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Nerivio is indicated for acute and/or preventive treatment of migraine with or without aura in patients 8 years of age or older. It is a prescription use, self-administered device for use in the home environment at the onset of migraine headache or aura for acute treatment, or every other day for preventive treatment.

Nerivio Infinity is indicated for acute and/or preventive treatment of migraine with or without aura in patients 8 years of age or older. It is a prescription use, self-administered device for use in the home environment at the onset of migraine headache or aura for acute treatment, or every other day for preventive treatment.

The Nerivio and Nerivio Infinity are wearable, battery-powered, Remote Electrical Neuromodulation (REN) devices that are controlled by a mobile application. The systems deliver low energy electrical pulses to the upper arm for 45 minutes per treatment, after which the device turns off automatically.

The devices are composed of:

• A pair of UltraStim® electrodes (K130987) covered with hydrogel and removable protective film. In NerivioInfinity, the electrodes are embedded in a disposable, replaceable pad. In Nerivio, the electrodes are not disposable or replaceable.
• An electronic circuitry that includes microcontroller with firmware, LED indicator, a power button for activating the device, and Bluetooth radio for wireless connection to Android and iOS mobile platforms. The circuitry also includes a battery, which is rechargeable in NerivioInfinity and not rechargeable in Nerivio.
• An armband that is wrapped over the device to secure the device position on the user's arm is also included.

The devices are operated and controlled via mobile application software that is installed and run on the user's personal mobile device, such as a mobile phone or tablet. The device's hardware communicates with the mobile application through Bluetooth protocol. This mobile application software allows the user to control the stimulation intensity from 0 to 100% (representing intensity levels of 0-40 mA), to start, pause or stop the stimulation program, and to view device status such as the device's connection state, stimulation duration, battery level (when connected to Nerivio Infinity), remaining number of treatments (when connected to Nerivio), and user notifications.

The user is instructed to adjust the intensity to the strongest stimulation level just below the perceived pain level. Treatments with Nerivio and Nerivio Infinity are intended to be self-administered by the user immediately after the onset of migraine headache or aura or every other day for migraine prevention.

The provided FDA 510(k) clearance letter and summary for Nerivio and Nerivio Infinity primarily focus on demonstrating substantial equivalence to a previously cleared predicate device (K241756). It discusses minor changes and states that extensive non-clinical and clinical testing was not needed for this specific 510(k) submission because of the close similarity to the predicate.

Therefore, the document does not contain detailed acceptance criteria and studies demonstrating device performance against those criteria in the way one might expect for an initial device clearance or a completely new technology. Instead, it refers to existing knowledge and prior clearances, and specifically addresses the basis for revising certain labeling precautions.

I will extract the information available, acknowledging the limitations inherent in this type of submission.

1. Table of Acceptance Criteria and Reported Device Performance

As this K250405 submission is for modifications to an already cleared device, it doesn't present new acceptance criteria or new primary performance study results in the typical format. Instead, it relies on the predicate device's established performance and justifies that the minor changes do not raise new questions of safety or effectiveness. The "reported device performance" here relates to the basis for modifying labeling precautions.

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

• For long-term use data:
  • Sample Size: Not explicitly stated in the 510(k) document, but the cited study (Synowiec A, et. al. Adv Ther. 2024 Jan;41(1):170-18) would contain this information. The description mentions "real-world data on use of Nerivio collected from US patients."
  • Data Provenance: United States patients, retrospective (post-market studies).
• For pregnancy data:
  • Sample Size: Not explicitly stated in the 510(k) document, but the cited study (Peretz A, et. al. Headache. 2023;63(7):968-970) would contain this information.
  • Data Provenance: Not explicitly stated regarding country, but described as a "retrospective survey-study."

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

This information is not provided in the 510(k) document. The cited studies are "post-market studies of real-world data" and a "retrospective survey-study," which typically rely on patient-reported outcomes or clinical records rather than expert adjudication for ground truth directly related to device performance in the same way, for example, a diagnostic imaging AI would.

4. Adjudication Method for the Test Set

This information is not provided in the 510(k) document. Given the nature of the evidence (real-world data, survey), formal adjudication by a panel of experts for a test set is unlikely to have been the primary method for establishing "ground truth."

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 and is not applicable to this device or its clearance. Nerivio/Nerivio Infinity is a direct therapeutic device, not an AI-assisted diagnostic tool that involves human "readers."

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

N/A. This device is a transcutaneous electrical nerve stimulator for migraine treatment, not an algorithm that performs a standalone task for evaluation. It is a user-controlled device with specific treatment parameters. The "algorithm" in this context refers to the device's firmware controlling the stimulation, which is part of the integrated device used by the patient. Its performance is evaluated through patient response to the therapy, not an "algorithm-only" performance in isolation.

7. The Type of Ground Truth Used

• For long-term use data: Patient-reported outcomes and potentially clinical records from "real-world data on use of Nerivio."
• For pregnancy data: Patient responses from a "retrospective survey-study."
• The fundamental "ground truth" for therapeutic neurological devices like this is reduction in migraine symptoms, frequency, and severity, typically assessed through patient diaries and validated questionnaires. This specific 510(k) focuses on validating the safety aspects of long-term and pregnancy use, drawing from real-world data.

8. The Sample Size for the Training Set

The document does not contain information about a "training set" in the context of machine learning, as this is a neuromodulation device, not an AI/ML diagnostic or predictive algorithm being trained. The development of the device's therapeutic parameters would have been established through prior clinical trials (likely supporting the predicate device's initial clearance) and engineering design, not an ML training process.

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

N/A, as there is no "training set" in the context of machine learning described in this 510(k) submission. The efficacy and safety data upon which the device's design and indications are based would have come from the clinical trials that established the predicate device's clearance.

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The Nerivio is indicated for acute and/or preventive treatment of migraine with or without aura in patients 8 years of age or older. It is a prescription use, self-administered device for use in the home environment at the onset of migraine headache or aura for acute treatment, or every other day for preventive treatment.

The Neriviolnfinity is indicated for acute and/or preventive treatment of migraine with or without aura in patients 8 years of age or older. It is a prescription use, self-administered device for use in the home environment at the onset of migraine headache or aura for acute treatment, or every other day for preventive treatment.

The Nerivio and NerivioInfinity are wearable, battery-powered, Remote Electrical Neuromodulation (REN) devices that are controlled by a mobile application. The systems deliver low energy electrical pulses to the upper arm for 45 minutes per treatment, after which the device turns off automatically.

The devices are composed of:

• A pair of UltraStim® electrodes (K130987) covered with hydrogel and removable protective . film. In NerivioInfinity, the electrodes are embedded in a disposable, replaceable pad. In Nerivio, the electrodes are not disposable or replaceable,
• An electronic circuitry that includes microcontroller with firmware, LED indicator, a power button for activating the device, and Bluetooth radio for wireless connection to Android and iOS mobile platforms. The circuitry also includes a battery, which is rechargeable in NerivioInfinity and not rechargeable in Nerivio.
• An armband that is wrapped over the device to secure the device position on the user's arm is also included.

The devices are operated and controlled via mobile application software that is installed and run on the user's personal mobile device, such as a mobile phone or tablet. The device's hardware communicates with the mobile application through Bluetooth protocol. This mobile application software allows the user to control the stimulation intensity from 0 to 100% (representing intensity levels of 0-40mA), to start, pause or stop the stimulation program, and to view device status such as the device's connection state, stimulation, battery level (when connected to NerivioInfinity), remaining number of treatments (when connected to Nerivio), and user notifications.

The user is instructed to adjust the intensity to the strongest stimulation level just below the perceived pain level. Treatments with Nerivio and NerivioInfinity are intended to be self-administered by the user immediately after the onset of migraine headache or aura or every other day for migraine prevention.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) summary:

The core of this submission is to expand the indicated age range of the Nerivio and NerivioInfinity devices to include children aged 8-11. Therefore, the acceptance criteria and study focus on demonstrating the safety and effectiveness of the device in this younger population, showing it is comparable to its performance in the previously cleared adolescent and adult populations.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is an age range expansion for an already cleared device, the "acceptance criteria" are implicitly demonstrating comparable safety and effectiveness in the new age group (8-11 years old) to the previously cleared age group (12 years and older). The performance metrics align with what would be expected for a migraine treatment device.

Implicit Acceptance Criteria (for the 8-11 age group) and Reported Device Performance:

*Note: The study population included patients aged 6-11 years old. The device indication sought and granted in the 510(k) is for 8 years of age or older. The use of data from 6-7 year olds in the study would further support the safety and effectiveness for 8-11 year olds, as younger children might present more challenges in terms of compliance or adverse events.

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

• Sample Size: The clinical investigation included n=293 patients aged 6-11 at their first use of Nerivio (for safety and overall usage patterns in the real world). For effectiveness endpoints (acute treatment), analyses were performed on a subset of patients who completed voluntary pre- and post-treatment surveys, with the number of patients varying for each specific outcome (e.g., 18 for headache relief, 25 for headache freedom, 18 for functional disability, 10 for nausea/vomiting, 8 for phonophobia, 9 for photophobia).
• Data Provenance: The study consisted of a retrospective analysis of prospectively-collected real-world data for children in the United States. The data was collected between May 2020 to October 2023.

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

This type of study does not involve expert readers establishing ground truth in the traditional sense (e.g., for image interpretation). The "ground truth" for effectiveness is patient-reported outcomes of migraine symptoms, consistent with how efficacy trials for migraine treatments are typically conducted. Safety data is collected via customer service reports, which are also patient-reported or initiated.

4. Adjudication Method for the Test Set

Not applicable in this context. Adjudication methods (e.g., 2+1, 3+1) are typically used in studies where multiple expert readers interpret subjective data (like medical images) and their disagreements need to be resolved to establish ground truth. This study relies on patient-reported outcomes for effectiveness and adverse event reporting for safety.

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 standalone therapeutic device for migraine treatment, not an AI-assisted diagnostic tool that would involve human "readers" interpreting cases.

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

This is a device that directly treats a condition; it's not an AI algorithm that provides a diagnosis or analysis. Therefore, a "standalone algorithm performance" evaluation is not relevant in the same way it would be for an AI diagnostic device. The device's performance is its direct therapeutic effect, not its output as an algorithm.

7. The Type of Ground Truth Used

The ground truth for effectiveness was patient-reported outcomes (PROs) on migraine symptoms (headache pain, functional disability, nausea/vomiting, phonophobia, photophobia) via voluntary pre- and post-treatment surveys. For safety, the ground truth was based on reported adverse events through customer service complaints and other product issue reports.

8. The Sample Size for the Training Set

Not applicable. This is not a study validating an AI model that requires a distinct training set. The clinical investigation is a real-world study assessing the device's performance in a new age group. The "knowledge" or "training" for the device itself comes from its prior development and existing clinical data which supported its previous clearances for older populations.

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

Not applicable, as there is no "training set" in the context of an AI/ML model for this specific submission. The established efficacy and safety data from prior clinical trials in adolescents and adults (e.g., K223169 and K232152) serve as the benchmark against which the performance in the 8-11 age group is compared for equivalence.

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The Neriviolnfinity is indicated for acute and/or preventive treatment of migraine with or without aura in patients 12 years of age or older. It is a prescription use, self-administered device for use in the onset of migraine headache or aura for acute treatment, or every other day for preventive treatment.

The Neriviolnfinity is a wearable, battery-powered device that is controlled by a mobile application. The system delivers low energy electrical pulses to the upper arm for 45 minutes per treatment, after which the device turns off automatically. The device is composed of: A pair of UltraStim® electrodes (K130987) covered with hydrogel and removable protective film, embedded in an electrodes pad set. The electrodes pad is disposable and replaceable. An electronic circuitry that includes microcontroller with firmware and for wireless connection to Android and iOS mobile platforms, LED indicator, a USB-C charging port, a power button for activating the device and a battery contained in a plastic enclosure. An armband that is wrapped over the device to secure the NerivioInfinity position on the user's arm is included. The device is operated and controlled via mobile application software that is installed and run on the user's personal mobile device, such as a mobile phone or tablet. The device's hardware communicates with the mobile application through Bluetooth protocol. This mobile application software allows the user to control the stimulation intensity from 0 to 100% (representing intensity levels of 0-40mA), to start, pause or stop the stimulation program, and to view device status such as the device's connection state, stimulation duration, battery level, and user notifications.

The provided text is a 510(k) summary for the NerivioInfinity device. It details the device, its intended use, and a comparison to a predicate device (Nerivio). However, it does not contain the information requested regarding acceptance criteria, specific performance data (beyond "functioned as expected"), sample sizes for testing, ground truth establishment, or multi-reader multi-case studies.

The summary explicitly states: "No clinical trials were performed with the subject device, given that the therapeutic elements (electrodes, electrical waveform, location on the body, treatment instructions, treatment duration, etc.) are the same as in the predicate device." This means that the device's performance was not evaluated through a new clinical study. Instead, substantial equivalence was claimed based on its similarity to the predicate device, which presumably underwent clinical testing for its original clearance.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document for the NerivioInfinity, nor details about its test set, ground truth establishment, or clinical study design, as these were not conducted for this specific device clearance.

The "Performance Data" section solely describes non-clinical bench tests and usability tests.

Here's what can be extracted based on the provided text, while also noting what cannot be provided:

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

• Cannot be provided for the NerivioInfinity from this document. The document states that "No clinical trials were performed with the subject device." The "Performance Data" section refers to non-clinical bench tests and usability tests, stating that "In all instances, the NerivioInfinity functioned and expected." No specific quantitative acceptance criteria or performance metrics (e.g., sensitivity, specificity, accuracy, or clinical efficacy outcomes like pain reduction percentages) are detailed for the non-clinical tests.

2. Sample sizes used for the test set and the data provenance:

• A "test set" in the context of clinical performance or AI evaluation (as implied by the question) was not used for this device's clearance according to the document.
• For non-clinical bench tests and usability tests: The specific sample sizes are not provided. The document mentions "internal bench tests and external lab testing" and "Human factor (Usability) tests were performed to validate that all critical tasks related to use-errors and knowledge errors were successfully performed by representative intended users." No details on the number of "representative intended users" or the number of units tested are given.
• Data provenance: N/A for clinical data directly from this device's testing. For the non-clinical tests, the provenance is "internal bench tests" and "external lab testing" without further geographical details. The company is based in Netanya, Israel.

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

• N/A. As no clinical "test set" for performance evaluation (in the sense of the original prompt's context, i.e., diagnostic accuracy or clinical efficacy) was used for this device's clearance, there was no need for experts to establish ground truth in that context. Usability tests involved "representative intended users" but not "experts" establishing "ground truth" on medical outcomes.

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

• N/A. No clinical test set.

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:

• N/A. This device is a direct neuromodulation device, not an AI-assisted diagnostic or therapeutic device that would typically involve human "readers" or an MRMC study.

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

• N/A. This device is a standalone therapeutic device, not an algorithm. Its performance is evaluated through its physical and electrical characteristics and clinical outcomes (established by the predicate device's studies).

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

• N/A for the NerivioInfinity's clearance under this 510(k). The basis for clearance is "substantial equivalence" to the predicate device, meaning its safety and effectiveness are inferred from the predicate's established performance. For the predicate device, it would have been clinical outcomes data (e.g., migraine reduction, pain relief).

8. The sample size for the training set:

• N/A. This device does not have a "training set" in the context of machine learning or AI.

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

• N/A. This device does not have a "training set."

Summary of Device Performance (from the document but not necessarily "acceptance criteria"):

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The Nerivio is indicated for acute and/or preventive treatment of migraine with or without aura in patients 12 years of age or older. It is a prescription use, self-administered device for use in the home environment at the onset of migraine headache or aura for acute treatment, or every other day for preventive treatment.

The Nerivio is a wearable, battery-powered device that is controlled by a mobile application. The system delivers low energy electrical pulses to the upper arm for 45 minutes per treatment, after which the device turns off automatically. The device is composed of a pair of UltraStim® electrodes (K130987) covered with hydrogel and removable protective film, an electronic circuitry that includes firmware, LED indicator and a power button for activating the device and for wireless connection with Android and iOS mobile platforms and a battery contained in a plastic case situated within thermoplastic elastomers ("TPE") shell. In addition, an armband that is wrapped over the device to secure the Nerivio position on the user's arm is included. The device is operated and controlled via software that is installed and run on a user's personal mobile device such as a mobile phone or tablet. The device hardware communicates with the mobile application through a Bluetooth protocol. This mobile application software allows the user to control the stimulation intensity from 0 to 100% (representing intensity levels of 0-40mA), to start or stop the stimulation program, and to view device status such as the device's connection state, stimulation duration, remaining number of treatments, and user notifications. The user is instructed to adjust the intensity to the strongest stimulation level just below the perceived pain level. Treatments with Nerivio are intended to be self-administered by the user immediately after the onset of migraine headache or aura.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

Device Name: Nerivio
Indications for Use (New/Expanded): Acute and/or preventive treatment of migraine with or without aura in patients 12 years of age or older. It is a prescription use, self-administered device for use in the home environment at the onset of migraine headache or aura for acute treatment, or every other day for preventive treatment.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes a clinical study for the preventive indication for Nerivio, comparing it against a sham device. The "acceptance criteria" are implied by the primary and secondary efficacy endpoints of the clinical trial designed to demonstrate superiority over sham for migraine prevention.

2. Sample Size and Data Provenance

• Test Set Sample Size: 248 participants randomized (Active: 128, Sham: 120) for the Intent-to-Treat (ITT) dataset. Analysis for the primary endpoint was also performed on a modified ITT (mITT) dataset of 95 active and 84 sham participants (total 179) who completed at least 12 treatments.
• Data Provenance: The randomized, controlled trial was prospective and multicenter. While the specific countries are not mentioned, the context of FDA submission suggests it was likely conducted, at least primarily, within the United States. It was a prospective study.
• For the adolescent real-world data: 61 patients. Data collected prospectively through the Nerivio App between January 2, 2021, and November 26, 2022, from US patients.

3. Number of Experts and Qualifications for Ground Truth (Clinical Trial)

• The document does not explicitly state the number or qualifications of experts used to establish the ground truth for the clinical trial. However, the ground truth was based on participants' self-reported data using an electronic daily migraine diary application installed on their smartphones, following the International Classification of Headache Disorders (ICHD-3) criteria for migraine. This suggests that the diagnostic criteria were applied by healthcare professionals at the 15 study sites, who would be qualified to diagnose migraine. The assessment of efficacy endpoints (migraine days, headache days, medication usage) relied on the self-reported diary data.

4. Adjudication Method for the Test Set

• The document does not mention an adjudication method for the test set data (e.g., 2+1, 3+1 for imaging reads). The data collection for efficacy endpoints was through self-reported daily diaries.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not performed. This study was a Randomized Controlled Trial (RCT) comparing the device directly against a sham control for migraine prevention, not a study evaluating human reader performance with or without AI assistance.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop)

• This device is a physical neuromodulation device, not an AI algorithm for diagnosis or image interpretation. Therefore, the concept of "standalone performance" for an algorithm without human-in-the-loop does not directly apply in the typical sense of AI/imaging devices. The "performance data" presented is clinical efficacy and safety data from a human-device interaction (patients using the device).

7. Type of Ground Truth Used

• For the main clinical trial: The ground truth for headache/migraine days and medication usage was established through patient self-reported daily migraine diaries collected prospectively via an electronic application on smartphones. Migraine diagnosis itself was based on ICHD-3 criteria.
• For the adolescent real-world data: Similar to the clinical trial, the ground truth for migraine headache days was collected through the Nerivio App from self-reported data.

8. Sample Size for the Training Set

• This device is not an AI/ML algorithm that requires a "training set" in the conventional sense of supervised learning. The device's mechanism of action is electrical neuromodulation, not a learned algorithm.
• The clinical trial mentioned (K223169) is a validation study for the new preventive indication, building upon prior studies (like K203181) for acute treatment. The "training data" for the device's design would effectively be the pre-clinical research and prior clinical studies that informed its development and established its mechanism of action (conditioned pain modulation).

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

• As a hardware medical device with a well-defined physical mechanism, there's no "training set" ground truth in the AI sense. The "ground truth" for the device's development and prior understanding of its mechanism (e.g., conditioned pain modulation) would be based on previous basic science, preclinical studies, and prior clinical trials (such as K203181 which established its acute treatment efficacy). The current submission leverages this existing knowledge and demonstrates expanded efficacy for prevention using a randomized controlled trial. For the extrapolation to adolescents, the "ground truth" relies on the established mechanism of action (CPM) being the same across age groups, supported by real-world evidence collected via the device's app.

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The AD-2126 Transcutaneous Electrical Nerve Stimulators TENS device is intended for temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities, It is also intended for symptomatic relief and management of chronic, intractable pain associated with arthritis.

The AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS) is transcutaneous electrical nerve stimulator for relief of muscular pain and sold without prescription.

The device consists of a microprocessor, buttons, electrical pads, and display. Keys can control the device to choose the operation modes, adjust pulse output strength, then the channel that effectively transfers your desired choice of programmed electrical pulses directly through electrode adhesive pads to the suggested area of the body where the electrodes are placed, causing minimal muscle stimulation. The LCD display can show user the mode and strength chosen and other information.

Self-adhesive electrodes are used in this device, and they are designed with conductive adhesive interface between the patient's skin and the Electrical Stimulator which help electrical signals transferred from the TENS device to the body and complete its function. The electrodes to be used with the device have been cleared under submission number K130987 with the trade name of ValuTrode® Neurostimulation Electrodes; model number: 50X50.

This document refers to a 510(k) premarket notification for the AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS). There is no acceptance criteria or study information for an AI/ML device in this document. The document describes non-clinical testing performed to establish substantial equivalence to a predicate TENS device, not an AI/ML device.

Therefore, I cannot provide the requested information.

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The Shoulder PacemakerTM electrotherapy device is intended for neuromuscular electrical stimulation (NMES).

The Indications for Use for the Shoulder PacemakerTM device are:

• Prevention or retardation of disuse atrophy;
• Muscle re-education;
• Maintaining or increasing range of motion.

The device is intended for adults and adolescents age 14 and older.

The Subject device, Shoulder Pacemaker, is a wearable muscle stimulator, powered by an internal battery, used for rehabilitation/physiotherapy purposes to produce muscle contraction, through the passage of electric current, by means of conductive electrodes positioned on the body area of interest, in patients with shoulder functional pathologies.

The Shoulder Pacemaker device is intended to be used as a shoulder muscle stimulation tool to reduce and eliminate related functional pathologies.

The subject device can be used in stand-alone mode or in wireless mode.

The Shoulder Pacemaker should be used in combination with:

• conductive electrodes, that are applied directly to the patient's skin to ensure muscle electrostimulation;
• saver protection, interposed between the stimulator and the patient's arm. -

The device is equipped with a goniometer (product code KQX, Class I, 510 (k) exempt), which can record the acceleration and angular velocity data of the device and allows to estimate the movement of the subject's arm. In this way, the device automatically detects the elevation angle of the arm and based on that information it can modulate the electrical stimulation.

The Shoulder Pacemaker is a prescription device and is intended to be used following the directions of a healthcare provider; additionally, the device may be used in a healthcare facility setting or by a patient or lay operator in a home environment.

The provided text describes a 510(k) submission for the Shoulder PacemakerTM device, focusing on expanding its indications for use to include adolescents aged 14 and older. The submission primarily relies on demonstrating substantial equivalence to a previously cleared predicate device (K210674), which is also the "Shoulder PacemakerTM" from the same manufacturer, NCS Lab Srl.

The core of the submission addresses the device's safety and effectiveness through non-clinical testing and leveraging existing clinical data through pediatric extrapolation, rather than conducting a new clinical study.

Here's an analysis of the requested information based on the provided text:

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

The document does not explicitly present a table of "acceptance criteria" in the traditional sense for a new clinical study comparing the device to a threshold or another device. Instead, the "acceptance criteria" for this 510(k) submission revolve around demonstrating substantial equivalence to the predicate device (K210674) and compliance with relevant medical device standards. The "reported device performance" is primarily the affirmation that the device meets these standards and is functionally identical to the predicate for all characteristics except the expanded age range.

The "performance data" section states: "All non-clinical, BLE module, battery, electrical safety, EMC and software testing was reviewed in K210674. No substantial changes have been made to the device since it was cleared by the FDA on August 24, 2021 that would affect prior testing results."

This implies that the device's performance aligns with the predicate device, which had already met the necessary performance criteria for its original clearance.

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

There was no new clinical "test set" or study conducted for this specific 510(k) submission in the traditional sense of prospectively enrolling patients for direct device performance testing. The clinical evaluation for the expanded age indication was based on pediatric extrapolation as per FDA guidance. This means:

• Sample Size: Not applicable for a new clinical test set. The submission relies on existing clinical literature and real-world use data.
• Data Provenance: The text mentions "Published literature and real-world use data." The specific countries or whether this data was retrospective or prospective from the original studies are not detailed within this summary, but it generally refers to existing, previously collected 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. No new clinical test set was created, and thus no new ground truth was established by experts for this specific submission. The clinical evidence for pediatric extrapolation relied on published literature.

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

Not applicable. No new clinical test set requiring adjudication was conducted.

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 powered muscle stimulator, not an AI-powered diagnostic or assistive tool for human readers, so an MRMC study comparing human performance with and without AI assistance is irrelevant to this submission.

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

Not applicable. This is a physical medical device (muscle stimulator), not an algorithm in the context of standalone diagnostic performance. The device does operate in a "stand-alone mode" (uncontrolled by a wireless tablet) but this refers to its operational mode, not a standalone algorithm performance test.

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

For the pediatric extrapolation, the "ground truth" would be considered the established clinical outcomes data from published literature and real-world use for NMES devices in both adult and pediatric populations, as well as the comparison of patient, disease, and device characteristics. This is a form of outcomes data and literature-based evidence analyzed to support equivalence in a younger population.

8. The sample size for the training set

Not applicable. This submission concerns a hardware device with an expanded indication for use, not an AI/ML algorithm requiring a training set in the typical sense. The software validation mentioned (IEC 62304) involves testing against design requirements, not training on a dataset.

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

Not applicable. There was no training set for an AI/ML algorithm.

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Shoulder PacemakerTM is an electrotherapy device intended for neuromuscular electrical stimulation (NMES).

The Indications for Use for Shoulder PacemakerTM are:

• Prevention or retardation of disuse atrophy;
• Muscle re-education;
• Maintaining or increasing range of motion.

The device is intended for adults only.

The Subject device, Shoulder Pacemaker, is a wearable muscle stimulator, powered by an internal battery, used for rehabilitation/physiotherapy purposes to produce muscle contraction, through the passage of electric current, by means of conductive electrodes positioned on the body area of interest, in patients with shoulder functional pathologies.

The Shoulder Pacemaker device is intended to be used as a shoulder muscle stimulation tool to reduce and eliminate related functional pathologies.

The subject device can be used in stand-alone mode or in wireless mode.

The Shoulder Pacemaker should be used in combination with:

• conductive electrodes, that are applied directly to the patient's skin to ensure muscle electrostimulation;
• saver protection, interposed between the stimulator and the patient's arm.

The device is equipped with a goniometer (product code KQX, Class I, 510 (k) exempt), which can record the acceleration and angular velocity data of the device and allows to estimate the movement of the subject's arm. In this way, the device automatically detects the elevation angle of the arm and based on that information it can modulate the electrical stimulation.

The Shoulder Pacemaker is a prescription device and is intended to be used following the directions of a healthcare provider; additionally, the device may be used in a healthcare facility setting or by a patient or lay operator in a home environment.

The provided text describes a 510(k) summary for a medical device called "Shoulder Pacemaker™," an electrotherapy device for neuromuscular electrical stimulation (NMES). It outlines the device's characteristics, indications for use, comparison to predicate devices, and performance data to support its substantial equivalence.

However, the document does not contain the level of detail typically found in a clinical study report or a formal acceptance criteria document for an AI/ML medical device. Specifically, it lacks information regarding:

• Quantitative acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy). The document focuses on electrical safety, EMC, and compliance with standards rather than clinical performance metrics for a specific diagnostic or therapeutic outcome.
• A "study" that proves the device meets acceptance criteria in the context of clinical effectiveness with quantitative results. The performance data section refers to non-clinical testing (electrical safety, EMC, software validation) and compliance with standards, not a clinical trial or performance study involving a test set, ground truth, or expert readers.
• Sample sizes, data provenance, ground truth establishment, expert qualifications, or adjudication methods as these pertain to clinical performance studies.
• MRMC studies or standalone algorithm performance as these are relevant for AI/ML devices analyzing complex data like images, which is not the primary function described for this NMES device.

Given that the device is a Powered Muscle Stimulator (Product Code IPF) intended for NMES, its performance evaluation focuses on electrical parameters, safety, and functional equivalence to predicate stimulators, rather than diagnostic accuracy as one might expect from an AI/ML imaging device.

Therefore, I cannot populate all sections of your requested outline based on the provided text. I will, however, extract the relevant information regarding acceptance criteria (as implied by the testing performed) and the "study" (non-clinical testing) that demonstrates compliance.

Acceptance Criteria and Device Performance for Shoulder Pacemaker™

Based on the provided 510(k) Summary, the acceptance criteria and performance are primarily related to electrical safety, electromagnetic compatibility (EMC), software validation, and general functional equivalence to predicate devices. There are no explicit quantitative performance metrics (e.g., sensitivity, specificity, or accuracy scores) for a clinical outcome mentioned for the Shoulder Pacemaker™, as it is a muscle stimulator focused on electrical stimulation parameters rather than a diagnostic AI/ML device.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria (Implied) and Reported Device Performance

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The Nerivio is indicated for acute treatment of migraine with or without aura in patients 12 years of age or older. It is a prescription use, self-administered device for use in the home environment at the onset of migraine headache or aura.

The Nerivio is a wearable, battery-powered device that is controlled by a mobile application. The system delivers low energy electrical pulses to the upper arm for 45 minutes per treatment, after which the device turns off automatically. The Nerivio is identical to the previously cleared Nerivio device with a modification to the indications for use to allow treatment in patients aged 12 years and older.

The device is composed of a pair of UltraStim® electrodes (K130987) covered with hydrogel and removable protective film, an electronic circuitry that includes firmware, LED indicator and a power button for activating the device and for wireless connection with Android and iOS mobile platforms and a battery contained in a plastic case situated within thermoplastic elastomers ("TPE") shell. In addition, an armband that is wrapped over the device to secure the Nerivio position on the user's arm is included.

The device is operated and controlled via software that is installed and run on a user's personal mobile device such as a mobile phone or tablet. The device hardware communicates with the mobile application through a Bluetooth protocol. This mobile application software allows the user to control the stimulation intensity from 0 to 100% (representing intensity levels of 0- 40mA), to start or stop the stimulation program, and to view device status such as the device's connection state, stimulation duration, remaining number of treatments, and user notifications.

The patient is instructed to adjust the intensity to the strongest stimulation level just below the perceived pain level. Treatments with Nerivio are intended to be self-administered by the user immediately after the onset of migraine headache or aura.

The provided text describes a clinical study for the Nerivio device, indicated for acute treatment of migraine. However, it does not detail acceptance criteria in the typical format of a table with specific metrics and thresholds for a device's performance. Instead, it presents results of clinical endpoints related to safety and efficacy.

Based on the provided text, here's an attempt to structure the information according to your request, inferring acceptance criteria from the reported efficacy outcomes:

1. Table of "Acceptance Criteria" (Inferred from Efficacy Endpoints) and Reported Device Performance

Note: The document does not explicitly state numerical acceptance thresholds. The "acceptance criteria" listed above are derived directly from the endpoints measured in the clinical study, implying that meeting these outcomes was considered sufficient for demonstrating safety and effectiveness for the expanded indication.

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

• Sample Size for Final Analysis Set (Test Set): 39 participants (adolescents aged 12-17 years old) for efficacy endpoints. A total of 45 participants entered the treatment phase, and safety analyses were performed on all 45.
• Number of treated migraine headaches: 159 qualifying migraine headaches.
• Data Provenance: Prospective, open-label, single-arm, multicenter study conducted at 12 sites in the USA.

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

The study involved self-reported pain scores, absence/presence of migraine-associated symptoms, and functional disability recorded by participants using an electronic diary application. The ground truth for headache diagnosis (ICHD-3 criteria for migraine) would have been established by healthcare professionals at the study sites; however, the number and specific qualifications of these professionals are not detailed in the provided text. No independent expert panel was used for establishing individual case ground truth during the treatment phase as data was self-reported.

4. Adjudication Method for the Test Set

No explicit adjudication method (like 2+1 or 3+1 consensus by experts) is described for the patient-reported outcomes that formed the test set. The data was collected directly from participants via electronic diaries. For "missing data" for the primary efficacy endpoint, a worst-case scenario imputation was used, where all treatments with missing pain level data were considered failures.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This was a single-arm study evaluating the device's effect in adolescents, not a comparative effectiveness study involving human readers assisting AI or comparing human performance with and without AI assistance. The device functions as a direct treatment, not an AI diagnostic aid.

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

This question is not applicable in the context of this device. Nerivio is a medical device that delivers electrical stimulation for migraine treatment, not an algorithm, so evaluation of "standalone (algorithm only)" performance is not relevant. The performance evaluated is that of the device in use by humans.

7. The Type of Ground Truth Used

The ground truth for the effectiveness of the device was established based on:

• Patient-reported outcomes: Self-reported pain scores (mild, moderate, severe, none), presence/absence of associated symptoms (nausea, photophobia, phonophobia), and functional disability (via electronic diary).
• Validated questionnaire: Pediatric Migraine Disability Assessment (PedMIDAS) questionnaire for migraine-related disability.
• Safety data: Incidence and characteristics of adverse events reported by participants.

8. The Sample Size for the Training Set

The text does not refer to a "training set" in the context of machine learning, as this is a medical device for treatment, not an AI model. The study described is a clinical investigation to evaluate the device's safety and efficacy in a specific patient population (adolescents), thus acting as a validation study for the expanded indications.

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

Not applicable, as there is no "training set" in the context of an AI model to which this question would apply. The "ground truth" for the device's intended use (migraine treatment) is established through clinical practice guidelines (ICHD-3 criteria for migraine diagnosis) and observed patient responses to treatment.

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The Nerivio Migra is indicated for acute treatment of migraine with or without aura in patients 18 years of age or older who do not have chronic migraine. It is a prescription use, selfadministered device for use in the home environment at the onset of migraine headache or aura.

The Nerivio Migra is a wearable, battery-powered device that is controlled by a mobile application. The system delivers low energy electrical pulses to the upper arm for 45 minutes per treatment, after which the device turns off automatically.

The device hardware consists of an armband intended to be worn on a user's upper arm. The armband contains the electronic circuitry and the battery in a plastic storage case as well as two electrodes that are attached to the interior of the armband and placed against the user's skin.

The device is operated and controlled via software that is installed and run on a user's personal mobile device such as a mobile phone or tablet. The device hardware communicates with the mobile application through a Bluetooth protocol. This mobile application software allows the user to control the stimulation intensity from 0 to 100% (representing intensity levels of 0-40mA), to start or stop the stimulation program, and to view device status such as the device's connection state, a progress bar for stimulation duration, battery level, and user notifications.

The patient is instructed to adjust the intensity to the strongest stimulation level below the perceived pain level. Treatments with Nerivio Migra are intended to be self-administered by the user immediately after the onset of migraine headache or aura.

The basic pulse structure is biphasic, with symmetrical interleaving phases and rectangular shape. The amplitude shift signal alternates between a nominal maximum and a nominal minimum of the amplitude signal. The maximal output current is 40mA. The assumed impedance is 1K ohm +/- 500 ohms.

The provided text describes the regulatory information, device description, non-clinical/bench studies, and clinical study details for the Nerivio Migra device. It does not contain information about a study that specifically proves the device meets acceptance criteria in the formal sense often used for AI/ML medical devices (e.g., target metrics for sensitivity, specificity, or similar performance measures).

Instead, the document details a clinical trial designed to demonstrate the safety and effectiveness of the Nerivio Migra device for its intended use compared to a sham device. The "acceptance criteria" here are implicitly tied to the statistical significance and clinical meaningfulness of the primary and secondary endpoints in this clinical trial, as well as satisfactory results from non-clinical testing.

Based on the provided text, here's a breakdown of the information that aligns with your request, interpreting "acceptance criteria" as the successful demonstration of safety and effectiveness through the described clinical study and non-clinical testing:

Acceptance Criteria and Device Performance (Interpreted from Clinical Trial Endpoints and Non-Clinical Testing)

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Ennova Self-adhesive Electrode is intended to transmit electrical current to patient skin for use with transcutaneous electrical stimulation devices. Some common types of the stimulation devices include, but are not limit to TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). The electrode is for OTC (Over-The -Counter) or Prescription use.

Ennova Self-adhesive Electrode is used as an accessory to the TENS or EMS device unit, which transmits electrical current to patient skin. The electrical current is first transmitted via the lead wire or snap button then transmitted to the conductive gel which is adhered to patient skin. Ennova Self-adhesive Electrode is composed of a cover, connector lead wire or snap button, conductive carbon film, conductive hydrogel, and an electrode carrier liner. It is non-sterile and intended for single adult patient(age=18) multiple application use. Ennova Self-adhesive Electrode has various shapes and sizes. To connect with a nerve or muscle stimulator, this Electrode has lead wire type and snap button type. For lead wire type electrode, the wire is at least 40mm long, with 2.0~3.5mm diameter female socket. For snap button type electrode, the connector is male snap button. The individual electrodes are electrically connected in pairs. When not in use, the hydrogel face is covered by a PET (polyethylene terephthalate) release liner.

The provided text describes a 510(k) premarket notification for the Ennova Self-adhesive Electrode. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study.

Therefore, many of the requested details about a study proving device acceptance criteria cannot be extracted from this document, as a clinical study was explicitly not included in this submission.

Here's an analysis based on the information available:

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

The document doesn't define "acceptance criteria" in the traditional sense of a clinical trial's primary or secondary endpoints. Instead, it outlines design specifications and performance standards for the device and compares them to predicate devices to establish substantial equivalence.

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

• Sample Size for Test Set: Not applicable for a clinical study in this submission. The tests performed are bench tests on the physical device components. The document does not specify the number of individual electrodes or batches tested for these non-clinical evaluations.
• Data Provenance: The tests were conducted by Suzhou Ennova Electronics Technology Co., Ltd. in China ("Bench tests were conducted on the proposed Self-adhesive Electrode to verify that the proposed device met all design specifications"). The data is non-clinical, originating from laboratory testing. It is neither retrospective nor prospective in the clinical study sense.

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

• Not applicable. This submission relies on non-clinical bench testing against recognized industry standards (e.g., ASTM, ISO, AAMI/ANSI, IEC) and comparison to legally marketed predicate devices. Ground truth in the context of expert consensus (e.g., for image interpretation) is not relevant here. The "ground truth" for these tests comes from objective measurements and adherence to specified performance metrics in the standards.

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

• Not applicable. Adjudication methods are typically used in clinical studies, particularly for subjective assessments or when reconciling differing expert opinions. The tests performed here are objective bench tests.

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 self-adhesive electrode, not an AI-powered diagnostic tool. No MRMC study was conducted or is relevant.

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

• Not applicable. This is a hardware component (electrode), not an algorithm.

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

• The "ground truth" for this submission is based on established industry standards (e.g., ISO, ASTM, AAMI/ANSI, IEC) and the performance characteristics of legally marketed predicate devices. For example, biocompatibility is assessed against ISO standards, and electrical performance against AAMI/ANSI and IEC standards. The efficacy is inferred from the substantial equivalence to predicate devices that have already demonstrated safety and effectiveness for their intended use.

8. The sample size for the training set:

• Not applicable. This device's approval is based on substantial equivalence demonstrated through bench testing and comparison to predicates, not through machine learning model training.

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

• Not applicable. See point 8.

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