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Embozene® Microspheres are intended for embolization of arteriovenous malformations, and hypervascular tumors, including uterine fibroids.

Embozene® Microspheres are tightly calibrated, compressible microspheres intended to occlude vasculature for the purpose of blocking blood flow to a target tissue such as a hypervascular tumor (HVT) or arteriovenous malformation (AVM). Embozene® Microspheres are manufactured from sodium polymethacrylate and coated with proprietary Polyzene®-F. The microspheres are compressible to enable smooth delivery through the indicated delivery catheter. Embozene® Microspheres are color coded by size to allow easy identification of the different sizes. Embozene® Microspheres are supplied sterile and packaged in 20ml polycycloolefin syringes with a standard 7ml fill volume across the range. Embozene® Microspheres syringes or vials are available in 1 ml or 2 ml microsphere volume.

The acceptance criteria for the Embozene® Microspheres and the study demonstrating its performance are detailed below.
It's important to note that this submission relies heavily on substantial equivalence to previously cleared predicate devices, rather than establishing entirely new performance criteria through a de novo study.

Acceptance Criteria and Reported Device Performance

Study Details

The submission's primary evidence for meeting acceptance criteria for the expanded indication (uterine fibroids) comes from a review of clinical information, specifically a published study by Smeets et al., and a comparison to predicate devices. No new, prospective, de novo clinical trial was conducted for this 510(k) submission.

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

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

• Sample Size for Clinical Data:
  • Smeets et al. study: n=85 patients for initial 3-month follow-up on UFS-QOL scores. n=81 patients for extended 12.8-month follow-up on UFS-QOL scores.
• Data Provenance:
  • Smeets et al. study: Published data, conducted outside the United States. The document states "published and unpublished data on the use of use of Embozene® for the treatment of uterine fibroids (outside the United States)". This indicates a retrospective or prospective observational study conducted previously.

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

• This information is not provided in the summary. The clinical study (Smeets et al.) relied on patient-reported outcomes (UFS-QOL) and objective measurements from MRI (uterine and fibroid volume, fibroid infarction). The interpretation of MRI results would have been by medical professionals (radiologists), but their number and specific qualifications are not specified in this 510(k) summary.

4. Adjudication method for the test set:

• This information is not provided in the summary. For the Smeets et al. study, it doesn't mention any specific adjudication method for patient-reported outcomes or MRI interpretations.

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, an MRMC comparative effectiveness study was not done. This device is a vascular embolization device, not an AI-assisted diagnostic tool. Therefore, the concept of "human readers improve with AI assistance" is not applicable.

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

• No, this is not an algorithm or AI-based device. It is a physical device (microspheres) for embolization. Therefore, standalone algorithm performance is not relevant.

7. The type of ground truth used:

• For the clinical effectiveness concerning uterine fibroids, the ground truth was established through:
  • Patient-reported outcomes: Uterine Fibroid Symptom Quality of Life (UFS-QOL) instrument.
  • Imaging-based objective measures: Uterine and fibroid volume reduction and percent fibroid infarction as determined by MRI.

8. The sample size for the training set:

• Not applicable / Not explicitly stated. This is not an AI/machine learning device that involves a training set in the conventional sense. The "training" for the device's effectiveness is based on the general understanding of embolization therapy and the established performance of predicate devices. The clinical data from Smeets et al. serves as evidence for effectiveness, not as a training set for an algorithm.

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

• Not applicable. As mentioned, there isn't a "training set" in the context of an algorithm. The evidence base relies on existing medical knowledge, predicate device performance, and clinical study outcomes.

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ONCOZENE™ Microspheres are intended for embolization of hypervascular tumors and arteriovenous malformations.
ONCOZENE™ Microspheres are indicated for the embolization of hypervascular tumors and arteriovenous malformations.

ONCOZENE™ Microspheres are precise dimensioned, soft, deformable microspheres intended to occlude vasculature for the purpose of blocking blood flow to a target tissue such as hypervascular tumor (HVT) or arteriovenous malformation (AVM). ONCOZENE™ Microspheres are manufactured from sodium polymethacrylate and coated with proprietary Polyzene®-F. The fully polymerized microspheres are compressible to enable smooth delivery through the indicated delivery catheter. ONCOZENE™ Microspheres contain no added dyes and are visually opaque. ONCOZENE™ Microspheres are supplied sterile and packaged in 20ml polycycloolefin syringes with a standard 7ml fill volume across the range. Available as 40μm, 75μm and 100μm microsphere diameter sizes, the ONCOZENE™ syringes are available with 2ml or 3ml microsphere volume per syringe.

The provided text describes a 510(k) premarket notification for a medical device called ONCOZENE™ Microspheres. This submission is for demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria in a clinical study with an aim to assess algorithm performance. Therefore, many of the requested categories, such as "reported device performance," "sample size for the test set," "number of experts," "adjudication method," "MRMC study," "standalone algorithm performance," "type of ground truth," "sample size for training set," and "how ground truth for training set was established," are not directly applicable or available in this type of submission.

Instead, the submission focuses on demonstrating equivalence based on similar design, specifications, fundamental scientific technology, and performance established through in-vitro testing, literature review, and post-market surveillance of the predicate device.

Here's the information that can be extracted or inferred based on the nature of a 510(k) submission for this type of device:

Acceptance Criteria and Device Performance (Based on Substantial Equivalence to Predicate)

Since this is a 510(k) submission establishing substantial equivalence for a medical device that physically occludes vasculature, the "acceptance criteria" are not performance metrics of an AI algorithm, but rather a demonstration that the new device (ONCOZENE™ Microspheres) is as safe and effective as the predicate device (Embozene Microspheres). The "reported device performance" is essentially showing that ONCOZENE™ Microspheres meet or fall within the established specifications and safety profile demonstrated by the predicate.

1. A table of acceptance criteria and the reported device performance:
See table above. The "acceptance criteria" here refers to the parameters for demonstrating substantial equivalence. The "reported device performance" refers to how ONCOZENE™ Microspheres compare to these parameters and to the predicate device.

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

• Sample Size: Not applicable in the context of a traditional "test set" for an AI algorithm. The evaluation relies on in-vitro testing of the ONCOZENE™ Microspheres and a broad review of clinical experience with the predicate device and similar embolic agents.
• Data Provenance: The "clinical experience" review involved:
  • 1029 abstracts from a PubMed search.
  • CeloNova's adverse event data resulting from over 70,000 units of the predicate device distributed worldwide.
  • This data is retrospective, covering experience over the last ten years with Transarterial Embolization (TAE) using various embolic agents. The countries of origin for the PubMed abstracts and worldwide distribution would be global.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This is a medical device submission based on substantial equivalence, not an AI algorithm performance study requiring expert ground truthing. The "ground truth" concerning the safety and effectiveness of embolization with these types of microspheres is established through decades of medical practice, clinical trials (for the predicate and similar devices), and post-market surveillance summarized in the literature review.

4. Adjudication method for the test set:
Not applicable. No "test set" in the sense of a set of cases requiring adjudication for ground truth.

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. This device is a physical embolization microsphere, not an AI diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is not an AI algorithm. The device itself is "standalone" in that it performs its physical function (occlusion) without human-in-the-loop interaction during its mechanism of action, but its performance evaluation in this submission is not in the context of an algorithm.

7. The type of ground truth used:
For the conclusion of safety and effectiveness, the "ground truth" is based on:

• Expert Consensus/Clinical Evidence: Derived from a comprehensive literature review of Transarterial Embolization (TAE) using various embolic agents, including the predicate device, performed over the last ten years.
• Outcomes Data/Post-Market Surveillance: Adverse event data from over 70,000 units of the predicate device distributed worldwide.
• In-vitro Testing: Summary of in-vitro data for ONCOZENE™ Microspheres showing that minor manufacturing changes (for tighter pH control) did not necessitate additional testing.

8. The sample size for the training set:
Not applicable. There is no AI training set involved in this submission.

9. How the ground truth for the training set was established:
Not applicable. There is no AI training set involved in this submission.

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Embozene™ Microspheres are indicated for the embolization of hypervascular tumors and arteriovenous malformations. Embozene™ Microspheres may be used for vasculturion of blood vessels within the neurovascular system.

Celonova BioSciences, Inc. Embozene™ Microspheres are spherical embolic hydrogels. They are artificial embolization devices used to obstruct or reduce blood flow to hypervascularized tumors or artenovenous mall ormations via selective microcatheter delivery.

The embolization particles are available in seven (7) size ranges of 40, 100, 250, 400, 500, 700 and 900 um diameters to enable appropriate size selection for the turnor or malformation to be treated. Embozene™ Microspheres are designed for use under fluoroscopic guidance through compatible delivery catheters. The product is provided as a sterile, non pyrogenic, single use device. It is an uncolored or color-coded particle that is opaque under fluoroscopy. The product and its delivery container are steam sterlized.

The provided text is a 510(k) summary for the Embozene™ Microspheres. It states "Clinical Data: None required." and does not contain information about acceptance criteria or a study proving the device meets said criteria. Therefore, most of the requested information cannot be extracted from the given text.

However, I can provide what little information is available:

1. A table of acceptance criteria and the reported device performance
Not provided. The submission states, "Clinical Data: None required."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable, as no clinical data was required or provided.

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)
Not applicable, as no clinical data was required or provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical data was required or provided.

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 no clinical data was required or provided, and this is not an AI/imaging device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is not an AI/algorithm device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable, as no clinical data was required or provided. The device relies on substantial equivalence to predicate devices.

8. The sample size for the training set
Not applicable, as no clinical data was required or provided, and this is not an AI/algorithm device.

9. How the ground truth for the training set was established
Not applicable, as no clinical data was required or provided, and this is not an AI/algorithm device.

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