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The EMBOTRAP III Revascularization Device 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.

The EmboTrap™ III Revascularization Device is composed of a retrievable, self-expanding, Nitinol shaped section at the distal end of a tapered Nitinol shaft. It is designed to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke. The EmboTrap™ III Revascularization Device is supplied sterile and is intended for single-use only by physicians trained in neuro-interventional catheterization and the treatment of ischemic stroke.

The provided text describes the EMBOTRAP III Revascularization Device and demonstrates its substantial equivalence to a predicate device, the EmboTrap® II Revascularization Device (K173452). The acceptance criteria and the study that proves the device meets them are primarily based on non-clinical performance data (biocompatibility, sterilization, shelf life, in vitro/bench testing, and in vivo animal studies), as no clinical study was performed.

Therefore, a table of acceptance criteria and reported device performance as typically understood for an AI/software device studying human-in-the-loop or standalone performance, sample size for test/training sets, expert ground truth adjudication for these, MRMC studies, or specific "effect sizes" of AI assistance, are not applicable in this context. The document focuses on demonstrating physical and functional equivalence of a medical device (a mechanical thrombectomy device) to a legally marketed predicate.

Here's an interpretation of the requested information based on the provided document, adapting where necessary for a medical device rather than a software/AI product's performance study:

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

The document defines acceptance criteria through various tests (biocompatibility, bench, and animal studies) and concludes that "All required specifications were met." and "demonstrate substantial equivalence." for the subject device compared to the predicate. The "reported device performance" is framed as meeting these specifications and being comparable or equivalent to the predicate device.

Table: Acceptance Criteria and Device Performance (Summary derived from the document)

2. Sample sized 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: The document doesn't provide specific numerical sample sizes (e.g., "N" units) for each bench test. Instead, it refers to "a range of device dimensions," "representative (worst-case) device model," or "worst-case subject device." For animal studies, it refers to "the swine model" implying multiple animals, but no specific number is given.
• Data Provenance: Not explicitly stated as country of origin of the data. The studies are non-clinical (bench and animal lab tests). They appear to be prospective for the purpose of demonstrating equivalence, testing newly manufactured devices.

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 concept is not directly applicable. For this type of medical device clearance, "ground truth" is established through physical and mechanical measurements, chemical analyses, and biological responses in laboratory or animal settings.
• For the "Physician Usability Study," it states "The physician usability study demonstrated that the subject device met user needs." It doesn't specify the number of physicians or their qualifications, but these would be the "experts" assessing usability.

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

• Not applicable for non-clinical testing. Adjudication methods like 2+1 or 3+1 are used for expert consensus on clinical data (e.g., image interpretation). Here, the "truth" is determined by measured physical properties or biological responses against predefined engineering or biological standards.

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 or human-in-the-loop study was done. This device is a mechanical thrombectomy device, not an AI/software product intended to assist human readers (e.g., radiologists). The performance assessment focuses on its physical and biological attributes.

6. 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. Its "performance" is its ability to meet engineering specifications and biocompatibility.

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

• The "ground truth" for this device's performance evaluation is established through:
  • Defined Engineering Specifications: For bench tests like dimensions, radial force, durability, etc.
  • Validated Biological/Chemical Standards: For biocompatibility tests (e.g., ISO 10993 series for cytotoxicity, sensitization, irritation, etc.).
  • Histopathological Analysis: For animal studies assessing tissue response.
  • Direct Observation/Measurement: For performance attributes like clot retrieval in simulated anatomy.

8. The sample size for the training set

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

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

• Not applicable, as there is no training set for this device.

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