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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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