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Contour SE™ Microspheres may be used for the embolization of hypervascular tumors, including leiomyoma uteri, and arteriovenous malformations (AVMs).

Contour SET™ Microspheres may be used for the embolization of hypervascular tumors, including leiomyoma uteri, and arteriovenous malformations (AVMs).

The provided text is a summary of safety and effectiveness for a medical device (Contour SET™ Microspheres) and a letter from the FDA regarding its 510(k) premarket notification. This document outlines the general provisions, intended use, and substantial equivalence to predicate devices for the Contour SET™ Microspheres.

However, the document does not contain information about acceptance criteria, specific device performance metrics, detailed study designs (sample sizes for test/training sets, data provenance, expert qualifications for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance), or the type of ground truth used, in the context that would be expected for a typical AI/ML device study.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details as requested. The document focuses on regulatory approval based on substantial equivalence to existing devices and biocompatibility, not on a performance study against predefined acceptance criteria for a new AI/ML-driven device.

No information is available in the provided text to fulfill the request for a table of acceptance criteria and reported device performance, or the detailed study information regarding sample sizes, ground truth establishment, expert qualifications, or MRMC studies.

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Contour SETM Microspheres are indicated for use for the embolization of hypervascular tumors and arteriovenous malformations.

The Contour SE TM Microspheres are spherical embolic particles and are available in a variety of particle sizes and are indicated for use for the embolization of hypervascular tumors and arteriovenous malformations. These particles are provided in a sterilized syringe.

The provided text is a 510(k) Summary for the Contour SE™ Microspheres. It states that the device has been tested for biocompatibility per ISO 10993 and demonstrated to be substantially equivalent to predicate devices. However, the document does NOT contain explicit acceptance criteria or a detailed study description with performance metrics in the format requested.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a breakdown of what can and cannot be answered:

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

• Acceptance Criteria: Not explicitly stated in terms of specific performance thresholds (e.g., "particle size must be within X um"). The document states the device has been tested for biocompatibility per Biocompatibility ISO 10993 and that all data demonstrate this device is biocompatible for its intended use. It also states the device has been tested and compared to the Summary of Substantial predicate device and all data gathered demonstrate this device as substantially Equivalent equivalent. No new issues of safety or efficacy have been raised.
• Reported Device Performance: The only "performance" reported is compliance with biocompatibility standards and substantial equivalence to predicate devices, but no specific quantitative metrics are provided.

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

• Sample Size: Not specified.
• Data Provenance: Not specified.

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 this is a device for embolization, not an diagnostic imaging AI. The "ground truth" here would relate to device properties (e.g., particle size, mechanical integrity, biocompatibility) rather than diagnostic interpretations. No experts are mentioned in this context.

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

• Not applicable/Not specified.

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 is not an AI/software device. It's a medical device (microspheres for embolization).

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

• No, this is not an AI/software device.

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

• For biocompatibility: Adherence to ISO 10993 standards and a review of test results (likely chemical analysis, in vitro cytotoxicity, sensitization, irritation tests).
• For substantial equivalence: Comparison of characteristics (e.g., material, dimensions, intended use, manufacturing process, physical properties) with predicate devices.

8. The sample size for the training set

• Not applicable, as this is not a machine learning model.

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

• Not applicable, as this is not a machine learning model.

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Contour SE™ Microspheres are indicated for use for the embolization of hypervascular tumors and arteriovenous malformations.

The Contour SE TM Microspheres are spherical embolic particles and are available in a variety of particle sizes and are indicated for use for the embolization of hypervascular tumors and arteriovenous malformations. These particles are provided in a sterilized glass vial.

The provided documents are a 510(k) summary and an FDA clearance letter for Contour SETM Microspheres. These documents do not contain detailed acceptance criteria or a study that specifically "proves" the device meets acceptance criteria in the way a clinical trial report or a comprehensive validation study would for a new AI or diagnostic device.

Instead, this submission is for a medical device seeking substantial equivalence to existing predicate devices. Therefore, the "acceptance criteria" and "study" are focused on demonstrating that the new device is as safe and effective as legally marketed predicate devices, not on achieving specific performance metrics in a clinical context.

Here's a breakdown based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

The documents do not present a formal table of acceptance criteria with specific performance metrics (e.g., sensitivity, specificity, accuracy) like one would expect for an AI diagnostic tool. Instead, the "acceptance criteria" implicitly revolve around demonstrating biocompatibility and substantial equivalence to predicate devices. The "reported device performance" is essentially the finding of biocompatibility and substantial equivalence.

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

• Sample Size for Test Set: Not specified in these documents. The testing for biocompatibility per ISO 10993 would involve specific sample sizes and protocols as defined by that standard, but the exact numbers are not detailed here. Similarly, the comparison to predicate devices would involve testing of the Contour SE™ Microspheres, but the "sample size" of devices tested is not provided.
• Data Provenance: Not explicitly stated regarding country of origin or retrospective/prospective. Biocompatibility testing is typically performed in laboratory settings. Given the nature of a 510(k) for a physical medical device, the "data" would primarily come from laboratory testing of the physical properties and biological interactions of the microspheres, and possibly from existing literature or data on the predicate devices.

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

This information is not applicable in the context of this 510(k) submission for a physical embolic device. "Ground truth" established by experts (like radiologists for image analysis) is relevant for diagnostic or AI devices, not for assessing the basic safety and performance of microspheres in a substantial equivalence pathway. The "ground truth" here is the scientific standards of biocompatibility (ISO 10993) and the established safety and efficacy of the predicate devices.

4. Adjudication Method for the Test Set

This is not applicable as it pertains to expert consensus on interpretation, which is not the primary assessment method for this device.

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

No, a MRMC comparative effectiveness study was not done, and it would not be relevant for this type of device submission. MRMC studies are used for evaluating diagnostic performance, particularly of AI-assisted systems, comparing human reader performance with and without AI. This submission is for a physical embolic device.

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

No, this is not an algorithm or AI device. Therefore, a standalone performance assessment in the context of computing algorithms is not applicable.

7. The Type of Ground Truth Used

For biocompatibility, the "ground truth" is adherence to the ISO 10993 series of standards, which are internationally recognized guidelines for evaluating the biological compatibility of medical devices. For substantial equivalence, the "ground truth" is established by comparing the device's characteristics (materials, design, performance, intended use) to those of legally marketed predicate devices that have already demonstrated safety and efficacy.

8. The Sample Size for the Training Set

Not Applicable. This is not an AI/ML device that requires a training set.

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

Not Applicable. This is not an AI/ML device.

In summary:

The provided documents describe a 510(k) submission for a physical medical device (Contour SETM Microspheres) seeking clearance based on substantial equivalence to predicate devices. The "acceptance criteria" and "study" are framed around demonstrating biocompatibility according to ISO standards and showing that the device is as safe and effective as existing, legally marketed embolization devices. This is a different paradigm than what would be described for an AI-powered diagnostic tool, which typically involves detailed performance metrics, test sets, expert ground truth, and comparative effectiveness studies.

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Contour SET ™ Microspheres are indicated for use for the embolization of hypervascular tumors and arteriovenous malformations.

Contour SET ™ Microspheres

The provided document is a 510(k) summary for the Contour SE™ Microspheres. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain any information about specific acceptance criteria, device performance studies, or clinical (or human-related) effectiveness data.

Therefore, I cannot fulfill your request for the following sections based on the provided text:

• A table of acceptance criteria and the reported device performance
• Sample sizes used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts
• Adjudication method for the test set
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
• The type of ground truth used
• The sample size for the training set
• How the ground truth for the training set was established

The document primarily focuses on demonstrating substantial equivalence through non-clinical means (biocompatibility testing and comparison to predicate devices). The relevant information from the document is related to the substantial equivalence claim, not specific performance study results meeting acceptance criteria in the way you've described.

Here's what can be extracted from the document:

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

Not provided in the document. The document states: "All data demonstrate this device is biocompatible for its intended use" and "All data gathered demonstrate this device as substantially equivalent." These are general statements of compliance, not specific performance metrics against acceptance criteria.

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

Not provided. The document mentions "All data" but does not specify sample sizes for any test sets, nor provenance.

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 human-read test sets or ground truth establishment by experts are described for performance.

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

Not applicable.

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. The device (microspheres for embolization) is a medical implant, not an AI or imaging diagnostic tool that would typically involve human readers or AI assistance in the described manner.

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

Not applicable. This device is not an algorithm.

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

The document refers to biocompatibility testing (per ISO 10993) and comparison to predicate devices, implying that "ground truth" for substantial equivalence would be based on established standards, predicate device characteristics, and the results of the biocompatibility tests (e.g., cytotoxicity, sensitization, irritation indices). No clinical ground truth based on patient outcomes or expert consensus is mentioned for performance criteria.

8. The sample size for the training set

Not applicable, as this is not an AI/ML device requiring a training set in that context.

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

Not applicable.

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