(172 days)
Used to occlude a blood vessel temporarily. Used in pulmonary and gastrointestinal procedures and can be used to clamp over indwelling catheters. Also used in minimally invasive and standard open cardiovascular procedures for temporary occlusion of a blood vessel.
The Allegiance Cosgrove™ Clamp is a reusable device which features a stainless steel handle, flexible shaft and jaws. The Cosgrove™ Clamp is designed to be used with a variety of inserts which gently surround blood vessels and offer differing degrees of atraumatic occlusion. Following the clamping of the blood vessel, the shaft of the device can be bent out of the way to enhance visualization of and access to the operative field.
The provided document describes the Allegiance Cosgrove™ Clamp, a reusable device for temporary occlusion of blood vessels. However, it is a Premarket Notification 510(k) submission, which focuses on demonstrating substantial equivalence to a predicate device rather than conducting a full clinical study with acceptance criteria and detailed performance metrics as would be found in a Premarket Approval (PMA) application.
Therefore, many of the specific questions regarding acceptance criteria, study details, and ground truth establishment cannot be fully answered from this document. The submission states that testing was performed but provides a summary rather than detailed results or the methodology for establishing acceptance criteria for specific performance metrics.
Here's what can be extracted and inferred from the document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with corresponding performance data in the traditional sense of a clinical study. Instead, it makes a general statement:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| All materials used in the composition were subjected to performance and physical tests to evaluate safety, effectiveness, and reliability. | "All test results were acceptable." |
This statement indicates that internal testing was conducted, and the device met the manufacturer's internal criteria for safety, effectiveness, and reliability. The specific quantitative acceptance criteria and the detailed test results are not provided in this summary.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not provide information on the sample size used for the "performance and physical tests" or the data provenance (e.g., country of origin, retrospective or prospective nature of the data). This type of detail is typically found in full test reports, which are not part of this summary document.
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 applicable and not provided. The testing described appears to be engineering/ bench testing, not a clinical study where expert-established ground truth would be relevant for diagnostic accuracy or clinical outcomes.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as this was not a clinical study involving human assessment that would require adjudication of expert opinions.
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 device is a surgical clamp, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance is irrelevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the "performance and physical tests," the ground truth would be engineering specifications, material standards, and perhaps simulated use conditions for mechanical integrity and functionality. It would not typically involve expert consensus, pathology, or outcomes data in the way these terms are used for diagnostic or therapeutic efficacy studies.
8. The sample size for the training set
Not applicable. There is no mention of a training set as this is not a machine learning or AI-based device.
9. How the ground truth for the training set was established
Not applicable.
Summary from the provided text:
The core of the submission focused on demonstrating substantial equivalence to predicate devices (Fogarty-Hydragrip® Surgical Clamps and Applied Vascular Atraumax™ Surgical Clamps) based on:
- Same Intended Use: "to be used for the temporary occlusion of blood vessels and other delicate vessels during surgery."
- Same Performance Attributes: General statement.
- Same Atraumatic Jaw design characteristic: General statement.
The document states: "All materials used in the composition of the Cosgrove™ Clamp were subjected to performance and physical tests to evaluate the safety, effectiveness and reliability of the device. All test results were acceptable." This indicates that internal design verification and validation (DV&V) testing was performed to meet internal acceptance criteria, which were deemed satisfactory by the FDA for the purpose of 510(k) clearance based on substantial equivalence. However, the specifics of these tests and their acceptance criteria are not detailed in this public summary.
§ 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).