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510(k) Data Aggregation
(122 days)
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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(265 days)
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Primary Effectiveness Endpoint: Mean reduction in headache days over a 28-day period at 12±1 weeks. | FAS: Mean reduction of 2.8 days (from a baseline mean of 9.1 days). Statistically significant (P<0.0001). |
| Performance Goal (PGMD) for Primary Effectiveness Endpoint: ≥ -0.633 days reduction in migraine headache days. (H0: μT ≥ PGD versus Ha: μT < PGD) | The observed mean reduction of 2.8 days is well below -0.633 days, thus rejecting the null hypothesis and demonstrating a significant reduction. |
| Primary Safety Endpoint: The proportion of patients experiencing any adverse event in aggregate and by event. | Approximately 29% (62/217) of subjects in the Safety Dataset reported at least one adverse event. No serious adverse events were determined. Common AEs (reported >2%) included headache (2.30%), scalp discomfort (2.30%), tingling (3.23%), lightheadedness (3.69%), discomfort from noise (2.30%), dizziness (2.77%), ringing in ears (3.23%), and worsened headache pain (2.30%). |
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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(127 days)
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
| Testing Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Performance Bench Testing | ||
| Magnetic Pulse Characteristics vs. Time | Within specification for magnetic pulse shape (identical to predicate) | "Both devices have the same specification for magnetic pulse shape and both tested within specification. No new issues of safety or efficacy have been raised. The measured rate of change of the magnetic field is substantially equivalent." |
| Magnetic Pulse Field Map | Substantially equivalent to predicate device's field map, raising no new safety/efficacy issues. | "No new issues of safety or efficacy have been raised. The Magnetic Pulse Field Maps for the SpringTMS and the predicate device are substantially equivalent." |
| Location of 5 Gauss Line | Substantially equivalent to predicate device's location of the 5 Gauss line, raising no new safety/efficacy issues. | "No new issues of safety or efficacy have been raised. The location of the 5 Gauss line for the SpringTMS and the predicate are substantially equivalent." |
| Software Verification Validation Testing | Meeting all requirements of the Software Requirements Specification (SRS), with safety/performance specifications substantially equivalent to predicate's SRS. | "SpringTMS Software met all requirements of the SRS. No new issues of safety or efficacy have been raised. All safety and performance specifications for the SpringTMS SRS are substantially equivalent to those in the SRS for the predicate." |
| Electromagnetic Compatibility & Electrical Safety | Meeting acceptance criteria of specified standards (IEC 60601-1:2005, IEC 60601-1-2:2007), raising no new safety/efficacy issues. | "The SpringTMS and the predicate device met all acceptance criteria. No new issues of safety or efficacy have been raised. Therefore the SpringTMS is substantially equivalent to the predicate." |
| Clinical Performance (e.g., treatment efficacy) | Not specified in this document. The document states the device has the "identical" indication for use as the predicate, meaning its clinical effectiveness is assumed to be equivalent based on the predicate's prior approval. | No new clinical performance data is presented in this document to establish efficacy percentages or outcomes for the SpringTMS. It relies on the substantial equivalence to the predicate device, which was presumably justified by its own clinical data at the time of its approval (K130556). |
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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