(56 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 is coiled and packaged in a hoop dispenser.
The AMPLATZER® Vascular Pluq II is available in fully-expanded diameters of: 4mm, 6mm, 10mm, 12mm, 14mm and 16 mm.
The provided 510(k) summary for the AMPLATZER® Vascular Plug II does not contain the level of detail regarding acceptance criteria and performance studies typically associated with AI/ML device submissions. This document describes a medical device, an embolization plug, which is a physical device, not a software algorithm. Therefore, many of the requested categories related to software performance, AI/ML models, and clinical study design (like ground truth, expert consensus, MRMC studies, large training/test sets, etc.) are not applicable or detailed in this type of submission for a physical device.
However, I will extract and synthesize the relevant information presented in the document to address as many of your points as possible, adapting the interpretation to fit the context of a physical medical device.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative "acceptance criteria" in the format typically seen with software performance metrics (e.g., sensitivity > X%, specificity > Y%). Instead, the "acceptance criteria" for this physical device are implicitly tied to demonstrating "substantial equivalence" to the predicate device through various verification and validation tests. The "reported device performance" refers to the successful completion of these tests, confirming functional equivalence.
| Acceptance Criteria (Implicit from Substantial Equivalence Claim) | Reported Device Performance (Summary of Test Data) |
|---|---|
| Functional characteristics substantially equivalent to predicate device (K031810) | - Radial force testing: Confirmed functional equivalence. |
- Handoff and advancement forces: Confirmed functional equivalence.
- Device deployment: Confirmed functional equivalence.
- Recapture and detachment verification: Confirmed functional equivalence.
- Overall strength determinations: Confirmed functional equivalence. |
| Validation of product under simulated conditions of use | - Animal testing: Validated the product under simulated conditions of use. |
| Maintain identical intended uses as predicate device | - The AMPLATZER® Vascular Plug II is indicated for arterial and venous embolizations in the peripheral vasculature, identical to the predicate device. |
| Maintain same patient-contacting materials | - The AMPLATZER® Vascular Plug II has exactly the same patient-contacting materials as the predicate. |
| Maintain same Nitinol Delivery Wire | - The AMPLATZER® Vascular Plug II has the same Nitinol Delivery Wire as the predicate. |
| Maintain same operating principle | - Both devices operate on the principle of a self-expanding Nitinol mesh delivered through a catheter, expanding to occlude the vessel upon release. |
| Device modifications (shape, braid layers, loader material) do not adversely affect performance and substantial equivalence. | - Verification and validation testing (radial force, deployment, etc.) confirms the functional characteristics are substantially equivalent despite these modifications. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify a numerical sample size for the "test set" in terms of cases or patients. The testing described (radial force, handoff, deployment, etc.) likely involved a number of device units or components, and animal testing would have involved a certain number of animals. However, these specific numbers are not provided.
- Data Provenance:
- Country of Origin: Not specified. Standard practice for such tests often involves in-house labs or contract research organizations, but the geographical location is not mentioned.
- Retrospective or Prospective: The testing described (radial force, deployment, animal testing) is inherently prospective. These are laboratory and in-vivo tests conducted specifically for the purpose of demonstrating device performance and safety for the 510(k) submission. They are not analyses of pre-existing clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This concept is not applicable to this type of device submission. "Ground truth" established by experts (e.g., radiologists interpreting images) is a concept relevant to AI/ML or diagnostic devices where human interpretation is being benchmarked or assisted. For a physical embolization device, the "ground truth" is determined by direct physical measurements (e.g., radial force, deployment success) and direct observation of physiological effects in animal models. No human experts are described as establishing a "ground truth" in the diagnostic sense for these tests.
4. Adjudication Method for the Test Set
This is not applicable in the context of this device and testing. Adjudication methods like 2+1 or 3+1 are used to resolve discrepancies in human interpretations or expert opinions when establishing ground truth for diagnostic accuracy studies. For physical device performance tests (e.g., radial force, deployment), results are typically objective measurements or observations, rather than subjective interpretations requiring adjudication.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
- Done?: No, an MRMC comparative effectiveness study was not done or reported.
- Effect Size of Human Readers Improve with AI vs. Without AI Assistance: This question is not applicable. An MRMC study with AI assistance is specifically designed for AI/ML diagnostic or assistive devices to measure the impact of AI on human reader performance. The AMPLATZER® Vascular Plug II is a therapeutic embolization device, not an AI-powered diagnostic tool.
6. Standalone (i.e., algorithm only without human-in-the loop performance) Study
This is not applicable. The AMPLATZER® Vascular Plug II is a physical embolization device, not an algorithm. Therefore, there is no "standalone algorithm" performance to report.
7. Type of Ground Truth Used
The "ground truth" for this device's performance evaluation was based on:
- Engineering and Biomechanical Measurements: Objective measurements of physical properties (e.g., radial force, handoff force, deployment success, recapture, detachment, strength).
- In Vivo Observation: Direct observation of the device's performance and physiological interaction in animal models under simulated conditions of use. Essentially, the "truth" was whether the device performed as expected and intended in a controlled physical/biological environment.
8. Sample Size for the Training Set
This is not applicable. The concept of a "training set" refers to data used to train an AI/ML model. This device is a physical product, not an AI/ML system.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reasons as point 8.
§ 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).