(21 days)
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.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Biocompatibility per ISO 10993 | Device is biocompatible for its intended use. |
| Substantial Equivalence to Predicate Devices (Contour® Emboli PVA, Embosphere Microspheres, EmboGold Microspehers) | Substantially equivalent. No new issues of safety or efficacy. |
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.
§ 882.5950 Neurovascular embolization device.
(a)
Identification. A neurovascular embolization device is an intravascular implant intended to permanently occlude blood flow to cerebral aneurysms and cerebral ateriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in other vascular applications are also not included in this classification, see § 870.3300.(b)
Classification. Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 882.1(e).