Search Results

The ECG Disposable Lead Wires are intended to be used with ECG. The lead wire is used to connect electrodes placed at appropriate sites on the patient to ECG for general monitoring and/or diagnostic evaluation by health care professional.

The ECG Disposable Lead Wires are comprised of patient end termination, leadwire and patient leadwire connector. The device is used to transmit ECG signals from electrodes which are affixed to the patient's body for both diagnostic and monitoring purposes. Each lead wire is attached to ECG patient electrodes. The lead wire connector plugs into one end of the external trunk cable which are plug into an ECG monitor.

The provided document is a 510(k) premarket notification for an ECG Disposable Lead Wires device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving the device meets specific acceptance criteria in the context of an AI/ML algorithm or diagnostic accuracy testing.

Therefore, many of the requested details regarding acceptance criteria, study design for proving performance (e.g., sample size for test sets, expert involvement, MRMC studies, ground truth establishment), and specific performance metrics for an AI/ML device are not applicable to this type of submission.

The document states:

• "No clinical study is included in this submission." This explicitly means there isn't a study designed to prove clinical performance or diagnostic accuracy in the way described in your request.
• The "Non-Clinical Test Conclusion" section lists compliance with various electrical and biocompatibility standards, not performance against clinical acceptance criteria.
• The "Substantially Equivalent (SE) Comparison" table details similarities in product codes, regulations, classification, indications for use, anatomical sites, physical components, and compliance with general safety and performance standards for medical electrical equipment. It does not provide accuracy metrics or clinical performance data.

Given this, I can only extract information relevant to the device's characteristics and the basis for its marketing clearance, which is substantial equivalence to an existing legally marketed device, not a new performance claim based on a dedicated clinical study or AI algorithm validation.

Here's a breakdown based on the provided text, highlighting what is not available from this document:

Acceptance Criteria and Device Performance (as understood from a 510(k) for a conventional medical device)

The acceptance criteria for this device are largely implied by its substantial equivalence to the predicate device and compliance with recognized standards. The "performance" is demonstrated through meeting these standards and having similar characteristics to the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

• Indications for Use: "The ECG Disposable Lead Wires are intended to be used with ECG. The lead wire is used to connect electrodes placed at appropriate sites on the patient to ECG for general monitoring and/or diagnostic evaluation by health care professional." (Similar to predicate's broader use with ECG, EKG, SpO2, invasive BP monitoring devices)
• Anatomical sites: "Attached to electrodes placed at standard specified locations on chest wall or extremities." (Similar to predicate's "Attached to electrodes placed at standard specified locations on chest wall")
• Patient end termination: Clip, Snap (Same as predicate)
• Leadwire material: Polyvinyl chloride (PVC) (Similar to predicate's Shielded & Unshielded Copper with PVC or TPU Jacket)
• Sterile: Non sterile (Same as predicate) |

Information NOT available from the document (as it pertains to AI/ML or diagnostic performance studies):

2. Sample size used for the test set and the data provenance: Not applicable. No test set for AI/ML performance is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment for AI/ML performance is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) 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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

In summary, this 510(k) submission for ECG Disposable Lead Wires is for a conventional medical device, not an AI/ML-driven diagnostic tool. Therefore, the "study" described is a series of non-clinical bench tests and a comparison to a predicate device to demonstrate substantial equivalence to legally marketed devices, rather than a clinical trial proving specific diagnostic accuracy or AI performance metrics.

Ask a specific question about this device