(440 days)
The Patient Monitoring Cables are intended to be used with SpO2, Temperature, BP, ECG, Cardiac Output, and related monitoring devices. The Patient Monitoring Cables are used to connect electrodes, catheters, and/or sensors placed at appropriate sites on the patient to a monitoring devices, or between monitoring devices, for general monitoring and/or diagnostic evaluation by health care professionals.
The Patient Monitoring Cables are replacements for similar accessory cables manufactured or specified by Original Equipment Manufacturers (OEM) for their respective transducers, monitors, and peripheral equipment. These are non-patient-contact, insulated, electrical cables with a connector (plug or receptacle) at each end, designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect SpO2 sensor, IBP transducer to a patient monitor). They are not intended to connect to the mains (i.e., not mains power cables), do not generate any type of power and/or signal, and have no additional non-electrical conducting or processing functionality.
The provided text describes a 510(k) premarket notification for "Fogg System Patient Monitoring Cables." This document focuses on the substantial equivalence of the cables to a predicate device based on bench testing of physical and electrical properties, not on a clinical "study" involving AI or human-in-the-loop performance. Therefore, many of the questions related to AI device performance evaluation (such as MRMC studies, training set details, and expert ground truth establishment for AI) are not applicable to this submission.
Here's a breakdown of the acceptance criteria and the "study" (nonclinical test data) presented in the document:
1. A table of acceptance criteria and the reported device performance
The document does not present a formal table of acceptance criteria with corresponding performance results. Instead, it states that the Fogg System Patient Monitoring Cables "met all acceptance criteria from the testing and analyses". The testing and analyses performed were:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Cable assembly resistance and continuity | Conformed to standards |
| Cable material signal integrity | Conformed to standards |
| Electromagnetic interference and safety analysis | Conformed to standards |
| Conformance to applicable sections of standards | Met IEC 60601 and AAMI/ANSI BP22 |
2. Sample size used for the test set and the data provenance
- Sample Size: The document mentions "worst case representative cable assemblies and cable material" were used for performance testing. It does not provide a specific number for the sample size.
- Data Provenance: The testing was "nonclinical" and performed on the physical devices/materials. The document does not specify a country of origin for the data, but given it's a US FDA submission, it's implied that the testing was conducted in a manner acceptable for US regulatory purposes. The testing is not retrospective or prospective clinical data; it's laboratory bench testing.
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. The "ground truth" for this type of device (patient monitoring cables) is established by engineering specifications, international standards (IEC 60601, AAMI/ANSI BP22), and established testing methodologies for electrical and material properties, not by human expert review of clinical cases or images.
4. Adjudication method for the test set
This question is not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical imaging studies, often involving expert readers. For physical device testing, the "ground truth" is determined by whether the device's electrical and material properties meet established engineering and safety standards. There is no human adjudication process described for this type of nonclinical 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
This question is not applicable. This submission is for patient monitoring cables, which are passive accessories, not an AI-powered diagnostic device. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. This submission is for patient monitoring cables, not a standalone AI algorithm.
7. The type of ground truth used
The "ground truth" for this device's performance is based on engineering specifications and adherence to recognized international standards such as IEC 60601 and AAMI/ANSI BP22 for patient transducer and electrode cables. It is a technical ground truth related to electrical continuity, signal integrity, electromagnetic compatibility, and material properties, not clinical outcomes or expert consensus on clinical data.
8. The sample size for the training set
This question is not applicable. There is no AI component requiring a training set for this device.
9. How the ground truth for the training set was established
This question is not applicable. As there is no AI component, no training set or its ground truth was established for this submission.
§ 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).