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The CAPERE™ Thrombectomy System is indicated for:

• Non-surgical removal of soft emboli and thrombi from blood vessels.
• Injection, infusion and/or aspiration of contrast media and other fluids into blood vessel.
  The CAPERE™ Thrombectomy System is intended only for use in the peripheral vasculature and is not intended for use in the pulmonary arteries.

The CAPERE™ Thrombectomy System consists of a 12Fr Delivery Catheter and a 20Fr Guide Catheter. The 12Fr Delivery Catheter consists of a nitinol basket that comes in two different sizes (10 mm and 18 mm). The 20Fr Guide Catheter consists of an inner and outer guide and an inner and outer introducer. The CAPERE™ Thrombectomy System is delivered percutaneously via transfernoral or jugular venous access. Once delivered, the System's fine mesh nitinol wire basket is used to capture and mechanically remove emboli and thrombi. The CAPERE™ System does not use aspiration to extract thrombus but does have a side port in the guide catheter that allows aspiration or injection of saline or fluids if needed.

The provided text describes a medical device, the CAPERE™ Thrombectomy System, and its regulatory clearance by the FDA based on a 510(k) submission. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing a full premarket approval (PMA) process that would typically involve extensive clinical trials with human subjects.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria in human subjects, specifically for an AI/ML medical device. The data provided focuses on:

• Nonclinical performance testing: Biocompatibility, package integrity, accelerated aging, functional bench testing (visual inspection, dimensional testing, guidewire compatibility, catheter trackability, etc.).
• Simulated Use Testing: Demonstrating clot retrieval without device damage under simulated conditions.
• In vivo testing in an animal model: Evaluating acute and chronic performance, handling, vascular safety, and clinical outcomes compared to a predicate device.

Key reasons why the provided document cannot fulfill the request:

• No AI/ML Component: The CAPERE™ Thrombectomy System is a mechanical device (embolectomy catheter system with a nitinol basket), not an AI/ML driven device. The request specifically asks about "device meets the acceptance criteria" in the context of an AI/ML study, which is not applicable here.
• No Human Clinical Performance Study: The 510(k) submission for this device does not describe a human clinical trial to establish performance metrics like sensitivity, specificity, accuracy, or reader improvement with AI assistance. The "performance data" section refers to non-clinical and animal studies.
• No Ground Truth Generation: Since there's no human clinical performance study, there's no mention of expert consensus, pathology, or outcomes data used to establish ground truth for a test set.
• No Multi-Reader Multi-Case (MRMC) Study: This type of study is relevant for evaluating the impact of AI on human readers, which is not discussed for this mechanical device.

To directly answer your prompt based only on the provided text, I must state that the information is not present for an AI/ML device.

However, if we interpret "acceptance criteria" and "study" in the context of this 510(k) submission for a mechanical device, we can infer what constitutes "meeting the criteria" for regulatory clearance.

Here's an attempt to structure an answer, while clearly highlighting what information is not available due to the nature of the provided document:

Acceptance Criteria and Device Performance (Based on 510(k) for a Mechanical Device)

The provided document (K180722 510(k) for CAPERE™ Thrombectomy System) describes the non-clinical and animal testing conducted to demonstrate substantial equivalence to predicate devices, which served as the "acceptance criteria" for its regulatory clearance. It does not describe an AI/ML-driven device or human clinical performance studies with metrics like sensitivity, specificity, or reader improvement. Therefore, the information requested regarding AI/ML device performance (like accuracy, F1 score, MRMC study results, etc.) is not present in this document.

The "acceptance criteria" for this device were met by successfully completing a battery of non-clinical and animal tests, demonstrating that the device functions as intended and is safe and effective when compared to its predicates.

1. Table of Acceptance Criteria and Reported Device Performance (Inferred from the document for a mechanical device):

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

• Test Set (for a mechanical device, relevant to animals/bench): The document does not specify exact "sample sizes" (e.g., number of animals, number of bench test iterations) for each test. For instance, it mentions "in vivo testing in an animal model" without detailing the number of animals.
• Data Provenance: Not explicitly stated for each test beyond "nonclinical performance testing" and "in vivo testing in an animal model." Specific country of origin or whether data was retrospective/prospective is not mentioned. Given the nature of a 510(k), these studies are typically conducted by the manufacturer as prospective engineering/animal tests.

3. Number of Experts and Qualifications for Ground Truth:

• Not applicable for a mechanical device 510(k) submission. The concept of "ground truth" established by experts (e.g., radiologists for image interpretation tasks) is primarily relevant for AI/ML devices or diagnostic accuracy studies on human data. The assessment of this mechanical device relied on engineering specifications and animal model observations.

4. Adjudication Method for the Test Set:

• Not applicable for a mechanical device 510(k) submission. Adjudication methods like 2+1 or 3+1 are used in clinical trials or reader studies where human interpretation of data is involved.

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

• No MRMC study was done. This type of study is relevant for evaluating the impact of AI assistance on human readers, which is not applicable to this mechanical medical device.

6. Standalone (Algorithm Only) Performance:

• Not applicable. The CAPERE™ Thrombectomy System is a physical, mechanical medical device. There is no algorithm to assess independently.

7. Type of Ground Truth Used:

• For a mechanical device: The "ground truth" was established by comparing the device's performance against pre-defined engineering specifications, in vitro test protocols, and observations in an animal model, all benchmarked against the performance of predicate devices. There was no "expert consensus," "pathology," or "outcomes data" in the sense of clinical diagnoses from human subjects.

8. Sample Size for the Training Set:

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

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

• Not applicable. This is a mechanical device, not an AI/ML device that requires a training set with established ground truth.

In summary, the provided FDA 510(k) summary (K180722) details the engineering, in vitro, and animal studies used to demonstrate substantial equivalence for a mechanical thrombectomy system. It does not contain information relevant to AI/ML device performance evaluation, human clinical studies, or associated methodologies like MRMC studies or expert-driven ground truth.

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