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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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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 Cefaly® Dual 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 Cefaly® Dual device indicated for an OTC (also referred to as the Subject Device) is a supraorbital transcutaneous electrical nerve stimulator device to be applied on the forehead. A self-adhesive electrode with 2 conductive zones is placed on the forehead. This double electrode is directly connected to the device. The Subject Device is operated by a rechargeable battery. Pressure on the single button allows selecting and starting a stimulation program, which runs automatically. The electrical impulses generated by the Subject Device are transmitted transcutaneously via the supraorbital electrode to excite (trigger action potentials on) the supratrochlearis and supraorbitalis nerves. Supratrochlearis and supraorbitalis (or supratrochlear and supraorbital) nerves belong to the upper branch of the trigeminal nerve (V1). Therefore, the supraorbital neurostimulation is also known as external trigeminal nerve stimulation. The supraorbital neurostimulation generates an analgesic effect and is intended to treat migraine headaches.

This document is a 510(k) premarket notification approval letter for the Cefaly® Dual device, indicating its substantial equivalence to a previously cleared predicate device. It primarily focuses on the device's technological characteristics, indications for use, and a non-clinical human factors study to support a change from prescription (Rx) to over-the-counter (OTC) use.

Based on the provided text, the device itself does not involve an AI/ML algorithm that requires specific acceptance criteria related to its performance in tasks like image classification or predictive modeling. Instead, it's a Transcutaneous Electrical Nerve Stimulator (TENS) device. Therefore, many of the requested points regarding AI/ML acceptance criteria, performance metrics (like sensitivity, specificity, AUC), ground truth establishment, training sets, and MRMC studies are not applicable to this submission.

The "study that proves the device meets the acceptance criteria" in this context refers to demonstrating the device's equivalent performance and safety to its predicate, particularly for its proposed OTC use.

Here's a breakdown based on the document:

Acceptance Criteria for Cefaly® Dual (for OTC use):

The acceptance criteria are implicitly tied to demonstrating the substantial equivalence to the predicate device (Cefaly® Dual K173006) and showing that the device is safe and effective for over-the-counter use without requiring a prescription.

The document highlights the following as crucial for demonstrating equivalence/acceptance:

• Identical Technological Characteristics: The device must be technologically identical to the predicate device in design, materials, energy source, electrical impulse parameters (pulse width, frequency, current, waveform), and software.
• Identical Intended Use/Clinical Application: The clinical application and intended users (patients 18 years or older for acute treatment of migraine with or without aura, and prophylactic treatment of episodic migraine) must remain the same as the predicate.
• Safety and Effectiveness for OTC Use: The primary additional "acceptance criterion" for the OTC claim is demonstrating that the device can be used safely and effectively by lay users without professional guidance. This is addressed through a Human Factors validation study.

Study Proving Device Meets Acceptance Criteria:

The study that proves the device meets the (implicit) acceptance criteria for OTC marketing is primarily a Non-Clinical Human Factors Validation Study.

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

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

• Test Set Sample Size: The document only mentions a "Human Factors validation study" but does not specify the sample size for this study.
• Data Provenance: Not explicitly stated, but Human Factors studies are typically prospective tests conducted in a simulated or real-world use environment. The manufacturer is CEFALY Technology, based in Belgium, so participants could be from Europe or the US, but this is not detailed.

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

• This question is not applicable in the context of this device. A TENS device does not generate data that requires expert labeling or ground truth establishment in the way an AI/ML algorithm for medical image analysis would.
• For Human Factors studies, "experts" are typically human factors specialists, usability engineers, and potentially clinicians who understand the device's use environment, rather than experts establishing "ground truth" in clinical data. The document does not detail the expertise of those involved in the human factors study design or evaluation.

4. Adjudication Method for the Test Set:

• Not applicable for this type of device and study. Human Factors studies involve observing user interactions, identifying use errors, and assessing user comprehension, rather than adjudicating clinical findings.

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

• No, this was not done. The device cleared via a 510(k) pathway by demonstrating substantial equivalence to a predicate. The document explicitly states: "Clinical performance testing was not performed with the Subject Device to support equivalence, as there are no differences between the Subject Device and the Predicate Device."
• MRMC studies are typically for AI/ML algorithms where human performance with and without AI assistance is being compared. This device is a direct-to-patient TENS.

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

• Not applicable. This device is hardware with simple embedded software. It is not an AI/ML algorithm that operates in a "standalone" analytical capacity. Its performance is tied directly to its hardware function and user interaction.

7. The Type of Ground Truth Used:

• Not applicable for clinical efficacy. As noted, clinical performance testing was not performed for this submission. The "ground truth" for the Human Factors study would be the identification of all potential use errors and the successful demonstration that lay users can safely and effectively operate the device according to its instructions for use. This isn't "ground truth" in the diagnostic or prognostic sense.

8. The Sample Size for the Training Set:

• Not applicable. This device does not use an AI/ML algorithm that is "trained" on a dataset in the conventional sense. The software functions are fixed programs (Program 1 for acute treatment, Program 2 for prophylactic treatment) identical to the predicate device.

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

• Not applicable. See point 8.

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The Cefaly® Dual 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 Cefaly® Dual device is a supraorbital transcutaneous electrical nerve stimulator device to be applied on the forehead. A self-adhesive electrode with 2 conductive zones is placed on the forehead. This double electrode is directly connected to the device.

The Cefaly® Dual is operated by a rechargeable battery. A pressure on the single button allows selecting and starting a stimulation program, which runs automatically.

The electrical impulses generated by the Cefaly® Dual device are transmitted transcutaneously via the supraorbital electrode to excite (trigger action potentials on) the supratrochlearis and supraorbitalis nerves. Supratrochlearis and supraorbitalis (or supratrochlear and supraorbital) nerves belong to the upper branch of the trigeminal nerve (VI). Therefore, the supraorbital neurostimulation is also known as external trigeminal nerve stimulation. The supraorbital neurostimulation generates an analgesic effect and is intended to treat migraine headaches.

This document does not contain the detailed information necessary to complete the requested table and provide answers for all points. The provided text is a 510(k) summary for the Cefaly® Dual device, making a claim of substantial equivalence to two predicate devices (Cefaly® Acute and Cefaly®). While it describes the device's technical specifications and indications for use, it does not include the results of a clinical study or performance testing against specific acceptance criteria for efficacy or safety.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. Table of acceptance criteria and reported device performance:

This information is not available in the provided text. The document focuses on showing the Cefaly® Dual is technically equivalent to its predicates. It does not present clinical performance data or acceptance criteria for that data in this summary.

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

This information is not available as no clinical test set or study data is presented.

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

This information is not available as no clinical test set or ground truth establishment is described.

4. Adjudication method for the test set:

This information is not available.

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:

This information is not available. The Cefaly® Dual is a transcutaneous electrical nerve stimulator, not an AI-assisted diagnostic device that would involve human readers.

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

This information is not applicable. The Cefaly® Dual is a medical device, not an algorithm.

7. The type of ground truth used:

This information is not available.

8. The sample size for the training set:

This information is not available as no training set for a machine learning algorithm is mentioned.

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

This information is not available.

Summary of what the document does provide:

• Device: Cefaly® Dual, a supraorbital transcutaneous electrical nerve stimulator.
• Indications for Use:
  • Acute treatment of migraine with or without aura in patients 18 years of age or older.
  • Prophylactic treatment of episodic migraine in patients 18 years of age or older.
• Mechanism of Action: Transmits electrical impulses via a supraorbital electrode to excite supratrochlearis and supraorbitalis nerves (external trigeminal nerve stimulation) to generate an analgesic effect.
• Substantial Equivalence: Claimed against Cefaly® Acute (K171446) and Cefaly® (K160237). The Cefaly® Dual combines the stimulation programs and indications of these two predicate devices.
• Technical Characteristics: Detailed comparison of Cefaly® Dual with its predicates, showing identical physical dimensions, weight, housing materials, electrodes, power source, pulse width, waveform, and net charge per pulse. The key difference is that Cefaly® Dual includes two fixed programs (one for acute treatment at 100 Hz, one for prophylactic at 60 Hz), whereas each predicate only had one.
• Non-Clinical Performance Testing: Cefaly® Dual is compliant with the same international standards (IEC 60601-1, -1-2, -1-6, -1-11, -2-10, IEC 62366) as the predicate devices. This indicates electrical safety, electromagnetic compatibility, usability, and specific requirements for nerve stimulators.

The provided text is a regulatory submission for substantial equivalence based on technical and performance similarities to previously cleared devices, rather than a report on a clinical trial with specific acceptance criteria and outcome measurements for the new device.

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Cefaly® Acute is indicated for the acute treatment of migraine with or without aura in patients 18 years of age or older.

The Cefaly® Acute device is a supraorbital transcutaneous electrical nerve stimulator device to be applied on the forehead. A self-adhesive electrode with 2 conductive zones is placed on the forehead. This double electrode is directly connected to the device. The Cefaly® Acute is operated by a rechargeable battery. A pressure on the single switch starts a program, which runs automatically for 60 minutes.

This document describes the Cefaly® Acute device and its substantial equivalence to a predicate device (Cefaly®). It includes a summary of a clinical trial used to support its safety and efficacy.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" for the device's performance in a table format with specific numerical targets. However, the primary outcome of the clinical study serves as the de-facto performance measure demonstrating efficacy. The performance of the Cefaly® Acute is compared against a sham group.

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The Cefaly® device is indicated for the prophylactic treatment of episodic migraine in patients 18 years of age or older.

Cefaly® device is a supraorbital transcutaneous nerve stimulator device to be applied on the forehead. A self-adhesive electrode with 2 conductive zones is placed on the forehead. This double electrode is directly connected to the device.

Cefaly® is operated by a rechargeable battery. A pressure on the single switch starts a program, which runs automatically for 20 minutes.

The electrical impulses generated by the Cefaly® device are transmitted transcutaneously via the supraorbital electrode to excite (trigger action potentials) the supratrochlearis and supraorbitalis nerves. Supratrochlearis and supraorbitalis (or supratrochlear and supraorbital) nerves belong to the upper branch of the trigeminal nerve (V1). Therefore the supraorbital neurostimulation is also known as external trigeminal nerve stimulation. The supraorbital neurostimulation generates a sedative effect and is intended to treat migraine headaches.

This document describes the CEFALY® device, a supraorbital transcutaneous nerve stimulator for the prophylactic treatment of episodic migraine. It is a 510(k) premarket notification for a modified version of an already legally marketed device.

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

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes a 510(k) for a modified version of the CEFALY® device. The core of this submission is substantial equivalence to a predicate device (the original CEFALY® device, De Novo Number DEN120019 and 510(k) Number K122566). The document explicitly states that the "scientific technology of the modified Cefaly® device are identical to those of the original version of the Cefaly® device" and "The modified version of the Cefaly® has exactly the same output stimulation parameters than the legally marketed Cefaly®."

Therefore, the acceptance criteria are implicitly that the modified device's performance, particularly its safety and effectiveness for its indicated use, is equivalent to the predicate device. The performance is reported as being identical to the predicate.

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

The provided document for the 510(k) (K160237) does not describe a new clinical study with an independent test set for the modified device. Instead, it relies on demonstrating substantial equivalence to a predicate device. The modifications concern "power supply, the dimensional specifications, and the fixing system between the device and the electrode." The submission indicates that a "risk analysis did not show any unacceptable risk resulting from these device modifications."

Therefore, there is no information about a "test set" in the context of evaluating a new algorithm or clinical performance for this specific 510(k) submission. Any clinical data supporting the original predicate device (DEN120019, K122566) would be the basis for efficacy and safety, but that data is not detailed in this document.

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

As there is no new clinical study or test set described for the modified device in this 510(k) submission, this information is not available in the provided text.

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

Not applicable, as no new test set 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. The device is a transcutaneous electrical nerve stimulator, not an AI-powered diagnostic or assistive tool for human readers.

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

This refers to an algorithm-only performance study. The CEFALY® device is a physical medical device (nerve stimulator), not an algorithm or AI. Hence, this question is not applicable in the context of this device.

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

For the predicate device, the "ground truth" for its safety and effectiveness would have been established through clinical trials and medical assessments related to migraine frequency, intensity, and duration, as well as adverse events. The specific methodologies (e.g., patient-reported outcomes, physician diagnosis, headache diaries) are not detailed in this 510(k) summary but would have been part of the original De Novo or 510(k) submission for the predicate. For this modified device, the "ground truth" is its equivalence to the predicate device's established performance based on identical stimulation parameters and a risk analysis of the changes.

8. The sample size for the training set

Not applicable, as this is a physical medical device, not an AI/ML algorithm that requires a "training set."

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

Not applicable, as this is a physical medical device.

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