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The IB-Stim is a percutaneous electrical nerve field stimulator (PENFS) system intended to be used in patients 8-21 years of age with functional abdominal pain associated with irritable bowel syndrome (IBS) and functional dyspepsia (FD). The IB-Stim is intended to be used for 120 hours per week, using 1 device per week for 4 consecutive weeks, through application to branches of Cranial Nerves V, VII, IX and X, and the occipital nerves identified by transillumination, as an aid in the reduction of pain when combined with other therapies for IBS and FD. FD patients for whom IB-Stim is indicated have also been shown to experience reduction of nausea symptoms.

IB-Stim stimulator is a battery-operated micro-stimulation appliance weighing 5 grams designed as a disposable product for a single use. IB-Stim stimulator is placed behind the patient's ear and connected to stimulation needles on the auricle. IB-Stim stimulator offers regular therapy over several days. The appliance transmits low-frequency electric pulses.

IB-Stim is a device system that consists of a (1) percutaneous electrical nerve field stimulator (PENFS); (2) sterile multi-pin wire harness array; (3) round bandages to fasten the appliance leads, stimulator skin adhesive, alcohol swab, transparent dressing, biohazard bag, and Patient ID card; (4) tweezers; (5) surgical marker; and (6) transilluminator for use in transillumination technique that aids in needle implantation. The wire harness array consists of 4 leads. The 1-1-1-4 configuration consists of three single-needle leads, and one 4-needle array. The transilluminator emits a light for use in the trans-illumination technique to aid the clinician in identifying the nerve bundles in the ear.

This document is a 510(k) clearance letter for the NeurAxis IB-Stim device. It does not contain the detailed acceptance criteria or the study protocol and results that would prove the device meets specific performance metrics typically associated with AI/ML-driven medical devices. Instead, it focuses on substantial equivalence to a predicate device and provides a brief summary of a clinical study supporting an expanded indication for use.

Therefore, many of the requested items (e.g., acceptance criteria table, sample size for test set with provenance, number and qualifications of experts, adjudication method, MRMC study, standalone performance, training set details) are not present in this document.

However, I can extract information related to the device, its intended use, and the summarized clinical evidence presented for the expanded indication.

Here's what can be extracted from the provided text, addressing the questions where possible and noting when information is unavailable:

Device: NeurAxis IB-Stim
Classification: Class II
Regulation: 21 CFR 876.5340 - Nonimplanted Nerve Stimulator for Functional Abdominal Pain Relief
Product Code: QHH
Predicate Device: NeurAxis, Inc. IB-Stim (K241533)
Indication for Use (Expanded): The IB-Stim is a percutaneous electrical nerve field stimulator (PENFS) system intended to be used in patients 8-21 years of age with functional abdominal pain associated with irritable bowel syndrome (IBS) and functional dyspepsia (FD). The IB-Stim is intended to be used for 120 hours per week, using 1 device per week for 4 consecutive weeks, through application to branches of Cranial Nerves V, VII, IX and X, and the occipital nerves identified by transillumination, as an aid in the reduction of pain when combined with other therapies for IBS and FD. FD patients for whom IB-Stim is indicated have also been shown to experience reduction of nausea symptoms.
Reason for new 510(k): Expansion of the indication to include functional dyspepsia (FD).

Acceptance Criteria and Device Performance

The concept of "acceptance criteria" and "reported device performance" as typically applied to AI/ML software (e.g., in terms of metrics like sensitivity, specificity, AUC) is not directly applicable to this 510(k) summary. This device is a hardware stimulator. The "performance" assessment here is about clinical effectiveness for a new indication, not an algorithmic output.

The information primarily addresses clinical efficacy for the expanded indication of Functional Dyspepsia (FD).

Study Details (for Expanded FD Indication)

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

   • Test Set Sample Size: 23 subjects who met Rome III criteria for FD. This was a subgroup analysis.
   • Data Provenance: Extracted from a prospective study that enrolled 115 adolescents with pain-associated DGBIs. The origin of the broader study (e.g., country) is not specified in this document. The study design was prospective, but the analysis for this specific submission was a post-hoc analysis of a subgroup.

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

   • This is not applicable in the context of this device. The "ground truth" here is the patient's self-reported pain and nausea, assessed relative to a baseline, within a clinical trial setting. There's no image interpretation or diagnostic performance that would require expert consensus for ground truth.

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

   • Not applicable. This study is a clinical efficacy trial comparing a device to a sham, with patient-reported outcomes. Adjudication methods like 2+1 are typically for diagnostic assessments (e.g., image reading).
   • The study involved a sham control arm, which serves as a method to control for placebo effect and natural history of the condition.

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:

   • Not applicable. This is not an AI/ML diagnostic device that assists human readers. It is a therapeutic nerve stimulator.

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

   • Not applicable. This is a physical medical device, not a standalone algorithm.

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

   • Outcomes Data: Patient-reported abdominal pain reduction (at least 30%) and qualitative reduction in nausea symptoms. Patients met Rome III criteria for FD at enrollment.

7. The sample size for the training set:

   • Not applicable. This device is hardware; it does not involve AI/ML training on a dataset. The term "training set" would not apply in this context. The study described is a clinical efficacy validation for an expanded indication.

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

   • Not applicable (as above).

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