(64 days)
The EWC: ECG II Cable and Leadwire Systems are reusable electrode cable systems used to transmit signals from patient electrodes (not supplied by EWC) to various electrocardiographic recorders and/or monitors (not supplied by EWC) for both diagnostic and monitoring purposes. The EWC: ECG II Cable and Leadwire System is limited by the indication 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 II Cable and Leadwire System is a reusable electrode cable designed to transmit signals from the patient connect electrodes (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: ECG II Cable and Leadwire System is offered in a 3, 5, 7, and 10 lead design. All cables have detachable leadwires that have AAMI compatible plug (patient side) and are supplied with user defined patient electrode connectors (snap, banana, pin or gripper style).
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| Mandatory Performance Standard: 21 CFR Part 898: Performance Standard for Electrode Leadwire and Patient Cables (effective May 11, 1998) | "shown to comply" |
| Voluntary Standard: ANSI/AAMI, EC53-1995, ECG Cables and Leadwires | "Laboratory testing indicates compliance to the standard." |
| Voluntary Standard: ANSI/AAMI, EC13-92, Standard, Cardiac monitors, heart rate meters and alarms; part 3.1.1.5 only (Color coding for labels and leadwire requirements) | "Color coding for the labels and leadwires comply with the ANSI/AAMI standard EC13-92... Visual inspection confirms appropriate color coding." |
| Comparative Performance to Predicate Device: Tronomed Patient Cable and Lead Wire Systems | "favorable and similar performance of both cables" (EWC: ECG II Cable and Leadwire System vs. Tronomed) |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: The document specifies "a five lead version of the predicate device and the five lead version of the EWC: ECG II Cable and Leadwire System" were used for simulated use testing. This indicates a sample size of one of each device type (total of two devices) for this specific test.
- Data Provenance: The document does not explicitly state the country of origin of the data. Given the context of FDA submission in the US, it's highly probable the testing was conducted in the United States. The testing appears to be prospective as it's described as "Simulated use testing" and "Laboratory testing" conducted to show compliance before market release.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not specify the number of experts or their qualifications for establishing ground truth. The evaluation largely relies on compliance with established technical standards (21 CFR 898, ANSI/AAMI EC53-1995, ANSI/AAMI EC13-92) and comparative testing with a predicate device, rather than expert-derived ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
The document does not describe any adjudication method. It primarily relies on objective measurements against engineering standards and comparison with a predicate device. Visual inspection for color coding is mentioned, implying a single assessment or team assessment without a formal adjudication process described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, an MRMC comparative effectiveness study was not done. This device is an ECG cable and leadwire system, a hardware accessory for medical monitoring equipment. It does not involve AI or human readers in the way typically seen in diagnostic AI systems.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical cable and leadwire system, not an algorithm, so a standalone algorithm-only performance assessment is irrelevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is primarily compliance with mandatory and voluntary engineering/performance standards (21 CFR Part 898, ANSI/AAMI EC53-1995, ANSI/AAMI EC13-92). Additionally, comparative technical performance against a legally marketed predicate device served as a form of reference for "expected performance." There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for this type of device.
8. The sample size for the training set
Not applicable. This device is a hardware component and does not involve a "training set" in the context of machine learning or AI algorithms.
9. How the ground truth for the training set was established
Not applicable. See point 8.
§ 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).