(167 days)
The UnBalloon Non-Occlusive Modeling Catheter is intended to assist in the modeling of self-expanding endoprostheses in large diameter vessels.
The UnBalloon Non-Occlusive Modeling Catheter consists of an expandable Nitinol mesh in a 14F retractable sheath. The Nitinol mesh design allows for expansion without occluding blood flow. The Nitinol mesh and radiopaque markers are highly visible under fluoroscopy and assist in the positioning of the device. The inner lumen allows for a 0.035 or 0.038 inch guidewire for over-the-wire access. Side ports and clear handle/luer allow the device and guidewire lumen to be flushed. The blue handle allows the device to be sheathed/unsheathed while the clear handle/luer controls the expansion of the Nitinol mesh.
The provided text describes a medical device, the "UnBalloon Non-Occlusive Modeling Catheter," and its premarket notification (510(k) summary). It focuses on demonstrating the device's substantial equivalence to predicate devices rather than providing a detailed study that proves the device meets specific acceptance criteria for performance as an AI/ML product.
Therefore, many of the requested elements are not applicable or cannot be extracted from this document, as they pertain to performance testing of AI/ML devices.
However, I can extract information related to the device's functional performance and safety as described in the "Summary of Product Testing" and "Summary of OUS Post Market Surveillance" sections.
Here's the breakdown of what can be populated based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" with numerical targets in the same way an AI/ML device would have for metrics like sensitivity, specificity, etc. Instead, it lists various assessments performed and their outcomes, indicating successful performance or minimal issues.
| Acceptance Criteria (Implicit from Tests Performed) | Reported Device Performance |
|---|---|
| Product Characterization and Validation: | |
| Worst case Simulated use | Assessed (Implicitly successful) |
| Inflation/Deflation time | Assessed (Implicitly successful) |
| Freedom from leakage | Assessed (Implicitly successful) |
| Kink resistance | Assessed (Implicitly successful) |
| Fatigue | Assessed (Implicitly successful) |
| Hemostasis | Assessed (Implicitly successful) |
| Bond tensile strength | Assessed (Implicitly successful) |
| Radial outward force | Assessed (Implicitly successful) |
| Compatibility with endoprostheses | Assessed (Implicitly successful) |
| Physiological insult (Acute and 28-day) | Assessed via animal testing (Implicitly successful) |
| OUS Post Market Surveillance: | |
| Technical success rate | 100% technical success (13 cases) |
| Adverse events/device related malfunctions | No reported adverse events or device related malfunctions |
| Resheathing of Nitinol cage | Resheathed in all cases without issues |
| Nitinol cage getting hooked/caught | No reports of getting hooked or caught |
| Other complications/adverse events | No other complications or adverse events were reported |
| Blood loss through device | Minimal; 1 recorded result of 3ml through guidewire lumen (as expected) |
| Radiopacity | Overall rating of 'good' in most cases; 2 cases reported some difficulty seeing inner marker bands or sheath marker. |
| Applied modeling force (radial force) | "Appropriate" in 8 (62%) cases; "unknown/cannot judge" in 5 (37%) |
| Device failures | No device failures reported |
| Performance as intended, safe, and effective | "These initial clinical results indicate that the UnBalloon Non-Occlusive Modeling Catheter performs as intended and is as safe and effective as the predicate devices." |
| Biocompatibility | Tested per ISO10993-1 (Implicitly successful) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: 13 cases (OUS Post Market Surveillance).
- Data Provenance: Retrospective collection of data from 13 cases attended by LeMaitre Vascular in Brazil and the European Union. Dates: June 14, 2011 to August 16, 2011.
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 information is not provided. The "Summary of OUS Post Market Surveillance" describes direct observation and recording of outcomes by LeMaitre Vascular staff during cases rather than a formal expert-adjudicated ground truth process. The clinicians performing the procedures are the "evaluative experts" in a practical sense, but their specific qualifications are not detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This type of adjudication method is used for establishing ground truth in diagnostic studies, which is not the nature of this device's evaluation. The data seems to be collected directly from the surgical cases by LeMaitre Vascular personnel.
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/ML device, and no MRMC study was conducted. The evaluation is a direct assessment of the device's performance in clinical use, and a comparison to human readers with/without AI assistance is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the "OUS Post Market Surveillance," the "ground truth" is operational and clinical outcomes observed directly during surgical procedures, reported by LeMaitre Vascular personnel attending the cases. This includes observations on technical success, device performance (e.g., resheathing, non-occlusion), and adverse events, as well as subjective assessments like "radiopacity" and "appropriate modeling force."
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no training set in the context of machine learning.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).