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The AWQ-104 is intended for use in the symptomatic relief of chronic intractable pain, post traumatic acute pain, and post surgical pain.

The device consists of a battery powered instrument with four channel outputs. A hand held probe allows treatment at individual sites. Output polarity, frequency, intensity, and voltage are controlled by four independent channels. Each channel drives a pair of self adhesive electrodes. A grounding pole electrically grounds the device when using the hand held probe.

The provided text describes a 510(k) submission for a transcutaneous electrical nerve stimulator (TENS) device, the AWQ-104. However, it does not contain a study proving the device meets specific acceptance criteria in the way medical imaging or AI diagnostic devices typically would.

Instead, the "Performance" section states that the device has been "designed and tested to conform to the following standards." This implies compliance with recognized safety and performance standards rather than a clinical study demonstrating efficacy against specific metrics for pain relief.

Therefore, the requested information elements related to a "study that proves the device meets the acceptance criteria" cannot be fully addressed from the provided text because such a study, with performance metrics like sensitivity, specificity, accuracy, or a multi-reader comparative effectiveness study, is not present.

Here's a breakdown of what can be extracted and what is missing based on the prompt's requirements:

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

Missing Information (Not applicable or not present in the document):

• 2. Sample size used for the test set and the data provenance: Not applicable. This device is not an AI diagnostic device. The "test set" would be the device itself undergoing engineering and safety tests, not a dataset of patient cases.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for pain relief via TENS is subjective and usually assessed clinically, not via expert labeling of data for a device performance study as 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. This is a TENS device, not an AI diagnostic tool.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
• 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): For a TENS device, "ground truth" for its effectiveness would typically be patient-reported pain scales or outcomes data from clinical trials. However, the provided document focuses on substantial equivalence to a predicate device and compliance with technical standards, not new clinical efficacy data.
• 8. The sample size for the training set: Not applicable. This device does not use a "training set" in the context of machine learning.
• 9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) summary for a TENS device, which relies on demonstrating substantial equivalence to a legally marketed predicate device and compliance with relevant safety and performance standards. It does not describe a clinical study with performance metrics or ground truth establishment in the way the prompt's questions imply for AI-powered or diagnostic devices.

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The ES-160 is intended for use in pain relief. It can be used by a physician on his patients. This is a prescription device and should be used under continued medical supervision. The intended use of the Pointer F-3 is identical. It does not have curative value, but relieves pain symptoms.

The ES-160 is designed to be used in the treatment of chronic, acute and post-operative pain.

The device consists of a battery powered portable instrument with a remote grounding pole and a hand held locator/stimulator probe. Six output channels are grounding polo and time. The grounding pole is held in order to make contact with the skin. Moving the probe tip across the skin identifies places where the risk of skin burns is low. Auditory signals as well as a meter reading indicate when this has occurred. Holding the probe in place and pushing the stimulation button generates low level electrical pulses as long as the button is pressed.

The provided text is a 510(k) summary for the ES-160 Transcutaneous Electrical Nerve Stimulator (TENS) unit. It focuses on demonstrating substantial equivalence to a predicate device, the Pointer F-3 (K904388), rather than presenting a study specifically designed to establish acceptance criteria and prove the device meets them through performance testing with human subjects or a large test set.

Therefore, many of the requested elements for describing an acceptance criteria study are not present in the provided document.

Here's an analysis based on the available information:

Acceptance Criteria and Device Performance

Explanation: The document's primary goal is to show the ES-160 is "substantially equivalent" to an already marketed device (Pointer F-3). This means the device doesn't necessarily need to meet new, quantitative performance acceptance criteria in a clinical trial setting. Instead, the "acceptance criteria" are effectively that the device's technological characteristics and intended use are similar enough to the predicate that it raises no new questions of safety or effectiveness.

1. Sample Size for Test Set and Data Provenance:

   • Not Applicable/Not Provided. The submission does not detail a study with a test set of patients or a dataset to prove performance against specific clinical acceptance criteria. The "performance data" listed refers to compliance with electrical and safety standards, not clinical efficacy data.

2. Number of Experts for Ground Truth and Qualifications:

   • Not Applicable/Not Provided. No ground truth establishment is described for a clinical performance study. The "ground truth" here is essentially the regulatory acceptance of the predicate device.

3. Adjudication Method for Test Set:

   • Not Applicable/Not Provided.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No. This is a TENS unit, not an imaging or diagnostic device where an MRMC study would typically be performed.

5. Standalone (Algorithm Only) Performance Study:

   • No. This device is a physical medical device providing electrical stimulation, not an algorithm.

6. Type of Ground Truth Used:

   • Not Applicable/Not Provided in the context of a clinical performance study. The "ground truth" for the submission is the regulatory acceptance and safety/efficacy profile of the legally marketed predicate device (Pointer F-3), and compliance with recognized safety and electrical standards.

7. Sample Size for Training Set:

   • Not Applicable/Not Provided. The document describes a physical medical device, not a machine learning algorithm that would require a training set.

8. How the Ground Truth for the Training Set Was Established:

   • Not Applicable/Not Provided.

In summary, this 510(k) submission relies on demonstrating substantial equivalence to a predicate device and compliance with applicable safety standards, rather than proving performance against quantitative acceptance criteria through a specific clinical study with a detailed test set and ground truth establishment.

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The ProStim Reusable Neurostimulation Electrodes are intended for use as a disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. ProStim Reusable Neurostimulation Electrodes are designed and intended to be used with marketed Electrical Stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation), MENS (Microcurrent Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), IF (Interferential) or PGF (Pulsed Galvanic Stimulation).

ProStim Reusable Neurostimulation electrodes arc non-sterile, disposable laminated. flexible structures composed of materials commonly used in this application: First Layer-White spun laced nonwoven tape or White 1/32" thick Polyethylene foam or a polypropylene substrate, coated with biocompatible adhesive. Second Layer- Conductive plastic film. Third Layer-Biocompatible conductive hydrogel coupling media. The electrodes are designed for single-patient/multiple application use. Because of the adhesive nature of the biocompatible hydrogel, no securing materials are required to secure the device to the patient's skin. The electrode has one type of connection point that can be used to connect the stimulation device to the electrodes. This connection point is compatible with all standard, marketed Neurostimulation devices. Lead wire assembly - 6" wire with .080 in. diameter female socket connected to one side of the wire.

The provided document describes the ProStim Reusable Neurostimulation Electrodes and its 510(k) summary for market clearance. The study presented focuses on demonstrating substantial equivalence to predicate devices, primarily through impedance testing and biocompatibility assessments, rather than a clinical efficacy study with human readers or outcomes data.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size for the impedance testing or biocompatibility tests. It only states that the gels "have passed" the required tests and that impedance values "were comparable."

• Test Set Sample Size: Not explicitly stated for either biocompatibility or impedance testing in this summary.
• Data Provenance: Not explicitly stated. The biocompatibility tests refer to file numbers for the specific gels, implying these are existing test results for components rather than a new study specific to the ProStim device's final configuration. The impedance testing is described as being performed for the subject device in comparison to predicate devices, but details on where or when this was conducted are not provided.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. The study did not involve human expert interpretation or ground truth establishment in the context of clinical images or diagnoses. The "ground truth" for biocompatibility is established by standardized testing protocols, and for effectiveness, it's defined by impedance measurements against predicate devices.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical study with human readers requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. This device is an electrode for neurostimulation, not an AI-powered diagnostic tool. The submission is a 510(k) for substantial equivalence based on technological characteristics and safety/effectiveness data, not a clinical efficacy study involving human readers.

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

Yes, in a conceptual sense. The "performance" of the device was assessed on its intrinsic characteristics (biocompatibility and electrical impedance) without human intervention in the measurement of these characteristics, or human interpretation as part of a diagnostic workflow. The device itself is a component in a system where a human typically applies it and uses it with an electrical stimulator.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• For Biocompatibility: The "ground truth" was established by the results of standardized in vitro and in vivo tests for cytotoxicity, sensitization, and primary skin irritation as specified by the "Tripartite Biocompatibility Guidance for Medical Devices and ISO 10993-1 requirements for skin contact."
• For Effectiveness (Impedance): The "ground truth" was indirectly established by the electrical impedance values of legally marketed predicate devices. The acceptance criterion was that the subject device's impedance values were "comparable" to these predicate devices.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI algorithm and therefore does not have a "training set" in the machine learning sense. The safety and effectiveness data were generated through specific tests and comparisons to predicate devices, not through a learning phase.

9. How the Ground Truth for the Training Set was Established

Not applicable, as no training set was used.

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SOF-PACH™ Reusable Cutaneous Neurostimulation Electrodes are intended for use as the disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. SOF-PACH™ Reusable Electrodes are designed and intended to be used with marketed. Electrical Stimulators i.e. TENS (Transcutaneous Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), IF (Interferential) of PGF (Pulsed Galvanic Stimulation).

These electrodes will include the precaution statement: Federal Law restricts the device to sale by or on the order of a licensed practitioner or therapist.

SOF-PACH™ Reusable Neurostimulation Electrodes are non-sterile laminated, flexible structures composed of materials commonly used in this application:

First layer - Various cloths, tapes, etc. including Tricot/polyester fabric, polyethylene foam or a polypropylene substrate, coated with biocompatible adhesive.

Second layer Electrically conductive carbon coated with or without Ag/AgCl, and Activated Carbon Mesh material.

Third layer Biocompatible conductive hydrogel coupling media (CATHAY's Gel) which has passed the required skin sensitivity testing criteria as specified in the Tripartite Biocompatibility Guidance for Medical Devices and ISO 10993-1 requirements for skin contact. These tests include Cytotoxicity, Sensitization and Primary Skin Irritation Tests.

The electrodes are designed for single-patient/multiple application use. They have a low profile construction designed for comfort under clothing and utilize tan-tone fabric for reduced visibility. Because of the adhesive nature of the biocompatible hydrogel, no securing materials are required to secure the device to the patient's skin. The electrodes have two different types of contact points that can be used to link the stimulation device to the electrodes. These contact points are compatible with standard marketed Neurostimulation devices.

1. Lead wire assembly 6" wire with .080 inch diameter recessed female socket connected to one side of the wire. The lead wire assembly is in compliance with the requirements of FDA performance standard 21 CFR Part 898
2. Male snap assembly Two-part sensor and stud mated together.

This document is a 510(k) summary for the SOF-PACH™ Reusable Neurostimulation Electrodes (K020735). It describes the device, its technological characteristics, and how its safety and effectiveness were established by comparison to predicate devices.

Here's an analysis of the provided text in relation to your questions:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "CATHAY's Gel has passed the required skin sensitivity testing criteria" and "point-to-point impedance testing for all manufacturers' electrodes (including SOF-PACH™) ranged from 125-250 ohms". However, the specific sample sizes for these tests (both for the gel biocompatibility and the impedance testing) are not explicitly stated in the provided text.

Data Provenance: The document does not specify countries of origin for the test data. The biocompatibility tests are likely conducted in a lab setting, and impedance tests on the devices themselves. There is no indication of retrospective or prospective patient data, as the tests are on the device itself and its components, not involving human subjects in a clinical trial for effectiveness.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is not applicable to this 510(k) submission. The "ground truth" for this device's acceptance criteria relies on standardized material testing (biocompatibility) and direct physical measurement (electrical impedance), not on expert clinical interpretation of data.

4. Adjudication Method for the Test Set

This is not applicable. As mentioned above, the acceptance criteria are based on standardized tests and direct measurements, not on subjective interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, an MRMC comparative effectiveness study was not done. This device is a neurostimulation electrode, and its safety and effectiveness are established through testing its physical and material properties, and comparison to predicate devices' stated characteristics, not through analyzing human reader performance with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone algorithm performance study was not done. This device is a physical medical device, not an AI or software algorithm.

7. The Type of Ground Truth Used

The ground truth for the safety criteria (skin irritation/sensitivity) was established by passing standardized biocompatibility tests (Cytotoxicity, Sensitization, and Primary Skin Irritation Tests) as specified in the Tripartite Biocompatibility Guidance for Medical Devices and ISO 10993-1.

The ground truth for the effectiveness criteria (impedance) was established by direct electrical measurement using a standard voltmeter (point-to-point impedance at 1 K-Hz). The acceptance was based on comparability to predicate devices.

8. The Sample Size for the Training Set

This is not applicable. This submission describes a physical medical device, not an algorithm that requires a training set. The device itself is manufactured, and its components and final product are tested.

9. How the Ground Truth for the Training Set Was Established

This is not applicable as there is no training set for this type of device submission.

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