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The Medusa™ Vascular Plug is intended for arterial and venous embolizations in the peripheral vasculature. The product is intended for use by physicians trained in embolization techniques. Standard techniques for placement of vascular access sheaths, angiographic catheters, and guide wires should be employed.

The Medusa™ Vascular Plug is a coil-based occlusion device intended for embolization procedures in the peripheral vasculature. The Medusa™ Vascular Plug consists of an implant and a delivery system. The implant is constructed of multiple polymer coils that are pre-loaded on to the delivery system. The Medusa™ Vascular Plug coils are delivered concurrently for vascular occlusion in a single application. Like predicate embolic coils, vascular occlusion with the Medusa™ Vascular Plug is achieved by mechanical flow restriction resulting from coil pack delivery that leads to thrombus formation and rapid cessation of blood flow.

This document is a 510(k) Pre-market Notification for the Medusa™ Vascular Plug, and it describes modifications made to an existing device (Delta model MVP-020) to create a new model (Epsilon models MVP-022, and MVP-025). The purpose is to demonstrate substantial equivalence to the predicate device.

Here's an analysis of the acceptance criteria and study data based on the provided text, recognizing that this is a medical device submission and not a typical AI/software study. Therefore, some categories may not be directly applicable or will have different interpretations.

Acceptance Criteria and Reported Device Performance

Study Details (Interpreted for a Medical Device)

1. Sample size used for the test set and the data provenance:

   • Animal Study: An "ovine model" was used for the in-vivo animal testing. The specific number of animals (sample size) is not provided in this document.
   • Bench Testing: Nonclinical, bench testing was conducted as part of the design verification. The sample size for these tests is not provided.
   • Data Provenance: The animal study was conducted in-vivo (within living organisms). The document does not specify the country of origin, but generally, medical device testing for FDA submission is expected to adhere to international standards or US-based regulations. This is a prospective experimental study in an animal model.

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

   • This is not applicable in the typical sense of AI/software studies where human experts annotate data. For a medical device like this, "ground truth" and "expert assessment" would be based on established physiological measurements and observations during the animal study, likely conducted by qualified veterinary and medical researchers/staff. The document does not specify the number or qualifications of these individuals directly, but it's implied that the studies were performed by appropriately trained personnel.

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

   • This concept is not directly applicable to the device testing described. Adjudication typically refers to resolving disagreements among multiple human readers on diagnostic tasks. For device testing, measurements and observations (e.g., occlusion time, coil pack length, complications) are objectively recorded or assessed by trained individuals. Standard scientific protocols and statistical analyses would be used to interpret results, rather than an adjudication process between conflicting readings.

4. 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, an MRMC comparative effectiveness study was not done. This document pertains to a medical device (a vascular plug), not an AI algorithm. Therefore, the concept of human readers improving with or without AI assistance is not relevant here. The study compares the performance of the modified device to its predicate, not human performance.

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

   • Yes, in concept. The "standalone" performance here refers to the device itself operating according to its design specifications. The nonclinical bench testing and the animal study evaluate the device's intrinsic performance (e.g., stability, occlusion ability, mechanical integrity) independent of human-in-the-loop diagnostic interpretations. The device's function is to occlude vasculature, and its performance is measured directly (e.g., as measured occlusion time, coil pack characteristics).

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

   • For the animal study, the "ground truth" was established by direct physiological measurements and observations in the ovine model. This would include:
     • Direct observation: For stability, acute complications.
     • Measurement: For size of coil pack, occlusion time.
     • Pathology/Histology: Although not explicitly stated as "pathology," assessment of occlusion and any tissue reactions would inherently involve pathological evaluation.
   • For bench testing, "ground truth" is defined by engineering specifications and established test methodologies to evaluate material properties, mechanical integrity, and functional performance.

7. The sample size for the training set:

   • Not applicable. This submission is for a physical medical device, not an AI model requiring a training set. The device itself is "designed," "verified," and "validated," not "trained."

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

   • Not applicable. As there is no training set for an AI model, there is no ground truth establishment for a training set in this context.

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The Medusa™ Vascular Plug is intended for arterial and venous embolizations in the peripheral vasculature. The product is intended for use by physicians trained and experienced in embolization techniques. Standard techniques for placement of vascular access sheaths, angiographic catheters, and guide wires should be employed.

The Medusa™ Vascular Plug is a coil-based occlusion device intended for embolization procedures in the peripheral vasculature. The Medusa™ Vascular Plug consists of an implant and a delivery system. The implant is constructed of multiple polymer coils that are pre-loaded on to the delivery system. The Medusa™ Vascular Plug coils are delivered concurrently for vascular occlusion in a single application. Like predicate embolic coils, vascular occlusion with the Medusa™ Vascular Plug is achieved by mechanical flow restriction resulting from coil pack delivery that leads to thrombus formation and rapid cessation of blood flow.

This document describes the premarket notification (510(k)) for the Medusa™ Vascular Plug, focusing on its substantial equivalence to predicate devices. The review is based on non-clinical and animal testing.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The study was an in-vivo animal validation study conducted in an ovine (sheep) model. The sample size for this animal study is not explicitly stated in the provided text.

The data provenance is prospective animal study data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document mentions "occlusion assessed by the physician" during the angiographic assessment. This implies clinical assessment was part of the ground truth determination. However, the number of physicians/experts and their specific qualifications are not explicitly stated.

4. Adjudication Method for the Test Set

The adjudication method for the angiographic assessment and subsequent histopathology is not explicitly detailed. It mentions "occlusion assessed by the physician," but whether this involved multiple physicians, consensus, or a specific rule (e.g., 2+1) is not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This study focused on an animal model, not human readers assessing cases.

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

Not applicable. This device is a vascular plug, not an AI algorithm. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" does not apply. The performance evaluated here is the physical device's occlusive capabilities.

7. The Type of Ground Truth Used

The ground truth was established through a combination of:

• Angiographic assessment (visual assessment of occlusion by a physician).
• Gross necropsy (post-mortem examination of the animal).
• Microscopic examination.
• Histopathology (microscopic examination of tissues for disease or abnormalities).

This provides a multi-faceted biological and anatomical ground truth from the animal model.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical device (vascular plug), not an AI algorithm that requires a training set. The "testing" in this context refers to performance validation of the physical device.

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

Not applicable, as there is no training set for a physical device like a vascular plug. The "ground truth" (or established performance criteria) for the device's function was derived from the performance of the predicate devices.

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