(62 days)
These devices are intended to be used with various electrocardiograph recorders/monitors for both diagnostic and monitoring purposes. They are solely intended to be used between the electrode in contact with the patient's skin and the recording/monitoring device. This cabling facilitates the conduction of signals between the patient and the monitoring device. AIV cables are limited by the Indications for Use of the connected recording/monitoring device.
AlV's Electrocardioaraph (ECG) cables (also sometimes referred to as trunk or leadwires) are replacements for similar cables manufactured by the Original Equipment Manufacturers (OEM) and other third party after market manufacturers for their respective monitors. The Trunk Cables connect the OEM patient monitor to the patient leadwires connect the trunk cable to the skin mounted ECG electrodes.
These cables consist of connectors on each cable end and a shielded bulk cable. The cables are used to transfer the signals from the electrodes to the patient monitor. The Trunk Cables have limited skin contact with the patient, while the Leadwires attached on the patient's chest have more continuous skin contact.
The AIV cables use the same type of construction and have the same technological characteristics as the predicate devices. They use a medical grade PVC cable jacket with medical grade PVC overmolded connectors with an integral strain relief.
The provided document describes the 510(k) summary for AIV's ECG Cables, Trunk and Patient Lead Wires, seeking substantial equivalence to existing devices. As such, the study described here is NOT an AI/ML device study. The acceptance criteria and "device performance" in this context refer to engineering specifications and compliance with recognized standards for medical devices, rather than an AI model's predictive accuracy.
Here's the information extracted and formatted according to your request, with clarifications due to the nature of the device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard / Key Characteristic) | Reported Device Performance (Compliance / Equivalence) |
|---|---|
| Connector Retention Force (ANSI/AAMI EC53A-1998/(R)2001) | Declared conformity to standard; equivalent to predicates. |
| Electrical Performance and Safety (ANSI/AAMI EC53-1995/(R)2001) | Declared conformity to standard; equivalent to predicates. |
| Design/Appearance (Cables with various connectors) | Same as predicate devices. |
| Type of Construction (Flexible, shielded, multi-conductor) | Same as predicate devices. |
| Connector Design (Keyed, snap and grabber) | Same as predicate devices. |
| Cable Length (Various specified lengths) | Same as predicate devices. |
| Wire Colors (Snappers and grabbers color coded) | Same as predicate devices. |
| Wire Material (Braided shield, tin/copper with elastomer jacket) | Same as predicate devices. |
| Sterility (Used non-sterile) | Same as predicate devices. |
| Intended Use (Conduct impulse signals from electrode to patient monitor) | Same as predicate devices. |
| Patient Usage (Reusable) | Same as predicate devices. |
| Anatomical Sites (Attached to electrodes at specified locations on chest wall) | Same as predicate devices. |
| Technological Characteristics (Construction, materials) | Same as predicate devices. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated as a "test set" in the context of an AI/ML study. The evaluation was based on bench testing of the AIV cables. The sample size for these physical tests is not specified in the provided summary.
- Data Provenance: Not applicable in the sense of data origin for an AI model. This is a physical device and the "data" comes from bench testing of the manufactured cables.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This is not an AI/ML device requiring expert ground truth for image interpretation or similar. The "ground truth" for these cables is compliance with engineering standards (ANSI/AAMI EC53 and EC53A) and functional equivalence to legally marketed predicate devices, assessed through bench testing. The evaluation was done by the manufacturer (AIV) and reviewed by the FDA.
4. Adjudication method for the test set
- Not applicable. There was no "test set" requiring adjudication in the AI/ML sense. Compliance was determined by meeting consensus standards and demonstrating equivalence to predicate devices through bench testing.
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. This is not an AI/ML device. Therefore, no MRMC study with human readers or AI assistance was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm. The "standalone performance" for this device would be its ability to physically and electrically perform its intended function (signal conduction) when bench tested, which was stated to be "as intended."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this device is based on compliance with recognized consensus standards (ANSI/AAMI EC53 and EC53A) for electrical and mechanical performance, and demonstrated functional and technological equivalence to legally marketed predicate devices.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device, so there is no training set.
9. How the ground truth for the training set was established
- Not applicable. There is no training set for this device.
§ 870.2900 Patient transducer and electrode cable (including connector).
(a)
Identification. A patient transducer and electrode cable (including connector) is an electrical conductor used to transmit signals from, or power or excitation signals to, patient-connected electrodes or transducers.(b)
Classification. Class II (performance standards).