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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

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.

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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.

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.

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