(86 days)
The MO.MA® ULTRA Proximal Cerebral Protection Device is indicated as an embolic protection system to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures involving lesions of the internal carotid artery and or the carotid bifurcation. The reference diameter of the external carotid artery should be between 3-6 mm and the reference diameter of the common carotid artery should be between 5-13 mm.
The MO.MA® ULTRA Proximal Cerebral Protection Device consists of a multi-lumen shaft integrating two compliant occlusion balloons. The device is packaged with one hollow mandrel, one hemostatic valve with two-way stopcock and extension tubing, three 40 um filter baskets, one 30 cc syringe with male luer, one T-safety connector and two 1-way stopcocks. The MO.MA® ULTRA Proximal Cerebral Protection Device achieves cerebral protection by occluding the common carotid artery (CCA) and the external carotid artery (ECA) with two compliant balloons. Occluding the CCA and ECA produces blockage of antegrade and retrograde blood flow at the carotid bifurcation to prevent distal embolization of particulate debris and allow removal of particulate debris by blood aspiration.
Here's the analysis of the provided text regarding the MO.MA® ULTRA Proximal Cerebral Protection Device:
Acceptance Criteria and Device Performance Study
The provided 510(k) summary for the MO.MA® ULTRA Proximal Cerebral Protection Device focuses on establishing substantial equivalence to a predicate device and relies on clinical data compared against a pre-established performance goal. It does not explicitly define traditional "acceptance criteria" in terms of specific performance metrics (like sensitivity, specificity, accuracy) but rather sets a performance goal for a clinical outcome.
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Goal | Reported Device Performance |
|---|---|
| 30-day major adverse cardiac and cerebrovascular events (MACCE) composite rate compared to a performance goal derived from previous carotid stenting trials. | "The primary endpoint results of the trial were successful compared to the established performance goal and thus demonstrated the safety and efficacy of the Mo.Ma® device." (Specific quantitative rate not provided in the abstract) |
Note: The exact quantitative performance goal for MACCE and the device's actual MACCE rate are not explicitly stated in this 510(k) summary, only that the device met the goal.
2. Sample Size and Data Provenance for the Test Set
- Sample Size for Test Set: 262 patients
- Data Provenance: Prospective, multi-center study conducted in the United States (184 patients at 20 sites) and Europe (78 patients at 5 sites).
3. Number of Experts and Qualifications for Ground Truth
The document does not specify the number of experts used to establish ground truth or their qualifications. The study focused on clinical outcomes (MACCE), which are typically assessed by physicians and clinical staff involved in patient care and follow-up, but no independent expert panel for ground truth assessment is described.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method for the test set. Clinical endpoints like MACCE are usually determined by the treating physicians and confirmed through medical records, but there's no mention of a specific adjudication panel or method (e.g., 2+1, 3+1).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There was no MRMC comparative effectiveness study described. This device is a physical medical device (cerebral protection device) used during a procedure, not an AI/software product requiring human reader interpretation or assistance. Therefore, the concept of human readers improving with or without AI assistance does not apply.
6. Standalone (Algorithm Only) Performance
This question is not applicable as the device is a physical medical device, not an algorithm or AI.
7. Type of Ground Truth Used
The ground truth used was outcomes data, specifically the 30-day major adverse cardiac and cerebrovascular events (MACCE) composite rate.
8. Sample Size for the Training Set
This question is not applicable. The device is a physical medical device, not an AI/software requiring a training set.
9. How the Ground Truth for the Training Set was Established
This question is not applicable as there was no training set for an algorithm.
§ 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).