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

The Transcutaneous Electrical Applicator (TEA) is a transcutaneous electrical nerve field stimulator system intended to be used in adult patients with functional abdominal pain associated with irritable bowel syndrome (IBS) through application to Cranial Nerves V, VI, IX and X, and the occipital nerves, as an aid in the reduction of pain when combined with other therapies for IBS. TEA device is intended to be used for 7-120 hours per week up to 3 consecutive weeks.

The TEA Device is a non-invasive, battery-operated, prescription-based transcutaneous electrical nerve field stimulator indicated for use in adult patients with functional abdominal pain associated with the irritable bowel syndrome (IBS). The system includes the following components: TEA Device, lead cable, USB charging cable, USB power adapter, electrode pads, holding clip, and TEA IBS app. The device can be used in clinical environments (i.e., outpatient clinics and hospitals) and/or at home. The TEA Device is powered by an internal rechargeable lithium polymer battery and uses a microprocessor to control the working modes, the waveform and strength of the output pulse. The electric pulse generator is based on a current source circuit. The power management module contains a DC-DC boost conversion circuit that provides the required voltage for the electric pulse generator. The TEA Device is able to connect with the TEA IBS app, which is located on a smartphone. The user interface is available on both the TEA Device and TEA IBS app. The user can power on/off the device, adjust treatment time and treatment intensity. Treatment time is adjustable within the of range 5~240 minutes per treatment session with a maximal operating time of 8.6 hours per day. In addition, there is over-load, over-current and no-load protection as well as an automatic shut-off function. The Bluetooth transceiver module is responsible for communication between the TEA Device and TEA IBS app located on a smartphone.

The provided document describes the Transtimulation Research Inc.'s Transcutaneous Electrical Applicator (TEA) Device (Model: SNM-FDC01) and its substantial equivalence to a predicate device, the IB-Stim.

The acceptance criteria are derived from the special controls for devices under 21 CFR 876.5340, as well as general performance requirements for medical devices. The study provided focuses on the clinical effectiveness of the device.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Ask a specific question about this device

The First Relief v1 is a percutaneous electrical nerve field stimulator (PENFS) system intended to be used in patients 11-18 years of age with functional abdominal pain associated with irritable bowel syndrome (IBS). The First Relief v1 is intended to be used for 120 hours per week up to 3 consecutive weeks, through application to Cranial Nerves V, VII, IX and X, and the occipital nerves identified by trans-illumination, as an aid in the reduction of pain when with other therapies for IBS.

The First Relief v1 is designed to aid in the reduction of pain when combined with other therapies of IBS in patients 11 - 18 years of age with Functional Pain associated with the Irritable bowel syndrome (IBS) by the method of Cranial electrical stimulation at the auricular stimulation points. The First Relief v1 is a wearable, battery-operated device that is designed to administer Periodical low level electrical pulses to the ear over Five days / 120 hours from the time of activation of the device.

The electrical pulse from the device will be delivered to the branches of Cranial Nerves (V, VII, IX and X) on the ear through a set of wire assembly and Stimulation needles. Three zinc air batteries with 1.4 V each provides the required stimulation energy for a maximum of 120 hours. There are three Stimulation electrodes and one ground electrode - which constitute of a needle and lead/ wire with the snap-fit ring. The stimulation needles are inserted at three specific points, which have the ability to stimulate the cranial nerves. The ground electrode is inserted at one specific point (constant in all treatments) which forms the functional earthing to the device.

This constant current source guarantees equivalent stimulation energy regardless of the individual impedance of the skin.

The stimulation pattern consists of Rectangular pulses with differing inter-pulse intervals.

This FDA 510(k) summary for the "First Relief v1" device does not contain a study that establishes acceptance criteria and then proves the device meets those criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device ("IB-Stim", DEN180057) through non-clinical testing and comparison of technical characteristics.

Here's a breakdown of the information that is and is not available in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not present a formal table of acceptance criteria derived from a clinical trial or performance study, nor does it report specific device performance metrics against such criteria. The comparison table provided (pages 4-5) details the technical characteristics of the applicant's device (First Relief v1), their own previous device (Drug Relief), and the predicate device (IB-Stim). It highlights similarities and minor differences in design and specifications, not performance outcomes against predefined acceptance criteria.

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

• Sample size: Not applicable, as no clinical test set for performance against acceptance criteria is described. The document mentions "non-clinical testing" and "bench tests" but does not specify sample sizes for these.
• Data provenance: Not applicable for a clinical test set. The data presented are technical specifications and test results from non-clinical (bench) testing.

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

Not applicable, as no clinical test set with human-established ground truth is described.

4. Adjudication method for the test set:

Not applicable, as no clinical test set requiring adjudication is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size:

No MRMC comparative effectiveness study is mentioned. The document focuses on demonstrating physical and technical equivalence to a predicate device.

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

Not applicable. The "First Relief v1" is a physical medical device (percutaneous electrical nerve field stimulator), not an algorithm or software requiring standalone performance evaluation in the context of AI.

7. The type of ground truth used:

Not applicable, as there is no clinical study that would require a ground truth determination for diagnostic or treatment outcomes. The "ground truth" in this context refers to engineering specifications and performance benchmarks established during non-clinical testing (e.g., electrical output measurements).

8. The sample size for the training set:

Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

Not applicable.

Summary of what is presented in the document instead:

The document demonstrates substantial equivalence to the predicate device (IB-Stim) based on:

• Intended Use: Nearly identical.
• Technological Characteristics: Very similar, with minor differences outlined in the table (e.g., product dimensions, weight, battery type/capacity, wire assembly type, sterilization method, shelf life).
• Non-Clinical Performance Testing: "The First Relief v1 has equivalent Performance specifications when compared to the predicate device." This includes functional testing for 120 hours to monitor continuous performance, capturing pulse width, pulse duration, amplitude, and current values.
• Compliance with Standards: The device complies with a list of IEC and ISO standards related to electrical safety, EMC, biocompatibility, and sterilization.
• Sterilization Testing: Detailed information on EtO sterilization validation for the needle package.
• Biocompatibility Testing: Performed per ISO 10993.

The key statement regarding performance is: "The First Relief v1 has equivalent Performance specifications when compared to the predicate device." This is a qualitative statement based on non-clinical (bench) testing, rather than a quantitative comparison against specific acceptance criteria from a clinical study. The FDA's clearance is based on the argument that these similarities and non-clinical test results demonstrate that the new device is as safe and effective as the predicate.

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 11-18 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 up to 3 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.

The IB-Stim is a device that delivers electrical stimulation through percutaneous electrodes to areas usually innervated by branches of occipital nerves and cranial nerves V, VII, IX and X that are located by transillumination. The device consists of (1) a percutaneous electrical nerve field stimulator (PENFS), (2) a multi-pin wire harness percutaneous electrode array, and (3) a pen light for use in the transillumination technique that aids in positioning of the percutaneous electrodes (Figure 1).

The wire harness percutaneous electrode array consists of 4 leads. The 1-1-1-4 configuration consists of three single-needle leads, and one 4-needle array (Figure 2).

The stimulator is placed behind the ear and the percutaneous electrodes are positioned utilizing the transillumination function of the device (Figure 1). The transillumination technique assists in the visualization of the vasculature of the ear to aid in the placement of the percutaneous electrodes near the nerve branches in the ear.

The provided text describes the regulatory evaluation of the IB-Stim device, a non-implanted nerve stimulator for functional abdominal pain relief associated with Irritable Bowel Syndrome (IBS) in adolescents. The document outlines the studies conducted to establish the device's safety and effectiveness.

It is important to note that the IB-Stim is a medical device performing nerve stimulation, not an AI/ML powered device. Therefore, typical acceptance criteria and study designs for AI/ML devices (e.g., mMRMC studies, stand-alone algorithm performance, ground truth establishment through expert consensus or pathology for image classification, separate training and test sets the way an AI/ML device would need them, etc.) are NOT directly applicable to this device.

The "acceptance criteria" for the IB-Stim are essentially the demonstration of safety and clinical effectiveness as outlined by the FDA's De Novo classification process, largely evidenced through a randomized, double-blind, sham-controlled clinical trial and various non-clinical tests.

Here's an attempt to structure the information according to your request, adapting the concepts to fit a medical device rather than an AI/ML system:

Acceptance Criteria and Device Performance for IB-Stim

The acceptance criteria for the IB-Stim device are based on demonstrating its safety and effectiveness for its intended use, as required by FDA for a De Novo classification. This is primarily achieved through non-clinical testing and a pivotal clinical trial.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Clinical Trial Test Set Sample Size:
  • Total randomized: 115 subjects (60 active treatment, 55 sham treatment).
  • Completed the trial (primary analysis cohort): 104 subjects (57 active, 47 sham).
  • IBS Subgroup Analysis (post-hoc, for final indication): 51 subjects met Rome III criteria for IBS at baseline. 50 of these completed the study (27 active IB-Stim, 23 sham). This IBS subgroup formed the basis for the specific indication granted.
• Data Provenance: The study was a randomized, double-blind, sham-controlled clinical trial. It is stated to be published in Lancet Gastroenterol Hepatol in 2017, suggesting it was a prospective clinical trial. The location of the clinical trial (country of origin) is not explicitly stated in the provided text, but the authors listed (K. Kovacic, etc.) typically indicate US-based research centers.

3. Number of Experts and Qualifications for Ground Truth

• The "ground truth" in this context refers to the patient-reported outcomes of pain and symptom scores (e.g., worst pain, PFSD, SRS). These are direct measures from the participants themselves, not interpretations by experts.
• The diagnosis of functional abdominal pain, including IBS, was based on established clinical criteria (Rome III criteria for IBS) by the clinicians conducting the study. The number or specific qualifications of these clinicians are not detailed as "experts establishing ground truth" in the way it would be for, e.g., image annotation.

4. Adjudication Method for the Test Set

• Adjudication methods (e.g., 2+1, 3+1) are typically used for establishing ground truth in AI/ML model training or evaluation where human reviewers provide labels or assessments that need to be reconciled.
• This was a clinical trial with patient-reported outcomes. While there would be standard operating procedures for data collection and monitoring, there was no "adjudication" in the sense of reconciling disagreeing expert labels. The "ground truth" was the direct patient report and clinical diagnosis.

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

• An MRMC study evaluates the performance of multiple human readers on multiple cases, often comparing performance with and without AI assistance.
• No MRMC study was performed as this is a medical device for direct patient treatment, not an AI-based diagnostic tool that assists human readers in interpreting data or images. The study design was a standard randomized controlled trial comparing the device to a sham control.

6. Standalone (Algorithm Only) Performance

• "Standalone performance" refers to the performance of an algorithm without human-in-the-loop.
• Not applicable to this device. The IB-Stim is a physical medical device that delivers electrical stimulation to a patient. Its functionality is inherently tied to its application to a patient's body under clinical guidance. There is no "algorithm only" component that could be evaluated for standalone performance.

7. Type of Ground Truth Used

• The primary ground truth for effectiveness was patient-reported outcome data (pain scores, symptom improvement) collected during the clinical trial.
• The patient cohort was defined by clinical diagnostic criteria (Rome III for IBS) established by medical professionals.

8. Sample Size for the Training Set

• Not applicable in the context of AI/ML. The IB-Stim design and functionality are based on medical principles and prior devices, not on machine learning from a "training set." The clinical trial data (the "test set" in your original framework) was used to demonstrate safety and effectiveness for regulatory approval.

9. How Ground Truth for Training Set was Established

• Not applicable as there is no "training set" for an AI/ML model. The device's design and parameters (e.g., electrical characteristics, duty cycle) were based on existing medical understanding of nerve stimulation and were verified through bench testing. The clinical trial then assessed the device's efficacy in a target patient population.

Ask a specific question about this device