(436 days)
The Nfocus Neuromedical Acta Vessel Occlusion System (VOS) is indicated for arterial and venous embolizations in the peripheral vasculature specifically within the abdominal and thoracic cavities.
The Acta "Vessel Occlusion System (VOS) is provided sterile and is intended for one-time use. The implant is a self-expandable, ovoid shaped implant with delivery device. The implant is made from a double layer of Nitinol wire mesh which is secured at proximal and distal ends with platinum marker bands. The delivery device allows the implant to be delivered through commercially available catheters. Detachment of the implant from the delivery device is achieved by operator activation of the delivery handle.
The provided text describes a Premarket Notification [510(k)] Summary for the Nfocus Neuromedical Acta™ Vessel Occlusion System (VOS). This device is an arterial embolization device. The document primarily focuses on establishing substantial equivalence to a predicate device (Amplatzer Vascular Plug) rather than detailing specific acceptance criteria and a study to prove meeting those criteria in the way one might typically find for an AI/ML medical device.
Therefore, many of the requested categories (especially those related to AI/ML device performance, human reader studies, and ground truth establishment for training/test sets) are not directly applicable or explicitly mentioned in this type of regulatory submission for a physical medical device.
However, I can extract the information that is present:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present specific quantitative acceptance criteria or reported device performance in a table format that mimics an AI/ML model's output metrics (e.g., sensitivity, specificity, AUC). Instead, it lists various tests that have been or will be performed prior to commercialization to ensure the product meets requirements and conforms to needs and intended uses. These are related to the physical integrity, material properties, and functionality of the device.
| Criteria Category | Specific Test / Implication | Reported Device Performance (Implied) |
|---|---|---|
| Delivery System | Dimensional | Not explicitly stated, but implied to meet defined engineering specifications for dimensions. |
| Tensile Strength | Not explicitly stated, but implied to meet defined engineering specifications for strength. | |
| Corrosion Resistance | Not explicitly stated, but implied to meet defined engineering specifications for corrosion resistance. | |
| Force to Deploy | Not explicitly stated, but implied to meet defined engineering specifications for deployment force. | |
| Implant | Dimensional | Not explicitly stated, but implied to meet defined engineering specifications for dimensions. |
| Tensile Testing | Not explicitly stated, but implied to meet defined engineering specifications for tensile properties. | |
| Recapture Force | Not explicitly stated, but implied to meet defined engineering specifications for recapture force. | |
| Radial Force | Not explicitly stated, but implied to meet defined engineering specifications for radial force. | |
| Corrosion | Not explicitly stated, but implied to meet defined engineering specifications for corrosion resistance. | |
| MRI Compatibility | Not explicitly stated, but implied to meet defined engineering specifications for MRI compatibility. | |
| Radiopacity | Not explicitly stated, but implied to meet defined engineering specifications for visibility under X-ray. | |
| Fatigue | Not explicitly stated, but implied to meet defined engineering specifications for fatigue life. | |
| System | Simulated Device Use | Not explicitly stated, but implied that the device will perform as intended during simulated use scenarios, confirming functionality for vascular occlusion. |
| Substantial Equivalence | "Any differences in technological characteristics... do not raise any new issues of safety or effectiveness." | The overall conclusion is that the Acta VOS is substantially equivalent to the predicate device, implying its performance is comparable and safe/effective for its intended use based on these tests and design similarities. This is the primary "performance" reported in this 510(k) summary. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. The document refers to "testing" (e.g., tensile strength, corrosion, simulated use) which typically involves a number of physical units, but the specific sample sizes for each test are not provided.
- Data Provenance: Not applicable in the context of this device type. These are engineering and biocompatibility tests performed on the physical device, not clinical data from patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not applicable for a physical device like the Acta VOS. "Ground truth" in this context would be engineering specifications and standards, verified by qualified engineers and lab personnel, not medical experts establishing a diagnosis from patient data.
4. Adjudication method for the test set
- Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing clinical ground truth from expert reads of medical images/data. For device performance testing, results are measured against established engineering standards and specifications.
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 a physical medical device, not an AI/ML algorithm intended to assist human readers. Therefore, an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a physical medical device.
7. The type of ground truth used
- The "ground truth" for this device's performance testing would be established technical specifications, engineering standards, biocompatibility requirements, and regulatory guidelines (e.g., for MRI compatibility, material properties). The device's performance is measured against these established quantitative and qualitative criteria to demonstrate safety and effectiveness and substantial equivalence.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established
- Not applicable.
§ 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).