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Tyco Electronics Electrocardiograph (ECG) Leadwire Sets are indicated for use in the monitoring of cardiac signals for both diagnostic and monitoring purposes. Use is limited by the indications for use of the connected monitoring or diagnostic equipment.

Tyco Electronics Electrocardiograph (ECG) Leadwire Sets are intended for use with ECG monitors manufactured by Philips Medical Systems. Both the Philips and the Tyco Electronics groups of leadwire sets are designed specifically for compatibility with Philips ECG monitors and consist of insulated copper conductors with connectors on each cable end. The term leadwire set includes ECG leadwires as well as the attached proximal and distal connectors. Leadwire sets are used to transfer signals originating from skin-mounted ECG electrodes (distal end) to a patient monitoring device (proximal end). Tyco Electronics ECG Leadwire Sets are single-use devices within the meaning of that term as used by FDA - that is, they cannot be reprocessed and re-used. As described by FDA, a single-use device, also referred to as a disposable device, is not intended to be reprocessed (cleaned, disinfected/sterilized) and used on another patient. All leadwire sets addressed within this 510(k) submission are produced in a configuration that is shielded against electromagnetic interference; they are single-use devices, not sterilizable and not reusable, intended for short-term use only (recommended use duration 7 days or less).

The provided text describes the submission of a 510(k) premarket notification for the Tyco Electronics Electrocardiograph (ECG) Leadwire Set. This document is for a medical device that acts as a conductor of electrical energy and is explicitly stated not to be an AI/ML device. Therefore, many of the requested categories related to AI/ML device studies (e.g., sample size for test set, number of experts, adjudication method, MRMC studies, standalone performance, training set size, ground truth for training set) are not applicable to this submission.

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

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that compliance with recognized standards will be achieved through verification testing. However, it explicitly mentions that testing against these standards is not complete at the time of 510(k) filing. Therefore, there is no table showing reported device performance against specific acceptance criteria for a completed study.

The acceptance criteria are generally defined by compliance with the following standards:

2. Sample size used for the test set and the data provenance:

• Sample Size: Not applicable. (The device is a physical medical electrical equipment component, not an AI/ML diagnostic software).
• Data Provenance: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. (No diagnostic ground truth is established for this device).

4. Adjudication method for the test set:

• Not applicable.

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/ML device).

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

• Not applicable. (This is not an AI/ML device).

7. The type of ground truth used:

• Not applicable. (The study focuses on compliance with electrical and biocompatibility standards for a physical device, not diagnostic ground truth).

8. The sample size for the training set:

• Not applicable. (No training set is involved for this physical device).

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

• Not applicable.

Summary of the Study and Device:

The device is the Tyco Electronics Electrocardiograph (ECG) Leadwire Set, intended to transmit cardiac signals from electrodes to Philips ECG monitors. Its substantial equivalence is claimed against Philips' ECG Cables (K020531). The primary difference noted is that the Tyco device is single-use, while the predicate is reusable.

The "study" in this context refers to verification testing against established medical device standards for electrical safety (IEC 60601-1, AAMI EC13, AAMI EC53) and biocompatibility (ISO 10993-5, ISO 10993-10). At the time of the 510(k) filing, these tests were not yet complete, but the manufacturer committed to completing them and meeting the specified acceptance criteria prior to market release. This approach demonstrates a plan to prove the device meets acceptance criteria, but the results are not included in this particular document.

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