Search Results

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).

Ask a specific question about this device

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). 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.

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 technician in identifying the nerve bundles in the ear.

The provided FDA 510(k) document for the NeurAxis IB-Stim (01-1020) does not contain detailed information regarding acceptance criteria or a specific study proving the device meets those criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device (NeurAxis, Inc. IB-Stim – DEN180057) to justify its market clearance.

The document explicitly states: "There are no changes to the device design. Therefore, previously conducted testing in DEN180057 remains applicable and no additional performance testing is required." This indicates that the 510(k) relies on the performance data and acceptance criteria established for the predicate device.

However, the document does mention updates to the "intended treatment population" and "treatment duration" with clinical literature supporting these changes. This implies that while no new performance testing was required for the device itself, the justification for these expanded indications likely involved a review of existing clinical evidence.

Given the information provided, it's not possible to populate all the requested sections. Here's what can be inferred or stated as not provided:

1. Table of Acceptance Criteria and 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)

The document for K241533 does not describe a new test set or its provenance for device performance. It refers to "clinical literature" for supporting expanded indications. This literature would represent a collection of studies, each with its own sample size and provenance, but these details are not aggregated or provided here.

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

Not applicable, as no new test set is described for K241533. For the predicate device, or within the supporting clinical literature, this information would have been specific to each study, but it is not provided in this 510(k) summary.

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

Not applicable, as no new test set is described for K241533.

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 NeurAxis IB-Stim is a nerve stimulator, not an AI-assisted diagnostic device. Therefore, MRMC studies related to human reader improvement with AI are not relevant to this device.

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

Not applicable. The NeurAxis IB-Stim is a medical device, not a standalone software algorithm.

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

For the expanded indications (age range, treatment duration), the document states that "Real world evidence including clinical literature support these changes" and "Recommendation from the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN) based on clinical literature and current practice of medicine support the 4-week treatment. In addition, clinical literature supports safe and effective use of the IB-Stim device in children as young as 8 years old." This implies that the 'ground truth' for validating the expanded indications relies on clinical outcomes data and expert consensus/recommendations derived from existing clinical literature.

8. The sample size for the training set

Not applicable, as this device is not an AI/machine learning device that requires a training set.

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

Not applicable, as this device is not an AI/machine learning device that requires a training set.

Ask a specific question about this device