Search Results

The Kepler MedTec Disposable Bipolar Cables are intended to connect an electrosurgical device to an electrosurgical generator. They are indicated for use with bipolar forceps during general surgical procedures.

The Kepler MedTec Disposable Bipolar Cable includes available in multiple colors. The Kepler MedTec Disposable Bipolar Cable is provided sterile.

Bipolar forceps (handpiece) are connected to a generator through a bipolar cable. The bipolar cable is flexible and delivers the electrical power from the generator to the binolar forcep. There is a male and female end termination on the cable. The male end termination (2-pin banana connector) is connected to the generator; the female end termination (2-pin plug type connector) to the bipolar forceps.

The Kepler MedTec Disposable Bipolar Cable is compatible with:

• Bipolar Forceps using standard US connection with 5.8 mm spaced pins .
• . VallyLab, Conmed, Medtronic and Bovie generators

The provided text describes a 510(k) premarket notification for a medical device, the Kepler MedTec Disposable Bipolar Cable. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing extensive clinical trials for efficacy.

Here's a breakdown of the acceptance criteria and the "study" (which in this case is primarily a comparison) that proves the device meets those criteria, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not applicable in the context of clinical testing. This submission did not involve a "test set" in the sense of patient data or clinical samples.
• Data Provenance: Not applicable. The "study" for this 510(k) is a comparison of technical specifications and intended use against a legally marketed predicate device, not a clinical data collection.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

• Not applicable. Ground truth from experts is typically for diagnostic devices or those requiring expert interpretation of results, which is not the case for a disposable bipolar cable.

4. Adjudication Method for the Test Set

• Not applicable. There was no test set requiring adjudication in this 510(k) submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, a MRMC comparative effectiveness study was not done. This type of study is for evaluating the diagnostic or therapeutic effectiveness of a device compared to a standard of care, often with human readers interpreting results. This is beyond the scope of demonstrating substantial equivalence for a disposable cable.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• No, a standalone (algorithm only) performance study was not done. This device is a passive accessory and does not involve algorithms or human-in-the-loop performance evaluation beyond its basic function of conducting electrical current safely.

7. The Type of Ground Truth Used

• The "ground truth" for this 510(k) submission is the specifications and performance of the legally marketed predicate device (DeRoyal Industries, Inc. - Disposable Bipolar Electrosurgical Cable, K970993). The manufacturer established that the new device's features, intended use, and technical compliance meet or exceed those of the predicate. This is a regulatory "ground truth" rather than a clinical ground truth.

8. The Sample Size for the Training Set

• Not applicable. This device does not involve a "training set" in the machine learning or clinical study sense.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. There was no training set. The "ground truth" for showing substantial equivalence was established by comparing the Kepler MedTec Disposable Bipolar Cable's specifications and performance to the pre-existing FDA-cleared predicate device (DeRoyal Disposable Bipolar cables). The applicant asserts that the devices share the same intended use, target population, clinical setting, and technology, and that any differences do not raise new issues of safety or effectiveness.

Ask a specific question about this device

The Kepler MedTec Single Patient Use ECG Lead Wire is a electrode cable system used to transmit signals from patient electrodes to various electrocardiograph recorders / monitors for both diagnostic and monitoring purposes. Use is limited by the indications for use of the connected monitoring or diagnostic equipment. The Single Patient Use ECG Lead Wire Set is intended to be used by trained operators in a medical professional's environment.

The Single Patient Use ECG Lead Wire is a single patient, electrode cable system used to transmit signals from patient surface electrodes to various electrocardiograph recorders/monitors for both diagnostic and monitoring purposes. This type of device is common to both industry and to most medical establishments. The system is designed to provide a family of lead wires that will link the patient and the compatible patient trunk cable system.

Here's a breakdown of the acceptance criteria and study information based on the provided 510(k) summary for the Single Patient Use ECG Lead Wire Set:

This submission is for an ECG Lead Wire Set, which is a fairly straightforward electromechanical device. Unlike AI/ML-driven software, its performance is primarily evaluated through adherence to established engineering standards and physical testing, not through clinical efficacy studies involving human readers or extensive AI model training. Therefore, many of the requested elements (like sample sizes for test/training sets, expert ground truth, MRMC studies, and standalone AI performance) are not applicable in the context of this device and typical regulatory submissions for such products.

Acceptance Criteria and Reported Device Performance

Note: The document primarily outlines the standards met rather than providing specific raw performance data. The "reported device performance" is the statement of compliance with these standards, implying that the device successfully passed the tests required by each standard.

Study Details (Applicability for ECG Lead Wires)

1. Sample Size used for the test set and the data provenance:

   • Sample Size: Not explicitly stated in the summary. For electrical and mechanical performance testing (e.g., connector retention force, electrical integrity, biocompatibility), sample sizes are typically determined by the respective standards (e.g., ANSI/AAMI EC53A, ISO 10993). These are usually small, representative batches or a statistically significant number of units to ensure consistency.
   • Data Provenance: Not explicitly stated. Such testing is typically conducted in designated test laboratories, either in-house or by third-party contractors. The location (country) of these labs is not specified. The testing is prospective for the device under review.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not Applicable. For an ECG lead wire set, "ground truth" as it relates to clinical diagnosis or interpretation by experts (e.g., radiologists) is not relevant. The device's performance is objectively measured against engineering specifications and physical standards. Expert consensus would not be used to assess, for example, connector retention force.

3. Adjudication method for the test set:

   • Not Applicable. Adjudication methods (like 2+1 or 3+1) are for resolving discrepancies in expert interpretations, typically in clinical studies or image analysis. This is not how an ECG lead wire's compliance with engineering standards is assessed. Compliance is determined by objective measurements meeting predefined thresholds.

4. 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, not applicable. MRMC studies are designed for assessing the impact of diagnostic aids (often AI-powered) on human reader performance. An ECG lead wire is a passive component for signal transmission, not a diagnostic aid that assists a human reader in interpretation. Therefore, such a study would not be performed.

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

   • No, not applicable. "Standalone performance" refers to the performance of an algorithm without human intervention, typically for AI/ML software. An ECG lead wire is a physical device that transmits electrical signals, not an algorithm.

6. The type of ground truth used:

   • Objective Engineering Standards / Physical Measurements: The "ground truth" for this device's performance relies entirely on objective measurements against established engineering standards (e.g., force in Newtons for retention, electrical resistance/impedance values, biocompatibility profiles) and visual inspection where applicable. There is no subjective ground truth or clinical outcome data used directly for this type of device's regulatory review in this context.

7. The sample size for the training set:

   • Not Applicable. "Training set" refers to data used to train an AI/ML model. This device is not an AI/ML product; it is an electromechanical accessory.

8. How the ground truth for the training set was established:

   • Not Applicable. As there is no AI/ML model, there is no training set or ground truth establishment for a training set. The device's "ground truth" for its design and manufacturing is based on adherence to the listed industry standards and specifications.

Ask a specific question about this device