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The Rich-Mar AutoPrism is an infrared lamp as classified under 21 CFR Part 890.5500. As such, it emits energy to provide topical heating for the temporary increase in local blood circulation, temporary relief of minor muscle and joint aches, pains and stiffness, and the relaxation of muscles; for muscle spasms, and for temporary relief of minor pain and stiffness associated with arthritis. For use when heat is indicated for the treatment of the fore mentioned conditions

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I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a specific medical device (Rich-Mar AutoPrism Infrared Lamp). It contains information about the regulatory classification, indications for use, and substantial equivalence to predicate devices.

However, it does not contain any information about acceptance criteria, study details, performance metrics, sample sizes, expert qualifications, ground truth establishment, or any kind of AI or algorithm performance study. The document is a regulatory communication, not a technical study report.

Therefore, I cannot fulfill your request with the input provided.

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Conductive medium for transmission of therapeutic ultrasound to tissue.

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The provided text is a 510(k) premarket notification letter from the FDA regarding a medical device called "AutoGel Pad." This document pertains to the regulatory clearance of a device based on substantial equivalence to a predicate device, rather than a de novo approval that would detail extensive performance studies against acceptance criteria.

Therefore, the input document does not contain the information requested in the prompt regarding:

1. A table of acceptance criteria and reported device performance.
2. Sample size and data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
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 training set ground truth was established.

This document merely states that the FDA found the "AutoGel Pad" to be substantially equivalent to a legally marketed predicate device, indicating it can be marketed for its stated "Indications For Use: Conductive medium for transmission of therapeutic ultrasound to tissue." The FDA's determination of substantial equivalence often relies on demonstrating that the new device has the same intended use, technological characteristics, and safety and effectiveness as the predicate device, but it does not typically involve the detailed performance study reporting requested in the prompt.

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Muscle stimulator indications for treatment using Quadpolar, Bipolar, Monophasic, and Russian waveforms:

• 1. Relaxation of muscle spasms.
• Prevention or retardation of disuse atrophy. 2.
• 3. Increasing local blood circulation.
• 4. Muscle re-education.
• 5. Maintaining or increasing range of motion.
• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. 6.

Indications for treatment using Quadpolar Interferential and Microamperage Pulsed Current (Microcurrent) waveforms:

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

Rich-Mar ultrasound devices are indicated to produce therapeutic deep heat for the following conditions:

• 1. Relief of pain
• 2. Muscle spasms
• 3. Joint contractures

But NOT for the treatment of malignancies

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The provided text is a Letter of Substantial Equivalence from the FDA for a device called "Rich-Mar AutoSound 7.6". This document does not contain any information about acceptance criteria or a study proving that the device meets such criteria.

The letter essentially states that the device is substantially equivalent to legally marketed predicate devices and therefore can be marketed. It lists the indications for use of the device but offers no performance metrics, study designs, or data to support any acceptance criteria.

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

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Rich-Mar ultrasound devices are indicated to produce therapeutic deep heat for the following conditions:

• Relief of pain
• Muscle spasms
• Joint contractures
  But NOT for the treatment of malignancies

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The provided text is a 510(k) premarket notification approval letter for the Rich-Mar Therasound 6.5 Therapeutic Ultrasound device. It does not contain information about acceptance criteria, study details, performance metrics, ground truth, sample sizes, or expert qualifications as typically found in a clinical study report or a more detailed technical submission.

The letter simply states that the FDA has reviewed the submission and determined that the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market. It lists the "Indications For Use" which are the conditions for which the device is intended (relief of pain, muscle spasms, joint contractures, but not for the treatment of malignancies), but these are not acceptance criteria in the sense of performance thresholds.

Therefore,Based on the provided document, the following information cannot be extracted:

1. A table of acceptance criteria and the reported device performance: This document is an FDA approval letter, not a study report. It does not contain specific acceptance criteria for device performance or reported performance metrics.
2. Sample sized used for the test set and the data provenance: No study details are provided, so sample size and data provenance are unknown.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no specific test set or ground truth establishment method is described.
4. Adjudication method for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No such study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this device is a therapeutic ultrasound, not an AI algorithm.
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 is a regulatory approval notice based on substantial equivalence to existing devices, not a scientific study detailing device performance against specific criteria.

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Muscle stimulator indications for treatment using Quadpolar, Bipolar, Monophasic, and Russian waveforms:

• 1. Relaxation of muscle spasms.
• 2. Prevention or retardation of disuse atrophy.
• 3. Increasing local blood circulation.
• 4. Muscle re-education.
• 5. Maintaining or increasing range of motion.
• 6. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.

Indications for treatment using Quadpolar Interferential and Microamperage Pulsed Current (Microcurrent) waveforms:

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

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I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (Rich-Mar Winner ST-2, a muscle stimulator and TENS unit). It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any of the other specific details you requested regarding a medical device study.

Therefore, I cannot extract the requested information from the given text. This document serves as regulatory clearance based on substantial equivalence to predicate devices, not a detailed report of a performance study.

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Muscle stimulator indications for treatment using Quadpolar, Bipolar, Monophasic, and Russian waveforms:

1. Relaxation of muscle spasms.
2. Prevention or retardation of disuse atrophy.
3. Increasing local blood circulation.
4. Muscle re-education.
5. Maintaining or increasing range of motion.
6. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.

Indications for treatment using Quadpolar Interferential and Microamperage Pulsed Current (Microcurrent) waveforms:

1. Symptomatic relief of chronic intractable pain.
2. Management of pain associated with post-traumatic or post operative conditions.

Rich-Mar ultrasound devices are indicated to produce therapeutic deep heat for the following conditions:

1. Relief of pain
2. Muscle spasms
3. Joint contractures
   But NOT for the treatment of malignancies

Not Found

This document is a 510(k) substantial equivalence determination letter from the FDA for a medical device called the "Rich-Mar Winner CM-2". It does not contain information about acceptance criteria, device performance, or details of a study with sample sizes, expert qualifications, or ground truth establishment.

Here's why the requested information cannot be found in the provided text:

• Nature of the Document: This letter is an FDA approval (or clearance) document, indicating that the device has been deemed "substantially equivalent" to predicate devices already on the market. It confirms that the device can be legally marketed. It is not a report detailing the results of clinical trials, performance studies, or validation efforts.
• Focus on Equivalence: The primary purpose of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to prove absolute efficacy or performance against a set of predefined acceptance criteria through a specific study. While manufacturers perform testing to support their claims, the FDA letter itself doesn't typically provide those detailed results.
• Missing Sections: The document lacks sections such as "Study Design," "Methods," "Results," "Performance Metrics," or "Clinical Data," which would be present in a study report.

Therefore, I cannot extract the requested information (table of acceptance criteria, device performance, sample sizes, data provenance, number of experts, adjudication methods, MRMC study details, standalone performance, types of ground truth, training set size, or ground truth establishment for the training set) from this document.

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THERAPEUTIC ULTRASOUND
Rich-Mar Ultrasound devices are indicated to produce therapeutic deep heat for the following conditions:

1. Relief of pain
2. Muscle Spasms
3. Joint contractures
   But NOT for the treatment of malignancies

MICROAMPERAGE PULSED CURRENT INDICATIONS FOR TREATMENT (Microcurrent)
Microcurrent output is indicated for the following conditions:

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

Quadpolar, Bipolar, Monophasic and Russian Waveforms
This device is indicated for the following conditions:

1. Relaxation of muscle spasms.
2. Prevention or retardation of disuse atrophy.
3. Increasing local blood circulation.
4. Muscle re-education.
5. Maintaining or increasing range of motion.
6. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
   Powered muscle stimulators should only be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions.

(Quadpolar Interferential and Microamperage Pulsed Current)

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

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This is a 510(k) clearance letter for the Rich-Mar Winner CM4 device, which is a combination of several therapeutic modalities including powered muscle stimulator, TENS, ultrasonic diathermy, ultrasound and muscle stimulator, and interferential current therapy.

The document does not describe a study involving AI or machine learning algorithms, nor does it provide acceptance criteria and performance data in the typical format for such studies. This letter is a regulatory document confirming substantial equivalence to predicate devices, not a performance study report for a novel AI-powered device.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truthing, adjudication methods, MRMC studies, standalone performance, or training set details from the provided text. The document pertains to a medical device's regulatory clearance based on its similarity to previously approved devices, not on the performance of an AI component.

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Rich-Mar Ultrasound devices are indicated to produce therapeutic deep heat for the following conditions:

• l) Relief of pain
• 2. Muscle Spasms
• 3. Joint contractures
     But NOT for the treatment of malignancies

Rich-Mar US500, US750, US1000, Therapeutic Ultrasound Devices

This document is a 510(k) clearance letter from the FDA for therapeutic ultrasound devices. It does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria. Therefore, I cannot fulfill your request based on the provided text.

Ask a specific question about this device