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• I. Relief of chronic intractable pain, acute post traumatic pain or acute post surgical pain (Interferential, TNS and Microcurrent waveforms);
• 2. Relaxation of muscle spasm (all waveforms except Microcurrent);
• 3. Prevention or retardation of disuse atrophy (all waveforms except Microcurrent);
• 4. Increasing local blood flow (all waveforms except Microcurrent);
• 5. Muscle re-education (all waveforms except Microcurrent);
• 6. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis (all waveforms except Microcurrent); and
• 7. Maintaining or increasing range of motion (all waveforms except Microcurrent).

Not Found

This FDA 510(k) clearance letter for the Metron Multi-Stim Model MS-100A does not contain any information regarding acceptance criteria or a study proving the device meets those criteria.

The document is a clearance letter, which means the FDA has determined the device is substantially equivalent to legally marketed predicate devices. This determination is based on a comparison to existing devices, and typically involves demonstrating similar technological characteristics and performance specifications. However, the letter itself does not provide the details of those performance specifications or the studies conducted to demonstrate them.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and the study proving the device meets them because that information is not present in the provided text.

The document states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This indicates a comparison to predicate devices, but the specifics of how that substantial equivalence was demonstrated (i.e., performance criteria and study results) are not elaborated upon in this letter.

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1. Relief or reduction of pain;
2. Reduction of muscle spasm;
3. Joint contracture; and
4. Local increase in circulation.

Not Found

The provided FDA 510(k) summary for the Accusonic Advantage Model AA170 does not contain any information regarding specific acceptance criteria, device performance studies, or clinical trial data.

The document is a substantial equivalence determination letter, indicating that the device is similar enough to previously approved devices that it does not require a new premarket approval application. This type of FDA letter typically refers to information submitted by the manufacturer, but the letter itself does not detail the studies or criteria used.

Therefore, for each of your requested points, the answer is:

1. A table of acceptance criteria and the reported device performance: This information is not provided in the document.
2. Sample size used for the test set and the data provenance: This information is not provided in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided in the document.
4. Adjudication method for the test set: This information is not provided in the 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 information is not provided in the document. The device is an ultrasonic diathermy device, not an AI diagnostic tool, so an MRMC study for AI assistance would not be applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This information is not provided in the document. The device is a physical therapy device and not a standalone diagnostic algorithm.
7. The type of ground truth used: This information is not provided in the document.
8. The sample size for the training set: This information is not provided in the document.
9. How the ground truth for the training set was established: This information is not provided in the document.

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The indications for use are:

1. Relief or reduction of pain;
2. Reduction of muscle spasm;
3. Joint contracture; and
4. Local increase in circulation.

Not Found

I am sorry, but based on the provided text, I cannot extract the information required to describe the acceptance criteria and the study that proves the device meets those criteria. The document is an FDA 510(k) clearance letter confirming that the Accusonic Advantage – AA 170 device is substantially equivalent to legally marketed predicate devices.

This type of document primarily focuses on regulatory approval rather than providing details about specific performance acceptance criteria or the study data used to establish them. It mentions general controls and regulations but does not include:

• A table of acceptance criteria and reported device performance.
• Sample sizes, data provenance, or details about the test set.
• Information on experts for ground truth or adjudication methods.
• Details about MRMC comparative effectiveness studies or standalone algorithm performance.
• The type of ground truth used.
• Training set sample size or how its ground truth was established.

To obtain this information, you would typically need to refer to the full 510(k) submission summary or technical reports related to the device's testing and validation, which are not included in this document.

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The indications for use for the interferential therapy are:

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

The indications for use for the ultrasound therapy are:

• 1. Relief or reduction of pain;
• 2. Reduction of muscle spasm;
• 3. Joint contracture; and
• 4. Local increase in circulation.

The indication for use for the combined therapy is:

• Reduction of muscle spasm. 1.

Not Found

This document is a 510(k) premarket notification letter from the FDA regarding the Vectorsonic Model VU 270. It confirms that the device is substantially equivalent to legally marketed predicate devices. However, the document does not contain information about acceptance criteria or a study proving the device meets those criteria.

Specifically, the document:

• Identifies the device (Vectorsonic Model VU 270) and its manufacturer.
• States the regulation number, name, and regulatory class for the device (Ultrasound and muscle stimulator, Class II).
• Lists the indications for use for interferential therapy, ultrasound therapy, and combined therapy.
• Confirms the FDA's finding of substantial equivalence.

Therefore, I cannot provide the requested information as it is not present in the provided text. The document is a regulatory approval, not a technical report detailing performance study results.

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The indications for use are: - Relief or reduction of pain; 1. - Reduction of muscle spasm; 2. - Joint contracture; and 3. - Local increase in circulation. 4.

Not Found

The provided document is a 510(k) premarket notification letter from the FDA to Metron Medical Australia Pty. Ltd. for a device called "Accusonic, Model AS-270," which is classified as an Ultrasonic Diathermy device.

This document does not contain any information about acceptance criteria, device performance metrics, or study details such as sample size, data provenance, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or training set information.

The letter confirms that the FDA has reviewed the 510(k) submission and determined the device to be substantially equivalent to legally marketed predicate devices for the stated indications for use:

• Relief or reduction of pain
• Reduction of muscle spasm
• Joint contracture
• Local increase in circulation

The document is a notification of regulatory clearance, not a technical report or scientific study detailing how the device met specific performance criteria through testing. Therefore, I cannot provide the requested information based on this document.

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The indications for use are:

1. Relief of chronic intractable pain, acute post traumatic pain or acute post surgical pain (TNS Mode);
2. Relaxation of muscle spasm (Interferential Mode);
3. Prevention or retardation of disuse atrophy (Interferential Mode);
4. Increasing local blood flow (Interferential Mode);
5. Muscle re-education (Interferential Mode);
6. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis (Interferential Mode); and
7. Maintaining or increasing range of motion (Interferential Mode).

Not Found

I am sorry, but based on the text provided, I cannot answer your question. The document is a 510(k) premarket notification letter from the FDA regarding a medical device, the "Vectorsurge 5 Model VS 470." It discusses regulatory classifications, general controls, and indications for use, but it does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any details about a multi-reader multi-case comparative effectiveness study or standalone algorithm performance.

The document primarily states that the device is substantially equivalent to legally marketed predicate devices and outlines the regulatory requirements for marketing the device.

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The indications for use are:

• Relief or reduction of pain;
• Reduction of muscle spasm;
• Joint contracture; and
• Local increase in circulation.

Not Found

The provided document is a 510(k) premarket notification letter from the FDA for a device named "AP170 Accusonic Plus," an Ultrasonic Diathermy device. It is a regulatory approval document and does not contain information about the acceptance criteria, study details, or performance metrics of the device as related to its efficacy or safety.

Therefore, I cannot provide the requested information from this document. The letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices and outlines the regulatory requirements the manufacturer must adhere to.

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The indications for use for the interferential therapy are:

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

The indications for use for the ultrasound therapy are:

1. Relief or reduction of pain;
2. Reduction of muscle spasm;
3. Joint contracture; and
4. Local increase in circulation.

The indication for use for the combined therapy is:

1. Reduction of muscle spasm.

Not Found

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, any specific study, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details. The document is an FDA 510(k) clearance letter for the Vectorsonic Model VU-200, which outlines its indications for use and regulatory classification, but does not contain the detailed study information you've requested.

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The indications for use are:

• Relief or reduction of pain; 1.
• Reduction of muscle spasm; 2.
• Joint contracture; and 3.
• 4. Local increase in circulation.

Modification to: Accusonic Plus, Model AP-100

The provided document is a 510(k) clearance letter from the FDA for a device called "Accusonic Plus, Model AP-100." This letter indicates that the device has been found substantially equivalent to a predicate device for its stated indications for use (relief or reduction of pain, reduction of muscle spasm, joint contracture, and local increase in circulation).

However, the letter does not contain any information regarding acceptance criteria, study details, device performance data, sample sizes, ground truth establishment, or expert qualifications. These types of details would typically be found in the 510(k) summary or the full submission, which are not provided here.

Therefore, I cannot fulfill your request with the given input. The information you are asking for is not present in this regulatory clearance letter.

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