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The Skylark Uro Probe is indicated for pelvic floor stimulation use in the treatment of urinary incontinence and allows assessment of EMG activity of the pelvic floor muscles.

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The provided document is a 510(k) clearance letter from the FDA for a device called "Skylark Uro Probe." This document primarily focuses on regulatory approval and does not contain information about specific acceptance criteria for device performance, the results of a study proving those criteria were met, or details regarding the methodologies of such a study (sample sizes, ground truth establishment, expert qualifications, etc.).

The letter confirms:

• Trade/Device Name: Skylark Uro Probe
• Regulation Number: 21 CFR §876.5320
• Regulation Name: Nonimplanted electrical continence device
• Regulatory Class: II
• Product Code: KPI
• Indications for Use: The Skylark Uro Probe is indicated for pelvic floor stimulation use in the treatment of urinary incontinence and allows assessment of EMG activity of the pelvic floor muscles.

Therefore, I cannot provide the requested information from the given document as it does not contain the details about acceptance criteria or a study proving device performance.

To answer your request, I would need a different type of document, such as a summary of safety and effectiveness data (SSED) or a clinical study report that explicitly details the device's performance testing and the criteria it needed to meet.

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This BIO-STIM KIT is intended for temporary relief of pain associated with sore and aching muscle in the lower back due to strain from exercise or normal household and work activities.

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This is a scanned FDA 510(k) clearance letter for the "BIO-STM KIT", a transcutaneous electrical nerve stimulator for pain relief. The document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The letter is a regulatory document confirming that the device is substantially equivalent to legally marketed predicate devices and therefore can be marketed. It does not include performance data or studies.

Therefore, I cannot provide the requested information.

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To provide infrared lamp energy that penetrates the skin to promote increased blood flow and circulation, thereby, providing temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, and muscle spasm. The elevated tissue temperature also promotes relaxation of muscles of muscles and relief from pain resulting in improved range of motion.

Skylark Infrared Lamp, Models SD-956IR and SD-100IR

This looks like a 510(k) clearance letter for an infrared lamp, not a study report for a medical device with performance metrics. The provided document is an FDA clearance letter for a device, not a study describing acceptance criteria and performance data. Therefore, I cannot extract the requested information about device performance and study methodology.

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Indication Use For EMS (Code 10, 20-22,30-33_) Only Relax muscle Spasms Prevent or retard disuse atrophy Maintain or increase range of motion Increase local blood circulation Re-educate muscle Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis Indication Use For IF (Code 11-18, 20-22,30-33) For symptomatic relief and management of chronic pain and /or as an adjunctive treatment in the management of post -surgical and post-traumatic acute pain. Powered muscle stimulators should only be used under medical supervision

The SDS-41 like a number of legally marketed predicate devices incorporates traditional muscle stimulation and interferential current stimulation modalities into one unit. The SDS-41 is housed in a plastic enclosure. The front of the enclosure house character LCD display. The accessories provided with the SDS-41 include the output cable, the electrode pads, and the AC Charging Adapter. The SDS-4I muscle stimulation modality operates at a specified 23 volts max (into a 500 ohm load) and 46mA max (into a 500 ohm load) with a pulse width of 520us Max and a cycle frequency of 75 Hz (±5%). The pulse is Symmetrical bi-phasic. The waveform includes an on/off ramp, which slowly increases the pulse width to the desired setting. The SDS-4I interferential modality operates at a specified 80 mA max (into a 500 ohm load). The carrier and interferential signals are sine wave symmetric, balanced outputs with zero net charge. The interferential modality can operate in a true interferential mode (4 pad mode) or the signals can be pre-mixed and only the pre-mixed signals sent to the patient (2 pad mode). The interference Signal frequency can be fixed (continuous) or carried based on three selections (variable).

This document is a 510(k) summary for the SDS-4I Muscular and Interferential Current Stimulator. It describes the device, its indications for use, and its substantial equivalence to previously marketed devices. However, it does not contain information about acceptance criteria, a specific study proving the device meets those criteria, or details regarding ground truth, expert adjudication, or sample sizes related to performance evaluation.

Therefore, for the requested information, the response is as follows:

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

• Acceptance Criteria: Not specified in the provided document.
• Reported Device Performance: Not specified in the provided document.

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

• Not specified in the provided document.

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 specified in the provided document.

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

• Not specified in the provided document.

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

• This document describes a muscle stimulator device, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study involving AI assistance for human readers is not applicable and not mentioned.

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

• This document describes a muscle stimulator device, not an algorithm. Therefore, standalone algorithm performance is not applicable and not mentioned.

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

• Not specified in the provided document. The document pertains to a medical device for muscle stimulation and interferential current, not an diagnostic or AI-driven system that would typically require "ground truth" in the context of diagnostic accuracy.

8. The sample size for the training set

• Not specified in the provided document.

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

• Not specified in the provided document.

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1.Symptomatic relief of chronic, intractable pain

2.Management of pain associated with post-traumatic or post-operative conditions

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The provided document is a 510(k) clearance letter from the FDA for a device named SD-730 IF-SDS (also known as Perfect Pulse IF-SDS). This letter indicates that the device has been found substantially equivalent to a predicate device, allowing it to be marketed.

However, the document does NOT contain information about acceptance criteria, specific device performance data from a study, sample sizes, expert qualifications, adjudication methods, details of comparative effectiveness studies (MRMC), standalone performance, types of ground truth used, or training set information.

The document is a regulatory approval letter, not a study report. It outlines the indications for use for which the device was cleared ("Symptomatic relief of chronic, intractable pain" and "Management of pain associated with post-traumatic or post-operative conditions") but does not present the data used to support these claims or demonstrate performance against specific criteria.

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

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The INFRAREX temporarily increases local blood circulation where applied, and temporarily relieves minor muscle and joint aches and pains.

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I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a device called "ST-302 Infrarex." This letter does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methodologies.

The letter is a regulatory document stating that the FDA has reviewed the device and determined it is substantially equivalent to a legally marketed predicate device, allowing the manufacturer to market it. It details regulatory provisions and contact information but does not include technical study details.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance: This information is not present.
2. Sample sized used for the test set and the data provenance: This information is not present.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present.
4. Adjudication method for the test set: This information is not present.
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: This information is not present. The device is a "ST-302 Infrarex," which is likely a physical therapy or pain relief device, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This information is not present. Again, this type of study is irrelevant for the described device.
7. The type of ground truth used: This information is not present.
8. The sample size for the training set: This information is not present.
9. How the ground truth for the training set was established: This information is not present.

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The SD-100 SKYEAR THERMOMETER is designed for file 3D 100 -

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I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets those criteria. The document is an FDA letter to a device manufacturer, confirming the substantial equivalence of the "SD-100 Skyear Thermometer" to legally marketed predicate devices. It discusses regulatory matters, such as the classification of the device, applicable regulations, and marketing permissions, but it does not detail performance acceptance criteria or study results.

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The SD-956 generates deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies.

SD-956 Ultrasound Therapy

This document is a 510(k) clearance letter from the FDA for the SD-956 Ultrasound Therapy device. It does not contain information about acceptance criteria, study details, or device performance. The letter confirms that the device is substantially equivalent to legally marketed predicate devices for the indications of use detailed in the enclosure.

Therefore, the requested information about acceptance criteria and a study proving device performance cannot be extracted from the provided text.

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FOR USE WITH TENS (TRANSCUTANEOUS ELECTRICAL NERVE STIMULATORS) AND EMS (ELECTRICAL MUSCLE STIMULATORS). CONDUCTIVE GEL IS USED WITH EXTERNAL ELECTRODES TO REDUCE THE IMPEDACE OF THE CONTACT BETWEEN THE ELECTRODE SURFACE AND THE SKIN.

BATCH #6060 CONDUCTIVE GEL

The document provided is a 510(k) clearance letter for the "BATCH #6060 Conductive Gel." This type of document from the FDA primarily focuses on establishing substantial equivalence to a predicate device, rather than presenting detailed performance studies with acceptance criteria and specific statistical results.

Therefore, the information required to fully answer your request regarding acceptance criteria and the study that proves the device meets them is not available in the provided text.

Here's a breakdown of why and what information is present:

Why the requested information is not available:

• Nature of 510(k) Clearance: A 510(k) submission typically demonstrates that a new device is "substantially equivalent" to a legally marketed predicate device. This often involves demonstrating similar technological characteristics and performance, but it doesn't necessarily require extensive, standalone clinical studies with pre-defined acceptance criteria in the same way a PMA (Premarket Approval) would. For simple, lower-risk devices like conductive gels, performance data might be limited to bench testing (e.g., conductivity, impedance reduction, biocompatibility) and comparisons to the predicate device's known performance, rather than complex human-in-the-loop or multi-reader studies.
• Document Content: The provided text is the FDA's clearance letter, not the original 510(k) submission itself. The clearance letter confirms that the FDA reviewed the submission and found the device substantially equivalent. It summarizes the regulatory decision but does not detail the specific performance data or study methodologies presented by the manufacturer in their submission.

Specific Points from your Request and why they cannot be answered from the text:

1. Table of acceptance criteria and the reported device performance: Not present. The letter states the device is for use with TENS and EMS and "is used with external electrodes to reduce the impedance of the contact between the electrode surface and the skin." However, no numerical performance targets (acceptance criteria) or specific performance results (e.g., "impedance reduced by X%," "conductivity of Y S/m") are mentioned.
2. Sample size used for the test set and the data provenance: Not present. No details about any test sets, sample sizes, or data origin for performance evaluation are provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not present. This type of detail is relevant for diagnostic or image-based AI devices, not for a conductive gel. No ground truth establishment is described.
4. Adjudication method: Not applicable/Not present for the same reason as above.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable/Not present. This is relevant for diagnostic devices where human readers interpret data, often in radiology or pathology. A conductive gel does not involve human interpretation in this manner.
6. Standalone (algorithm only without human-in-the-loop performance) study: Not applicable/Not present. This applies to AI algorithms. No algorithm is part of this device.
7. Type of ground truth used: Not applicable/Not present.
8. Sample size for the training set: Not applicable/Not present. This applies to AI/machine learning models.
9. How the ground truth for the training set was established: Not applicable/Not present.

In summary, the provided document confirms the regulatory clearance of a conductive gel but does not contain the detailed performance study information, acceptance criteria, or ground truth establishment methods typically found in scientific publications or specific sections of a 510(k) submission that describe performance testing.

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