(31 days)
The Pruitt-Inahara®, Inahara-Pruitt® and Pruitt® F3 carotid shunts are indicated for use in carotid endarterectomy as a temporary conduit to allow for blood flow between the common and internal carotid arteries. The size 8 French Shunt is intended for use on those patients whose vasculature is too small to accommodate a size 9 French Shunt.
The proposed Pruitt® F3 Shunts are designed to serve as temporary blood conduits connecting one section of a vessel to a second area of the same vessel. This allows blood to continuously flow to the patient's brain during an endarterectomy procedure. The device is manufactured using a clear, plastic, sterile conduit, which is held in place by a stabilization technique on both ends of the conduit. The Pruitt® F3 Shunts are tri-lumen devices with balloons on both the distal (internal carotid) and proximal (common carotid) ends of the shunt. The balloons, when inflated independently, act as a stabilization mechanism to maintain the position of the shunt when it is placed within the common and internal carotid arteries. An external safety balloon, located on the inflation arm internal ourbild afternal carotid) balloon, acts as a mechanism to relieve pressure on the internal carotid balloon in the event it inflates above the maximum stated volume. The external safety balloon feature reduces the possibility of balloon over-inflation and resultant vessel damage.
The provided document is a 510(k) summary for the Pruitt® F3 Carotid Shunt, seeking substantial equivalence to a predicate device. It details the device's design, intended use, and technological characteristics. However, it does not contain acceptance criteria or a study report proving the device meets specific performance criteria in the way a clinical or AI performance study would.
Instead, this document focuses on demonstrating substantial equivalence to an already approved predicate device (Next Generation Pruitt-Inahara® Outlying Carotid Shunt, K043023) primarily through comparisons of materials, design, and bench testing.
Therefore, the requested information elements related to acceptance criteria, device performance, sample sizes for test/training sets, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance are not available in this specific document.
The document states:
"The safety and effectiveness of the proposed Pruitt® F3 Shunts has been demonstrated through data collected from bench tests and analyses."
This implies that the "study" demonstrating safety and effectiveness was a series of bench tests, not a clinical trial or an AI algorithm performance study.
Here's an analysis based on the available information:
1. Table of acceptance criteria and the reported device performance:
This information is not provided in the document. The document primarily focuses on demonstrating substantial equivalence to a predicate device through technological characteristics and bench tests, rather than setting and reporting against specific quantitative acceptance criteria for device performance (e.g., accuracy, sensitivity, specificity for an AI device).
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not applicable/not provided as this document describes bench testing for a physical medical device, not an AI/software device that would typically have a "test set" of data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable/not provided. Ground truth in the context of this device would relate to engineering specifications and performance during bench testing, not expert consensus on medical images or diagnoses.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable/not provided.
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:
This information is not applicable/not provided. This is a physical medical device, not an AI system assisting human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable/not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For this type of device, the "ground truth" would be established by engineering specifications, material properties, and physical performance under controlled bench testing conditions, comparing against the predicate device and established standards. The document does not explicitly state the specific ground truth types (e.g., specific tensile strength values, flow rates, balloon inflation pressures).
8. The sample size for the training set:
This information is not applicable/not provided. This is for a physical device, not an AI training set.
9. How the ground truth for the training set was established:
This information is not applicable/not provided.
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).