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ONCOZENE Microspheres are intended for embolization of arteriovenous malformations and hypervascular tumors including hepatoma.

ONCOZENE Microspheres (hereafter may be referenced as ONCOZENE Microspheres or ONCOZENE) are spherical, tightly calibrated, biocompatible, non-resorbable, hydrogel microspheres coated with an inorganic perfluorinated polymer shell (Polyzene-F). The microspheres are suspended in liquid and then injected into the bloodstream to permanently occlude blood vessels. They are used to stop bleeding when the underlying lesion is not likely to heal or block arteries supplying a tumor to cause tumor necrosis and/or shrinkage.

ONCOZENE Microspheres are sterile, single use devices and are supplied in pre-filled 20 ml syringes containing 2ml or 3 ml of microspheres in approximately 7 ml of transport solution. The ONCOZENE Microspheres are available in 40, 75 and 100 um sizes.

The provided text is a 510(k) Premarket Notification from the U.S. Food and Drug Administration (FDA) regarding a medical device called "ONCOZENE Microspheres." The document primarily addresses the substantial equivalence of a modified device (new syringe) to a previously cleared predicate device.

Based on the provided text, the device in question is a medical device (microspheres for embolization), not an AI/software-based medical device that would require the types of studies and acceptance criteria typically associated with AI performance.

Therefore, I cannot extract information related to:

• A table of acceptance criteria and reported device performance (in the context of AI performance metrics like sensitivity, specificity, AUC). The document speaks of "acceptance criteria" but in the context of physical device testing such as mechanical performance, sterilization, biocompatibility, packaging integrity, and shelf-life.
• Sample size used for the test set and data provenance (for AI model evaluation).
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for the test set.
• Multi reader multi case (MRMC) comparative effectiveness study or human reader improvement with AI assistance.
• Standalone (algorithm only without human-in-the-loop performance) study.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for AI evaluation.
• Sample size for the training set (for AI models).
• How the ground truth for the training set was established (for AI models).

The document outlines the following types of performance data and their "acceptance criteria" in a general sense:

1. Non-clinical Testing: To demonstrate the design and performance met established design criteria and is substantially equivalent to the predicate device. Specifically, mechanical testing was performed to verify the Syringe Volume Identification, and results "met all related specifications."
2. Sterilization: To ensure a minimum sterility assurance level of 10⁻⁶ in accordance with ISO standards. Half and full cycles were used, and results "met all acceptance criteria."
3. Biocompatibility: In accordance with ISO 10993-1, demonstrating that patient-contacting components are biocompatible. Testing was performed for genotoxicity, hemocompatibility, cytotoxicity, implantation effects, irritation and sensitization, pyrogenicity, subacute/subchronic systemic toxicity, toxicological risk assessment of chemistry results, chemical characterization, and irritation. The text states testing "demonstrated compliance."
4. Packaging Integrity and Shelf Life: Performed in accordance with ISO 11607-1 and ISO 11607-2, supporting a three-year shelf-life. Testing included label adhesion, legibility, packaging seal integrity, bubble leak test, peel strength test, and dye penetration.

In summary of what is available in the provided text:

• Device Type: Vascular embolization device (ONCOZENE Microspheres). This is a physical medical device, not an AI/software device.
• Study Purpose: To demonstrate substantial equivalence of a device with an updated syringe to a predicate device.
• Methods: Non-clinical testing, sterilization testing, biocompatibility testing, packaging integrity, and shelf-life testing.
• Acceptance: For all listed performance data, the results "met all acceptance criteria" or "demonstrated compliance/substantial equivalence."
• Ground Truth: For these types of physical device tests, "ground truth" is typically defined by adherence to established engineering specifications, ISO standards, and regulatory requirements (e.g., a specific sterility assurance level, a certain peel strength, or passing toxicology tests).

Since the nature of the device and the provided documentation does not pertain to AI/software performance evaluation, the requested details regarding AI model acceptance criteria, test sets, expert involvement, and ground truth for AI are not applicable and thus not present in the provided text.

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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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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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