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The OmniVersa™ Multi Modality Therapy and Omnistim® FX2 Professional Therapy Systems by ACP use the Omnistim® FX2 Stimulator for the following indications for use:

• · Relaxation of muscle spasms
• · Re-education of muscle
• · Prevention or retardation of disuse atrophy
• · Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
• Increases local circulation
• · Maintains or increases range of motion

Stimulator waveforms: IFC, LVPC, and VMS:
· Symptomatic relief and management of chronic intractable pain and as an adjunctive treatment of acute pain, post-surgical pain and pain associated with post-traumatic injury.

Electrical muscle stimulator devices should be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions.

The OmniVersa™ Multi-Modality Therapy System also uses Omnisound® Ultrasound Transducer(s) for the following indications for use:

• Relieves pain
• · Decreases joint stiffness and contractures
• · Reduction of muscle spasm
• · Increases local circulation
• · Relief of pain, muscle spasms, and joint contractures that may be associated with: adhesive capsultiis, bursitis with slight calcification, myositis, soft tissue injuries, shortened tendons due to past injuries and scar tissues
• · Relief of sub-chronic, chronic pain and joint contractures resular tightness, capsular scaring

Not Found

I am sorry, but the provided text from the FDA 510(k) letter for the OmniVersa™ Multi-Modality Therapy System and Omnistim® FX2 Professional Therapy System does not contain information about acceptance criteria or a study proving a device meets these criteria in the context of AI/ML performance.

This document is a letter from the FDA determining substantial equivalence for a medical device (an ultrasound and muscle stimulator). It outlines:

• The trade/device name and regulatory classification.
• The indications for use of the device.
• Regulatory compliance requirements.

It does not include:

• Information about a study on device performance against specific acceptance criteria.
• Any mention of AI or machine learning.
• Details on sample sizes, ground truth, expert qualifications, or adjudication methods for any performance studies.
• Data on multi-reader multi-case (MRMC) comparative effectiveness or standalone algorithm performance.

Therefore, I cannot fulfill your request for the specific details outlined in your prompt based on the provided text.

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Diathermy is used therapeutically to increase the temperature of tissues. It is generally accepted that heat produces the following desirable therapeutic effects:

• · Relieves pain
• · Increases the extensibility of collagen tissues
• · Decreases joint stiffness
• · Relieves muscle spasm
• Increases local blood flow

Megapulse Shortwave Diathermy system is indicated for use in the following conditions or applications:

• · Disorders of the musculoskeletal system
  • o Muscle spasm
  • o Joint stiffness
  • o Joint contractures
• · Chronic inflammatory or infective conditions
  • o Tenosynovitis
  • o Bursitis
  • o Synovitis
  • o Chronic inflammatory pelvic diseases

Not Found

I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA to a medical device manufacturer, along with the device's indications for use. It primarily focuses on the regulatory approval of the "Megapulse III Shortwave Diathermy" device based on substantial equivalence to existing devices.

This document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert ground truth, or adjudication methods. It does not present data from a study proving the device meets specific performance criteria.

Therefore, I cannot provide the requested table and information as it is not present in the given text.

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A non-implanted electrical stimulator for urinary incontinence is intended to retrain the urinary continence mechanisms by way of electrical stimulation applied to the pelvic floor musculature and surrounding structures. Typically, these devices are indicated for use in females for treatment of stress incontinence, urge incontinence, or mixed incontinence (a combination of stress and urge incontinence).

Intended for use in acute and ongoing treatment of urinary incontinence in cases where the following results may improve urinary control: Improvement of urethral sphincter closure, strengthening of pelvic floor muscles, Inhibition of the detrusor muscle through reflexive mechanisms.

Non-implanted electrical stimulator for urinary incontinence

This document is an FDA 510(k) clearance letter and an "Indications for Use" statement for the Omnistim® Continence+ Pelvic Floor Stimulation System. Unfortunately, this type of regulatory document does not typically contain the detailed information required to answer your specific questions about acceptance criteria and the underlying study data.

Regulatory clearance for medical devices like this often relies on demonstrating "substantial equivalence" to a predicate device, rather than requiring new, extensive clinical trials that would generate the detailed performance metrics you've requested.

Therefore, I cannot provide the following information based on the text provided:

1. A table of acceptance criteria and the reported device performance: This document specifies the intended use but not specific performance metrics or their acceptance criteria.
2. Sample size used for the test set and the data provenance: Not available in this document.
3. Number of experts used to establish the ground truth for the test set and their qualifications: Not available.
4. Adjudication method for the test set: Not available.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not available.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable for this type of device (it's a physical stimulator, not an AI algorithm).
7. The type of ground truth used: Not applicable or available.
8. The sample size for the training set: Not applicable or available.
9. How the ground truth for the training set was established: Not applicable or available.

What the document does tell us:

• Device Name: Omnistim® Continence+ Pelvic Floor Stimulation System
• Regulation Number: 21 CFR 876.5320
• Regulation Name: Non-implanted electrical continence device
• Regulatory Class: II
• Product Code: KPI
• Indications for Use: A non-implanted electrical stimulator for urinary incontinence, intended to retrain urinary continence mechanisms by electrical stimulation to pelvic floor musculature and surrounding structures. Indicated for use in females for treatment of stress incontinence, urge incontinence, or mixed incontinence. It aims to improve urethral sphincter closure, strengthen pelvic floor muscles, and inhibit the detrusor muscle through reflexive mechanisms to improve urinary control.
• Approval Status: Received 510(k) clearance, deemed substantially equivalent to legally marketed predicate devices.

To get the type of detailed study information you're asking for, you would typically need to consult the full 510(k) submission summary (if available publicly, often redacted), peer-reviewed publications about the device, or clinical trial reports, which are not part of this FDA clearance letter.

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This device is intended to for use to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pains, minor arthritis pain and muscle spasm; relieving stiffness; promoting relaxation of muscle tissue and to temporarily increase local blood circulation

OmniProbe Infrared Lamp, OmniProbe 500 Infrared Lamp Control Unit

The provided FDA letter for K060191 describes the OmniProbe Infrared Lamp and OmniProbe 500 Infrared Lamp Control Unit. However, it is a 510(k) clearance letter, which determines substantial equivalence to a legally marketed predicate device. This type of regulatory submission typically does not contain detailed information about specific acceptance criteria, performance studies with sample sizes, or ground truth establishment in the way that would be found in a De Novo or PMA submission for novel devices or higher-risk devices.

Therefore, many of the requested details about acceptance criteria and study particulars are not present in the provided text. The letter focuses on the regulatory determination of substantial equivalence based on the device's indications for use and general controls.

Here's a breakdown of what can and cannot be answered based on the provided document:

1. A table of acceptance criteria and the reported device performance

• Not available in the provided text. The 510(k) clearance is based on substantial equivalence to a predicate device, not on specific acceptance criteria and performance metrics for the new device as would be detailed in a PMA or De Novo.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not available in the provided text. The document does not describe any specific clinical or performance studies with test sets, sample sizes, or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable/Not available in the provided text. A 510(k) clearance, especially for an infrared lamp, typically does not involve establishing ground truth by a panel of experts in the way an AI/CAD device would. The safety and effectiveness are inferred from the predicate device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable/Not available in the provided text. No adjudication method for a test set is mentioned as no such study is described.

5. 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/Not available in the provided text. The device is an infrared lamp, not an AI/CAD system. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or described.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable/Not available in the provided text. The device is not an algorithm; it's a physical medical device (an infrared lamp).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable/Not available in the provided text. Ground truth in the context of diagnostic or AI devices is not relevant to an infrared lamp's 510(k) submission.

8. The sample size for the training set

• Not applicable/Not available in the provided text. This device does not involve a training set as it is not an AI/machine learning product.

9. How the ground truth for the training set was established

• Not applicable/Not available in the provided text. As there is no training set, there is no ground truth establishment for one.

Summary based on the provided document:

The provided document is an FDA 510(k) clearance letter for the OmniProbe Infrared Lamp and OmniProbe 500 Infrared Lamp Control Unit. Its purpose is to state that the device is "substantially equivalent" to legally marketed predicate devices. This regulatory pathway primarily relies on demonstrating that the new device has the same intended use, technological characteristics, and similar safety and effectiveness profile as a previously cleared device. It does not typically require or describe the detailed performance studies, specific acceptance criteria, sample sizes, or ground truth establishment that would be associated with novel or higher-risk devices, especially those incorporating AI or complex diagnostic algorithms.

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