(55 days)
The AMPLATZER® Vascular Plug II is indicated for arterial and venous embolizations in the peripheral vasculature.
The AMPLATZER® Vascular Plug II is a sterile, single-use, triple-lobed, self-expanding Nitinol mesh occlusion device, with a screwattachment for a Delivery Wire and radiopaque marker bands at both ends. The Plug is attached to a 135 cm Delivery Wire with a stainless steel screw. The AMPLATZER® Vascular Plug II is provided contained within a Loader Device that facilitates loading into a delivery catheter. The Delivery Wire comes coiled in a hoop dispenser. The AMPLATZER® Vascular Plug II is available in fully-expanded diameters of: 3 mm to 22 mm.
The provided document is a 510(k) summary for the AMPLATZER® Vascular Plug II, which describes a medical device, not an AI/ML device. Therefore, the typical acceptance criteria and study design elements requested in the prompt, such as test sets, ground truth definitions, expert qualifications, and MRMC studies, are not applicable here.
The document primarily focuses on demonstrating substantial equivalence to a predicate device, which is the standard for 510(k) clearances.
However, I can extract the relevant information from the provided text to demonstrate the device's performance against its stated equivalence.
1. A table of acceptance criteria and the reported device performance
The "acceptance criteria" for a medical device in a 510(k) submission are typically related to demonstrating that the modified device performs as intended and is as safe and effective as the predicate device. These are generally not quantitative metrics like precision or recall, but rather tests confirming functional equivalence.
| Acceptance Criteria (Demonstrated Equivalence) | Reported Device Performance (Test Data) |
|---|---|
| Intended Use Equivalence: | The AMPLATZER® Vascular Plug II has an identical intended use to the predicate device: "arterial and venous embolizations in the peripheral vasculature." |
| Design/Material Equivalence: | Both devices are sterile, single-use, triple-lobed, self-expanding Nitinol mesh occlusion devices. Both have a screw attachment for a Delivery Wire and radiopaque marker bands. Both use identical patient-contacting materials and the same Nitinol Delivery Wire. Both come preloaded in a loader device. Both have the same operating principle. The only modification is an extended size range (3mm, 18mm, 20mm, 22mm added to 4-16mm). |
| Functional Equivalence: | "Verification and validation testing confirms that the functional characteristics of the AMPLATZER® Vascular Plug II are substantially equivalent to the predicate device cited." This included: Radial force testing, Handoff and advancement forces, Device deployment, Recapture and detachment verification, Overall strength determinations. |
| Performance Equivalence (In Vivo): | "Animal testing was also performed to validate the product under simulated conditions of use." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a "test set" in the context of an AI/ML device. For this medical device, the "test data" refers to the studies performed to validate its functional characteristics and in vivo performance.
- Sample Size: Not explicitly quantified. For bench testing (radial force, handoff, etc.), it would depend on the specific test protocols. For animal testing, the number of animals or procedures is not disclosed in the summary.
- Data Provenance: Not specified within the provided summary. Typical for such a submission, bench testing would be conducted in a laboratory setting, and animal testing would be conducted under appropriate ethical and regulatory guidelines, likely within the US or a country with comparable standards.
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 concept is not applicable as the submission is for a medical device, not an AI/ML diagnostic or predictive tool that requires expert-established ground truth for a test set. The validation relies on engineering and biological tests demonstrating physical and functional attributes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no "test set" requiring expert adjudication as would be found in an AI/ML study.
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 is not an AI-assisted device, and thus no MRMC study would be performed for human reader improvement.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the verification and validation (V&V) of this device, the "ground truth" is established by:
- Engineering specifications and standards: For bench tests like radial force, deployment, and strength. The "ground truth" is adherence to predefined engineering requirements.
- Physiological and anatomical suitability: For animal testing, the "ground truth" would be successful embolization and lack of adverse events in a simulated biological environment, demonstrating the device performs its intended function in vivo without unforeseen complications.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI/ML model, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no "training set."
§ 870.3300 Vascular embolization device.
(a)
Identification. A vascular embolization device is an intravascular implant intended to control hemorrhaging due to aneurysms, certain types of tumors (e.g., nephroma, hepatoma, uterine fibroids), and arteriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in neurovascular applications are also not included in this classification, see § 882.5950 of this chapter.(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 § 870.1(e).