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The device is intended to be used with ECG. The lead wire is used to connect electrodes placed at appropriate sites on the patient to ECG for general monitoring and/or diagnostic evaluation by health care professional.

The device is used to transmit ECG signals from electrodes which are affixed to the patient's body for both diagnostic and monitoring purposes. Each lead wire is attached to ECG patient electrodes. The lead wire connector plugs into one end of the trunk cable which are plug into an ECG monitor. The proposed devices are available in disposable and reusable two types.

The provided text is a 510(k) summary for Patient Cables and Leadwires, Disposable ECG Leadwires. It focuses on demonstrating substantial equivalence to a predicate device based on non-clinical testing and does not include a study proving that the device meets specific performance acceptance criteria in the context of a clinical or standalone effectiveness study.

Therefore, many of the requested elements for describing acceptance criteria and a study proving device performance are not applicable based on the provided document.

Here's a breakdown of what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

The document does not present explicit performance acceptance criteria in the format typically used for studies evaluating a device's diagnostic or monitoring accuracy against a specific metric. Instead, it refers to compliance with safety and performance standards for non-clinical aspects.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Not applicable. The document describes non-clinical tests (biocompatibility, electrical safety, functional performance) on the device itself or its materials, not studies with a "test set" of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable. There is no test set or ground truth established by medical experts for evaluating clinical performance.

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

Not applicable. No test set requiring expert adjudication is mentioned.

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 device is an ECG leadwire, not an AI-powered diagnostic or assistive tool. No MRMC study was conducted.

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

Not applicable. This device is an ECG leadwire, which facilitates signal transmission, not an algorithm.

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

Not applicable. For the non-clinical tests, the "ground truth" is defined by the requirements of the standards (e.g., cytotoxicity assays, electrical safety measurements, material property tests).

8. The sample size for the training set

Not applicable. This is not an AI/algorithm-based device requiring a training set.

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

Not applicable. This is not an AI/algorithm-based device requiring a training set.

Summary of the Study (as described in the document):

The "study" described in this 510(k) summary consists of non-clinical tests performed to verify that the proposed device (Patient Cables and Leadwires, Disposable ECG Leadwires) meets design specifications and is substantially equivalent to a predicate device (K120010).

• Type of Study: Non-clinical bench testing.
• Purpose: To demonstrate compliance with recognized industry standards for biocompatibility (ISO 10993 series), electrical safety (IEC 60601-1), and functional performance of ECG leadwires (ANSI/AAMI EC53).
• Conclusion: "The test results demonstrated that the proposed device complies with the following standards." and "No clinical study is included in this submission."
• General conclusion: Based on these non-clinical tests, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.

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The cables are used to transfer monitoring signals from a patient's electrodes, which are connected to leadwires, to a patient's monitor, resulting in no direct contact with the patient. While medical personnel observe the patient, information is received through the cables and is displayed on the monitor. This information can then be used by medical personnel to assess the patient and determine the proper course of medical action.

Not Found

I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving that a device meets those criteria. The document is an FDA 510(k) clearance letter for a "Patient Cable" device, indicating that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory requirements and the device's indications for use but does not include performance data, study designs, or ground truth establishment details.

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These patient cables and leadwires are intended to be used with ECG, EKG, Sp02 and Blood Pressure monitoring devices.

Advantage Medical Cables are produced using purchased 5 conductor cable and single conductor leadwire, both shielded and un-shielded, which is cut to various lengths, terminated with the appropriate type terminals and housed in a protective covering made from different types of FDA Grade thermoplastic elastomers, (polypropylene and TPR), using an injection molding process and custom built molds to achieve the desired shape and size. The cito-toxticity test results are in Attachment J1.

The most common cable configuration is of a three or five conductor cable with a metal or plastic connector terminated on one end by crimp or solder method, using various keyway configurations depending on the make and model of the monitor, for connection to the monitoring device, and the three or five conductors terminated into a yoke assembly for the leadwires to attach on the other end. The leadwires may be permanently attached to the yoke or terminated on one end with a .060 diameter pin and over molded with the mating DIN style connector and a snap or pinch type connector on the other end for connection to the patient electrodes. The leadwires may be shielded or unshielded construction. See Attachment E2-1 Patient Cable Drawing CB-71330R, and Illustration E1.

Advantage Medical Cables and leadwires are used in conjunction with various patient monitoring equipment such as ECG, EKG, SpO2 and Blood Pressure equipment for short term diagnostic monitoring. They are not intended to be used in any manner other than as the connection between the monitoring equipment and the electrode pads to monitor the signals between the patient and the transmitter/receiver.

The provided text is a 510(k) summary for patient monitoring cables and leadwires, and it does not contain information about a study proving device performance against acceptance criteria in the context of an AI/ML medical device.

The document discusses patient monitoring cables (ECG, EKG, SpO2, Blood Pressure) and their manufacturing process. It focuses on demonstrating substantial equivalence to predicate devices, but it references performance testing in Attachment K, which is not provided in the input.

Therefore, I cannot fulfill your request for details on acceptance criteria and a study proving device performance, as the provided text pertains to a hardware device (cables) and lacks the specific information you're asking for regarding AI/ML device validation.

If you can provide the relevant Attachment K or a document describing the performance study for an AI/ML device, I would be happy to analyze it according to your requested categories.

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