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The CSM monitor is intended for use in monitoring the hypnotic state of the brain by data acquisition of EEG signals of the anaesthetized or sedated patient in all areas of the hospital.

The Cerebral State Monitor (CSM) is a non-invasive measurement tool for use by trained healthcare professionals to measure the level of consciousness (LOC) in all areas of the hospital. Based on EEG, an index (CSI) is calculated, which is used in the estimation of LOC. The CSM displays the CSI but does not perform any data interpretation (i.e., all data interpretation is performed by a physician).

The provided document is a 510(k) summary for the Cerebral State Monitor (CSM) and the FDA clearance letter. It states that the device is substantially equivalent to predicate devices but does not contain detailed information about acceptance criteria or specific studies showcasing performance data in the structured format requested. The document explicitly states: "The CSM displays the CSI but does not perform any data interpretation (i.e., all data interpretation is performed by a physician)". This indicates that the device itself is a measurement tool and not an AI or algorithm-driven diagnostic device as implied by some of the questions.

Therefore, many of the requested details, such as sample sizes for test and training sets, the number and qualifications of experts, adjudication methods, MRMC studies, standalone performance details, and how ground truth for training was established, are not present in this regulatory document.

However, based on the information available, I can construct a table for the acceptance criteria and intended use, and provide what limited information is available regarding performance.

Acceptance Criteria and Device Performance (Based on available information)

Study Details and Data Provenance

1. Sample size used for the test set and the data provenance: Not specified in the provided document. As the device is primarily a measurement tool and does not perform "data interpretation," it is unlikely a "test set" in the context of an algorithm's diagnostic performance was used or described in this type of submission. Performance is assessed against technical specifications and equivalence to predicate devices.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified. Ground truth in the context of diagnostic accuracy is not directly applicable here as the device does not perform diagnosis. The document states "all data interpretation is performed by a physician."
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable based on the information provided.
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: Not applicable. The CSM is a monitoring device that provides an index (CSI) for human interpretation; it is not described as an AI-assisted diagnostic tool designed to improve human reader performance.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The document states, "The CSM displays the CSI but does not perform any data interpretation (i.e., all data interpretation is performed by a physician)." This confirms that the device is not designed for standalone diagnostic performance; it is a measurement tool.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not specified as the device does not perform diagnosis. The "ground truth" for a monitor typically relates to the accuracy and reliability of its measurements against established physiological standards or reference devices, which is not detailed here. The "level of consciousness" is a clinical assessment made by a physician using various inputs, including the CSI.
7. The sample size for the training set: Not specified and likely not applicable in the context of an AI training set, as the device is not described as an AI/ML algorithm for diagnosis.
8. How the ground truth for the training set was established: Not specified and likely not applicable for the reasons stated above.

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ELPHA // 500, ELPHA // 1000: This Danmeter device is designed for the symptomatic relief and management of chronic intractable pain and as an adjunctive treatment in the management of post-surgical pain and post traumatic acute pain.

ELPHA // 2000: This Danmeter device is designed for the relaxation of muscle spasms, prevention or retardation of disuse atrophy, increasing local blood circulation, muscle re-education, immediate post-surgical stimulation of calf muscles to prevent venous thrombosis and maintaining or increasing range of motion.

ELPHA II 3000: This Danmeter device is designed for:

• Symptomatic relief and management of chronic (long-term), intractable pain and as an adjunctive treatment in the management of post-surgical pain and post traumatic acute pain.
• Relaxation of muscle spasms, prevention or retardation of disuse atrophy, increasing local blood circulation, muscle re-education, immediate post-surgical stimulation of calf muscles to prevent venous thrombosis and maintaining or increasing range of motion.

Not Found

The provided document is a 510(k) clearance letter from the FDA for several models of the ELPHA device. It does not contain any information about acceptance criteria or a study proving that the device meets those criteria.

The letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices and outlines the regulatory requirements for marketing the device. The "Indications for Use" section describes the intended medical purposes of the different ELPHA models, but it does not specify performance metrics, study designs, or analytical results.

Therefore, I cannot fulfill your request for the following information based on the provided text:

1. A table of acceptance criteria and the reported device performance: Not present.
2. Sample size used for the test set and the data provenance: Not present.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
4. Adjudication method: Not present.
5. Multi-reader multi-case (MRMC) comparative effectiveness study information: Not present.
6. Standalone performance information: Not present.
7. Type of ground truth used: Not present.
8. Sample size for the training set: Not present.
9. How the ground truth for the training set was established: Not present.

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Stroke Rehab by Muscle Reeducation
Relaxation of muscle spasms
Prevention or retardation of disuse atrophy
Increasing local blood circulation
Muscle re-education
Maintaining or increasing range of motion

Not Found

The provided text is a 510(k) clearance letter from the FDA for a device named "AutoMove, model AM800." This letter determines that the device is substantially equivalent to legally marketed predicate devices.

Crucially, this document is an FDA clearance letter, not a study report or clinical trial summary. Therefore, it does not contain the detailed information requested regarding acceptance criteria, device performance, study methodology, sample sizes, ground truth establishment, or expert qualifications.

The letter focuses on regulatory approval based on substantial equivalence, which means it compares the new device to existing approved devices without necessarily presenting a full clinical study with acceptance criteria and direct performance evaluation against those criteria.

Therefore, I cannot provide the requested information from the given text.

To obtain the information you're asking for, you would typically need to refer to:

• The original 510(k) submission document itself.
• Clinical study reports that would have been part of that submission or publicly published.
• The applicant's (Danmeter A/S) technical documentation or website.

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Electrical stimulation of the pelvic floor muscles with the use of vaginal probe. The effect is strengthening the pelvic floor muscles and an activation of the central nervous system.

Electrical stimulation of the pelvic floor muscles can reduce urinary incontinence among stress and urge incontinent adult females.

Not Found

This document is a 510(k) clearance letter from the FDA for a medical device called ELPHA 4 Conti, a non-implanted electrical continence device. It does not contain the specific information required to answer the prompt regarding acceptance criteria and the study that proves the device meets those criteria.

Therefore, I cannot provide the requested information based on the given text.

The document does not describe:

• Any acceptance criteria.
• Any specific study performed to prove device performance.
• Sample sizes, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance, or ground truth details.

The letter merely states that the FDA has reviewed the 510(k) premarket notification and determined the device is substantially equivalent to legally marketed predicate devices for the indicated uses.

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