(441 days)
PCA-C100 Patient Cable is intended to be used with QT ECG device. The Patient Cable is used to connect electrodes placed at appropriate sites on the patient to an ECG device for general diagnostic evaluation by healthcare professionals.
The PCA-C100 Patient Cable is a reusable ECG patient cable that is used to transmit cardiac electrical signals (ECG) from electrodes, which are affixed to the patient's body for both diagnostic purposes. The PCA-C100 Patient Cable is a crucial part of the system used diagnose the cardiac electrical signal (ECG). It allows a safe connection between the electrodes on the patient and QT ECG (K180157). The PCA-C100 Patient Cable is composed of three components: Snap - Connected with Leadwire and commercial ECG electrode. Leadwire - fitted with Trunk, and connected with ten Snaps. Trunk - Fitted with two ends: one of them connects the QT ECG (K180157); and the other end connects the Leadwires.
The document provided is a 510(k) Summary for the PCA-C100 Patient Cable, which is a medical device for transmitting cardiac electrical signals. This type of device is relatively simple and does not involve AI or complex diagnostic algorithms, so many of the requested criteria (like ground truth, expert consensus, MRMC studies, or training/test set details) are not applicable.
Based on the provided information, here's a summary of the acceptance criteria and the study proving the device meets those criteria:
Device: PCA-C100 Patient Cable
Intended Use: To connect electrodes placed at appropriate sites on the patient to an ECG device (specifically QT ECG device, K180157) for general diagnostic evaluation by healthcare professionals.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally based on compliance with recognized medical device standards for electrical safety, biocompatibility, and performance for patient cables. The reported device performance indicates successful compliance with these standards.
| Acceptance Criteria Category | Specific Standard/Test | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | In Vitro Cytotoxicity Test | Pass (non-cytotoxic) | Met the requirements |
| White Rabbit Skin Irritation Test | Pass (non-irritating) | Met the requirements | |
| Skin Sensitization Study (Maximization Test) | Pass (non-sensitizing) | Met the requirements | |
| Electrical Safety | ANSI AAMI EC53:2013 (ECG Trunk Cables And Patient Leadwires) | Compliance with standard electrical safety requirements | Met the requirements |
| ANSI AAMI 60601-1: ES60601-1:2005/(R)2012 And A1:2012 C1:2009/(R)2012 And A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance | Compliance with general requirements for basic safety and essential performance | Met the requirements | |
| Performance | Safety and Essential Performance of Electrocardiographs | Compliance with relevant performance aspects for ECG patient cables | Met the requirements |
| Leadwires to trunk cable interconnection (ANSI AAMI EC53:2013) | Secure and proper interconnection | Met the requirements | |
| Bench Performance Testing | Met established protocols and requirements | Met the requirements | |
| Connector Retention Force | ANSI/AAMI EC 53:2013 | Retention force within specified limits | Met the requirements |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of diagnostic performance evaluation with a dataset of patient cases because this device is a patient cable, not a diagnostic algorithm.
- Sample Size: The testing was conducted on physical samples of the PCA-C100 Patient Cable. The exact number of samples used for each test (biocompatibility, electrical safety, performance) is not specified in this summary document.
- Data Provenance: Not applicable in the context of patient data for a diagnostic algorithm. The tests were performed in a laboratory setting on the device itself.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. This device is a passive patient cable, not a diagnostic algorithm that requires expert interpretation for establishing ground truth on patient data. Ground truth, in this context, refers to the verifiable correctness of the device's physical and electrical properties against established standards.
4. Adjudication Method for the Test Set
Not applicable for this type of device. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation or AI output review, which is not relevant for a patient cable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. Such studies are typically performed for diagnostic imaging or analytical devices where human readers interpret results, sometimes with and without AI assistance, to assess diagnostic accuracy or efficiency. This is not applicable to a patient cable.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This device is a patient cable, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance evaluation is established by objective measurements and assessments against recognized industry standards and scientific principles during non-clinical (bench) testing. For example:
- Biocompatibility: In-vitro and in-vivo tests to determine the material's interaction with biological systems according to ISO 10993 standards.
- Electrical Safety: Measurements of electrical parameters (e.g., leakage current, impedance) compared against limits specified in IEC 60601-1 and ANSI AAMI EC53.
- Performance: Functional testing to ensure proper signal transmission and mechanical integrity according to ANSI AAMI EC53.
8. The Sample Size for the Training Set
Not applicable. This device is a hardware component and does not utilize machine learning or AI, therefore it does not have a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for an AI algorithm, no ground truth needed to be established for it.
§ 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).