(57 days)
Compatibility ECG Trunk Cables with green monitor side plug are used to connect Datex-Ohmeda 300-series leadwire sets to GE Healthcare patient monitors having green and rectangle GEEC-type 11-pin ECG connector. Compatibility ECG Trunk Cables with blue monitor side plug are used to connect GE Multi-Link leadwire sets to legacy Datex-Ohmeda patient monitors having a blue and round Nicolay-type ECG connector.
Compatibility ECG Trunk Cables are used during ECG measurement. These ECG trunk cables consist of connectors on each cable end and a shiclded main electrical cable. Some products also have defibrillation protection resistors inside the yoke-connector. ECG trunk cables are used to transfer the ECG signal from lead sets to a patient monitor. These ECG trunk cables have limited skin contact with a patient while ECG leadwires attached on patient chest have more continuous skin contact.
Some products are used with legacy GE Medical System monitors like Dash 3000/4000, Solar, TRAM and also with the new S/5 modules like M-PRESTN. Before the patient monitor can display ECG signals on the screen, leadwire sets and electrodes are needed in addition to these trunk cables. With these trunk cables, 300-series Datex-Ohmeda ECG lead sets are needed.
Other products are used with legacy Datex-Ohmeda patient monitors and modules like Cardiocap 5, Light, or M-ESTPR having a blue and round 10-pin ECG connector. With these trunk cables, Multi-I ink leadwire sets are used.
Products are packed individually into a plastic bag in non-sterife condition. Package label describes product REF codes, manufacturing date, CE-mark, legal entity information and a caution "Federal (USA) law restricts this device to sale by or on the order of a physician".
The provided text describes a 510(k) premarket notification for "Compatibility ECG Trunk Cables." This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove acceptance criteria for an AI/CADe device. Therefore, much of the requested information regarding AI/CADe specific study details is not applicable or available in this document.
However, I can extract the information that is relevant to the type of device described and interpret the closest equivalent of "acceptance criteria" and "device performance" in this context.
Device Type: Compatibility ECG Trunk Cables are medical devices used to transmit ECG signals from lead sets to patient monitors. They are cables and connectors, not an AI/CADe device.
Acceptance Criteria and Device Performance (Interpreted for a Cable Device):
For a cable, "acceptance criteria" are generally met through adherence to established electrical, mechanical, and biocompatibility standards, ensuring the cable functions as intended without introducing new risks. "Device performance" refers to the cable's ability to maintain signal integrity, withstand use, and be safe for patients.
Here's an interpretation based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) summary for a kabel, the "acceptance criteria" are primarily a demonstration of compliance with recognized standards. The "reported device performance" is the assertion that the device meets these standards and is substantially equivalent to the predicate.
| Acceptance Criteria Category (Interpreted) | Specific Standard / Requirement | Reported Device Performance (Compliance) |
|---|---|---|
| Electrical Safety | EN 60601-1:1990 +A1:1993 +A2:1995 +A13: | "Assessed against" and "thoroughly tested through validation and verification of specifications." |
| Biocompatibility | ISO 10993-5:1995 (Cytotoxicity) | "Assessed against" and "thoroughly tested through validation and verification of specifications." |
| ISO 10993-10:1996 (Irritation & Hypersensitivity) | "Assessed against" and "thoroughly tested through validation and verification of specifications." | |
| EMC/Signal Integrity | ANSI/AAMI EC53-1995 | "Assessed against" and "thoroughly tested through validation and verification of specifications." |
| ANSI/AAMI EC13-2002 Paragraphs: - 4.2.2.2.1, 4.2.2.2.3, 4.2.6.1, 4.2.9.3, 4.2.9.4, 4.2.9.14 | "Assessed against" and "thoroughly tested through validation and verification of specifications." | |
| Labeling/Packaging | EN 980:2003 | "Assessed against" and "thoroughly tested through validation and verification of specifications." (Implicitly, as package label is described) |
| EN 1041:1998 | "Assessed against" and "thoroughly tested through validation and verification of specifications." | |
| Risk Management | ISO 14971:2000 | "Assessed against" and "thoroughly tested through validation and verification of specifications." |
| General Safety/Effectiveness | Substantial Equivalence to Predicate K980582 | "Substantially equivalent in safety and effectiveness" to the predicate. |
2. Sample size used for the test set and the data provenance
Not applicable for this type of device and submission. The testing described is against engineering standards, not a clinical "test set" with patient data. The provenance of the "data" would be engineering test reports and compliance documentation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth, in the context of an AI/CADe device, refers to a definitive diagnosis or finding. For a cable, "ground truth" is adherence to engineering specifications and performance within established standards, assessed by engineers and quality assurance personnel.
4. Adjudication method for the test set
Not applicable. Adjudication methods are used in studies involving human interpretation or clinical outcomes. For a cable, compliance is determined by meeting objective engineering specifications.
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/CADe device designed to assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithmic device.
7. The type of ground truth used
The "ground truth" for this device is the successful performance against specified engineering and safety standards, as well as functional equivalence to the predicate device. This is confirmed through a combination of:
- Engineering Test Results: Measurements and evaluations demonstrating the cable's electrical, mechanical, and material properties meet relevant standards.
- Biocompatibility Testing: Lab tests (e.g., cytotoxicity, irritation) to ensure materials are safe for limited skin contact.
- Predicate Device Comparison: Functional similarity and identical intended use as the legally marketed predicate device (Multilink ECG Cables K980582).
8. The sample size for the training set
Not applicable. This is not a machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not a machine learning 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).