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The HARBOR Occlusion Device is indicated for arterial embolization in the peripheral vasculature.

The HARBOR Occlusion Device is a self-expanding braided nitinol arterial embolization implant (Figure 1) supplied with components used for implantation (Figure 2). The Device has a radiopaque marker band attached to the proximal end of the implant. The implant is packaged collapsed within an Introducer sheath and attached to a Delivery System provided within a hoop dispenser.

The provided FDA 510(k) clearance letter and summary for the HARBOR Occlusion Device outlines the device's technical specifications and the testing performed to demonstrate its substantial equivalence to predicate devices, rather than a clinical study establishing performance criteria in relation to human interpretation or outcomes. Therefore, several requested sections (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC comparative effectiveness) are not applicable to the information provided.

However, the document does detail the acceptance criteria (implicitly, "Pass" for each test) and the studies (bench and animal) that prove the device meets these criteria in the context of its substantial equivalence submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly "Pass" for each test listed, indicating that the device must perform acceptably in those areas to demonstrate substantial equivalence.

2. Sample size used for the test set and the data provenance

Test Set Sample Size:

• Bench Tests: Not explicitly stated for each test, but implied to be sufficient for meeting ISO and ASTM standards.
• Animal Study: Not explicitly stated, but the study was described as "GLP Animal Study."

Data Provenance: Not explicitly stated. The document refers to "pre-clinical testing" and "GLP animal study," which are typically conducted in a controlled laboratory environment but the country of origin is not specified. The studies are prospective in nature, as they were conducted specifically for this device's submission.

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

Not applicable. This document describes the technical and biological performance of a medical device (an occlusion device) rather than an AI/CADe system or a diagnostic imaging device that would typically involve expert readers for establishing ground truth on image interpretation. The "acceptance criteria" here relate to the device's physical and biological functioning.

4. Adjudication method for the test set

Not applicable. As above, this is not a study assessing observer performance or diagnostic accuracy.

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. This document does not describe an AI-enabled device or an MRMC study. It pertains to a physical medical device.

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

Not applicable. This describes a physical medical device, not an algorithm.

7. The type of ground truth used

The "ground truth" for the performance tests is established by:

• Engineering specifications and standards: For bench testing (e.g., specific tensile strength values, radial force, dimensions, nickel ion release limits).
• Biological responses: For biocompatibility tests (e.g., absence of cytotoxicity, irritation, sensitization, pyrogenicity, hemolysis, complement activation as per ISO 10993 standards).
• Physiological and pathological observations in an animal model: For the GLP animal study (e.g., direct observation of delivery, acute complications, vessel recanalization, foreign body reactions, device migration, and effectiveness of occlusion).

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm or system that requires a "training set."

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

Not applicable. No training set exists for this type of device.

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