(28 days)
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.
§ 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).