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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 and facilitate muscle performance. The device is designed to temporarily increase local blood circulation in healthy leg muscles.

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The provided FDA 510(k) Clearance Letter for Shenzhen Yicai Health Technology Co. Ltd's Transcutaneous Electrical Nerve Stimulator (TENS) does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria, particularly for an AI/ML medical device.

This document is a standard clearance letter for a physical medical device (TENS/EMS) and focuses on regulatory aspects like:

• Substantial equivalence to predicate devices.
• General controls (registration, listing, GMP, labeling, misbranding).
• Quality System (QS) regulation.
• Unique Device Identification (UDI) requirements.
• Indications for Use.

It does not detail performance studies conducted to establish effectiveness or safety beyond establishing substantial equivalence to a predicate. Specifically, it lacks any mention of:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets or data provenance.
• Number/qualifications of experts for ground truth.
• Adjudication methods.
• Multi-reader multi-case (MRMC) studies or effect sizes for human readers.
• Standalone algorithm performance.
• Type of ground truth used.
• Training set sample size or ground truth establishment for training.

Therefore,Based on the provided FDA 510(k) clearance letter, I cannot describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the manner requested. The letter is for a physical medical device (Transcutaneous Electrical Nerve Stimulator) and outlines its regulatory clearance, not the details of a performance study, especially not one applicable to an AI/ML device as your detailed questions suggest.

The document does not contain any information related to:

1. A table of acceptance criteria and the reported device performance.
2. Sample sizes used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and their qualifications.
4. Adjudication method for the test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size.
6. If a standalone (algorithm only) performance study was done.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
8. The sample size for the training set.
9. How the ground truth for the training set was established.

This is a clearance letter for a device whose mechanism of action is electrical stimulation, not an AI/ML algorithm. The information you are seeking would typically be found in the 510(k) summary or the full submission, which are not included in this clearance letter.

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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.

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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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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.

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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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Patch-TEA is an Over-The-Counter device to be used by adults only for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, arm, and leg, due to strain from exercise or normal household work activities and suitable for home use.

The Patch-TEA device is a non-invasive, battery-operated, over-the-counter transcutaneous electrical nerve field stimulator indicated for use in adult patients for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, arm, and leg, due to strain from exercise or normal household work activities and suitable for home use.

The system includes the following components: Patch-TEA device, charging case, electrode pads, USB charging cable, and Patch-TEA app. The device can be used in clinical environments (i.e., outpatient clinics and hospitals) and/or at home.

The Patch-TEA device is powered by an internal rechargeable lithium polymer battery and uses a microprocessor to control the working modes, the waveform and strength of the output pulse. The electric pulse generator is based on a current source circuit. The power management module contains a DC-DC boost conversion circuit that provides the required voltage for the electric pulse generator. The Patch-TEA device is able to connect with the Patch-TEA app, which is located on a smartphone. The user interface is available on both the Patch-TEA device and Patch-TEA app. The user can power on/off the device, adjust treatment time and treatment intensity.

Treatment time is adjustable within the of range 5~240 minutes per treatment session. In addition, there is over-load, over-current and no-load protection as well as an automatic shut-off function. The Bluetooth transceiver module is responsible for communication between the Patch-TEA device and Patch-TEA app located on a smartphone.

The provided FDA 510(k) Clearance Letter for Patch-TEA (Model TRI-21) and its accompanying 510(k) Summary do not contain any information about a study involving human subjects or AI performance analysis. The summary focuses entirely on the "technological comparison" of the device's physical and electrical characteristics against predicate devices, and non-clinical testing for safety and compliance with standards.

Therefore, I cannot fulfill the request to build a table of acceptance criteria and reported device performance related to AI or human studies, nor can I provide details on sample sizes, ground truth establishment, or multi-reader multi-case studies, as this information is not present in the provided text.

The closest information available is related to non-clinical testing and technical conformance to standards, which are summarized below, but these are not in the context of human performance or AI-driven evaluation.

Summary of Device Acceptance Criteria and Performance (Based on provided text - Note: This does NOT relate to AI or human-in-the-loop performance, as no such data is supplied):

The acceptance criteria and performance data described in the 510(k) Summary are primarily focused on the device's technical specifications, safety, and compliance with recognized standards, demonstrating substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and the Reported Device Performance

As there is no data provided regarding acceptance criteria for clinical performance or AI performance, the table below reflects the technical comparison and non-clinical testing aspects as described in the 510(k) Summary. The "Reported Device Performance" column reflects the subject device's characteristics as compared to predicates.

Regarding the other requested information, the provided text does not contain:

2. Sample sizes used for the test set and the data provenance: No information on a test set involving human subjects is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no human subject test set or ground truth establishment process is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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. The device is a Transcutaneous Electrical Nerve Stimulator, not an AI-powered diagnostic or assistive tool for human "readers."
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as there is no mention of an algorithm or AI component for which standalone performance would be measured.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no human study or clinical ground truth is mentioned.
8. The sample size for the training set: Not applicable, as there is no mention of a training set for an AI/algorithm.
9. How the ground truth for the training set was established: Not applicable.

In conclusion, the FDA 510(k) clearance letter and its summary for Patch-TEA (Model TRI-21) pertain to a physical medical device (Transcutaneous Electrical Nerve Stimulator) and establish substantial equivalence based on technical specifications, safety testing (non-clinical), and compliance with electrical, mechanical, and biocompatibility standards. The document does not describe any AI component, human-in-the-loop studies, or clinical performance trials that would require the type of acceptance criteria and study details outlined in your comprehensive request.

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PZ-2622 is TENS and EMS Stimulator
Mode 1-12: TENS: This mode 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), and lower extremities (leg) due to strain from exercise or normal household work activities.
Mode 13-24: EMS: This mode is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.

PZ-2622E (Mode 1-24) is EMS Stimulator
This device is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.

PZ-2622T (Mode 1-24) is TENS Stimulator
This 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), and lower extremities (leg) due to strain from exercise or normal household work activities.

Not Found

I am sorry, but the provided FDA 510(k) Clearance Letter for "Smart Pulse Relief" (K250033) is for a Transcutaneous Electrical Nerve Stimulator (TENS) and Electrical Muscle Stimulator (EMS). This document does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria related to an AI or algorithm-driven component.

The letter primarily focuses on:

• Confirmation of 510(k) clearance and substantial equivalence to legally marketed predicate devices.
• Regulatory requirements and general controls for medical devices.
• Indications for Use for the various models (PZ-2622, PZ-2622T, PZ-2622E).

TENS and EMS devices typically operate based on electrical stimulation parameters (e.g., intensity, frequency, pulse width) and are cleared based on electrical safety, biocompatibility, and performance testing related to these physical parameters, rather than AI model performance or diagnostic accuracy.

Therefore, I cannot extract the requested information (acceptance criteria table, sample sizes, expert details, adjudication, MRMC, standalone algorithm performance, ground truth types, training set details) from this document, as it pertains to AI/algorithm performance studies which are not described here for this specific device.

To fulfill your request, I would need a 510(k) summary or a scientific publication that details the clinical validation or performance study for a medical device that incorporates an AI or algorithmic component, and explicitly outlines its acceptance criteria and the results of a study designed to prove those criteria are met.

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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.

The Progenix Select Stim (Model: PRO1205-OTC1) device is a portable, battery powered (9 V battery) two channel device designed to provide Transcutaneous Electrical Nerve Stimulation (TENS) for the purpose of the symptomatic relief of pain.

The device consists of the TENS stimulator, two lead wires and set of four Skin Electrodes. It provides 10 preset TENS treatment programmes. The programs include four modes of operation: Conventional TENS(Continuous), Burst Mode, Modulation mode and HAN TENS. The device LCD screen shows the information of program, intensity level of each channel and operating time.

The electrode pads are cleared by FDA (510(k) number K160138). They are used as an accessory to the TENS device unit, to transmit electrical current to patient skin. The electrodes consist of biocompatible self-adhesive conductive application use. These electrodes are sized 50x50mm and are sold under the model number PRO5050.

The provided FDA 510(k) clearance letter for the Progenix Select Stim (K242460) is for a Transcutaneous Electrical Nerve Stimulator (TENS) device. Based on the document, this device is cleared as substantially equivalent to a predicate device (HIVOX OTC Electrical Stimulator, K190347).

It is crucial to understand that a 510(k) clearance, especially for devices like TENS units, primarily relies on demonstrating substantial equivalence to a previously cleared predicate device, rather than requiring extensive de novo clinical trials or complex AI performance studies. The provided document explicitly states under "9. Clinical Performance Data" that it is "Not applicable." This means the clearance was granted based on non-clinical (bench) testing demonstrating that the device performs similarly to the predicate and meets relevant safety standards.

Therefore, the request to describe "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI performance metrics (like sensitivity, specificity, MRMC studies, ground truth establishment by experts, etc.) is not directly applicable to this specific device and clearance. The device is a TENS unit, not an AI/ML-driven diagnostic or interpretative system.

However, I can extract and structure the information related to the device's performance relative to its substantial equivalence claim and the non-clinical testing performed, which serves as its "proof of meeting acceptance criteria" in this context.

Here's a breakdown based on the provided document, addressing the closest relevant points:

Acceptance Criteria and Study that Proves the Device Meets the Acceptance Criteria (for a TENS Device)

For the Progenix Select Stim (K242460), the "acceptance criteria" are primarily defined by its substantial equivalence to the predicate device and compliance with applicable voluntary safety standards. The "study that proves the device meets the acceptance criteria" refers to the non-clinical (bench) testing performed to demonstrate this equivalence and safety.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is not an AI/ML device, the "performance" is about meeting electrical and mechanical specifications, and adherence to safety standards, rather than diagnostic accuracy metrics. The table below summarizes key comparative parameters that demonstrate substantial equivalence, which serve as "acceptance criteria" for the device's design and function.

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POCKET TENS (EP-300) which is home used device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities.

This device powered by CR2032 Lithium 3V battery is a self-adhesive TENS with 15 adjustable intensity levels falling into the electro-stimulation device category. It includes pocket storage rack for electrodes and TENS device. It designed for shoulder, back, upper extremities (arm) and lower extremities (leg) pain relief. Users only need to place the electrode gel pads on the sides of pain point and then power on the device, and adjust the pulse intensity to a proper level to start a 20 minute treatment session. For optimum result, rest 30 minutes between sessions.

TENS refers to the electrical stimulation of nerves through the skin which is a non-pharmacological method of pain relief. Any symptoms that could be relieved using TENS must be checked by patient's general practitioner who will also give patient instruction on how to carry out a TENS self-treatment regime.

This device is only compatible with the 75 mm x 48 mm gel pads which are the OTC medical device cleared by FDA under K083302 or K180865, and come with the device.

The provided text describes the acceptance criteria and the study conducted for the POCKET TENS (EP-300) device.

Here's the information extracted from the document:

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

The document states that the POCKET TENS (EP-300) device underwent a series of safety and performance tests. It doesn't explicitly list specific quantitative acceptance criteria values next to the device performance for most parameters, but generally states that "All the test results demonstrate the subject device, POCKET TENS (EP-300), meets the requirements of its pre-defined acceptance criteria and intended use, and is substantially equivalent to the predicate devices."

However, a comparison table (Section 12) between the subject device and two predicate devices provides various specifications. This comparison indirectly implies the acceptance criteria are met if the subject device's specifications are comparable or within acceptable ranges of the predicate devices and comply with relevant standards.

Here's a summary of the stated performance and comparison points, implying acceptance criteria are met by equivalence or compliance:

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

The document does not explicitly mention a "test set" in the context of clinical data. It states, "No clinical test data was used to support the decision of substantial equivalence."

Instead, the evaluation appears to be based on non-clinical testing, compliance with recognized standards, and comparison with predicate devices. For these non-clinical tests (e.g., biocompatibility, software validation, EMC, electrical safety, performance verification, usability), the sample sizes are not specified, nor is the country of origin or whether they were retrospective or prospective.

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, as no clinical test data was used and therefore no need for experts to establish ground truth for a clinical test set. The substantial equivalence relies on technical comparison and compliance with standards.

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

Not applicable, as no clinical test data was used and therefore no adjudication was necessary.

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. The device is a Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief, not an AI-assisted diagnostic or interpretative tool that would involve human readers.

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

Not applicable. The device is a physical TENS unit, not an algorithm.

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

Not applicable, as no clinical test data was used. The "ground truth" for the non-clinical tests would be the established scientific and engineering principles outlined in the referenced national and international standards (e.g., ISO, IEC, ANSI/AAMI standards, FDA guidance documents).

8. The sample size for the training set

Not applicable, as the device is not an AI/ML algorithm that requires a training set.

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

Not applicable, as the device is not an AI/ML algorithm.

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For Over-The-Counter Use:

TENS:

The device (SM9141, SM9142) is used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, leg and feet, due to strain from exercise or normal household and work activities and also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.

EMS/NMES:

The device (SM9141, SM9142) is used to stimulate healthy muscles in order to improve and facilitate muscle performance.

To be used for the improvement of muscle tone and firmness, and for strengthening muscles in the arms, abdomen, legs, feet and buttocks. Not intended for use in any therapy or for the treatment of any medical conditions or diseases.

The device (SM9141, SM9142) is also intended to temporarily increase local blood circulation in the healthy muscles of lower extremities.

For Prescription Use:

Device (SM9141, SM9142):

TENS:

• Symptomatic relief and management of chronic, intractable pain

• Adjunctive treatment for post-surgical and post-trauma acute pain

• Relief of pain associated with arthritis

EMS/NMES:

• Temporary relaxation of muscle spasm
• Prevention or retardation of disuse atrophy
• Muscle re-education
• Maintaining or increasing range of motion
• Increase of local blood flow in the treatment area
• Prevention of post-surgical venous thrombosis through immediate stimulation of calf muscles

Not Found

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (Nooro Body & Foot Stimulator). This document does not contain the specific information you requested regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.

A 510(k) clearance letter confirms that a device is substantially equivalent to a legally marketed predicate device, but it does not typically include the detailed technical study reports or statistical analysis that would contain the information you are asking for. Those details would be part of the original 510(k) submission, which is not publicly available in this format.

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