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Transcutaneous Electrical Nerve Stimulation (TENS):
The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities.

Electrical Muscle Stimulation (EMS):
The device is designed to be used to stimulate healthy muscles in order to improve or facilitate muscle performance.

Not Found

I am sorry, but the provided FDA 510(k) Clearance Letter for the "OTC 4-Channel Rechargeable TENS Unit" (K251429) does not contain the information requested regarding acceptance criteria and the study that proves the device meets those criteria.

This document is a clearance letter, which means the FDA has determined the device is substantially equivalent to legally marketed predicate devices. It focuses on the regulatory aspects of the clearance, such as:

• Device name and regulation
• Regulatory class and product code
• Substantial equivalence determination
• General controls and additional controls applicable to the device
• References to FDA guidance documents and regulations (e.g., Quality System regulation, UDI Rule)
• Contact information for the FDA

Specifically, the document does NOT include:

1. A table of acceptance criteria and reported device performance: This type of data would typically be found in the actual 510(k) submission, not the clearance letter.
2. Sample size used for the test set and data provenance: Again, this is detailed information from the testing portion of the submission.
3. Number of experts and their qualifications for establishing ground truth: Not mentioned in this regulatory letter.
4. Adjudication method: Not applicable or mentioned.
5. Multi-reader multi-case (MRMC) comparative effectiveness study results: This applies to AI/CAD devices, and the TENS unit is a physical device, so such a study would not be relevant.
6. Standalone (algorithm only) performance: Not applicable for a TENS unit.
7. Type of ground truth used: Not applicable or mentioned.
8. Sample size for the training set: Not applicable for a TENS unit (unless it incorporates some form of adaptive AI, which is not indicated here).
9. How the ground truth for the training set was established: Not applicable for a TENS unit.

The provided text only states the Indications for Use for the TENS and EMS functions. To find the specific performance data and acceptance criteria, you would need to access the full 510(k) submission (if it were publicly available in that format, which it generally is not for the detailed technical reports). The clearance letter confirms that the FDA reviewed such data and found it adequate for substantial equivalence, but it does not reproduce that data.

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As a TENS device, the CP Relief Wand Rx - TENS/NMES is intended for use as an adjunctive therapy for pain management for medical purposes such as symptomatic relief of chronic intractable pain and relief of acute post surgical and post-traumatic pain.

As an EMS device, the CP Relief Wand Rx - TENS/NMES is intended for use for relaxation of muscle spasm, increasing local blood circulation, muscle re-education, prevention or retardation of disuse atrophy, prevention of venous thrombosis of the calf muscles immediately after surgery, and maintaining on increasing range of motion.

The CP Relief Wand Rx - TENS/NMES®("Wand") is a multitherapy medical device that combines the treatment capabilities of TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation).

The CP Relief Wand Rx - TENS/NMES is portable with self-contained electrodes. The device is powered by a standard non-rechargeable 9-volt alkaline battery. A charger is not used due to the low current drain and long battery life of the low power circuitry.

In operation, the electrode end of the CP Relief Wand Rx - TENS/NMES is positioned to touch the skin. The electrical pulses travel from one electrode, through the skin, through the underlying tissue, and back through the skin to the other electrode. Controls on the unit are provided for power, intensity, pulse width, and pulse polarity.

This FDA 510(k) clearance letter pertains to a TENS/NMES device, not an AI/ML-driven medical device. Therefore, the information typically found in a study proving an AI/ML device meets acceptance criteria (such as performance metrics, sample sizes for test/training sets, expert qualifications, and ground truth establishment) is not present in this document.

The document discusses the substantial equivalence of the "CP Relief Wand Rx - TENS/NMES" to predicate devices based on regulatory parameters, specifications, and the leveraging of performance testing from the primary predicate. It does not describe a new study specifically designed to assess the performance of the device against acceptance criteria in the context of an AI/ML model.

Therefore, I cannot provide the requested information for acceptance criteria and study details as they relate to an AI/ML device, as this document does not contain that type of data.

The document primarily focuses on:

• Substantial Equivalence: Arguing that the new device is as safe and effective as previously cleared devices.
• Expansion of Indications for Use: Adding EMS functionality, which is justified by comparison to a second predicate device that already has EMS indications.
• Performance Data (Leveraged from Predicate): Citing existing standards compliance from the primary predicate device, rather than new performance studies on an AI/ML algorithm.

If you have a document describing an AI/ML device and its validation study, I would be happy to analyze it for the requested information.

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The device of this submission is designed to temporarily relieve muscle soreness and pain in the shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom caused by exercise or normal household activities. Also used to stimulate healthy muscles to improve muscle performance.

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The provided text is an FDA clearance letter for a medical device: "TENS and EMS Unit." This letter indicates that the device has been found substantially equivalent to a legally marketed predicate device.

Crucially, this document does NOT contain information about acceptance criteria or a study proving the device meets those criteria, as typically found in a clinical study report or a 510(k) summary.

The letter is a regulatory document stating market clearance and does not detail the technical performance or supporting studies for the device. Instead, it refers to the device's "Indications for Use" and mentions regulatory compliance.

Therefore, I cannot provide the requested information from the given text.

To answer your questions, I would need access to the 510(k) summary or the full 510(k) submission for K251706, which would typically contain the performance data and details of any studies conducted.

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1) TENS
The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities.

2) EMS
The device is designed to be used to stimulate healthy muscles in order to improve or facilitate muscle performance.

Not Found

I am sorry, but the provided text from the FDA 510(k) clearance letter for the "3 in 1 TENS UNIT" (K251187) does not contain any information about acceptance criteria or the specifics of a study proving the device meets those criteria, particularly not for an AI/ML medical device.

The document is a standard FDA clearance letter for a Class II medical device (Transcutaneous Electrical Nerve Stimulator For Pain Relief). It primarily covers:

• Device Identification: Trade name, regulation number, product code.
• Regulatory Status: Declaration of substantial equivalence to a predicate device.
• General Controls: Mentions requirements like annual registration, listing, good manufacturing practice, labeling, and prohibitions against misbranding/adulteration.
• Additional Controls: Notes potential for special controls for Class II devices and references regulations like the Quality System (QS) regulation.
• Compliance: Reminds the applicant of various other FDA regulations (e.g., UDI Rule, MDR).
• Contact Information: Provides resources for further inquiries.
• Indications for Use: Describes the intended use for TENS (pain relief) and EMS (muscle performance).

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based solely on the provided text. The information you're asking for typically comes from the premarket submission itself (which might include detailed validation studies, performance data, and the methodology for establishing acceptance criteria), not from the FDA's clearance letter. This type of detail is particularly crucial for AI/ML-based devices, which this TENS unit is not described as.

If you have a document describing the actual performance study and acceptance criteria for this specific device, please provide it, and I would be happy to help analyze it.

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1) TENS
The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities.

2) EMS
The device is designed to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

Not Found

The provided FDA 510(k) Clearance Letter for the "3 in 1 TENS UNIT" (K250759) does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria related to AI/algorithm-based medical devices.

This document is a standard FDA clearance letter for a Class II medical device (Powered Muscle Stimulator, TENS/EMS unit). It confirms that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls and other regulations like the Quality System (QS) regulation.

Specifically, the letter does not mention:

• Any AI or algorithmic components of the device.
• Specific performance metrics (e.g., sensitivity, specificity, AUC) that would require a clinical study with acceptance criteria.
• Test sets, training sets, ground truth establishment, expert readers, or MRMC studies.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them based solely on the provided text. The information required for your request (1-9) is typical for AI/ML-based medical devices that require performance validation, which is not described in this standard 510(k) clearance letter for a TENS/EMS unit.

This device, being a "Powered Muscle Stimulator" (TENS/EMS unit), typically undergoes electrical safety, electromagnetic compatibility (EMC), and performance testing related to its electrical output, waveform, and ability to deliver stimulation as intended, rather than AI-driven diagnostic or treatment algorithms.

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TENS (Transcutaneous Electric Nerve Stimulation):
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, abdomen, bottom, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.

EMS(Electrical Muscle Stimulation)/PMS (Powered Muscle Stimulation):
It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

Not Found

I am sorry, but the provided text from the FDA 510(k) Clearance Letter for the "TENS AND EMS (TENS and Muscle Stimulator)" device (K243856) does not contain the detailed information necessary to answer your request regarding acceptance criteria and performance study data.

This 510(k) letter is a legal document from the FDA stating that the device has been found substantially equivalent to a legally marketed predicate device. It primarily covers administrative details such as:

• The device name and models
• The applicant's information
• Regulation numbers and product codes
• Regulatory classification (Class II)
• The date of clearance
• General controls provisions (registration, listing, GMP, labeling)
• Information about when new 510(k) submissions might be needed for device changes
• Requirements for Quality System (QS) regulation, UDI rule, and adverse event reporting
• Contact information for the FDA

Crucially, it does not include any technical details about the device's performance, clinical study results, acceptance criteria, or the methodology of studies (e.g., sample size, expert qualifications, ground truth establishment, MRMC studies, or standalone performance). This information would typically be found in the manufacturer's 510(k) submission, which is not publicly available in this FDA clearance letter.

Therefore, I cannot populate the table or provide answers to the specific questions you've asked based on the provided text.

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TENS (Transcutaneous Electric Nerve Stimulation):
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, abdomen, bottom, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.

EMS(Electrical Muscle Stimulation)/PMS (Powered Muscle Stimulation):
It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

Not Found

I am sorry, but the provided FDA 510(k) clearance letter for the TENS AND EMS (TENS and Muscle Stimulator) devices (K250360) does not contain the information requested regarding acceptance criteria and the study that proves the device meets those criteria.

This document is a formal clearance letter confirming the substantial equivalence of the device to a legally marketed predicate device. It outlines regulatory information, such as:

• Device name and product codes
• Regulation numbers and regulatory class
• Indications for Use
• Requirements for manufacturing and post-market surveillance (e.g., Quality System regulation, MDR, UDI rule)

It does not include:

• Details on performance studies.
• Specific acceptance criteria used for performance verification.
• Information on study design (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance).

To provide the information you've requested, one would typically need access to the summary of safety and effectiveness data (SSED) or the full 510(k) submission, which are often much more detailed than the public clearance letter.

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TENS (Transcutaneous Electric Nerve Stimulation):
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, abdomen, bottom, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.

EMS (Electrical Muscle Stimulation):
It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

TENS AND EMS (TENS and Muscle Stimulator) (JT8012, JT8012B)

The provided text is a 510(k) clearance letter from the FDA for a TENS and EMS device (TENS and Muscle Stimulator). This type of letter does not contain the detailed information about the acceptance criteria and study data that would be submitted as part of the 510(k) premarket notification.

A 510(k) clearance signifies that the device is "substantially equivalent" to a legally marketed predicate device. While this process involves demonstrating safety and effectiveness, the FDA approval letter itself does not typically include the specific performance metrics, study designs, sample sizes, or ground truth methodologies that an AI/ML device submission would detail. Those technical details are part of the original submission package, not the clearance letter.

Therefore,Based on the provided FDA 510(k) Clearance Letter for the TENS AND EMS (TENS and Muscle Stimulator) device (K250053), there is no information available regarding the acceptance criteria or the specific study details that would prove the device meets these criteria. The letter is an official notification of clearance, stating that the device is substantially equivalent to a predicate device, and does not contain the detailed technical data typically found in a product's technical file or a clinical study report.

The following information cannot be extracted from the provided document:

1. Table of acceptance criteria and reported device performance: Not present.
2. Sample size used for the test set and data provenance: Not present.
3. Number of experts used to establish ground truth and qualifications: Not present.
4. Adjudication method for the test set: Not present.
5. Multi-reader multi-case (MRMC) comparative effectiveness study details: Not present.
6. Standalone (algorithm-only) performance: Not applicable, as this is a physical device, not an AI/ML algorithm.
7. Type of ground truth used: Not present.
8. Sample size for the training set: Not applicable (not an AI/ML device, so no training set in the typical sense).
9. How ground truth for the training set was established: Not applicable.

The letter focuses on regulatory compliance, outlining the device's classification, applicable regulations (e.g., Quality System regulation, UDI Rule), and general controls. It refers to the device as a "TENS and Muscle Stimulator," which is a traditional physical medical device, not an AI/ML software device. Therefore, the questions related to AI/ML specific studies (like MRMC, training sets, ground truth establishment methods for algorithms) are not relevant to this type of device and would not be found in its 510(k) clearance.

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TENS: The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities. EMS: The device is designed to be used to stimulate healthy muscles in order to improve or facilitate muscle performance.

Not Found

I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that the device meets such criteria.

The document is a clearance letter from the FDA for a "Wireless TENS & EMS Unit" (K243763). It states that the device is substantially equivalent to legally marketed predicate devices and outlines general controls, regulations, and reporting requirements for the manufacturer. It also includes the "Indications for Use" for the device.

However, it does not describe any specific performance acceptance criteria for the device, any study conducted to demonstrate that the device meets those criteria, or any details related to sample sizes, data provenance, expert qualifications, ground truth, or MRMC studies.

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The devices of this submission are designed to temporarily relieve muscle soreness and pain in the shoulder, wast, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom caused by exercise or normal household activities. Also used to stimulate healthy muscles to improve muscle performance.

Not Found

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for an "OTC TENS & EMS Unit." This document primarily focuses on regulatory approval, substantial equivalence to predicate devices, and general controls and regulations. It does not contain any information about acceptance criteria for device performance, scientific studies, or data related to the device's efficacy or safety.

Therefore, I cannot provide the requested information regarding acceptance criteria and the study that proves the device meets them from this document. The document explicitly 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... to legally marketed predicate devices."
• "Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading."
• "FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies."

The 510(k) process primarily confirms substantial equivalence to a legally marketed predicate device, not necessarily a de novo clinical study proving performance against specific criteria in the way you've outlined.

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