(183 days)
The AMPLATZER® Vascular Plug 4 is indicated for arterial and venous embolizations in the peripheral vasculature.
The AMPLATZER Vascular Plug 4 (AVP4) is a self expanding, Nitinol mesh occlusion device. The device has a radiopaque marker band at each end and a micro screw attachment at one end for attaching to the delivery wire. The device is an extension of the previously approved AMPLATZER Vascular Plugs and has the identical indications for use: arterial and venous embolizations in the peripheral vasculature.
Included in the AVP4 device package are:
• Loader - consisting of two tubes, one inside the other with a stainless steel spring attached to extend the inner retractable tube
• Delivery Wire - comprised of a PTFE covered coil with core wire and attached end screw
The provided text describes a 510(k) summary for the AMPLATZER® Vascular Plug 4, a medical device. This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving efficacy or determining specific acceptance criteria for performance metrics in the same way an AI/ML device would. Therefore, the information requested in your prompt regarding acceptance criteria, specific device performance numbers, sample sizes for test and training sets, expert consensus, and comparative effectiveness studies (MRMC) for AI performance is largely not applicable or not present in this type of document for this device.
However, I can extract and restructure the information that is relevant to the performance data and the study performed to demonstrate substantial equivalence for this type of medical device submission.
Acceptance Criteria and Reported Device Performance
For medical devices like the AMPLATZER® Vascular Plug 4, acceptance criteria are typically related to meeting established standards for safety, biocompatibility, and functional performance that demonstrate equivalence to a predicate device, rather than specific numerical performance metrics for an AI algorithm. The device performance is reported as successful completion of these tests, indicating conformance to requirements for its intended use.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Bench Testing | Successful completion |
| Sterilization | Conforms to requirements |
| Material Characterization | Conforms to requirements |
| Simulated Device Use (Design Verification) | Conforms to requirements |
| Corrosion Resistance | Conforms to requirements |
| Chemical Characterization (ISO 10993-18) | Conforms to requirements |
| MRI Compatibility | Conforms to requirements |
| Fatigue | Conforms to requirements |
| Product Performance Qualification | Conforms to requirements |
| Packaging Performance | Conforms to requirements |
| Biocompatibility (Implant and delivery system, ISO 10993-1) | Conforms to requirements |
| Toxicology Risk Assessment (ISO 10993-17) | Conforms to requirements |
| In-vivo Testing | Successful completion |
| Occlusion Canine Study | Conforms to requirements |
| Serum Analysis (Porcine Study) | Conforms to requirements |
| Acute Canine Study | Conforms to requirements |
Study Proving Device Meets Acceptance Criteria:
The study proving the device meets the acceptance criteria is a comprehensive set of bench testing (in-vitro) and animal studies (in-vivo) designed to demonstrate substantial equivalence to predicate devices (AMPLATZER® Vascular Plug II and AMPLATZER® Vascular Plug II Extended Sizes). The document states: "The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the testing and, therefore, these devices may be considered substantially equivalent to the predicate devices."
The following points address the specific questions from your prompt, acknowledging that many are not directly applicable to a 510(k) submission for a non-AI/ML medical device like a vascular plug.
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A table of acceptance criteria and the reported device performance: Provided above.
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Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated in terms of a "test set" for performance metrics like an AI model. For in-vivo studies, specific numbers of animals (canine and porcine) were used, but the exact count for each study is not provided in this summary document.
- Data Provenance: The in-vivo studies were conducted using canine and porcine models. This is prospective animal study data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI/ML (e.g., expert consensus on image interpretation) is not relevant for this device. The "ground truth" here is the physical and biological performance observed in laboratory and animal studies, assessed by engineers, scientists, and veterinarians against pre-defined safety and performance parameters.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are typically used for expert review in clinical trials or AI validation where subjective interpretation is involved. For this device, objective measurements and observations from animal studies and bench tests determine performance.
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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 a physical medical device (vascular plug), not an AI/ML diagnostic or assistive tool for human readers.
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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.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): For in-vitro tests, the ground truth is based on engineering specifications, material standards, and established physical/chemical properties. For in-vivo animal studies, the "ground truth" is derived from direct biological observations, histological analysis, and physiological measurements in the animal models, assessed against pre-defined safety and performance endpoints for embolization devices.
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The sample size for the training set: Not applicable. This is a physical medical device, not an AI/ML model that requires a training set. The device's design is based on engineering principles and prior knowledge from the predicate devices.
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How the ground truth for the training set was established: Not applicable, as there is no "training set" for this type of device. The design and manufacturing processes are validated through the specified bench and animal testing.
§ 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).