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The Esperance 3+ Aspiration Catheter with the Wallaby Aspiration Tubing set and a compatible aspiration pump is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within internal carotid, middle cerebral – M1 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 fail IV t-PA therapy are candidates for treatment.

The Esperance® 3+ Aspiration Catheter is a single-use, vascular catheter consisting of a single lumen, variable stiffness, composite catheter. The device has a tapered shaft with tapered inner diameter (ID) from 0.054'' (proximal) to 0.041'' (distal) and tapered outer diameter (OD) from 0.066'' (proximal) to 0.050'' (distal). It has five different working lengths: 120 cm, 133 cm, 145 cm, 153 cm, and 160 cm. The device is supplied as a kit with the Wallaby Aspiration Tubing Set provided with a single catheter. The distal tip of each catheter is visible under fluoroscopy and the distal shaft of each catheter is designed with an external hydrophilic coating to reduce friction during use. The proximal end of each catheter incorporates a strain relief and a standard luer adapter to facilitate the attachment of accessories. Each catheter has a semi-rigid proximal shaft which transitions into a flexible distal shaft to facilitate the advancement of the catheter in tortuous anatomy.

The Esperance 3+ Aspiration Catheter System is a non-active, surgically invasive device intended for short term use within the neurovasculature.

The document provided is a 510(k) premarket notification decision letter from the FDA for a medical device called the "Esperance 3+ Aspiration Catheter System." It primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data (bench testing and biocompatibility).

Based on the provided text, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

The document lists various performance tests and their outcomes, all indicating that the device met the acceptance criteria. The specific numerical acceptance criteria themselves are not detailed in this public FDA letter, but the conclusion for each test is consistently "All samples met the acceptance criteria" or similar.

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 dedicates a section to "PERFORMANCE TESTING - BENCH" and concludes most tests with "All samples met the acceptance criteria." However, it does not specify the sample size used for each of these non-clinical tests.

The data provenance is through non-clinical bench testing performed by the manufacturer, Wallaby Medical. There's no information about the country of origin of the data within the document, beyond the sterilization facility being in "Suzhou) Ltd., Jiangsu, China." The nature of the tests (bench testing, biocompatibility, sterilization, shelf life) indicates these are prospective tests performed specifically for this submission, rather than retrospective analysis of existing data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This section is not applicable as the document describes non-clinical bench performance testing, not a clinical study involving human or image-based data that would require expert ground truth labeling. The "ground truth" for these tests is based on objective measurements and established engineering standards (e.g., ISO, ASTM).

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

This is not applicable as the document describes non-clinical bench performance testing where adjudication methods typical for clinical or image-based studies are not relevant.

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

No MRMC comparative effectiveness study was done or reported. The device is a medical catheter and not an AI/imaging algorithm that would typically involve human readers.

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

This is not applicable. The device is a physical medical catheter, not an algorithm.

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

For the non-clinical tests described, the "ground truth" is based on:

• Engineering specifications and standards: Adherence to ISO standards (e.g., ISO 10993 for biocompatibility, ISO 11135 for sterilization, ISO 10555-1 and 80369 for bench tests) and relevant FDA guidance documents.
• Objective measurements: Dimensional verification, force measurements, flow rates, visual inspections for defects, etc.
• Comparison to predicate/reference device: Many tests involved comparing the subject device's performance (e.g., navigability, clot removal, lubricity, particulate generation) to the predicate or reference device to establish similarity and ensure similar safety and effectiveness profiles.

8. The sample size for the training set

This is not applicable. The document describes the testing of a physical medical device, not an AI or machine learning model that would require a training set.

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

This is not applicable for the same reason as point 8.

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The Esperance Distal Access Catheter is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.

The Esperance® Distal Access Catheter is a single-use, single lumen, variable stiffness, composite catheter. The device includes 5F and 6F catheters with inner diameters of 0.055" and 0.071", respectively, designed with three different working lengths for both sizes: 115 cm, and 131 cm. The device is supplied with a peelable introducer and shaping mandrel. The distal tip of each catheter is visible under fluoroscopy and the distal shaft of each catheter is designed with an external hydrophilic coating to reduce friction during use. The proximal end of each catheter incorporates a strain relief and a standard Luer adapter to facilitate the attachment of accessories. Each catheter has a semi-rigid proximal shaft which transitions into a flexible distal shaft to facilitate the advancement of the catheter in tortuous anatomy.

The Esperance® Distal Access Catheter is a non-active, surgically invasive device intended for short term use within the vasculature.

The provided document is a 510(k) Substantial Equivalence Determination letter from the FDA for a medical device called the "Esperance Distal Access Catheter." It details non-clinical performance testing but does not include information about a study proving device performance against acceptance criteria in the context of an AI/ML-driven device or human-in-the-loop performance.

Specifically, the document states:

• "Animal data were not deemed necessary as substantial equivalence was established based upon successful completion of non-clinical bench testing."
• "A clinical study was not deemed necessary as substantial equivalence was established based upon successful completion of non-clinical bench testing."

Therefore, I cannot extract the requested information points related to a study proving the device meets acceptance criteria for an AI/ML device, as such a study was not performed or detailed in this submission. The tests listed are primarily engineering bench tests for a physical catheter, not AI model validation.

However, I can extract the acceptance criteria for the physical device's performance from the "NON-CLINICAL PERFORMANCE DATA" section.

Here's what I can provide based on the document:

1. A table of acceptance criteria and the reported device performance (for non-clinical bench tests):

For the remaining points, the document explicitly states that clinical or animal studies were not deemed necessary beyond the non-clinical bench testing for this specific device (a physical catheter). Therefore, the following information cannot be provided from the given text:

2. Sample sized used for the test set and the data provenance: Not applicable for an AI/ML context, as no such test set was described. Bench tests were performed on physical units, but specific sample sizes for each test are not listed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML system is not relevant to this physical device's non-clinical bench testing. "Physician Validation" was mentioned, but no details on the number or qualifications of physicians, nor their role in establishing a ground truth for an AI system.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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, as this is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable for an AI/ML system. Ground truth in this context would refer to the reference standards for the physical tests (e.g., precise measurements, material specifications, functional performance during simulated use).
8. The sample size for the training set: Not applicable, as there is no AI/ML training set.
9. How the ground truth for the training set was established: Not applicable, as there is no AI/ML training set.

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