Search Results

The ADDNOX is indicated for the treatment of pediatric Attention Deficit Hyperactivity Disorder (ADHD) as a monotherapy in patients ages 7 through 12 years old who are not currently taking prescription ADHD medications.

The ADDNOX is intended for patient treatment by prescription only and for use at home under the supervision of a caregiver during periods of sleep.

The ADDNOX is a transcutaneous electrical trigeminal nerve stimulator for Attention Deficit Hyperactivity Disorder. It is a prescription device that stimulates transcutaneously or percutaneously through electrodes placed on the forehead.

The ADDNOX is intended for patient treatment by prescription only and for use at home under the supervision of a caregiver during periods of sleep.

The provided text describes a 510(k) premarket notification for the ADDNOX device, a transcutaneous electrical nerve stimulator for Attention Deficit Hyperactivity Disorder (ADHD). However, it explicitly states:

"No clinical testing was performed on the device."

This means that the submission does not include a study demonstrating device performance against specific acceptance criteria. The clearance for ADDNOX is based on its substantial equivalence to a legally marketed predicate device (SMILE) and non-clinical data (biocompatibility, electrical safety, performance, and software tests).

Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving the device meets them, nor can I provide information about sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for a clinical study, as these were not part of this 510(k) submission.

The document focuses on demonstrating that the ADDNOX has similar technological characteristics and performs as safely and effectively as the predicate device through non-clinical testing and comparison.

Ask a specific question about this device

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.

Ask a specific question about this device

The SMILE external Trigeminal Nerve Stimulation (eTNS) System is indicated for treatment of pediatric Attention Deficit Hyperactivity Disorder (ADHD) as a monotherapy in patients ages 7 through 12 years old who are not currently taking prescription ADHD medications.

The device is to be used for patient treatment by prescription only and is intended to be used in the home under the supervision of a caregiver during periods of sleep.

Transcutaneous electrical nerve stimulator for Attention Deficit Hyperactivity Disorder. A transcutaneous electrical nerve stimulator for Attention Deficit Hyperactivity Disorder (ADHD) is a prescription device that stimulates transcutaneously or percutaneously through electrodes placed on the forehead.

The SMILE eTNS System treatment protocol is administered each night while the patient is sleeping, for 7-9 hours. The device is designed to provide non-invasive electrical stimulation of the trigeminal nerve.

The provided document is a 510(k) summary for the Nu Eyne Co., Ltd. SMILE device, a transcutaneous electrical nerve stimulator for Attention Deficit Hyperactivity Disorder (ADHD). This document focuses on demonstrating substantial equivalence to a predicate device (Monarch eTNS System), rather than presenting a clinical study where the device performance against specific acceptance criteria is measured for an AI/algorithm-driven device.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, and ground truth establishment for an AI/algorithm is not available in this document.

The document details the device's technical specifications, indications for use, and a comparison to a predicate device to establish substantial equivalence. It also lists the non-clinical tests performed (electrical safety, EMC, performance, usability, and software validation according to relevant standards), which support the device's safety and effectiveness in general, but not a specific performance metric against a clinical acceptance criterion in the context of an AI/algorithm.

To directly answer your request based only on the provided text, I must state that the information is not present. This document describes a medical device clearance process focused on equivalence, not on the performance of a machine learning algorithm against a clinical endpoint with a dedicated test set and ground truth.

Ask a specific question about this device

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.

Ask a specific question about this device

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

The Allive 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 is a 510(k) summary for a medical device called "ALLIVE," a transcutaneous electrical nerve stimulator (TENS) intended for the prophylactic treatment of episodic migraine. It focuses on demonstrating substantial equivalence to a predicate device (CEFALY® K160237) rather than providing specific performance data against defined acceptance criteria from a clinical trial of the ALLIVE device itself.

Therefore, many of the requested details about acceptance criteria, performance data, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training data provenance cannot be extracted from this document, as the submission relies on non-clinical testing and a clinical evaluation report based on the predicate device's clinical data.

Specifically, the document states on page 12: "Although clinical performance data are required to demonstrate that the device is safe and effective as a treatment for headache in the indicated patient population on the special control according to clause b.6) of 21CFR882.5981, we consider that the subject device (Allive) is not applied with clause b.6) of 21CFR882.5981." and "Although there are not the clinical performance data of the subject device, we prepare the clinical evaluation report by using the collected clinical data of the predicate device."

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

Acceptance Criteria and Study Proving Device Meets Criteria

The document does not detail specific acceptance criteria for the ALLIVE device's clinical performance, nor does it present a clinical study of the ALLIVE device itself. Instead, it argues for substantial equivalence based on technical comparisons and a review of the predicate device's clinical data.

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

• Acceptance Criteria for ALLIVE's Clinical Performance: Not explicitly stated in this document for the ALLIVE device. The submission relies on demonstrating substantial equivalence to a predicate device.
• Reported Device Performance: No clinical performance data specific to the ALLIVE device is reported in this document. The document states, "Although there are not the clinical performance data of the subject device, we prepare the clinical evaluation report by using the collected clinical data of the predicate device."

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

• Test Set Sample Size: Not applicable/not provided for a clinical study of the ALLIVE device. The "test set" here refers to non-clinical tests (biocompatibility, electrical safety, performance, usability, software).
• Data Provenance: Non-clinical test data was generated for the ALLIVE device by the manufacturer (Nu Eyne Co., Ltd., Korea). The clinical evaluation references "collected clinical data of the predicate device," but specific provenance (e.g., country of origin, retrospective/prospective) for that predicate data is not detailed in this submission.

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

• Not applicable. This information pertains to medical imaging or diagnostics, where expert review establishes ground truth. The ALLIVE device is a therapeutic TENS device. Its performance is evaluated through technical specifications and indirectly through the predicate device's clinical outcomes.

4. Adjudication method for the test set

• Not applicable. As above, this typically applies to expert review processes for diagnostic accuracy, not physical device performance or therapeutic outcomes.

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. This is not an AI/imaging device. No MRMC study was conducted or referenced for the ALLIVE device.

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

• Not applicable. This device is a TENS unit, not an algorithm. Its performance is inherent to its physical operation and effect on the patient.

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

• For the non-clinical performance tests (electrical, biocompatibility, etc.), the "ground truth" is adherence to established international standards (e.g., IEC 60601-1, ISO 10993-5/10) and manufacturer's SOPs, verified through laboratory testing.
• For the clinical evaluation, the ground truth would have been derived from the outcomes data of the predicate device's clinical trials, as summarized in the Clinical Evaluation Report, which is not provided in detail here beyond its existence.

8. The sample size for the training set

• Not applicable. This device is not an AI algorithm that requires a "training set."

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

• Not applicable. See point 8.

Ask a specific question about this device