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Embozene® Microspheres are indicated for the embolization of arteriovenous malformations and hypervascular tumors including uterine fibroids and hepatoma.

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

Embozene® Microspheres and ONCOZENE™ 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). The 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 available opaque or color coded by size to allow easy identification of the different sizes; ONCOZENE™ Microspheres are available in opaque only.

Embozene® / ONCOZENE™ 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; ONCOZENE™ Microspheres are available in 2 ml or 3 ml microsphere volume.

The provided document is a 510(k) Summary of Safety and Effectiveness for CeloNova BioSciences' Embozene® Microspheres and ONCOZENE™ Microspheres. This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than establishing acceptance criteria and proving new device performance against those criteria as would be typical for a novel device.

The core of this submission is an expanded indication for use to explicitly include "hepatoma" among the hypervascular tumors treated with these embolization devices. Therefore, the "acceptance criteria" here are implicitly related to the safety and effectiveness for this expanded indication, demonstrated by comparison to predicate devices and existing clinical data.

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) for an expanded indication and not a de novo submission, there are no explicit, quantifiable "acceptance criteria" presented in the document in the format of a novel device performance study. Instead, the "acceptance criteria" are implied to be demonstration of substantial equivalence to legally marketed predicate devices, particularly regarding the safety and effectiveness for the embolization of hypervascular tumors, specifically hepatoma.

The "device performance" is primarily the finding that the subject devices are substantially equivalent to the predicate devices and that existing clinical data supports their safety and effectiveness for the expanded indication.

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

• Test Set Sample Size: Not explicitly stated as a defined "test set" with a specific sample size. The clinical information reviewed included "published and unpublished data on the use of Embozene® for the treatment of hypervascular tumor including hepatoma (outside the United States) and postmarket experience with the cleared device." The exact number of patients or cases in this cumulative "test set" is not provided.
• Data Provenance: The data provenance mentioned is "outside the United States" for the use of Embozene® for hepatoma, and general "postmarket experience" with the cleared devices. This suggests a mix of retrospective (published studies, postmarket reports) and potentially some prospective data if "unpublished data" includes ongoing registries or smaller studies.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not specify the number or qualifications of experts used to establish a "ground truth" for a specific test set. The clinical information reviewed was "published and unpublished data" and "postmarket experience," implying that the assessment of safety and effectiveness relied on existing medical literature and real-world usage data, which inherently includes diagnoses and outcomes established by medical professionals in various clinical settings.

4. Adjudication Method for the Test Set

No explicit adjudication method is mentioned. The review seems to be a synthesis of existing literature and postmarket surveillance rather than a specific study with a defined adjudication process.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This submission is for an expanded indication based on substantial equivalence and a review of existing data, not for a comparative effectiveness study of human readers with or without AI assistance.

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

This question is not applicable. The device is a medical product (microspheres for embolization), not an algorithm or AI.

7. The Type of Ground Truth Used

The "ground truth" for demonstrating safety and effectiveness for hepatoma embolization was based on the outcomes data and findings reported in published and unpublished clinical studies, as well as postmarket surveillance data. This includes diagnoses by clinicians, treatment effectiveness, and adverse events.

8. The Sample Size for the Training Set

This question is not applicable. The device is a medical product, not an AI or algorithm that requires a "training set." The submission relies on existing clinical evidence, not a machine learning model.

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

This question is not applicable for the reasons mentioned above.

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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

• Same method of delivery, Rx status.
• Same mechanism of action (mechanical occlusion).
• Same material class, design, and composition (Crosslinked polyacrylate hydrogel with Polyzene-F).
• Same size ranges, biocompatibility, microsphere volume, sterility assurance level ($10^{-6}$), pyrogen-free status, packaging, and shelf-life (3 years). | All technological characteristics are identical to the primary predicate device (Embozene® Microspheres, K073417 and K132675). The only difference is the broadened indication for use to explicitly include uterine fibroids, which is supported by clinical data. | Non-Clinical Performance Testing (bench testing) and comparison to predicate device. |
  | Safety | No unique safety concerns regarding use for uterine fibroid embolization. | Review of published and unpublished data regarding adverse events did not identify any unique safety concerns. Adverse events observed in the Smeets et al. study (hysterectomy due to incomplete fibroid expulsion or persistent pain) are documented, but not deemed "unique safety concerns" for the device itself. | Clinical Experience (Smeets et al.) |
  | Clinical Effectiveness (for Uterine Fibroids) | Improvement in fibroid symptoms and/or reduction in fibroid/uterine volume, successful infarction. (Implicitly comparable to predicate device performance) | - UFS-QOL Symptom Severity Scores: Mean score dropped from 64 at baseline to 23 at 3 months (n=85), and to 16 at 12.8 months (n=81).
• Fibroid/Uterine Volume Reduction: Mean dominant fibroid volume reduction of 45% at 3 months. Mean total uterine volume reduction of 42% at 3 months.
• Fibroid Infarction: 94% rate of >90% infarction of dominant fibroid at 3 months. 91% rate of >90% infarction of total fibroid load at 3 months. | Clinical Experience (Smeets et al.) |

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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Embozene® Microspheres are intended for embolization of hypervascular tumors and arteriovenous malformations.

Embozene® Microspheres are tightly calibrated, compressible 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). 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 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 and vials are available with 1 ml or 2 ml microsphere volume per syringe or vial.

This document is a 510(k) summary for Embozene® Microspheres, describing their intended use, device description, and a comparison to a predicate device. It does not describe a study involving an AI device or a direct performance evaluation against acceptance criteria in the context of AI/ML. Instead, it focuses on demonstrating substantial equivalence to a previously cleared device.

Therefore, many of the requested elements for an AI device study are not present in the provided text. I will answer based on the information available and indicate when information is not extractable from the provided text.

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

The provided text describes a submission for demonstrating substantial equivalence for an existing device, Embozene® Microspheres, with the addition of new sizes (1100 µm and 1300 µm). It does not present acceptance criteria for a "device performance" in the typical sense of accuracy, sensitivity, or specificity as might be seen for an AI/ML device.

Instead, the "performance" here relates to demonstrating that the new sizes of the Embozene® Microspheres maintain the same characteristics and safety profile as the predicate device. The implicit acceptance criteria are that the new sizes are substantially equivalent to the cleared predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable in the context of the provided document. The submission is for a medical device (microspheres), not an AI/ML diagnostic or prognostic tool that would typically use a test set of data. The "clinical evaluation" mentioned in Section 8 refers to a review of existing literature and post-market surveillance, not a specific prospective or retrospective study with a defined sample size for the purpose of validating an algorithm.

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 information is not applicable. The document describes a medical device, not an AI/ML algorithm that requires expert-established ground truth on a test set. The clinical evaluation process relies on existing scientific literature, a broad assessment by medical professionals, and regulatory review processes, rather than a specific number of experts labeling data for a test set.

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

This information is not applicable for the same reasons as points 2 and 3.

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

This information is not applicable. This document is a 510(k) summary for a medical device (microspheres), not an AI/ML device, and thus no MRMC study or AI assistance evaluation was conducted or reported here.

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

This information is not applicable. This document is a 510(k) summary for a medical device (microspheres), not an AI/ML device.

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

For the purpose of this 510(k) submission, the "ground truth" concerning the safety and effectiveness of the Embozene® Microspheres (including the new sizes) is established through:

• Engineering and material characterization: In-vitro testing for size distribution and catheter compatibility (Section 7). This confirms the physical properties.
• Scientific literature review: A comprehensive review of Transarterial Embolization (TAE) using various embolic agents, including the existing Embozene® Microspheres, over the last ten years (Section 8). This constitutes a form of aggregated "outcomes data" and medical consensus from the broader scientific community.
• Unpublished data and post-market surveillance: This also contributes to the "outcomes data" and real-world evidence confirming the safety and effectiveness of the existing device family (Section 8).

There is no "ground truth" established for an AI algorithm's performance.

8. The sample size for the training set

This information is not applicable. This is not an AI/ML device.

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

This information is not applicable. This is not an AI/ML device.

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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.

• Equivalence to predicate.
• Extensive review of scientific literature (1029 abstracts) on Transarterial Embolization (TAE) with various embolic agents, including the predicate.
• Review of CeloNova's adverse event data from >70,000 units of predicate distributed worldwide. |

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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