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The ELEXIR 2.0 is indicated for the acute treatment of migraine (Acute mode, frequency 100 Hz) and the prophylactic treatment of episodic migraine (Prevention mode, frequency 60 Hz) in patients 18 years of age or older.

The ELEXIR 2.0 is a transcutaneous electrical nerve stimulator (TENS) that is applied to the forehead using a self-adhesive electrode positioned over the upper branches of the trigeminal nerve bilaterally. It is intended to stimulate the upper branches of the trigeminal nerve in order to reduce the frequency of migraine attack. The ELEXIR 2.0 is indicated for the acute treatment of migraine and the prophylactic treatment of episodic migraine by applying 100 Hz (Acute mode) and 60 Hz (Prevention mode), low-frequency stimulation to the forehead area percutaneously to the trigeminal nerve.

The provided text is a 510(k) summary for the ELEXIR 2.0 (ALLIVE3) device, a transcranial electrical nerve stimulator for headache treatment. The document focuses on demonstrating substantial equivalence to a predicate device (ALLIVE2 (ELEXIR)) rather than presenting a study of the device's clinical performance against specific acceptance criteria.

Therefore, the requested information regarding "acceptance criteria" for device performance, a "study that proves the device meets the acceptance criteria," "sample size," "data provenance," "number of experts," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," "type of ground truth," and "training set details" cannot be extracted from this document, as it describes non-clinical testing for safety and electrical performance, and equivalence to a predicate, not clinical efficacy or diagnostic accuracy.

The document lists various non-clinical tests performed, such as:

• Biocompatibility tests: Cytotoxicity (ISO 10993-5:2009), Sensitization (ISO 10993-10:2010), and Intracutaneous Reactivity Test (ISO 10993-10:2010).
• Electrical Safety and EMC tests: IEC 60601-1:2005+A1:2012, IEC 60601-1-2:2014, IEC 60601-1-11:2015, and IEC 60601-2-10:2012/A1:2016.
• Performance Tests: IEC 60601-2-10:2012/A1:2016, Technical Test (IEC 60601-2-10:2012/A1:2016), Performance Test under wireless communication (Manufacturer's own standards), and Lifetime study (Manufacturer's own standards).
• Usability V&V: IEC 60601-1-6:2010/A1:2013 and IEC 62366-1:2015.
• Software Test: IEC 62304:2006/A1:2015.

These tests are primarily aimed at establishing the safety and fundamental performance characteristics to claim substantial equivalence, rather than demonstrating specific clinical effectiveness against quantified criteria. The document states, "the safety and performance test reports support the safety and effectiveness of the subject device," which is a general conclusion based on these non-clinical evaluations and comparison to the predicate.

Without a clinical study section, the specific details for clinical performance criteria and their evaluation are not available in this 510(k) summary.

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Cefaly Connected - OTC is indicated for:

• 1. Acute treatment of migraine with or without aura in patients 18 years of age or older
• 2. Preventative treatment of migraine in patients 18 years of age or older
     Cefaly Connected - Rx is indicated for:
• 1. Acute treatment of migraine with or without aura in patients 18 years of age or older
• 2. Prophylactic treatment of migraine in patients 18 years of age or older

CEFALY Connected - Rx and CEFALY Connected - OTC consists of neurostimulators, Cefaly Electrodes, and mobile application. The neurostimulators are small, non-invasive, and portable devices meant to be worn on the forehead using a self-adhesive electrode to treat migraines similar to Cefaly® Dual Connected - Rx, and Cefaly® Dual Connected - OTC of K212071. The mobile application, CeCe Miqraine Management App, is a two-way communicatinq, mobile application, installed and run on users' personal mobile devices such as smartphone or tablet. The app is compatible with neurostimulators of CEFALY Connected devices (Rx and OTC). The mobile application communicates with the neurostimulator through Bluetooth and allows users to track the treatments.

The provided text describes a 510(k) premarket notification for a medical device called "CEFALY Connected - OTC" and "CEFALY Connected - Rx." The submission focuses on demonstrating substantial equivalence to a predicate device, the "Cefaly® Dual Series" (K212071). Since this is a 510(k) submission, the primary aim is to show that the new device is as safe and effective as a legally marketed predicate device, not necessarily to prove absolute effectiveness against a specific disease. Therefore, the "acceptance criteria" and "study" are primarily focused on demonstrating equivalence and safety/performance as compared to the predicate, especially regarding changes made to the mobile application.

Here's an analysis of the acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

The core of the submission relies on demonstrating that while there are differences in the mobile application's functionalities, the fundamental medical device functions and underlying technology of the neurostimulator remain equivalent in terms of safety and efficacy to the predicate device.

Study Details

The provided document describes studies primarily focused on bench testing and software validation to demonstrate substantial equivalence, rather than a clinical trial proving direct efficacy of the new components.

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not explicitly stated in terms of patient numbers or a dataset size for evaluating device performance. The testing described is "Software Verification and Validation, including interoperability testing" and "Bench testing." These tests would typically use specific test cases and simulated scenarios rather than a traditional patient test set.
   • Data Provenance: Not applicable in the context of patient data. The tests are technical assessments of software functionality and device interoperability.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. The ground truth for software verification and validation, and bench testing, is established by predefined functional requirements, technical specifications, and expected outputs based on engineering principles and regulatory standards. It's not typically established by clinical experts in the same way as an AI diagnostic study.

3. Adjudication method for the test set:

   • Not applicable. As the testing pertains to technical performance and software functionality (e.g., whether a button does what it's supposed to, whether Bluetooth communication is stable, whether intensity values are within tolerance), there isn't a "ground truth" established by human experts that requires adjudication.

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:

   • No MRMC study was done. The device is a "Transcutaneous Electrical Nerve Stimulator to Treat Headache," and the changes concern the mobile application interface. This is not an AI-assisted diagnostic device, nor does it involve "human readers" in a clinical interpretation context.

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

   • The core neurostimulator device functions independently of the mobile app. The document explicitly states: "The neurostimulator can perform treatment sessions independent of the mobile application." The mobile app provides supplementary control and monitoring functions. So, in a sense, the neurostimulator's standalone performance (without the app) is inherent to its prior clearance (K212071) and acknowledged in this submission. The "algorithm" here refers to the software controlling the neurostimulator and the mobile app's functionalities. The studies performed were on the software (verification, validation, interoperability) and system (bench testing, cybersecurity).

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

   • The "ground truth" for the tests performed (software verification, validation, interoperability bench testing) would be the device's technical specifications, design requirements, and regulatory standards. For example, if the app is supposed to display device battery level, the ground truth is the actual battery level measured by the device. If the app sends control commands, the ground truth is whether the device responded correctly and within expected parameters.
   • The effectiveness of the core neurostimulator for migraine treatment was established in prior submissions (K212071) through clinical performance data, which would have involved outcomes data related to migraine treatment. However, this submission focuses on the safety and performance of the new software features in the mobile app.

7. The sample size for the training set:

   • Not applicable. This is not a machine learning or AI device that requires a training set in the conventional sense. The "software" in question refers to the mobile application's control logic and user interface, which are developed through traditional software engineering methods, not statistical learning from large datasets.

8. How the ground truth for the training set was established:

   • Not applicable, as there is no training set for an AI/ML algorithm.

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The DOOPANG(YPS-301BD) is indicated for:

• The acute treatment of migraine with or without aura in patients 18 years of age or older.
• The prophylactic treatment of episodic migraine in patients 18 years of age or older.

This product is a small, portable product that uses the principle of transcutaneous nerve stimulation. By attaching an electrode to the forehead, it transmits electrical stimulation to the upper branch of the trigeminal nerve transdermally. The electrode surface transmits electric current to the skin to generate action potentials on the nerves and adjusts the output mode (Program 1 and Program 2) to preventative treatment of episodic migraine(60Hz) and acute treatment of migraine(100Hz). Specially designed electrode of this product allows contact with the trigeminal nerve endings associated with migraine headaches. The electrodes give nerve stimulation to the orbital upper branch (V1) inside the forehead skin and transmit it to the trigeminal nervous system. This electrical stimulation is transmitted percutaneously through a bipolar adhesive electrode located on the forehead to preventative treatment of episodic migraine(60Hz) or acute treatment of migraine(100Hz).

This FDA 510(k) summary (K232749) describes the "DOOPANG (YPS-301BD)" device, a transcutaneous electrical nerve stimulator for headache treatment. The summary demonstrates substantial equivalence to a predicate device, "Cefaly Dual" (K201895).

However, the provided text does not contain information about acceptance criteria for performance metrics, nor does it detail a study that proves the device meets such criteria in terms of clinical effectiveness. This type of device, a transcutaneous electrical nerve stimulator, typically relies on established efficacy of its mechanism and comparative safety and technical specifications rather than a novel clinical performance study with defined acceptance criteria for diagnostic output.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document focuses on demonstrating substantial equivalence in technological characteristics, indications for use, and safety, as opposed to proving a specific clinical performance metric with a dedicated pivotal study.

Here's what the document does provide, structured according to your request where applicable:

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

• Not explicitly provided in terms of clinical acceptance criteria like sensitivity, specificity, accuracy, or similar outcome measures for a diagnostic device. The comparison focuses on technical specifications to demonstrate equivalence.

2. Sample size used for the test set and the data provenance

• Not applicable / Not provided. The summary focuses on non-clinical testing (electrical safety, EMC, software validation, biocompatibility, cybersecurity, performance, usability) to demonstrate equivalence based on technical specifications and regulatory standards. There is no mention of a clinical test set with patient data for performance evaluation in the context of diagnostic accuracy or therapeutic outcome metrics.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable / Not provided. No such clinical performance study is described.

4. Adjudication method for the test set

• Not applicable / Not provided. No such clinical performance study 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

• Not applicable. This device is a direct-to-patient neuromodulation device, 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. This device is a direct-to-patient neuromodulation device. The software validation mentioned refers to the proper functioning of the embedded software control, not an AI algorithm for clinical interpretation.

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

• Not applicable / Not provided for clinical performance. For the non-clinical tests, "ground truth" would be defined by the specifications of the standards (e.g., IEC 60601-1 for electrical safety).

8. The sample size for the training set

• Not applicable / Not provided. No machine learning model or training set is mentioned for clinical performance.

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

• Not applicable / Not provided. No machine learning model or training set is mentioned for clinical performance.

Summary of Device Rationale from the Document:

The DOOPANG (YPS-301BD) device demonstrates substantial equivalence to the Cefaly Dual (K201895) predicate device primarily through:

• Identical Indications for Use: Both devices are indicated for acute treatment and prophylactic treatment of episodic migraine with or without aura in patients 18 years or older.
• Similar Technological Characteristics: The devices share comparable design, intended population, use environment, power source, channels, software programs (two fixed programs for acute and prophylactic treatment with similar frequencies and pulse widths), waveform, and output parameters.
• Minor Differences Not Adversely Affecting Safety or Effectiveness: Slight differences in session duration (1 minute) and maximum current density are considered insignificant. The slightly lower current density of the proposed device is even considered less risky.
• Compliance with Regulatory Standards: The device underwent non-clinical testing for electrical safety (AAMI/IEC 60601-1, 60601-2-10), electromagnetic compatibility (IEC 60601-1-2), usability (IEC 60601-1-6, 62366-1), home healthcare environment compatibility (IEC 60601-1-11), software validation, biocompatibility (ISO 10993-1), and cybersecurity. These tests confirm the device meets established safety and performance benchmarks for its classification.

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The Milieve is indicated for

• The acute treatment of migraine with or without aura in patients 18 years of age or older.
• The prophylactic treatment of episodic migraine in patients 18 years of age or older.

The Milieve device is a transcutaneous electrical nerve stimulator (TENS) developed for the acute treatment of migraine and the prophylactic treatment of episodic migraine. The device is placed on the patient's forehead to stimulate the upper branch of the trigeminal nerve. It is harmless to the human body. The Milieve device is indicated for OTC use.
There are two treatment programs: ACUTE and PREVENT. The ACUTE treatment program is intended for treatment during migraine attack at the onset of a migraine. The PREVENT treatment program is meant for daily preventative treatment.
The Mileve device comprises a plastic external casing and electrical components. It is operated by an internal rechargeable battery.

The provided text is a 510(k) summary for the Milieve (YPS-301BD) device, a transcutaneous electrical nerve stimulator for migraine treatment. The summary demonstrates substantial equivalence to a predicate device (Cefaly Dual).

The document does not describe a study involving an AI/algorithm where acceptance criteria are set for the performance of the AI model itself. Instead, it focuses on demonstrating the Milieve device's substantial equivalence to a predicate device through bench testing and comparison of technical specifications. The acceptance criteria and "device performance" in this context refer to the physical and electrical characteristics of the Milieve device and how they compare to those of the predicate device.

Therefore, many of the requested points from your prompt (e.g., sample size for test/training sets, number of experts for ground truth, MRMC studies, standalone AI performance) are not applicable to this type of submission, as the Milieve device is a hardware medical device, not an AI/algorithm-based diagnostic or therapeutic system.

However, I can extract and present the relevant information regarding the device's "performance" and how its "acceptance criteria" (understood as equivalency to the predicate) are met based on the provided text.

Acceptance Criteria and Device Performance (Demonstration of Substantial Equivalence)

The acceptance criteria for the Milieve device are implicitly based on demonstrating substantial equivalence to the predicate device, Cefaly Dual. This is achieved by showing that the technological characteristics and performance parameters are either identical or substantially equivalent, and that any differences do not raise new questions of safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance:

The provided table directly compares the Milieve device to the Cefaly Dual (Predicate Device). The "Comparison" column indicates whether the parameters are "Identical" or "Substantially Equivalent (SE)" with notes explaining the implications of the differences.

Notes on Substantial Equivalence:

• Note 1 (Ramp down Time): "The subject device has a slightly longer ramp down time. This longer ramp time helps with subject comfort. This difference will not raise new questions of efficacy as the therapeutic session times (20 min and 60 min) are identical."
• Note 2 (Dimensions): "The dimension of the subject device is slightly different from the predicate device. This minor difference will however not raise any new safety and effectiveness issues."
• Note 3 (Weight): "The weight of the subject device is slightly more than the predicate device. This minor weight increase has not impacted the ability to hold device and electrode reliably on the forehead in the in-house tests conducted and the human factors validation study. It is therefore expected to not raise any new safety and effectiveness issues."

Regarding the AI/Algorithm-specific questions (which are not applicable to this submission):

• 2. Sample size used for the test set and the data provenance: Not applicable. The study was bench testing of a hardware device.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth was established by direct measurement against engineering specifications and comparison to the predicate device.
• 4. Adjudication method for the test set: Not applicable. Performance was assessed via bench testing.
• 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 hardware medical device, not an AI-assisted diagnostic tool.
• 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a TENS unit, not an algorithm, and its use is intended for direct patient application (OTC).
• 7. The type of ground truth used: For the technical specifications, the ground truth is the performance parameters of the predicate device and established engineering standards. For the human factors validation (mentioned for weight), the ground truth is likely defined by user feedback and ability to use the device as intended.
• 8. The sample size for the training set: Not applicable. No AI model was trained.
• 9. How the ground truth for the training set was established: Not applicable. No AI model was trained.

Summary of the Study Proving Acceptance Criteria:

The study involved bench testing to demonstrate that the Milieve device's performance parameters are "substantially equivalent" to those of the predicate device (Cefaly Dual). Additionally, software verification and validation and risk management were conducted to support this equivalence. A human factors validation study was also mentioned regarding the device's weight, indicating that the slightly increased weight did not negatively impact usability.

The overarching "acceptance criteria" here is the demonstration of substantial equivalence to a legally marketed predicate device, as per 510(k) requirements. The study successfully met these criteria by showing identical or non-concerning, explained differences in all critical parameters.

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The TENS device-HeadaTerm 2 is indicated for the prophylactic treatment of episodic migraine in patients 18 years of age or older.

TENS device-HeadaTerm 2 offers a drug-free scheme, which introduces electric impulses to act on the supraorbital nerve and supratrochlear nerve, the very nerves that transmit migraine pain, to treat and prevent migraine headaches. TENS device- HeadaTerm 2 enables an electronic feedback mechanism to adjust the electrical impulses to the specific requirements of the individual user for personalized efficacy and comfort. The device could adhere to patient's forehead with conductive paste, the current passing through the electrodes and release current stimulate the nerve underneath patients' forehead skin; the stimulation would alleviate migraine headaches, the product provides the user with 9 gear options, and the user can control the stimulating intensity by selecting one of gear.

The provided text describes the regulatory clearance of a medical device (TENS device-HeadaTerm 2) and its substantial equivalence to predicate devices, but it does not contain the detailed acceptance criteria and a study proving the device meets those criteria in the format requested.

The document primarily focuses on:

• Regulatory Clearance: FDA 510(k) clearance for the TENS device-HeadaTerm 2 (K230782).
• Device Description: What the device is and how it works.
• Indication for Use: Prophylactic treatment of episodic migraine in patients 18 years or older, for Over-The-Counter (OTC) use.
• Predicate Devices: Comparison to TENS device-HeadaTerm (K172450) and Cefaly® Dual (K201895).
• Technological Characteristics Comparison: A table detailing similarities and differences with predicate devices.
• Performance Data (Non-clinical): Lists standards the device was tested against (e.g., IEC 60601-1, IEC 60601-1-11, IEC 60601-2-10, IEC 62133-2, IEC 60601-1-2, ISO 10993-5, ISO 10993-10, ISO 10993-23) for safety, EMC, and biocompatibility.
• Usability Verification: A brief mention of a usability study.

Therefore, I cannot provide the requested information for the following points as they are not present in the provided text:

1. A table of acceptance criteria and the reported device performance: The document confirms the device passed tests according to various standards but does not list specific numerical acceptance criteria (e.g., a minimum sensitivity or specificity) or the resulting performance values for these criteria.
2. Sample size used for the test set and the data provenance: Only a usability study is mentioned with a sample size of 24 participants. No test set for measuring specific performance metrics (like efficacy in migraine treatment) is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as a performance test set with ground truth is not described.
4. Adjudication method: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not indicated. The document explicitly states "Clinical testing is not required."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a physical TENS device, not an AI algorithm.
7. The type of ground truth used: Not applicable as no such performance study is described.
8. The sample size for the training set: Not applicable as no AI/machine learning algorithm training is mentioned.
9. How the ground truth for the training set was established: Not applicable.

The only "study" mentioned with concrete numbers is a usability study:

• Sample size: 24 participants.
• Goal: To prove the device is appropriate for OTC use.
• Outcome: All 24 subjects completed specified tasks correctly (equipment wearing, power-off, intensity adjustment, changing, storage). This implicitly serves as an "acceptance criterion" for usability in an OTC setting, and the reported performance (all 24 subjects successful) meets it.
• Data Provenance: Not explicitly stated, but based on the manufacturer's location, likely China. It's a prospective study.
• Ground Truth: Established by observing correct completion of tasks by the participants and assessment by a "study team and the HCP" (Healthcare Professional), implying expert observation and judgment on task completion.

In summary, the provided document is a regulatory clearance letter and a 510(k) summary, not a detailed clinical or performance study report with specific acceptance criteria beyond adherence to recognized medical device standards and a basic usability verification.

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Cefaly Dual Connected - OTC and Cefaly Dual Enhanced with RFID - OTC are indicated for:

1. Acute treatment of migraine with or without aura in patients 18 years of age or older
2. Preventative treatment of migraine in patients 18 years of age or older

Cefaly Dual Connected - Rx and Cefaly Dual Enhanced With RFID - Rx are indicated for:

1. Acute treatment of migraine with or without aura in patients 18 years of age or older
2. Prophylactic treatment of migraine in patients 18 years of age or older

The Cefaly® Dual Series of devices are small, non-invasive, and portable devices meant to be worn on the forehead using a self-adhesive electrode to treat migraine similar to Cefaly® Dual (K201895 OTC and K173006 R.). The devices are similar in construction and materials and use the same components (electronics and electrical components, and firmware), including the component that comes into patient contact which is the CEFALY® Electrode. The notable differences between the Subject and Predicate devices are Bluetooth technology and mobile application for the purpose of displaying device data, the new docking station, RFID for electrode detection, audio/visual indicators, and the dimensions and the weight of the electrode.

The provided text is a 510(k) premarket notification for the Cefaly Dual Series devices. It details the device's characteristics and compares them to predicate devices to demonstrate substantial equivalence. Crucially, this document does not contain information about a study that proves the device meets specific acceptance criteria in the format typically used for demonstrating the performance of a novel AI/ML-based medical device.

The document states:

• "No animal testing was required to justify the differences with the corresponding Predicate Devices." (page 40)
• "No clinical testing was required to justify the differences with the corresponding Predicate Devices." (page 40)

This indicates that the submission relies on demonstrating substantial equivalence to existing devices through bench testing and comparison of technological characteristics, rather than new clinical performance data to prove efficacy. The changes made to the device (e.g., Bluetooth, RFID, audio/visual indicators, charging system, weight, dimensions, electrode thickness, packaging) are assessed against safety and electrical standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10) and adhesion performance.

Therefore, I cannot provide the requested information for a study proving acceptance criteria for an AI/ML device because:

• No acceptance criteria for an AI/ML device are listed. The document pertains to a Transcutaneous Electrical Nerve Stimulator, not a device incorporating AI/ML for diagnostic or therapeutic decision-making.
• No study proving device performance against such criteria is presented. The "Performance Testing - Bench" section (Table 5.7.1) lists general electrical and EMC safety standards, and adhesion testing for electrodes, but not performance metrics related to migraine treatment outcomes that would typically be evaluated in a clinical trial.

Without a study described as such in the provided text, I cannot fill in the requested table or additional details. The information provided heavily focuses on hardware changes and their compliance with general safety standards, and substantiates that the functionality of the device (e.g., electrical stimulation parameters) remains equivalent to the cleared predicate devices, thus not requiring new clinical evidence of effectiveness for migraine treatment.

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The Relivion® transcutaneous electrical nerve stimulator is indicated for the acute treatment of migraine with or without aura in patients 18 years of age or older. It is a prescription device to be self-used at home.

The modified Relivion® is an external non-invasive neurostimulator designed for transcutaneous electrical nerve stimulation. The modified Relivion® headset integrates three pairs of output electrodes which come in contact with the subject's scalp at the forehead and occiput. The electrodes deliver the stimulation pulses produced by the headset's stimulation unit to the subject's scalp. The frontal electrodes stimulate the trigeminal (supraorbital and supratrochlear) nerve branches and the posterior electrodes stimulate the greater occipital nerve branches.

The modified Relivion® includes single-use replaceable electrode pads that are positioned on-top of the electrodes prior to treatment and are wetted by the user before use, in order to provide proper conductivity between the electrodes and the scalp.

The modified Relivion® is powered by a rechargeable battery and the headset incorporates an onboard user interface that enables the user to activate/deactivate the device and to adjust the stimulation intensity. Upon treatment activation, the treatment automatically runs and ends after 60 minutes or alternatively, the user can stop the treatment when desired.

The modified Relivion® can communicate via a low energy Bluetooth link with the modified Relivion®'s dedicated mobile application on the patient's smartphone. The modified Relivion®'s mobile application is optional, and it is used by the patient to display the device status and provide indications and alerts. Additionally, the modified Relivion® mobile application also enables the patient to report their migraine headache status.

The main modification introduced in the Relivion® Device compared to the cleared predicate device (K203419) is an added optional Physician Interface that enables physicians to remotely follow-up on the patient's migraine attacks status and the treatments they performed using the Relivion device, based on the data transferred to it via the modified mobile application.

Both the modified Relivion®'s mobile application (for patients) and added physician interface (for physicians) are referred together as the optional "Patient Management Interface" (PMI) of the modified Relivion® Device.

This document is a 510(k) premarket notification from Neurolief Ltd. for their Relivion® device, seeking clearance for a modified version. The primary modification is the addition of an optional Physician Interface to the existing mobile application. This is not a study proving a device meets acceptance criteria, but rather a document seeking clearance by demonstrating substantial equivalence to a previously cleared predicate device based on bench testing and software validation.

Therefore, the requested information, specifically regarding acceptance criteria and performance data for a clinical study, cannot be extracted from this document, as it outlines bench testing and software validation for modifications to an already cleared device, not a new clinical study with specific performance acceptance criteria for human efficacy.

The document explicitly states: "Because the modification to the device impacted only the software, no further testing was required." This indicates that no new clinical study was performed.

The "Performance Data" section solely refers to:

• Bench testing for the modifications (output parameters meeting specifications).
• Software testing for the Patient Management Interface (PMI) and Physician Interface (verification and validation, cybersecurity).

It does not provide details of a clinical study, acceptance criteria for clinical performance, sample sizes for a test set or training set, expert adjudication, MRMC studies, or specific ground truth methodologies for clinical outcomes.

Therefore, I am unable to fulfill the request for this specific information based on the provided text.

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THE ELEXIR is indicated for the acute treatment of migraine (program 1) and the prophylactic treatment of episodic migraine (Program 2) in patients 18 years of age or older

The ELEXIR device is a transcutaneous electrical nerve stimulator (TENS) that is applied to the forehead using a self-adhesive electrode positioned over the upper branches of the trigeminal verve bilaterally. It is intended to stimulate the upper branches of the trigeminal verve in order to reduce the frequency of migraine attack.

The provided text does not contain specific acceptance criteria or performance data for the ELEXIR device itself. Instead, it states that the device's safety and effectiveness are supported by non-clinical (biocompatibility, electrical safety, performance, usability, software) tests and a clinical evaluation report based on data from the predicate device, CEFALY® Dual. The document claims that the ELEXIR device is "not applied with clause b.6) of 21CFR882.5981," which likely refers to a requirement for clinical performance data for devices to treat headache. However, it then states that a clinical evaluation report was prepared using collected clinical data of the predicate device, concluding that the subject device is safe and effective.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from the provided text, nor can I answer questions 2, 3, 4, 5, 6, 7, 8, and 9 for the subject device (ELEXIR). The document explicitly mentions that clinical performance data for the subject device are not available and that its safety and effectiveness are inferred from the predicate device's data.

Here's a summary of what can be extracted:

• Acceptance Criteria for Non-Clinical Tests: The acceptance criteria for the non-clinical tests are implicitly the successful fulfillment of the listed international and FDA guidance standards.
• Study Proving Device Meets Acceptance Criteria (Non-Clinical): Various non-clinical tests were performed.

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

The document does not provide specific numerical acceptance criteria or performance results for the ELEXIR device in a table format. It states that non-clinical tests were performed in accordance with various standards, implying that meeting these standards constitutes the acceptance criteria.

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

Not provided for ELEXIR. For the clinical evaluation, data was collected from the predicate device. No details on its sample size or provenance are given for the predicate device's clinical data, other than it was "collected clinical data."

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 direct clinical study data for the subject device (ELEXIR) is presented. The clinical evaluation relies on data from the predicate device.

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

Not applicable, as no direct clinical study data for the subject device (ELEXIR) is presented.

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 device is a transcutaneous electrical nerve stimulator, not an AI-assisted diagnostic tool.

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

Not applicable. This device is a transcutaneous electrical nerve stimulator.

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

For the clinical evaluation, the safety and effectiveness for headache treatment were established using "collected clinical data" of the predicate device. The specific type of "ground truth" (e.g., patient-reported outcomes, physician diagnosis, etc.) for the predicate device's data is not detailed in this document.

8. The sample size for the training set

Not applicable, as this is not an AI/ML device that requires a training set. If referring to the predicate device's clinical data used for evaluation, no sample size is provided.

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

Not applicable, as this is not an AI/ML device. If referring to the predicate device's clinical data, the method for establishing ground truth is not specified.

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Migraine TENS Digital Pain Reliever LT1103

• The acute treatment of migraine with or without aura in patients 18 years of age or older.
• The prophylactic treatment of episodic migraine in patients 18 years of age or older.

Migraine TENS Digital Pain Reliever LT1103-P

• The prophylactic treatment of episodic migraine in patients 18 years of age or older.

The Migraine TENS Digital Pain Reliever is a neurostimulator that is applied to the forehead using a self-adhesive electrode positioned bilaterally over the supratrochlearis and supraorbitalis nerves. Supratrochlearis and supraorbitalis (or supratrochlear and supraorbital) nerves belong to the upper branch of the trigeminal nerve (V1). The device uses electric impulses that are delivered to the supratrochlearis and supraorbitalis nerves to prevent and treat pain in the head area.

The Migraine TENS Digital Pain Reliever is operated by a rechargeable battery. Pressure on the single button allows selecting and starting a stimulation program, which runs automatically. And during ramping up, users could choose comfortable intensity level by pressing the button to lock up the current intensity.

The Migraine TENS Digital Pain Reliever consists of the following elements:

• Main Device
• Charging Station
• Electrode Pads
• USB cable

This document is a 510(k) summary for the Migraine TENS Digital Pain Reliever. It describes the device and compares it to a predicate device (Cefaly® Dual) to demonstrate substantial equivalence.

Based on the provided text, here's what can be extracted regarding acceptance criteria and the study proving the device meets them:

This device is a TENS unit for migraine relief, not an AI/imaging diagnostic device. Therefore, many of the requested criteria (like ground truth, expert consensus, MRMC studies, effect size of human improvement with AI, standalone AI performance, training set details) are not applicable to this type of medical device submission.

The acceptance criteria here pertain to safety and performance equivalence with a legally marketed predicate device, rather than diagnostic accuracy or human-AI reader performance.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't present a formal "acceptance criteria" table in the typical sense for AI/diagnostic devices. Instead, it demonstrates equivalence by comparing the technical specifications of the new device (Migraine TENS Digital Pain Reliever LT1103, LT1103-P) against the predicate device (Cefaly® Dual, K201895).

The "S.E. Discussion" column in the table below effectively serves as the "reported device performance" against the implicitly accepted predicate's performance.

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

This is not applicable as this is a TENS device, not an AI/imaging device that would use a test set of patient images or data in that context. The "testing" here refers to engineering and safety performance testing.

• Test Set Sample Size: Not applicable.
• Data Provenance: Not applicable. The "data" comes from engineering tests, not patient studies.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. "Ground truth" in the context of diagnostic accuracy is not relevant for this device. Safety and performance are established through objective engineering tests against international standards and comparison to a predicate device.

4. Adjudication Method for the Test Set

Not applicable. There is no concept of "adjudication" in the context of engineering and safety testing for a TENS device in this 510(k) summary.

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 device is a treatment device, not a diagnostic AI device. Human "readers" are not involved in its primary function, nor is AI assistance relevant to its therapeutic mechanism.

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

Not applicable. This is a physical medical device, not an algorithm. Its performance is inherent to its physical and electrical characteristics.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

Not applicable in the AI/diagnostic sense. The reference standard or "ground truth" for this submission are:

• International safety and performance standards (e.g., ISO 10993-1, IEC 60601 series).
• The established safe and effective performance of the predicate device (K201895 Cefaly® Dual).

8. The Sample Size for the Training Set

Not applicable. This device does not use machine learning or require a "training set."

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

Not applicable. There is no training set for this device.

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The Relivion® transcutaneous electrical nerve stimulator is indicated for the acute treatment of migraine with or without aura in patients 18 years of age or older. It is a prescription device to be self-used at home.

The Relivion® is an external non-invasive neurostimulator designed for transcutaneous electrical nerve stimulation. The Relivion® headset integrates three pairs of output electrodes which come in contact with the subject's scalp at the forehead and occiput. The electrodes deliver the stimulation pulses produced by the headset's stimulation unit to the subject's scalp. The frontal electrodes stimulate the trigeminal (supraorbital and supratrochlear) nerve branches and the posterior electrodes stimulate the greater occipital nerve branches.

The Relivion® includes single-use replaceable electrode pads that are positioned on-top of the electrodes prior to treatment and are wetted by the user before use, in order to provide proper conductivity between the electrodes and the scalp.

The Relivion® is powered by a rechargeable battery and the headset incorporates an on-board user interface that enables the user to activate/deactivate the device and to adjust the stimulation intensity. Upon treatment activation, the treatment automatically runs and ends after 60 minutes or alternatively, the user can stop the treatment when desired.

The Relivion® can communicate via a low energy Bluetooth link with the Relivion® dedicated mobile application on the user's smartphone. The Relivion® mobile application is optional and it is used to display the device status and provide indications and alerts.

The provided document is a 510(k) premarket notification for the Relivion® device, a transcutaneous electrical nerve stimulator for the acute treatment of migraine. It details the device's characteristics, performance data, and comparison to a predicate device (Cefaly® Acute).

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Relivion® device, as derived from the RIME study (the pivotal clinical trial for the commercial version of the device), focused on the efficacy of pain relief.

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