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Disposable 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) and Evoked Potential sigmals (EP). The electrodes are non-sterile and for single use only.

Disposable Adhesive Surface (Ring) Electrodes are intended to be used with diagnostic electromyography equipment that deliver an electrical stimulus and record electromyography signals for neurodiagnostic purposes. The electrodes are nonsterile and for single use only.

Disposable/Reusable Cup Electrodes are intended for non-invasive use with recording and monitoring equipment, (active and reference), of Electromyography (EMG), Electroencephalograph (EEG) and Evoked Potentials (EP).

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I am sorry, but this document contains general correspondence regarding an FDA 510(k) premarket notification for "Disposable Adhesive Surface Electrodes" and "Disposable/Reusable Cup Electrodes."

The document does not describe "acceptance criteria" for a study, nor does it present any "study that proves the device meets acceptance criteria" in the way one would analyze a medical device's performance in clinical or diagnostic tasks.

Instead, the document primarily focuses on:

• Regulatory classification: Class II (Special Controls) for Cutaneous Electrodes.
• Substantial equivalence: A determination that the device is substantially equivalent to legally marketed predicate devices.
• General regulatory requirements: Information about annual registration, labeling, manufacturing practices, etc.
• Indications for Use: What the electrodes are intended for (e.g., recording and monitoring biopotential signals like EEG, sEMG, EP).

Therefore, I cannot provide the requested information, which typically pertains to performance metrics (sensitivity, specificity, AUC), sample sizes for test/training sets, ground truth establishment, expert qualifications, or MRMC studies for AI/CADe devices. This document is related to a much simpler, non-AI medical device.

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Spes Medica Disposable Adhesive Surface Electrodes are intended for use with electrodiagnostic or neurological monitoring equipment for the recording of electrophysiological activity and for electrical stimulation. The electrodes are non-sterile and for single patient use only.

Spes Medica Disposable Adhesive Surface Electrodes are single patient use, disposable devices. Electrodes are non-invasive as they are applied to the patient's skin using a selfadhesive solid-gel surface. The electrodes consist of 3 different layers of materials.

The upper layer consists in a cotton non-woven pad, the second layer is the sensor and consists in a conductive layer. The lower layer, then the material in direct contact with the patient's skin consist in a solid Hydro-gel adhesive layer.

Spes Medica Disposable Adhesive Surface Electrodes are supplied with leads or with snap connector.

The electrodes which are attached to a lead wire terminate at the opposite end using different type of connectors such us:

• DIN 42802 "touch proof" safety connectors; .
• 0,7 mm "touch proof" pin; .
• Concentric "touch proof" bipolar socket; .
• 2 mm "touch proof" socket; .

The snap connector electrode uses Ag/AgCl pellet(s) as the conductive element. The active surface of the pellet is comprised between the cotton non-woven pad and the Hydro-gel adhesive layer. The pellet is attached to a stainless steel male snap connector which is used as connection.

The provided text is a 510(k) summary for Disposable Adhesive Surface Electrodes by Spes Medica s.r.l. It asserts that the device is substantially equivalent to legally marketed predicate devices. However, it does not include a study that proves the device meets specific acceptance criteria in the manner requested.

Instead, the document details a technological comparison to establish substantial equivalence, which is a regulatory pathway to market a device based on its similarity to existing, legally marketed devices (predicates). This pathway typically relies on demonstrating that the new device has the same intended use and similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness.

Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes for test/training sets, expert qualifications, ground truth establishment, and MRMC studies are not present in the provided document, as these are typically part of a de novo classification or premarket approval (PMA) application, not a 510(k) for substantial equivalence based on technological comparison.

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

Acceptance Criteria and Device Performance (Not Applicable - Substantial Equivalence Claim)

The document does not define specific performance acceptance criteria for the new device or present a study comparing its performance against such criteria. Instead, it states:

"Spes Medica Disposable Adhesive Surface Electrodes are similar in intended use, design, materials, packaging and other technological characteristics to the predicate devices. After analyzing performance and safety testing, it is the conclusion of Spes Medica s.r.I. that the Disposable Adhesive Surface Electrodes are safe and effective as the predicate devices and introduce no new questions concerning safety and effectiveness."

This suggests that the "acceptance criteria" were implied to be "as safe and effective as the predicate devices," and the "study" was an analysis of the device's characteristics against those of the predicates.

Other Requested Information (Not Present in the Document)

The document does not contain information regarding:

• Sample sizes used for the test set and the data provenance: No test set is described.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment for a test set is described.
• Adjudication method for the test set: No adjudication method is described.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: No MRMC study is mentioned.
• If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The device is a physical electrode, not software with an algorithm.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no performance study against a ground truth is described.
• The sample size for the training set: No training set is described.
• How the ground truth for the training set was established: Not applicable.

Device Description and Basis for Substantial Equivalence:

The document's "study" consists of a comparison to the following predicate devices:

The conclusion is based on the new device being similar in:

• Intended use
• Design
• Materials
• Packaging
• Other technological characteristics

The document explicitly states: "No new technology or basic materials are used in these designs."

In summary, the provided text is a 510(k) premarket notification for a Class II medical device, seeking clearance based on substantial equivalence to existing devices. It does not present a study with quantitative acceptance criteria and performance data as would be found in different types of regulatory submissions for novel devices or significant modifications.

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The Disposable 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.

Disposable 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. There are two types of electrodes, one with fixed lead wire and the other without lead wire, tab electrodes. The electrodes with lead wire have a safety DIN 42802 connector, several lengths and color combinations. Tab electrode can be connected, using a lead wire with alligator clip, to the gel free contact strip at the electrode end.

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific acceptance criteria with numerical targets or performance metrics for the device. Instead, it focuses on the device's adherence to intended use and its substantial equivalence to predicate devices, supported by bench testing.

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

• Sample Size for Test Set: Not specified. The document only mentions "bench testing" was performed, but no details on the number of samples or specific test cases are provided.
• Data Provenance: The testing was conducted by Technomed Europe, which is based in The Netherlands. It is implied to be internal (bench) testing, not necessarily human subject data. The study is retrospective in the sense that it's a summary of testing already performed, rather than a prospective trial design.

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

• The document does not mention the use of experts to establish a ground truth for any test set. The evaluation focuses on the physical and functional characteristics of the electrodes through bench testing and comparison to predicate devices, not on diagnostic accuracy requiring expert interpretation.

4. Adjudication Method for the Test Set

• Not applicable. No expert adjudication is mentioned or implied, as the study relies on bench testing and comparison to predicate devices for electrode performance, not subjective interpretation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Reader Improvement with AI vs. Without AI Assistance

• No MRMC study was done. This device (Cutaneous Electrodes) is a hardware component used in medical procedures, not an AI or imaging diagnostic tool that would typically involve human readers. Therefore, there's no mention of AI assistance or human reader improvement.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Study Was Done

• Not applicable. This is a hardware device (electrodes), not an algorithm or software. Its performance is assessed through physical and functional bench testing, not as an "algorithm only" study.

7. The Type of Ground Truth Used

• The "ground truth" for this device's evaluation is primarily engineering and manufacturing specifications, along with performance characteristics defined by relevant standards and the performance of the predicate devices. For example, the adhesive qualities, conductivity, material safety, and signal acquisition capabilities would be objectively measured without requiring a clinical "ground truth" like pathology or expert consensus.

8. The Sample Size for the Training Set

• Not applicable. This is a hardware device, not a machine learning model, so there is no concept of a "training set" in the context of an algorithm.

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

• Not applicable. As there is no training set for an algorithm, there's no ground truth established for one.

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