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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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1. The Trevo Retriever is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion, and smaller core infarcts who have first received intravenous tissue plasminogen activator (IV t-PA). Endovascular therapy with the device should start within 6 hours of symptom onset.
2. The Trevo Retriever is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
3. The Trevo Retriever is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion of the internal carotid artely (ICA) or middle cerebral artely (MCA)-Ml segments with smaller core infarcts (0-50 cc for age < 80 years, 0-20 cc for age ≥ 80 years). Endovascular therapy with the device should start within 6-24 hours of time last seen well in patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy.

The Trevo Retriever consists of a flexible, tapered core wire with a shaped section at the distal end. Platinum markers at the distal end allow fluoroscopic visualization. In addition, the shaped section is also radiopaque. Retriever dimensions are indicated on product label. The Retriever delivery wire has a hydrophilic coating on the distal 101cm length to reduce friction during use. The Retriever has a shaft marker to indicate proximity of Retriever tip relative to Microcatheter tip. A Torque Device is provided with the Retriever to facilitate manipulation and retrieval. The Retriever comes preloaded in an insertion tool to introduce the Retriever into a Microcatheter.

The provided document is a 510(k) summary for the Trevo NXT ProVue Retriever, a neurovascular mechanical thrombectomy device. It describes the device, its intended use, and a comparison to predicate devices, primarily focusing on non-clinical performance and biocompatibility data to establish substantial equivalence.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and the Reported Device Performance:

The document provides a table of various performance tests, their methods, and conclusions. The acceptance criteria themselves are explicitly stated for biocompatibility tests, but for performance tests, the conclusion is generally "meets acceptance criteria," implying that specific thresholds were defined internally and met.

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: Not explicitly mentioned for each specific performance test. The design validation states "All Users observed that the Trevo NXT ProVue Retrievers successfully met all the design attribute evaluations...". For biocompatibility, standard ISO tests were performed, which usually involve specific numbers of samples or animals as per the standard.
• Data Provenance: The studies are non-clinical (bench testing and in vitro simulated-use studies) and biocompatibility tests. They are not clinical studies involving human patient data, so concepts like country of origin or retrospective/prospective are not applicable in this context. The simulated-use studies were conducted internally for device verification and validation.

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

• Number of Experts: Not explicitly stated. The design validation study mentions "Users evaluated the device in a simulated use tortuous anatomical model". It doesn't specify if these "Users" are experts in establishing ground truth, nor their number or qualifications as one would typically see in a clinical study where expert consensus might establish ground truth for a diagnostic device. In this context of a mechanical device, performance is evaluated against defined physical and functional criteria rather than expert interpretation.

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

• Not applicable as this is a device performance study focusing on physical and functional attributes, not a study requiring adjudication of clinical outcomes or 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:

• Not applicable. This is a non-clinical evaluation of a mechanical thrombectomy device, not an AI-assisted diagnostic or decision support system.

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

• Not applicable. This is a mechanical device, not an algorithm.

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

• For performance testing, the "ground truth" (or reference standard) is based on defined engineering specifications, industry standards (e.g., ISO, ASTM), and predetermined functional requirements. For example, a successful test means the device's dimension falls within a specified range, or it withstands a certain force, or it shows no damage after simulated use.
• For biocompatibility testing, the ground truth is established by the criteria outlined in recognized international standards (ISO 10993-x), which define acceptable biological responses (e.g., hemolysis ≤ 5%, not a sensitizer).

8. The sample size for the training set:

• Not applicable. This is a non-clinical evaluation of a mechanical thrombectomy device, not a machine learning model that requires a training set.

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

• Not applicable.

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The AXS Vecta Aspiration Catheter, as part of the AXS Vecta Aspiration System, is indicated in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - MI and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who failed IV t-PA therapy are candidates for treatment.

The Stryker AXS Vecta Aspiration System includes an aspiration catheter and its accessories, including the Scout Introducer, the Peel-Away Introducers, the Hemostasis Valve, the AXS Universal Aspiration Tubing, the Medela Dominant Flex Pump, and the AXS Universal Liner Set.

The acceptance criteria and study proving the device meets them are described in the provided text.

Here's the breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document repeatedly refers to "test samples" for each test. However, the exact number of samples used for "Simulated Use - Bench," "Simulated Use – Usability," "Vacuum Drop / Suction Connector Secure Attachment," and "Lumen Patency" tests is not explicitly stated.
• Data Provenance: The tests are described as "benchtop model" tests and "Animal testing previously conducted for the Zenith Flex System was used to support this change." This indicates:
  • Bench Tests: Performed in a laboratory setting.
  • Animal Testing: The previous animal testing for the predicate device (Zenith Flex System) was retrospectively leveraged. The original context of this animal testing (country of origin, etc.) is not detailed in this document.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• For "Simulated Use - Bench" and "Simulated Use – Usability," the testing was conducted "by a physician." The document specifies "a physician" (singular).
• Qualifications of the physician: Not explicitly stated beyond "physician."

4. Adjudication Method for the Test Set

• The document does not describe a specific adjudication method (e.g., 2+1, 3+1). The "Simulated Use" tests were conducted "by a physician," and the "test samples must meet predetermined user needs." It implies a direct assessment by the physician against predefined criteria rather than an adjudication process involving multiple reviewers of outcomes.

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

• No MRMC study was done. The document explicitly states: "No clinical study was conducted as bench and animal testing was determined sufficient for verification and validation purposes."

6. Standalone (Algorithm Only) Performance Study

• Not applicable. This device is a medical aspiration system, not an AI algorithm. Therefore, a standalone (algorithm only) performance study would not be relevant.

7. Type of Ground Truth Used

• Expert Assessment/Predicate Device Performance:
  • For the "Simulated Use" tests, the ground truth was effectively whether the "test samples met predetermined user needs" as assessed by a physician.
  • For the engineering tests (Vacuum Drop, Lumen Patency, Calculated Force at Tip), the ground truth was based on meeting "existing pressure specifications" or "existing lumen patency specifications," which are predefined technical performance standards, and comparison to the performance of the predicate device.
  • For the animal testing (leveraged from the predicate), the ground truth would have been safety and efficacy outcomes observed in the animal model.

8. Sample Size for the Training Set

• Not applicable. This device is a physical medical device, not an AI algorithm. Therefore, there is no "training set."

9. How the Ground Truth for the Training Set Was Established

• Not applicable. As above, there is no training set for this type of device.

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