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Electrotherapy Electrodes are intended for use as the disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. Electrotherapy Electrodes are intended to be used with marketed Electrical Stimulators, (i.e. TENS (Transcutaneous Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), IF (Interferential) or PGF (Pulsed Galvanic Stimulation)) for transmitting electrical current. The electrodes are for OTC (Over-The-Counter) or Prescription use.

Electrotherapy Electrodes provide a means for establishing electrical contact between the lead connected to a TENS, EMS or NMES stimulation device and the skin, and are multi-layer, flexible structures composed of laminated materials commonly used in the application:

1st layer: Insulation material: Tan fabric
2nd layer: Double sides adhesive tape
3rd layer: Conductive film (Carbon Film)
4th layer: Self-adhesive conductive hydrogel
5th layer: Plastic release film
Connection: Leadwire/Snap button

The electrodes are designed for single-patient & single application use. Because of the adhesive nature of the conductive hydrogel, no securing materials are required to secure the device to the patient's skin.

The provided FDA 510(k) clearance letter and summary for the Electrotherapy Electrodes (K250841) does not describe a study involving AI or human reader performance. Instead, it focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance and biocompatibility testing.

Therefore, many of the requested details about acceptance criteria for AI and human performance studies, expert involvement, adjudication, MRMC studies, standalone AI performance, and ground truth establishment cannot be found in this document.

However, I can extract the acceptance criteria and performance data related to the non-clinical tests that were performed to demonstrate substantial equivalence for this device.

Acceptance Criteria and Device Performance (Non-Clinical)

The device, Electrotherapy Electrodes (K250841), is a Class II cutaneous electrode. The study described focuses on demonstrating its substantial equivalence to a predicate device (ZMI Self-Adhesive Electrodes, K180865) primarily through non-clinical performance and biocompatibility testing. No AI component or human reader study is discussed.

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)

Based on the provided document, the following information is NOT available as the submission does not involve an AI or human reader performance study:

2. Sample sizes used for the test set and the data provenance: Not applicable to this type of non-clinical device testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for these tests is based on objective measurements against engineering and safety standards.
4. Adjudication method for the test set: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For this device, "ground truth" refers to compliance with established industry standards (e.g., IEC, ISO, ASTM) and internal performance specifications.
8. The sample size for the training set: Not applicable (no AI model).
9. How the ground truth for the training set was established: Not applicable (no AI model).

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Electrosurgical Pads are Neutral Electrode which is also known as plate, plate electrode, passive, return, or dispersive electrode. They are indicated for use to adhere to the patient over the entire pad surface to complete an electrical circuit during electrosurgery between the electrosurgical generator, the active electrode and the patient.

Solid Electrosurgical Pads are for use with generators that do not have a Contact Quality Monitoring System (CQMS). Split Electrosurgical Pads are for use with generators that have a CQMS (i.e. REM, ARM, NESSY, etc.).

Electrosurgical Pads are single-use, non-sterile dispersive electrode with or without a pre-attached cord. This devices are used in monopolar surgery to complete the electrical circuit with the generator. Providing a low-impedance path back to the generator through the return electrode helps to prevent unintended RF burns. The Electrosurgical Pads are designed to be compatible with the return electrode monitoring function of compatible OBS generators.

This document is an FDA 510(k) Clearance Letter for "Electrosurgical Pads." It demonstrates no AI/ML algorithm in its description, and therefore, the requested information regarding acceptance criteria, study design, expert involvement, and ground truth for an AI-powered device is not applicable.

The document primarily focuses on demonstrating substantial equivalence of the Electrosurgical Pads to a predicate device and reference devices through:

• Indications for Use comparison: Showing the subject device has the same intended use as the predicate and highly similar indications for use as reference devices.
• Technological Characteristics comparison: Detailing material composition, size, corded/non-corded options, patient weight applicability, and safety/performance standards met.
• Non-clinical performance testing: Listing compliance with relevant IEC and ISO standards for electrical safety, EMC, performance, and biocompatibility.

Therefore, I cannot provide the requested information for an AI/ML device from this document.

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Electrosurgical Pads are Neutral Electrode which is also known as plate, plate electrode, passive, return, or dispersive electrode. They are indicated for use to the patient over the entire pad surface to complete an electrical circuit during electrosurgery between the electrosurgical generator. the active electrode and the patient. Solid Electrosurgical Pads are for use with generators that do not have a Contact Quality Monitoring System (CQMS). Split Electrosurgical Pads are for use with generators that have a CQMS (i.e. REM, ARM, NESSY, etc.).

Electrosurgical Pads (GBS-Dm 1030ac, GBS-Db 1031ac, GBS-Dm 1030a, GBS-Db 1031a, GBS-Dm 1130ac, GBS-Db 1131ac, GBS-Dm 1130a, GBS-Db 1131a, GBS-Dm 1040ac, GBS-Db 1041ac, GBS-Dm 1040a, GBS-Db 1041a, GBS-Dm 1140ac, GBS-Db 1141ac, GBS-Dm 1140a, GBS-Db 1141a. GBS-Db 4030c. GBS-Db 4030. GBS-Db 4040c. GBS-Db 4040. GBS-Dm 1030bc. GBS-Db 1031bc. GBS-Dm 1030b. GBS-Db 1031b. GBS-Dm 1130bc. GBS-Db 1131bc. GBS-Dm 1130b. GBS-Db 1131b, GBS-Dm 1030nc, GBS-Db 1031nc, GBS-Dm 1030n, GBS-Db 1031n, GBS-Dm 1130nc, GBS-Db 1131nc, GBS-Dm 1130n, GBS-Db 1131n, GBS-Dm 2030c, GBS-Db 2031c, GBS-Dm 2030, GBS-Db 2031, GBS-Dm 2130c, GBS-Dm 2130, GBS-Db 2131, GBS-Dm 3030c, GBS-Db 3031c, GBS-Dm 3030, GBS-Db 3031, GBS-Dm 3130, GBS-Db 3131, GBS-Dm 3130c, GBS-Db 3131c. GBS-Db 2131c)

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 text is a formal letter from the FDA regarding a 510(k) premarket notification for "Electrosurgical Pads," confirming substantial equivalence to legally marketed predicate devices. It discusses regulatory matters, such as general controls provisions, additional controls for Class II/III devices, and various regulations (Quality System regulation, MDR, etc.). The indications for use for the electrosurgical pads are also described.

There is no mention of:

• A table of acceptance criteria or reported device performance.
• Sample sizes for test sets or data provenance.
• Number/qualifications of experts for ground truth.
• Adjudication methods.
• MRMC comparative effectiveness studies.
• Standalone algorithm performance.
• Type of ground truth used.
• Sample size for training sets.
• How ground truth for training set was established.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input.

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The Electrosurgical Pencil (OBS-Db, OBS-Dr, OBS-Dr, OBS-Di, OBS-De) is used for cutting and coagulation to remove tissue and control bleeding by using high frequency current during electrosurgical surgery with an electrosurgical generator. The device is disposable and supplied sterile with an electrode tip.

The Electrosurgical Pencil (OBS-Dt, OBS-Ds, OBS-Ds, OBS-Da) is used for cutting and coagulation to remove tissue and control bleeding by using high frequency current during electrosurgical surgery with an electrosurgical generator, and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.

Not Found

This FDA clearance document is for an Electrosurgical Pencil and does not contain information about acceptance criteria or a study proving device performance as typically expected for AI/ML-enabled devices. The document is a 510(k) clearance letter, which determines substantial equivalence to a predicate device, rather than providing detailed performance data derived from clinical studies with specific acceptance criteria that would typically be seen for a new technology or diagnostic AI/ML device.

Therefore, I cannot provide the requested information in the format given because the input document does not contain:

1. A table of acceptance criteria and the reported device performance: The document does not define specific performance metrics or acceptance thresholds.
2. Sample size used for the test set and the data provenance: There is no mention of test sets, data, or their origin.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there is no mention of ground truth establishment.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not applicable.
6. If a standalone performance study was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document primarily focuses on the regulatory clearance process for a medical device (electrosurgical pencil) based on substantial equivalence to existing products, rather than a detailed performance study for an AI/ML algorithm.

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