Search Results

The CUP Electrodes are intended for non-invasive use with recording and monitoring equipment,(active and reference), of Electroencephalograph (EEG), electromyography (EMG)and Evoked Potentials(EP).

A cutaneous electrode is an electrode that is applied directly to a patient's skin to record physiological signals. In other words cutaneous devices are used in the acquisition of signals for the purpose of monitoring and recording Electroencephalograph(EEG), Electromyograph(EMG), and Evoked Potentials(EP) and the electroencephalograph/evoked potentials reading is completely non-invasive procedure that can be applied to children and adult patients. The electrodes are delivered non-sterile and are available in disposable version. DAEHAN Disposable CUP electrodes are for single patient use only. The electrodes have a disc manufactured of molded ABS, Ag/agcl plated. The disc is permanently adhered to a lead wire. The insulated lead wires terminate using a molded touch proof connector (DIN 42 802) for electrical safety.

This document is a 510(k) Summary for the DAEHAN Disposable CUP Electrodes. It describes the device, its intended use, and its substantial equivalence to predicate devices, but it does not contain the results of a study that proves the device meets specific acceptance criteria in the context of an AI/ML medical device.

The acceptance criteria mentioned in this document are for the DAEHAN Disposable CUP Electrodes as a cutaneous electrode, and the "studies" relate to general device performance and regulatory compliance for medical devices, not AI/ML performance.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving an AI/ML device meets them based on the provided text.

Specifically, the document discusses:

1. Non-Clinical Test Summary:
   • Biocompatibility: "Identical materials are used in legally marketed device"
   • Performance Testing:
     • Bond Test
     • Electrical Properties Test (AAMI/ANSI EC12: Disposable ECG Electrodes, IEC 60601-1 Ed3.1 CL 8.5.2.3: Patient Leads)
   • Shelf-life Testing (ASTM F1980-02)

These are standard tests for physical medical devices and do not involve AI/ML performance metrics like sensitivity, specificity, or AUC, nor do they involve a test set, ground truth established by experts, or MRMC studies.

If you have a different document related to an AI/ML medical device, please provide it, and I will be happy to extract the requested information.

Ask a specific question about this device

The DAEHAN Adhesive Surface Electrodes are intended for use with recording, monitoring and stimulation equipment for the purpose of stimulating/recording of biopotential signals. Electrodes are applied in the study of biopotentials such as Electroencephalograph (EEG), surface Electromyography (EMG), nerve conduction and Evoked potential signals (EP). Electrodes are non-invasive as they are applied to the, patient's skin using a self-adhesive solid-gel surface. The electrodes are non-sterile and for single patient use only.

DAEHAN Adhesive Surface Electrodes are non-invasive. Cutaneous devices are used in the acquisition of signals for the purpose of stimulating, monitoring and recording Electroencephalograph (EEG), surface Electromyography (EMG) and Evoked Potentials (EP). The electrodes are designed for single-patient/multiple application use and are very flexible. Because of the adhesive nature of the gel, no securing material is required for fixating the electrode to the patient's skin. The electrodes with lead wire have a safety DIN 42802 connector, several lengths and color combinations.

The provided text describes a 510(k) premarket notification for DAEHAN Adhesive Surface Electrodes. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting new clinical studies to prove effectiveness. Therefore, the information typically requested in your prompt (e.g., acceptance criteria, detailed study results, sample sizes, expert ground truth, MRMC studies, standalone performance, training set details) is not directly available or applicable in this context for a novel device performance study.

Instead, the submission focuses on comparing the new device to a predicate device based on technical characteristics and demonstrating that the new device meets relevant performance standards.

Here's how to address your request based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) of an adhesive surface electrode, acceptance criteria are typically defined by recognized consensus standards. The document states that the device was tested against these standards.

Ask a specific question about this device

The DMS Disposable Subdermal Needle Electrodes are intended for use with recording, monitoring equipment for the recording of biopotential signals including electroencephalograph (EEG), electromyograph (EMG) and nerve potential signals, and are intended for stimulation/recording with stimulation/recording equipment for electromyograph (EMG) and nerve potential signals.

The DMS Disposable Subdermal Needle Electrodes are supplied sterile and intended for single use. This subdermal needle electrodes can be used to record the neurological and neurophysiological evoked potentials. The connector is provided with touch-proof and cannot be connected to an AC outlet. This connector is designed for connecting the recording or monitoring equipment for the recording of biopotential signals including electroencephalograph (EEG), electromyograph (EMG) and nerve potential signals, and are intended for stimulation/recording with stimulation/recording equipment for electromyograph (EMG) and nerve potential signals. The DMS Disposable Subdermal Needle Electrodes are supplied sterile.

Here's an analysis of the provided text regarding the acceptance criteria and study for the DMS Disposable Subdermal Needle Electrodes, formatted to answer your questions:

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

The document does not explicitly state acceptance criteria in terms of specific performance thresholds for each test (e.g., "stiffness must be X Newton-meters"). Instead, it lists the types of non-clinical tests performed to demonstrate substantial equivalence to a predicate device. The implied acceptance criterion is that the device passes or meets the requirements of these standards and tests, demonstrating performance comparable to the predicate.

Note: The document states that the proposed device was "found to be similar to predicate device with regard to design, function, and technical characteristics" and "presented the substantial equivalence," implying all tests were successfully passed and demonstrated equivalency.

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

The document does not specify the sample sizes used for any of the non-clinical tests (biocompatibility, performance, shelf-life). These are typically laboratory tests performed on a limited number of device samples. The data provenance (country of origin, retrospective/prospective) is not mentioned, but given it's a 510(k) submission from "Daehan Medical Systems Co., Ltd." in "Republic of Korea," it's highly probable the testing was conducted in South Korea or by certified labs on behalf of the company. These are non-clinical, controlled laboratory studies, not human clinical trials, so the terms "retrospective" or "prospective" are not generally applicable in the same way they would be for 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)

This information is not applicable to the type of studies described. The "ground truth" here is based on standardized test methods and measurement results rather than expert interpretation of medical images or patient outcomes. The studies are non-clinical (biocompatibility, mechanical performance, electrical properties, shelf-life).

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

Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus in clinical studies, particularly when interpreting ambiguous medical data. The tests performed here are objective laboratory measurements against established standards.

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. MRMC studies are clinical studies involving human readers (e.g., radiologists) evaluating cases, often with and without AI assistance, to assess diagnostic performance. This submission is for a medical device (subdermal needle electrodes) and focuses on non-clinical testing to demonstrate substantial equivalence, not AI algorithm performance.

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

Not applicable, as this device does not involve an AI algorithm.

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

The ground truth for the non-clinical tests is based on established industry standards and test methods. For example:

• Biocompatibility: Ground truth is defined by the criteria within ISO 10993-5 (absence of cytotoxicity) and ISO 10993-10 (absence of irritation/sensitization).
• Performance (Stiffness, Breakage, Bond, Electrical Properties): Ground truth is defined by the expected physical and electrical characteristics as determined by engineering specifications and comparative data to the predicate device.
• Shelf-life: Ground truth is defined by the ability of the device and its packaging to maintain sterility and functional integrity after accelerated aging, conforming to ASTM F1980-07:2011.

8. The sample size for the training set

Not applicable. This device is not an AI algorithm, and therefore does not have a "training set."

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

Not applicable.

Ask a specific question about this device