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The Multi-Link X2 ECG Cable and Leadwire System is intended to transmit ECG signals from patient electrodes to patient monitors for monitoring purposes. The Multi-Link Cable and Lead Wire System is limited to indications for use of the connected monitoring equipment. The Multi-Link trunk cables) are reusable, nonsterile and can be reprocessed.

The Multi-Link™ X2 ECG Cable and Leadwire System is a product portfolio that is intended to transmit signals from patient electrodes to various electrocardiograph recorders / monitors for monitoring purposes. The system consists of Reusable Trunk Cables (K980582, K101660, K162432), Reusable Leadwires (K980582) and Disposable Single Patient Use Leadwires (K101660, K162432). The existing portfolio is compatible with the following ECG monitoring platforms: Philips, Mindray, Nihon Kohden, GE, and Spacelabs. The subject device of this pre-market notification consists of a modified set of Reusable Trunk Cables that are designed to be compatible with the following cardiac defibrillation systems: Physio Control Lifepak, Zoll R, and Zoll X monitoring platforms. The subject device is used to transmit signals from patient electrodes and sensors to support continuous ECG monitoring only. The subject device does not interpret or deliver the shock applied when the defibrillators are in use.

The provided text describes a 510(k) premarket notification for the "Multi-Link X2 ECG Cable and Leadwire System." This submission is to introduce a modified set of reusable trunk cables to expand system compatibility with additional FDA-cleared ECG monitoring platforms. The document outlines the device's intended use, indications for use, and a comparison to a predicate device (K162432).

Crucially, this document is for a medical device that transmits ECG signals from electrodes to monitors, i.e., it's a cable system. It is not an AI/algorithm-based diagnostic device. Therefore, the concepts of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the context of AI/algorithm performance (e.g., accuracy, sensitivity, specificity, expert ground truth, MRMC studies) are not applicable to this submission.

Instead, the acceptance criteria for this device are related to its electrical and mechanical performance, and its ability to properly and safely transmit signals without interference or degradation. The "study" proving it meets these criteria is a series of non-clinical performance tests against established industry standards.

Here's how to interpret the information provided in the context of the requested questions, noting where the requested information is not applicable:

1. A table of acceptance criteria and the reported device performance

For a cable system, acceptance criteria are typically defined by performance standards. The reported performance is "Pass" for all tests, indicating it met the criteria defined by the applicable standards.

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: Not explicitly stated in terms of number of cables tested, but the tests were performed on representative samples to demonstrate compliance with standards. For physical devices, sample sizes are typically determined by statistical methods or engineering judgment to ensure sufficient confidence in product safety and performance.
• Data Provenance: The testing is non-clinical performance testing of the device itself (a cable system), not data from patient studies. Therefore, concepts like "country of origin of the data" or "retrospective/prospective" do not apply. The tests were performed in a lab setting to relevant international and national standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

• Not Applicable. This is a hardware device (cable system) for signal transmission, not an AI/algorithm. "Ground truth" in the context of expert review of images or data is not relevant here. The ground truth for cable performance is defined by the technical specifications and standards (e.g., voltage, resistance, signal integrity, mechanical strength).

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Not Applicable. As explained above, this device does not involve human interpretation or subjective assessment of data for "ground truth" adjudication. The tests involve objective quantitative measurements against defined thresholds in relevant standards.

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

• Not Applicable. This is not an AI-assisted diagnostic device. MRMC studies are used to evaluate diagnostic accuracy and reader performance of AI systems.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable. This is a physical cable system, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• The "ground truth" for this device's performance is established by international and national engineering and medical device standards (e.g., ANSI AAMI IEC 60601 series, ANSI AAMI EC53, IEC 60068 series, IEC 60529). These standards define the acceptable performance characteristics for ECG cables, including electrical properties, mechanical durability, and safety features like defibrillation protection. The device's performance is measured against the thresholds and methodologies specified in these standards.

8. The sample size for the training set

• Not Applicable. This device does not use a "training set" as it is not an AI/machine learning algorithm.

9. How the ground truth for the training set was established

• Not Applicable. As above, no training set is used.

In summary, the document details the non-clinical performance testing of an ECG cable and leadwire system to demonstrate its substantial equivalence to a predicate device. The "acceptance criteria" are embodied by the various ANSI, AAMI, and IEC standards listed, and the "study" proving compliance is a series of laboratory tests where the device passed all criteria. The questions related to AI/algorithm development, such as "expert ground truth," "MRMC studies," and "training/test sets," are not relevant to this specific medical device submission.

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The Multi-Link™ X2 ECG Adapter and Direct Connect Lead Wire System are used in telemetry to transmit ECG signals from the electrodes to the transmitters on ambulatory patients within a defined coverage area for monitoring purposes. The Multi-Link Direct Connect Lead Wires are single-patient-use, non-sterile and cannot be reprocessed. The Multi-Link Adapters are reusable, non-sterile and can be reprocessed. The Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System are used with any patient population requiring ambulatory ECG, and are compatible with Philips, Mindray and Nihon Kohden electrocardiograph monitors.

The Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System is a combination of reusable adapters, already cleared lead wires (reusable K980582 and disposable single patient use K101660) and direct connect disposable single patient use lead wires, used to transmit signals from patient electrodes to the transmitters on ambulatory patients within a defined coverage area for monitoring purposes. This type of device is common to both the industry and to most medical establishments. The Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System are not stand alone devices, but are accessories to the host monitoring devices. The adapters and lead wires are conductors carrying the signal from the patient to the monitor.

This document is a 510(k) Premarket Notification from the FDA for a device called "Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System" (K163316). It primarily focuses on demonstrating substantial equivalence to predicate devices through performance and biocompatibility testing against international standards.

Given the nature of the device (ECG adapters and lead wires), the acceptance criteria are based on meeting specified performance standards rather than measures like accuracy, sensitivity, or specificity often associated with diagnostic AI tools. Therefore, information related to AI-specific elements such as training/test sets, ground truth establishment, expert adjudication, or MRMC studies for improved human reader performance will not be relevant.

Here's the breakdown of the acceptance criteria and study information provided:

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)

The document describes performance testing of physical components (adaptors and lead wires) against established engineering and safety standards. It does not refer to a "test set" in the context of clinical data or patient records. Therefore, information about sample size for a test set or data provenance (country of origin, retrospective/prospective) is not applicable or provided. The testing is likely conducted in a laboratory setting on a sample of manufactured devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not applicable. The device is a medical accessory, and its performance is evaluated against engineering and safety standards, not against "ground truth" established by clinical experts for diagnostic accuracy.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not applicable, as the testing involves meeting pre-defined objective engineering standards, not subjective clinical evaluations requiring adjudication.

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

An MRMC study is not relevant to this device. This device is an ECG adapter and lead wire system, which transmits ECG signals. It is not an AI-powered diagnostic tool, and therefore, there is no human reader "improvement with AI vs without AI assistance" to measure.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

This information is not applicable. The device is a physical accessory and does not contain an "algorithm" for standalone performance evaluation in this context.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device's performance is defined by the objective pass/fail criteria outlined in the referenced international engineering and safety standards (e.g., AAMI ANSI ES60601-1, AAMI ANSI IEC 60601-2-27, AAMI ANSI EC53, ISO 10993 series). There is no clinical "ground truth" like expert consensus or pathology involved in evaluating these performance characteristics.

8. The sample size for the training set

This information is not applicable. The device is a physical accessory and does not involve training data or algorithms in the way an AI-driven diagnostic device would.

9. How the ground truth for the training set was established

This information is not applicable for the reasons stated above.

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