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The SAVI Dual™ Migraine Therapy device is indicated for the acute and prophylactic treatment of migraine headache in adolescents (age 12 and older) and adults.

The SAVI Dual Migraine Therapy device is a portable, hand-held device that delivers a brief single pulse of magnetic energy at 0.9 Tesla to the back of the head to induce an electrical current in a portion of the brain, called the occipital cortex, to stop or lessen the effects of migraine headaches. Since a single pulse of magnetic stimulation is emitted, this method of stimulation is called single pulse transcranial magnetic stimulation or sTMS. The SAVI Dual is indicated for the acute and prophylactic treatment of migraine headache in adolescents (age 12 and older) and adults. The device is designed for patient use where treatments are self-administered and can be delivered in a variety of settings including the home or office. The device is intended for prescription use only. To use the device, the user must either insert a SIM chip to use the device for a programmed duration or the user may connect wirelessly via a cellular connection for the programmed duration. The programmed duration corresponds to the prescribed months of use.

The provided text describes the regulatory clearance for the SAVI Dual™ Migraine Therapy device and establishes its substantial equivalence to a predicate device (SpringTMS) and a reference device (sTMS mini). The focus is on non-clinical performance testing rather than clinical study results comparing device performance against specific disease metrics.

Therefore, the acceptance criteria and study information will be presented based on the available non-clinical testing data provided in the document.

Description of Acceptance Criteria and Study Proving Device Meets Acceptance Criteria

The SAVI Dual™ Migraine Therapy device underwent non-clinical performance testing to demonstrate its substantial equivalence to the predicate device, SpringTMS (K182976), and a reference device, sTMS mini (K161663). The acceptance criteria were primarily focused on ensuring that the SAVI Dual maintained similar performance characteristics to the predicate device regarding its magnetic pulse output and safety standards, despite hardware and software modifications.

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

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

The document details non-clinical performance testing rather than testing on human subjects or clinical data sets for efficacy. Therefore, there is no stated sample size for a "test set" in the context of patient data. The "test set" in this context refers to the individual SAVI Dual™ devices or components that underwent the various non-clinical engineering and safety tests (e.g., magnetic pulse characteristics, software performance, EMC/electrical safety). The provenance of this data is from eNeura, Inc.'s internal testing facilities. The testing described is prospective, as it was performed on the proposed SAVI Dual device to support its regulatory submission.

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

This question is not applicable in the context of the provided document. The "ground truth" for non-clinical performance testing is established by engineering specifications, international consensus standards (e.g., IEC 60601 series), and direct comparison to the predicate device's measured performance. It does not involve human expert adjudication in the way clinical diagnostic studies do. The experts involved would be the engineers and technicians performing the tests and comparing the results to established physical and regulatory requirements.

4. Adjudication method for the test set

Not applicable. As described above, the "test set" refers to physical device characteristics and engineering performance, not interpretative medical decisions requiring adjudication by experts. Results are compared against specific quantitative thresholds and established standards.

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 SAVI Dual™ Migraine Therapy device is a hardware device (transcranial magnetic stimulator), not an AI-powered diagnostic or interpretive tool. The provided document does not describe any MRMC studies or AI assistance in the context of its use.

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

Not applicable. The SAVI Dual is a therapeutic device that stimulates the brain. Its performance is evaluated based on its physical output (magnetic field characteristics) and safety, not as a standalone algorithm delivering a diagnosis or prediction without human interaction. While it has software/firmware, its "performance" in this context is its ability to produce the intended physical magnetic pulse, which was tested.

7. The type of ground truth used

The "ground truth" for the non-clinical performance testing (magnetic pulse characteristics, software function, electrical safety) was based on:

• Established engineering specifications and design requirements for the device.
• Measured performance of the legally marketed predicate device (SpringTMS) for comparative equivalence in magnetic field characteristics.
• International consensus standards for medical device safety and electromagnetic compatibility (IEC 60601 series).

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a "training set" of data. Its development involved engineering design and testing, not machine learning.

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

Not applicable, as there is no "training set" for this type of device.

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The eNeura Inc. SpringTMS® is indicated for the acute and prophylactic treatment of migraine headache in adolescents (age 12 and older) and adults.

The SpringTMS® is a portable, hand-held device that is designed and intended to deliver a brief single pulse of magnetic energy at 0.9 Tesla to the back of the head to induce an electrical current in a portion of the brain called the occipital cortex to stop or lessen the effects of migraine headaches. Since a single pulse of magnetic stimulation is emitted, this method of stimulation is called single pulse transcranial magnetic stimulation or sTMS. The SpringTMS is indicated for the acute and prophylactic treatment of migraine headache. The device is designed for patient use where treatments are self-administered and can be delivered in a variety of settings including the home or office. The device is intended for prescription use only.

The provided text is a 510(k) summary for the eNeura SpringTMS device and solely focuses on demonstrating substantial equivalence to a previously cleared predicate device (K162797) for an expanded indication for use (adolescents aged 12 and older).

The key takeaway is that no new performance data or clinical studies were conducted for this specific 510(k) submission (K182976) because the subject device is technically identical to its predicate, and no changes in design or manufacturing that would affect functionality have been made. Therefore, the device relies on the performance data from the predicate device (K162797).

As such, the information requested in your prompt related to new acceptance criteria, device performance, sample sizes for test and training sets, ground truth establishment, expert adjudication, or MRMC studies for K182976 is not available in the provided document. The document explicitly states: "Thus, clinical testing was not conducted for this premarket notification, nor was required to support the safety and performance of the SpringTMS for the expanded Intended Use/Indications for Use population. Please refer to K162797 for further information regarding the prospective, single-arm, non-randomized Non-Significant Risk clinical study (ESPOUSE) conducted by eNeura using the SpringTMS device."

Therefore, I cannot populate the table or answer the specific questions based only on the provided text, as the document points to K162797 for details on the original study that established performance.

To answer your questions fully, the 510(k) summary for the predicate device, K162797, would need to be reviewed.

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The eNeura Inc. SpringTMS® is indicated for the acute and prophylactic treatment of migraine headache.

The SpringTMS® is a portable, hand-held device that is designed and intended to deliver a brief single pulse of magnetic energy at 0.9 Tesla to the back of the head to induce an electrical current in a portion of the brain called the occipital cortex to stop or lessen the effects of migraine headaches. Since a single pulse of magnetic stimulation is emitted, this method of stimulation is called single pulse transcranial magnetic stimulation or sTMS. The SpringTMS is indicated for the acute treatment and prevention of migraine headache. The device is designed for patient use where treatments are self-administered and can be delivered in a variety of settings including the home or office. The device is intended for prescription use only.

The provided text describes a 510(k) premarket notification for the eNeura Inc. SpringTMS® device. This device is a transcranial magnetic stimulator indicated for the acute and prophylactic treatment of migraine headaches.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

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

• Sample Size for Test Set:
  • Safety Data Set: 217 subjects (assigned Spring TMS devices).
  • Full-Analysis Data Set (FAS): 132 subjects (met protocol requirements based on headache day definition).
  • Completed Cases (CC): 117 subjects (finished treatment and completed baseline and Month 3 diaries).
  • Per Protocol (PP) Data Set: 95 subjects (complied with protocol instructions regarding device use).
• Data Provenance: The study was a prospective, multicenter, observational, clinical study. The country of origin is not explicitly stated in the provided text, but the applicant's address (Sunnyvale, CA, USA) suggests it was conducted in the USA.

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)

This is a clinical efficacy study for a medical device, not an image-based diagnostic AI. Therefore, there are no "experts" in the typical sense establishing a ground truth from images. The "ground truth" for migraine efficacy is based on patient-reported outcomes via headache diaries and questionnaires, confirmed through established criteria for migraine diagnosis and headache day definitions. The study design (observational, multi-center) implies clinical investigators were involved in patient enrollment and oversight, but their specific qualifications beyond being clinicians involved in migraine care are not detailed.

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

Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in image analysis where multiple readers interpret data. This is not applicable here as the primary "ground truth" for effectiveness is derived from patient self-reporting (headache diaries) and safety is assessed through adverse event reporting, which are intrinsically different from image interpretation. The study was a "prospective, non-randomized, single arm, multi-center observational study," indicating no external adjudication process for reconciling different expert interpretations.

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. This study evaluates a medical device (Transcranial Magnetic Stimulator) directly, not an AI assisting human readers in interpreting data. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not relevant to this device or study design.

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

This refers to a medical device, not an algorithm. The device, SpringTMS®, operates as a standalone therapy administered by the patient for the treatment of migraine. It does not involve an algorithm providing diagnoses or interpretations. The study evaluates the device's performance as a standalone treatment.

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

The ground truth for effectiveness was established primarily through outcomes data, specifically:

• Patient-reported headache diaries: Defining "headache days" as ≥4 hours of headache pain which at any time reaches moderate or severe intensity. This is the basis for the primary effectiveness endpoint (mean reduction in headache days).
• Patient-reported medication use: For the secondary effectiveness endpoint regarding reduction in medication use.
• Patient-reported questionnaires: Like the HIT6 impact questionnaire for another secondary effectiveness endpoint.
• Adverse event reporting: For the primary safety endpoint.

8. The sample size for the training set

This study is a clinical trial for a medical device, not a machine learning model. Therefore, there is no "training set" in the context of AI/ML. The provided sample sizes (217 for safety, 132-95 for effectiveness) represent the sizes of the cohorts included in the clinical trial itself.

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

As there is no training set for an AI/ML model, this question is not applicable. The device's "training" or development would have been based on established scientific principles of transcranial magnetic stimulation and previous research into its effect on migraine. The clinical study described here serves to validate the device's safety and effectiveness in a real-world patient population.

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The eNeura® sTMS mini is indicated for the acute treatment of pain associated with migraine headache with aura.

The sTMS mini is a portable, hand-held device that delivers a brief single pulse of magnetic energy at 0.9 Tesla to the back of the head to induce an electrical current in a portion of the brain, called the occipital cortex, to stop or lessen the effects of migraine headaches. Since a single pulse of magnetic stimulation is emitted, this method of stimulation is called single pulse transcranial magnetic stimulation or sTMS. The sTMS mini is indicated for the acute treatment of pain associated with migraine headache with aura. The device is designed for patient use where treatments are self-administered and can be delivered in a variety of settings including the home or office. The device is intended for prescription use only.

This document describes the 510(k) premarket notification for the eNeura® sTMS Mini, a transcranial magnetic stimulator for headache. The submission focuses on demonstrating substantial equivalence to a predicate device, SpringTMS® (K140094).

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state "acceptance criteria" in a quantitative manner for clinical efficacy. Instead, it focuses on demonstrating technological equivalence to a predicate device through non-clinical performance testing. The "results supporting substantial equivalence" serve as the de facto "reported device performance" against the implicitly accepted "criteria" of being equivalent to the predicate.

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

The document describes non-clinical performance testing (bench testing) and software verification/validation. It does not mention any clinical studies, test sets involving human subjects, or data provenance (country of origin, retrospective/prospective). The assessment is based on physical and software characteristics compared to the predicate device.

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

Since no clinical test set with human subjects is described, there is no mention of experts establishing ground truth. The "ground truth" for the non-clinical tests is based on established engineering specifications, safety standards (e.g., IEC 60601 series), and the characteristics of the predicate device.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical test set is described.

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

No, an MRMC comparative effectiveness study was not done or mentioned in this document. This submission focuses on technological equivalence, not clinical efficacy or comparative effectiveness with human readers.

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

This device is a physical medical device (Transcranial Magnetic Stimulator) and not an algorithm or AI system in the typical sense that would have "standalone performance" evaluated as an algorithm. Its performance is evaluated through physical and software testing.

7. The Type of Ground Truth Used:

For the non-clinical performance testing, the "ground truth" is based on:

• Engineering specifications for magnetic pulse characteristics (e.g., 0.9 Tesla Peak @ 180 µs, 4 mA/cm² induced at 1 cm).
• International standards for safety and electromagnetic compatibility (IEC 60601-1-1, IEC 60601-1-2).
• Software requirements specifications (SRS).
• Characteristics of the legally marketed predicate device (SpringTMS®), which serves as the benchmark for "substantial equivalence."

8. The Sample Size for the Training Set:

Not applicable. This document does not describe the development or testing of an AI algorithm or model that would require a "training set." The device is a hardware product with associated software.

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

Not applicable, as no training set for an AI algorithm is mentioned.

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The eNeura Therapeutics® Spring TMS® is indicated for the acute treatment of pain associated with migraine headache with aura.

The SpringTMS® is a portable, hand-held device that delivers a brief single pulse of magnetic energy at 0.9 Tesla to the back of the head to induce an electrical current in a portion of the brain called the occipital cortex to stop or lessen the effects of migraine headaches. Since a single pulse of magnetic stimulation is emitted, this method of stimulation is called single pulse transcranial magnetic stimulation or sTMS. The SpringTMS is indicated for the acute treatment of pain associated with migraine headache with aura. The device is designed for patient use where treatments are selfadministered and can be delivered in a variety of settings including the home or office. The device is intended for prescription use only.

The provided document is a 510(k) premarket notification for the SpringTMS device. It describes the device, its intended use, and argues for its substantial equivalence to a predicate device (Cerena™ Transcranial Magnetic Stimulator).

However, it does not contain acceptance criteria related to clinical performance (e.g., diagnostic accuracy, treatment efficacy percentages) for the device itself. Instead, the "acceptance criteria" discussed are primarily related to engineering, safety, and performance bench testing to demonstrate substantial equivalence to a previously approved device.

Therefore, the requested information components related to clinical studies, ground truth, expert adjudication, sample sizes for test/training sets, and MRMC studies are largely not present in the provided text.

Here's a breakdown of what can be extracted and what is missing based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not applicable as the testing described is primarily bench testing and software verification, not clinical performance testing on a patient sample. No "test set" of patient data is mentioned.
• Data Provenance: Not applicable. The testing is internal engineering and software verification.

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

• Number of Experts: Not applicable. No clinical "ground truth" or expert adjudication for performance criteria is described.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. No clinical test set requiring adjudication is described.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not conducted or described in this document. The submission focuses on substantial equivalence to a predicate device based on technological characteristics and bench testing, not on comparative clinical efficacy against human readers or other treatments.

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

• Standalone Performance: Not applicable. This is a medical device (Transcranial Magnetic Stimulator), not an AI algorithm. Its "performance" refers to its physical output (magnetic pulses) and safety characteristics, not an algorithmic assessment of data.

7. The Type of Ground Truth Used

• Type of Ground Truth: For the technical and safety testing (magnetic pulse characteristics, software requirements, electrical safety), the "ground truth" involved adherence to established engineering specifications and international standards (e.g., IEC 60601-1, IEC 60601-1-2) or demonstrating equivalence to the predicate device's measured characteristics.
• There is no clinical ground truth (e.g., pathology, outcomes data, expert consensus on patient response) discussed for the SpringTMS itself in this document, as the submission relies on the predicate's known efficacy.

8. The Sample Size for the Training Set

• Sample Size: Not applicable. This refers to training data for an algorithm. The SpringTMS is a hardware device for treatment, not an AI/algorithm that is "trained."

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

• Ground Truth Establishment: Not applicable for the same reasons as #8.

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The eNeura Therapeutics® Cerena™ Transcranial Magnetic Stimulator is indicated for the acute treatment of pain associated with migraine headache with aura.

The Neuralieve Cerena Transcranial Magnetic Stimulator (TMS) is a portable, hand-held, ACpowered device that delivers a brief pulse of magnetic energy at 0.9 Tesla to the back of the head to induce an electrical current in a portion of the brain (occipital cortex). This stimulation to the occipital cortex is intended to stop or lessen the effects of migraine headaches (with aura). The device is designed to be used in a home or office setting.

Here's a breakdown of the acceptance criteria and the study details for the Cerena Transcranial Magnetic Stimulator (TMS) device, as per the provided text:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Cerena TMS device are based on its demonstrated safety and effectiveness in treating migraine headache with aura.

The study successfully demonstrated the device's effectiveness in reducing migraine pain at 2 and 24 hours post-treatment compared to sham, and showed non-inferiority for photophobia. However, it did not demonstrate effectiveness in relieving nausea or phonophobia. Safety was also established with a low incidence of adverse events and no reported seizures.

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

• Test Set (Effectiveness Evaluation): 113 subjects
  • 53 subjects in the Cerena group
  • 60 subjects in the Sham group
• Data Provenance: The study was a prospective, randomized, double-blind, multi-center, sham-controlled trial. The country of origin is not explicitly stated, but it is a clinical trial conducted to support FDA de novo classification, implying it was likely conducted in the US or in compliance with US regulatory standards.

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

The ground truth for the clinical study was established by the subjects themselves, who reported their pain severity, associated migraine symptoms, and use of rescue medications at specified time points. Therefore, there were no external "experts" establishing ground truth in the traditional sense of image interpretation for this device. The diagnosis of migraine with aura was based on ICHD-II criteria, which would have been confirmed by medical professionals (physicians) at the study sites. The text does not specify the number or qualifications of these diagnosing physicians.

4. Adjudication Method for the Test Set

The study design was a prospective, randomized, double-blind, multi-center, sham-controlled trial. The "ground truth" (patient-reported outcomes) was self-reported by the subjects. There is no mention of an independent adjudication method (like 2+1 or 3+1 expert consensus) for the patient-reported efficacy endpoints. The double-blind nature (neither patient nor investigator knew treatment assignment) served as a control against bias.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic devices involving human interpretation of images or other data. The Cerena TMS device is a therapeutic device, and its effectiveness was evaluated through direct patient outcomes (pain relief), not through human reader performance.

6. Standalone Performance Done

Yes, a standalone (algorithm only without human-in-the-loop performance) evaluation was done for the device's therapeutic effect. The clinical trial directly assessed the device's ability to reduce pain when used by subjects, without the intervention of an interpreting human expert at the point of treatment.

7. Type of Ground Truth Used

The primary ground truth used for effectiveness was patient-reported outcomes for pain severity, assessed on a scale of 0-3 (0=no pain, 3=severe pain), and for the presence of associated symptoms (photophobia, phonophobia, nausea). The initial diagnosis of migraine with aura was based on the International Classification of Headache Disorders, 2nd edition (ICHD-II) criteria, which serve as a clinically established ground truth for the patient population.

8. Sample Size for the Training Set

The document does not explicitly mention a separate "training set" in the context of device effectiveness, as would be common for AI/ML algorithms. The clinical trial of 201 subjects (102 Cerena, 99 sham) was the primary study for demonstrating safety and effectiveness. If "training set" refers to data used to inform the device's design or initial parameters, that information is not provided. For software, general verification, validation, and hazard analysis were performed, but not specifically in the context of an AI/ML training paradigm.

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

As noted above, a distinct "training set" with established ground truth for an AI/ML algorithm is not described in this regulatory submission. The device's "training" in a broader sense would be its design, engineering, and iterative development process, informed by scientific understanding of TMS and migraine, rather than a data-driven machine learning training set with ground truth labels.

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