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The First Relief is a percutaneous electrical nerve stimulator (PENS) system indicated for multiple treatments up to 56 days for symptomatic relief of chronic, intractable pain from diabetic peripheral neuropathy.

The First Relief is designed to aid in the treatment of chronic pain symptoms by the method of cranial electrical stimulation at the auricular stimulation points. The First Relief is a wearable, battery-operated device that is designed to administer periodical low level electrical pulses to the ear over seven days / 168 hours from the time of activation of the device.

The electrical pulse from the device will be delivered to the branches of cranial Nerves on the ear through a set of wire assembly and stimulation needles. Three zinc air batteries with 1.4 V each provide the required stimulation energy for 168 hours. There stimulation electrode 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.

Here's an analysis of the provided text to extract the requested information about the device's acceptance criteria and the study proving it:

The provided 510(k) Summary for the "First Relief" device (K212859) describes a clinical study to support its substantial equivalence to a predicate device. However, it does not present specific quantitative acceptance criteria or reported device performance in a direct comparison table as requested. Instead, it discusses the outcomes of the clinical study, focusing on statistical significance of pain and other related scores, and states that these "demonstrated the safety of the therapy" and "showed similar improvements."

There is no mention of a "test set" and its specific characteristics (sample size, data provenance), "ground truth" establishment, "adjudication method," or "MRMC comparative effectiveness study" in the context of specific quantitative metrics for acceptance. The study is a comparative clinical trial, not an AI or imaging-based device study that would typically involve those details.

Based on the provided text, I will present the information that is available and clearly state what is not available as per your request.

1. Table of acceptance criteria and the reported device performance:

As mentioned, the document does not explicitly state quantitative acceptance criteria (e.g., "VAS score reduction of X points is acceptable") or a direct comparison table of these criteria against reported device performance, which is common for algorithm-based devices. Instead, it describes the results of a clinical trial designed to show improvement. Therefore, the "reported device performance" below reflects the observed clinical outcomes rather than directly matching pre-defined acceptance criteria.

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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.

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