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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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TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION (TENS) DE VICES ARE USED FOR THE SYMPTOMATIC RELIEF AND MANAGEMENT OF CHRONIC (I ONG TERM) INTRACTABLE PAIN AND AS AN ADJUNCTIVE TREATMENT IN THE MANAGEMENT OF POST SURGICAL AND POST TRAUMATIC ACUTE PAIN PROBLEMS. A THERAPEUTIC VIBRATOR IS INTENDED FOR RELAXING MUSCLES AND RELIEVING MINOR MUSCLE ACTIES AND PAINS.

GB-1002 TENS WITH VIBRATOR

The provided document is a 510(k) clearance letter from the FDA for the GB-1002 Tens with Vibrator device. It states that the device is substantially equivalent to a predicate device already on the market.

However, this document does not contain any information regarding acceptance criteria, device performance, or any studies conducted to prove device performance.

Therefore, I cannot provide the requested information. The document focuses solely on the regulatory clearance process based on substantial equivalence, not on specific performance metrics or clinical study results.

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ARE USED FOR THE SYMPTOMATIC RELIEF AND MANAGEMENT OF CHRONIC (LONG TERM) INTRACTABLE PAIN AND AS AN ADJUNCTIVE TREATMENT IN THE MANAGEMENT OF POST SURGICAL AND POST TRAUMATIC ACUTE PAIN PROBLEMS.

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This document is a 510(k) clearance letter from the FDA for the IF-727 Interferential Stimulator. It does not contain information about acceptance criteria, device performance studies, or clinical trial methodology.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and 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
5. MRMC comparative effectiveness study results
6. Standalone 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 letter only states that the device is substantially equivalent to legally marketed predicate devices for the indicated uses, which are for symptomatic relief and management of chronic pain, and as an adjunctive treatment for post-surgical and post-traumatic acute pain.

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• 1. RELAXATION OF MUSCLE SPASM.
• 2. PREVENTION OR RETARDATION OF DISUSE ATROPHY.
• 3. INCREASING LOCAL BLOOD CIRCULATION.
• 4. MUSCLE-RE-EDUCATION.
• 5. IMMEDIATE POST SURGICAL STIMULATION OF CALF MUSCLES TO PREVENT VENOUS THROMBOSIS.
• 6. MAINTAINING OR INCREASING RANGE OF MOTION.

SD-970EMS ELECTRICAL MUSCULAR STIMULATOR

I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria. The document is an FDA 510(k) clearance letter for the "SD-970EMS Electrical Muscular Stimulator," indicating that the device has been determined to be substantially equivalent to a predicate device.

The letter mentions:

• Trade Name: SD-970EMS Electrical Muscular Stimulator
• Regulatory Class: II
• Product Code: IPF
• Indications For Use: Relaxation of muscle spasm, prevention or retardation of disuse atrophy, increasing local blood circulation, muscle re-education, immediate post-surgical stimulation of calf muscles to prevent venous thrombosis, and maintaining or increasing range of motion.

It does not include:

• A table of acceptance criteria or reported device performance.
• Details about a study (sample size, data provenance, expert numbers, adjudication methods, MRMC studies, standalone performance, ground truth types).
• Information on training sets or how their ground truth was established.

Therefore, I cannot fulfill your request for this specific information based on the provided text.

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