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The AXUS ES-5 Electro Acupuncture Device is an electro-acupuncture device indicated for use in the practice of acupuncture by qualified professionals of acupuncture as determined by the states.

The AXUS ES-5 is an electro-acupuncture device indicated for use in the practice of acupuncture by qualified professionals of acupuncture as determined by the state. The AXUS ES-5 is a battery operated prescription use only electro-acupuncture device used for applying electric stimuli to areas of preferred delivery (APD). The device uses a low-intensity, low-frequency pulse multimode generator through microalligator clips attached to commercially available and FDA-cleared stainless steel acupuncture needles. The device can also deliver stimulation with the included probe.

The provided text is a 510(k) summary for the AXUS ES-5 Electro-Acupuncture Device. It describes the device, its intended use, and its similarities to a predicate device (ES-130). However, the document does not contain any information about acceptance criteria or a study proving the device meets those criteria, especially in the context of AI/ML performance evaluation.

The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, primarily through:

• Technological characteristics: Comparing waveform shapes, maximum frequency, output voltage/current, power density.
• Performance testing: Stating that the device conforms to applicable technical standards, including electrical safety, electromagnetic compatibility, and biocompatibility.

There is no mention of a study involving AI, machine learning, human readers, or any metrics like sensitivity, specificity, or AUC related to diagnostic performance.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets the acceptance criteria, as the provided text does not contain such information for this medical device clearance. The device is a physical electro-acupuncture device, not an AI/ML-driven diagnostic tool.

If you have a document describing the testing for an AI/ML medical device, I would be happy to analyze it according to your criteria.

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The Neuro Wave 6 is intended for use in the symptomatic relief of chronic intractable pain, postoperative pain, and acute pain.

The device consists of a battery powered portable instrument with 6 channel outputs.
Weight- 2.6 kg.
Color- Grey
Pulse Shape- Asymmetrical, Biphasic Triangular Wave
Pulse Rate- 1-100 Hz
Pulse Width-
Impedance Value: 500 ohms, 1000 ohms, 2000 ohms, 5000 ohms, 10000 ohms
Pulse Width: 280 uS, 240 US, 220 US, 220 uS, 220 uS
Output- 80 volts maximum (under 500 ohm test load)
Stimulation time- stimulation time is adjusted by the timer up to 60 minutes.
Device Controls- Clearly indicated are the ON/OFF (Power switch), Frequency Adjuster, Timer, and Output Intensity Knobs.
Power- 6 1.5 volt C batteries

The provided text is a 510(k) summary for the Neuro Wave 6 Transcutaneous Electrical Nerve Stimulator (TENS) device. It focuses on device specifications, intended use, and the FDA's regulatory decision regarding substantial equivalence to a predicate device (ES-160, K051020).

Crucially, this document does not describe any clinical study, acceptance criteria, or performance data for the Neuro Wave 6 device itself.

The 510(k) process for TENS devices often relies on demonstrating substantial equivalence to a predicate device, meaning the new device has the same intended use, technological characteristics, and performs as safely and effectively as a legally marketed device. Clinical trials or detailed performance studies with acceptance criteria are not always required for 510(k) clearance, especially for well-established technologies like TENS.

Therefore, I cannot populate the table or answer most of the questions based on the provided text. The document confirms that:

• The intended use of the Neuro Wave 6 is identical to the predicate device, ES-160: symptomatic relief of chronic intractable pain, postoperative pain, and acute pain.
• The FDA reviewed the submission and found the device substantially equivalent, allowing it to proceed to market.

Based on the provided text, here's what can be stated and what cannot:

Acceptance Criteria and Reported Device Performance

Detailed Study Information (Not available in the provided text)

1. Sample size used for the test set and the data provenance: Not mentioned. No clinical test set data is provided.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned. No test set or ground truth establishment is described.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not mentioned.
4. 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 mentioned. This device is a TENS unit, not an AI-assisted diagnostic tool typically assessed with MRMC studies.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a hardware device, not an algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned.
7. The sample size for the training set: Not applicable. No training set is involved for this type of device and submission.
8. How the ground truth for the training set was established: Not applicable.

Conclusion:

The provided 510(k) summary is a regulatory filing document for a TENS device. It demonstrates substantial equivalence to a predicate device based on its technical specifications and intended use. It does not contain information about clinical studies, acceptance criteria for performance, or detailed data analysis typically found in reports of such studies. Therefore, I am unable to provide the requested information regarding study details and performance against acceptance criteria.

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The Pointer-Excel is intended for use in the symptomatic relief of chronic intractable pain, postoperative pain, and acute pain.

Not Found

This looks like a 510(k) clearance letter for a medical device called "Pointer Excel," a transcutaneous electrical nerve stimulator (TENS) for pain relief.

The provided document is a regulatory clearance letter, not a study report or a document that would contain the detailed information requested about acceptance criteria and study methodologies. Therefore, I cannot extract the specific information you've asked for from this text.

Here's why and what kind of document would typically contain that information:

• 510(k) Clearance Letter: This letter from the FDA confirms that a new device is "substantially equivalent" to a legally marketed predicate device. This process primarily relies on demonstrating that the new device has the same intended use, technological characteristics, and performance as a predicate device, often without requiring extensive new clinical trials like those needed for a Premarket Approval (PMA).
• Missing Information: The letter does not detail specific acceptance criteria, performance metrics, sample sizes, data provenance, expert qualifications, ground truth establishment, or study designs (like MRMC or standalone performance studies). This type of data would typically be found in:
  • The 510(k) submission document itself (which is much more extensive than this letter).
  • Clinical study reports or validation reports that the manufacturer might have submitted as part of their 510(k) application to demonstrate substantial equivalence, especially if performance data was required.
  • Scientific publications if the device underwent independent research.

Therefore, I cannot provide the requested table and study details based on the provided text.

If you had access to the full 510(k) submission for K060517, it might contain some of this information, particularly if performance data was submitted to support substantial equivalence.

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The Pointer Plus is intended for use in the symptomatic relief of chronic intractable pain, postoperative pain, and acute pain.

Not Found

I am sorry, but based on the provided text, there is no information available about acceptance criteria or a study proving the device meets acceptance criteria.

The document is a US FDA 510(k) clearance letter for the "Pointer Plus" device (K060508). This letter confirms that the device has been found substantially equivalent to a legally marketed predicate device, allowing it to be marketed.

The content focuses on:

• The device name and regulatory information.
• The FDA's review and determination of substantial equivalence.
• General controls and regulations applicable to the device.
• Contact information for further guidance.
• Indications for Use: "The Pointer Plus is intended for use in the symptomatic relief of chronic intractable pain, postoperative pain, and acute pain."

The letter does not contain any performance data, clinical study results, acceptance criteria, or details regarding how the substantial equivalence was demonstrated in terms of device performance. These details would typically be found in the 510(k) submission itself, which is not provided here.

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The IR Pro 250 is intended for use in the temporary relief of minor muscle and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and relaxation of muscles. In addition, the lamp may help muscle spasms, minor sprains and strains, and minor back pain.

The IR Pro 250 lamp can be used for topical heating of the body. It is designed to emit light between 700 to 50,000 nanometers in wavelength. The lamp uses 120 volts AC power at 250 watts. It is mounted on a swivel stand with 5 casters. An automatic timer controls exposure time.

The provided 510(k) summary for the IR Pro 250 Infrared Heating Lamp does not include information about acceptance criteria or a study that specifically proves the device meets such criteria in terms of clinical performance or effectiveness.

This submission is for an infrared heating lamp, which falls under a general controls class II device. For such devices, substantial equivalence is often demonstrated through comparison to a legally marketed predicate device and adherence to recognized safety standards, rather than extensive clinical studies with specific performance metrics and ground truth establishment.

Here's an analysis based on your requested information, highlighting what is present and what is absent in the document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not applicable in the context of clinical performance data. For safety testing, it states "A sample of the device was tested," implying at least one device was subjected to UL 482 tests, but the exact number isn't quantified.
• Data Provenance: Not applicable for clinical performance. The UL 482 testing is likely an internal or third-party laboratory test, not patient data.

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

• Not applicable as no clinical or diagnostic "ground truth" test set is described. The predicate device's established use history and accepted safety standards serve as the basis for equivalence.

4. Adjudication Method for the Test Set

• Not applicable as no clinical or diagnostic test set requiring adjudication is described.

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 MRMC study was conducted. This device is an infrared heating lamp, not an AI-powered diagnostic or assistive technology.

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

• No standalone algorithm performance study was done. This device is a physical heating lamp, not an algorithm.

7. The Type of Ground Truth Used

• For demonstrating substantial equivalence:
  • Predicate Device History: The regulatory history and accepted intended use of the legally marketed predicate device (TDP CQ-27 Lamp, K003538) serves as the primary "ground truth" for demonstrating similar safety and effectiveness.
  • Safety Standards: Compliance with UL 482 acts as "ground truth" for electrical and heating safety.
• No clinical "ground truth" (expert consensus, pathology, outcomes data) involving patient data was used for a de novo assessment of efficacy.

8. The Sample Size for the Training Set

• Not applicable. There is no training set for an algorithm as this is a physical device.

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

• Not applicable as there is no training set.

Summary of Device Acceptance:

The device's "acceptance" by the FDA, as indicated by the 510(k) clearance letter, is based on a demonstration of substantial equivalence to an existing legally marketed predicate device (the TDP CQ-27 Lamp). This means the FDA determined that the IR Pro 250 has the same intended use, and the same technological characteristics as the predicate device (or different characteristics that do not raise new questions of safety and effectiveness).

The primary evidence presented to support this claim includes:

• Identical Intended Use: The intended use of the IR Pro 250 is precisely the same as the predicate device.
• Similar Technological Characteristics: Both devices operate on similar power, emit infrared heat, and serve the same purpose.
• Compliance with Recognized Safety Standard: Testing against UL 482 (Standard for Safety for Portable Sun/Heat Lamp) ensures the device meets established safety requirements for its type.

For this type of device, a clinical study demonstrating therapeutic efficacy against specific acceptance criteria (like a reduction in pain score by X%) is typically not required for 510(k) clearance if substantial equivalence to a well-established predicate can be shown. The "study" here is the safety testing according to UL 482 and the regulatory comparison to the predicate.

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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 E-Stim II 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 portable instrument with dual channel outputs connected to lead wires and electrodes. Setting the output switch and the intensity controls will deliver the desired stimulation. Adjusting the frequency control will change the stimulation as well. Treatment continues as long as the intensity control dial switch is on.

This 510(k) summary describes a premarket notification for the E-Stim II, a portable transcutaneous electrical nerve stimulator (TENS) intended for pain relief.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly define acceptance criteria as typically seen for AI/ML device performance (e.g., sensitivity, specificity, AUC thresholds). Instead, the substantial equivalence determination for the E-Stim II is based on its conformity to established safety and performance standards and its similarity to a legally marketed predicate device (Well-TENS).

The "study" used here is a comparison of the E-Stim II to a predicate device and adherence to relevant standards.

2. Sample Size for Test Set and Data Provenance

This submission is for a medical device (TENS unit), not an AI/ML product that typically involves a "test set" of data. The "testing" refers to non-clinical bench testing for electrical safety, electromagnetic compatibility, and biocompatibility against recognized standards. Therefore, concepts like "sample size for the test set" and "data provenance" (country of origin, retrospective/prospective) are not directly applicable in the context of this 510(k) submission for a TENS device. The performance is assessed against engineering and medical device standards.

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

This information is not applicable to this 510(k) submission. "Ground truth" in the context of electrical device testing relies on adherence to the specifications of the standards (e.g., a waveform must be a square wave; a certain current must be delivered within a defined range). No human experts are used to establish "ground truth" for the device's electrical output or material properties in the same way they would for diagnostic image interpretation.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical studies, particularly for diagnostic imaging or similar scenarios where expert consensus is needed to define a reference standard. This is not relevant for the technical performance testing of a TENS device against established engineering standards.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. These types of studies are typically performed for diagnostic devices (especially AI-powered ones) to assess the impact of a device on reader performance. This submission is for a therapeutic TENS device, and its evaluation relies on its technical specifications, safety, and equivalence to a predicate device, not on how it changes human reader performance.

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

Not applicable. This device is a hardware-based TENS unit, not an algorithm or AI product. Its performance is inherently "standalone" in the sense that it delivers electrical stimulation as designed, but this is not an "algorithm-only" performance as understood in AI/ML contexts.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance, in the absence of an AI/ML component, is derived from:

• Compliance with Recognized Standards: The device meets the technical specifications and safety requirements outlined in the listed ISO, EN, IEC, and AAMI standards (e.g., electrical output parameters, biocompatibility, risk management). These standards define the expected and acceptable performance characteristics.
• Equivalence to Predicate Device: The electrical characteristics and intended use are considered "substantially equivalent" to a legally marketed predicate device (Well-TENS), implying that its performance is comparable and acceptable.

8. The Sample Size for the Training Set

Not applicable. This 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 there is no "training set" for this device.

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