (performance standards).