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Management and symptomatic relief of chronic intractable pain, posttraumatic and post-surgical pain.

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The provided document is a 510(k) clearance letter from the FDA for a device named "TruWave," which is a transcutaneous electrical nerve stimulator (TENS) for pain relief. This type of document, while indicating regulatory approval, does not contain the detailed acceptance criteria or the study data that proves the device meets those criteria.

FDA 510(k) clearances are based on a determination of "substantial equivalence" to a legally marketed predicate device, not necessarily on new clinical studies demonstrating device performance against specific, pre-defined acceptance criteria in the same way a PMA (Pre-Market Approval) or novel device would require.

Therefore, I cannot extract the requested information (acceptance criteria, device performance table, sample sizes, ground truth details, MRMC study results, etc.) from the provided text. This information would typically be found in the 510(k) submission itself, accessible only through a Freedom of Information Act (FOIA) request or directly from the manufacturer, not in the public clearance letter.

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Stroke Rehab by Muscle Re-education Relaxation of Muscle Spasms Prevention of retardation of disuse atrophy Increase local blood circulation Muscle re-education Maintaining or increasing range of motion

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The provided document is a 510(k) clearance letter from the FDA for the NeuroMove NM900 device. It states that the device is "substantially equivalent" to legally marketed predicate devices, but it does not contain the detailed study information, acceptance criteria, or performance data that would be used to prove the device meets specific acceptance criteria.

Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria, study design, sample sizes, expert qualifications, or ground truth details.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This indicates a comparison to existing devices, not necessarily a new clinical trial proving specific performance against set acceptance criteria in a standalone manner.

To provide the requested information, the actual 510(k) submission (which includes the supporting data and analysis) would be required. The document provided is the outcome of that review, not the review itself.

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In Interferential Mode: Symptomatic relief of chronic intractable pain, post-traumatic and postsurgical pain. In NMES Mode: 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 deep venous thrombosis. Maintaining or increasing range of motion.

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I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a medical device (IF8000) dated November 2, 1999. It states that the device is substantially equivalent to legally marketed predicate devices and outlines its indications for use in Interferential Mode and NMES Mode.

However, it does not include details about:

• Acceptance criteria and reported device performance.
• The study that proves the device meets the acceptance criteria.
• Sample sizes for test or training sets.
• Data provenance.
• Number and qualifications of experts for ground truth.
• Adjudication methods.
• MRMC comparative effectiveness studies or effect sizes.
• Standalone algorithm performance.
• Type of ground truth used.
• How ground truth for the training set was established.

This document is a regulatory approval, not a technical report detailing the device's validation studies.

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

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The provided text is a 510(k) clearance letter from the FDA for the "AM800 AutoMove EMG Triggered Electrical Muscle Stimulation" device.

This document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details.

The letter is a notification of substantial equivalence to a legally marketed predicate device, allowing the device to be marketed. It does not include the technical details or study reports that would contain the requested information about device performance and validation.

Therefore, I cannot populate the requested table and answer the study-related questions based on the provided text.

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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.

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The provided FDA 510(k) clearance letter and Indications for Use statement for the "Elpha 2000 CONTI" device do not contain information about acceptance criteria or a study demonstrating device performance.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method for the test set.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done.
6. If a standalone (algorithm only) performance study was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

This document is primarily a clearance letter affirming substantial equivalence to a predicate device for specific indications of use, rather than a detailed report of a performance study.

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