Search Results

9Line patient leadwires are intended to be used to connect electrodes placed at appropriate sites on the patient to an ECG or EKG monitoring device for general monitoring and/or diagnostic evaluation by a health care professional. The device is intended for single-patient use.

9Line is comprised of multiple patient leadwires that connect electrodes affixed to the patient's body either to an external trunk cable or directly into an electrocardiogram (ECG) monitor. Each leadwire connects to a separate patient electrode. Leadwires and electrode placement are color-coded in accordance with Association for the Advancement of Medical Instrumentation (AAMI) recommendations. The device transmits ECG signals from the patient for both diagnostic and monitoring purposes.

This document is a 510(k) Premarket Notification for a medical device called "9Line," which consists of patient leadwires for ECG/EKG monitoring. The purpose of this notification is to establish that the 9Line device is substantially equivalent to a previously cleared predicate device (APK Technology Co.'s ECG Disposable Lead Wires, K170536).

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission for a Class II device (patient transducer and electrode cable), the "acceptance criteria" are primarily established by demonstrating equivalence to a predicate device and adherence to recognized electrical, mechanical, and biocompatibility standards. Performance is reported in terms of compliance with these standards.

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

For this type of device (patient leadwires), the "test set" does not refer to a clinical study with a patient population in the way an AI/ML algorithm might. Instead, the testing is non-clinical and focuses on material properties, electrical, and mechanical performance. The "sample size" would refer to the number of leadwire units tested for each specific non-clinical test (biocompatibility, electrical safety, mechanical safety).

• Sample Size for Non-Clinical Testing: The document does not explicitly state the exact number of units tested for each non-clinical test (biocompatibility, electrical safety, mechanical safety). These numbers are typically found in detailed test reports referenced by the submission, but not usually in the summary document provided here.
• Data Provenance: The tests were conducted to FDA-recognized standards (ISO 10993-5:2009, ISO 10993-10:2010, IEC 60601-1:2005, ANSI/AAMI EC 53:2013). This implies that the testing was performed in a controlled laboratory environment, likely by accredited testing facilities specializing in medical device testing. The results are therefore prospective in nature, generated specifically for this submission. The country of origin of the data is not specified, but adhering to international standards suggests widely recognized testing practices.

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

This question is not applicable in the typical sense for this device. The "ground truth" for patient leadwires is their compliance with established engineering and safety standards, rather than expert interpretation of medical images or clinical outcomes. The "experts" involved are the engineers and scientists who developed and executed the non-clinical tests, and the regulatory reviewers at the FDA who assess the compliance of the device with these standards and guidelines. Their qualifications would be expertise in biocompatibility, electrical engineering, mechanical engineering, and medical device regulation.

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

This concept of adjudication (e.g., 2+1 reader scheme) is typically used in clinical studies where expert consensus is needed to establish a "ground truth" for diagnosis or evaluation, often in the context of imaging or pathology. For non-clinical testing of a device like leadwires, there is no such adjudication method. The outcomes are objective measurements against predefined thresholds specified by the recognized standards. If there is a dispute in test results, it would typically be resolved through repeat testing or verification by a different accredited lab, not through expert adjudication in the medical sense.

**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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices where the performance of human clinicians is assessed with and without AI assistance to measure the AI's incremental benefit. The 9Line device is a passive component (ECG leadwires) and does not involve AI or human interpretation in its function.

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

No, a standalone (algorithm only) performance study was not done. As explained above, the 9Line device is not an algorithm or an AI system. It is a physical medical device.

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

The "ground truth" for the 9Line device is based on objective engineering and scientific standards:

• Biocompatibility: Established by in-vitro and in-vivo tests according to ISO 10993 standards, demonstrating the material's safety for contact with the body.
• Electrical Safety: Established by measurements against thresholds defined in IEC 60601-1, ensuring the device does not pose electrical hazards.
• Mechanical Safety: Established by physical tests against specifications in ANSI/AAMI EC 53, ensuring mechanical integrity and performance.

These are not forms of expert consensus, pathology, or outcomes data in a clinical sense, but rather compliance with universally recognized standards for medical device safety and performance.

8. The sample size for the training set:

Not applicable. The 9Line device is a physical component, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.

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

Not applicable. As there is no training set, there is no ground truth establishment for it.

Ask a specific question about this device