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For Ultrasound: Ultrasound for use in applying deep heat can be used for treatment of selected medical Childious such as the relief of pain, muscle spasms and joint contractures. These conditions may be associated with adhesive capsulitis, bursitis with slight calcification, myositis and soft tissue injuries. Ultrasound can provide therapeutic deep heating between 40° and 45°C.

For VMS, Russian, Monophasic Hi-Volt:

• Relaxation of muscle spasms
• Prevention or retardation of disuse atrophy
• Increasing local blood circulation 1
• Muscle re-education
• Maintaining or increasing range of motion
• Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis

For Microcurrent, Interferential and Premodulated:

• = Symptomatic relief of chronic, intractable pain
• Management of pain associated with post-traumatic or post-operative conditions

Not Found

I am sorry but I am unable to answer your request. The document provided does not contain information about acceptance criteria, device performance, sample sizes, or study details. It is a letter from the FDA regarding 510(k) premarket notification for several medical devices, confirming their substantial equivalence to previously marketed devices and outlining regulatory requirements.

Ask a specific question about this device

For VMS, Russian, Monophasic Hi-Volt

• Relaxation of muscle spasms
• Prevention or retardation of disuse atrophy
• Increasing local blood circulation
• Muscle re-education
• Maintaining or increasing range of motion
• Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis
  For Microcurrent, Interferential and Premodulated
• Symptomatic relief of chronic, intractable pain
• Management of pain associated with post-traumatic or post-operative conditions

Not Found

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (Vectra 2C, 4C, 2S, 4S, Pro 2, and Pro 4). This document does not contain any information about acceptance criteria, device performance, study designs, sample sizes, ground truth establishment, or expert qualifications.

The letter primarily indicates that the devices are substantially equivalent to pre-amendment devices and can be marketed subject to general controls. It lists the indications for use of the devices but does not provide details on studies that support these indications or specific performance metrics.

Therefore, I cannot fulfill your request for the detailed information on acceptance criteria and study data based on the provided text.

Ask a specific question about this device

For Ultrasound: Ultrasound for use in applying deep heat can be used for treatment of selected medical conditions such as the relief of pain, muscle spasms and joint contractures. These conditions may be associated with adhesive capsulitis, bursitis with slight calcification, myositis and soft tissue injuries. Ultrasound can provide therapeutic deep heating between 40° and 45 °C.

For VMS, Russian, Monophasic Hi-Volt:

• Relaxation of muscle spasms
• Prevention or retardation of disuse atrophy
• Increasing local blood circulation
• Muscle re-education
• Maintaining or increasing range of motion
• Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis

For Microcurrent, Interferential and Premodulated:

• Symptomatic relief of chronic, intractable pain
• Management of pain associated with post-traumatic or post-operative conditions

Not Found

This document is an FDA 510(k) clearance letter for various Vectra devices (Vectra 2C, 4C, 2S, 4S, Pro 2, and Pro 4), which are indicated for physical therapy applications such as ultrasound and electrical stimulation. However, the provided text does not contain information about acceptance criteria or a study proving the device meets said criteria.

The document primarily states that the devices are substantially equivalent to legally marketed predicate devices, allowing them to proceed to market. It outlines general controls, regulations, and contact information for the manufacturer.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study results.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This information would typically be found in the 510(k) submission summary or detailed study reports, which are not provided in the given text. The FDA letter is an outcome of the review process, not the detailed review itself.

Ask a specific question about this device

For VMS, Russian, Monophasic Hi-Volt:

• Relaxation of muscle spasms
• Prevention or retardation of disuse atrophy
• Increasing local blood circulation
• Muscle re-education
• Maintaining or increasing range of motion
• Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis

For Microcurrent. Interferential and Premodulated:

• Symptomatic relief of chronic, intractable pain
• Management of pain associated with post-traumatic or post-operative conditions

Not Found

The provided text is a letter from the FDA regarding a 510(k) premarket notification for several medical devices. It does not contain any information about acceptance criteria, device performance, study details, or ground truth establishment.

Therefore, I cannot provide the requested information. The document primarily confirms the substantial equivalence of the listed devices to pre-amendment devices and outlines regulatory obligations for the manufacturer.

Ask a specific question about this device

Ultrasound for use in applying deep heat can be used for treatment of selected medical conditions such as the relief of pain, muscle spasms and joint contractures. These conditions may be associated with adhesive capsulitis, bursitis with slight calcification, myositis and soft tissue injuries. The CPS Ultrasound, while using any of the applicators available for this device, can provide therapeutic deep heating between 40° and 45°C in all of its operating modes.

Not Found

The provided document is a 510(k) clearance letter from the FDA for several devices manufactured by Chattanooga Group, Inc., specifically the Forte CPS 400 Stim, Forte CPS 200 Stim, Forte CPS Ultrasound, Forte CPS 400 Combo, and Forte CPS 200 Combo. These are physical therapy devices, and the letter confirms that they are substantially equivalent to devices marketed prior to May 28, 1976.

The document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment. The letter is a regulatory approval document, not a scientific study report. It states that the FDA has reviewed the submission and found the devices substantially equivalent based on the indications for use provided.

Therefore, I cannot fulfill your request for information on acceptance criteria and a study proving device performance from the provided text.

Ask a specific question about this device

For Ultrasound: Ultrasound for use in applying deep heat can be used for treatment of selected medical conditions such as the relief of pain, muscle spasms and joint contractures. These conditions may be associated with adhesive capsulitis; bursitis with slight calcification, myositis and soft tissue injuries. The Forte CPS Combo, while using any of the applicators available for this device, can provide therapeutic deep heating between 40° and 45°C in all of its operating modes.

For VMS. Russian, & Monophasic Hi-Volt:

• Relaxation of muscle spasms
• Prevention or retardation of disuse atrophy
• Increasing local blood circulation
• Muscle re-education
• Maintaining or increasing range of motion
• Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis

For Interferential, Microcurrent, and Premodulated:

• Symptomatic relief of chronic, intractable pain
• Management of pain associated with post-traumatic or post-operative conditions

Not Found

This document is a 510(k) clearance letter from the FDA for several medical devices manufactured by Chattanooga Group, Inc. It states that the devices (Forte CPS 400 Stim, Forte CPS 200 Stim, Forte CPS Ultrasound, Forte CPS 400 Combo, and Forte CPS 200 Combo) are substantially equivalent to legally marketed predicate devices.

However, this document does not contain any information regarding acceptance criteria or a study that proves the device meets specific acceptance criteria. It is a regulatory clearance based on substantial equivalence, not a detailed technical report of performance testing.

Therefore, I cannot provide the requested information based on the input text. The input text focuses on regulatory approval, product codes, trade names, and intended uses, not on performance metrics, study designs, or ground truth establishment.

Ask a specific question about this device

Useful in symptomatic relief of pain caused by medically diagnosed arthritis, bursitis, and chronic joint inflammation.

Relaxes muscles, relieves stiffness and muscle spasm.

Stimulates circulation and for other conditions where heat is indicated.

Not Found

The provided text is a 510(k) clearance letter from the FDA for a device called "Para-Care®". This document primarily focuses on the regulatory approval and indications for use of the device. It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or multi-reader multi-case studies.

Therefore, I cannot fulfill your request for this specific document. The information you are looking for would typically be found in a clinical study report or a 510(k) submission summary that details the testing and validation of the device.

Ask a specific question about this device

For Russian:

• Relaxation of muscle spasms
• Prevention or retardation of disuse atrophy
• Increasing local blood circulation
• Muscle re-education
• Maintaining or increasing range of motion
• Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis

For Monophasic Hi-Volt:

• Relaxation of muscle spasms
• Prevention or retardation of disuse atrophy
• Increasing local blood circulation
• Muscle re-education
• Maintaining or increasing range of motion
• Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis

For Interferential and Premodulated:

• Symptomatic relief of chronic, intractable pain
• Management of pain associated with post-traumatic or post-operative conditions

Not Found

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a device called "Intelect Legend Stim". It does not contain information about acceptance criteria, device performance, study details, or ground truth establishment. It primarily details the regulatory clearance for marketing the device based on substantial equivalence to pre-amendments devices. Therefore, I cannot fulfill your request for that specific information from this document.

Ask a specific question about this device

Ultrasound for use in applying deep heat can be used for treatment of selected medical conditions such as the relief of pain, muscle spasms and joint contractures. These conditions may be associated with adhesive capsulitis, bursitis with slight calcification, myositis and soft tissue injuries. The Intelect Legend Ultrasound, while using any of the applicators available for this device, can provide therapeutic deep heating between 40° and 45 °C in all of its operating modes.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA to Chattanooga Group, Inc. regarding their Intelect Legend Ultrasound device from 1997. This document primarily focuses on the regulatory clearance of the device based on substantial equivalence to pre-amendment devices. It does not contain information about acceptance criteria, detailed study designs, performance metrics, ground truth establishment, or sample sizes typically found in modern AI/ML device submissions.

Therefore, I cannot extract the requested information as the document does not describe any specific acceptance criteria or a study that proves the device meets those criteria.

The letter states that the device can provide therapeutic deep heating between 40° and 45°C, but this is a characteristic of the device's function, not a performance metric from a study against specific acceptance criteria in the context of an effectiveness study.

To answer your request based on the provided text, I must state that the information is not available in these documents.

Ask a specific question about this device