(212 days)
The CTS MIDCAB Coronary Shunt is intended to be used during minimally invasive direct coronary artery bypass ("MIDCAB") procedures in conjunction with or without the CTS MIDCAB™ Access Platform and Stabilizer. The CTS Coronary Shunt is designed to help reduce blood in the operative field by temporary occlusion of the artery and to provide blood flow distal to the arteriotomy. This CTS Coronary Shunt is not an implant and is removed prior to completion of the surgery.
The CTS MIDCAB Coronary Shunt is a hollow tube with atraumatic tips on each end and two seals which are utilized for proximal and distal occlusion of the artery. The atraumatic tips are tapered for easy insertion and removal from the artery. Each tip contains holes to provide for blood flow into and out of the CTS Shunt. The thread or tether is attached to a tab and is used to aid insertion and removal of the CTS Shunt. The blood is occluded and flows through the Shunt which reduces the blood in the operative field. Also included with the CTS MIDCAB Coronary Shunt is a Shunt Remover, which is a cylinder which can be used to withdraw the CTS Shunt following completion of the procedure.
The provided text is a 510(k) summary for a medical device (CTS MIDCAB™ Coronary Shunt) and does not describe a study that uses acceptance criteria and device performance metrics in the way typically seen for AI/ML-based medical devices or diagnostic tools.
Instead, this document describes a traditional medical device submission where the "acceptance criteria" are implied to be adherence to general safety and effectiveness standards, functional requirements, and biocompatibility, often benchmarked against predicate devices. The "study" refers to a series of tests performed to demonstrate this adherence.
Therefore, many of the specific questions you've asked (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance for AI, training set size) are not applicable to this type of device submission as they pertain to the evaluation of AI/ML algorithms or diagnostic performance, which is not what this document addresses.
However, I can extract the relevant information from the document as it pertains to traditional device acceptance.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied from document) | Reported Device Performance |
|---|---|
| Functional Performance: Device functions according to its intended use instructions. | "All testing conducted confirmed the acceptability of the CTS Shunt to perform as intended to help reduce blood in the operative field by temporary occlusion of the artery while providing blood flow distal to the arteriotomy." |
| Biocompatibility: Materials are acceptable for use as directed and do not cause adverse biological reactions. | "The biocompatibility testing was conducted on the CTS MIDCAB Coronary Shunt and Shunt materials to ensure the acceptability of the CTS MIDCAB Coronary Shunt when used as directed. The CTS Shunt and Shunt materials passed the necessary biocompatibility tests." |
| Substantial Equivalence: Device is substantially equivalent to predicate devices with regard to intended use, function, physical characteristics, materials, and sterilization method, with no significant effect on safety and effectiveness. | "The CTS MIDCAB Coronary Shunt is substantially equivalent to predicate devices currently being marketed... All necessary testing was performed... to ensure the product is substantially equivalent to the predicate devices and to ensure that the CTS Coronary Shunt does not have any differences which have a significant effect on safety and effectiveness." |
| Safety and Effectiveness: When used according to intended use. | "All necessary testing was conducted on the CTS MIDCAB Coronary Shunt to ensure that the device is safe and effective when used in accordance to its intended use." |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. The document states "All necessary testing was performed," but does not provide numbers for units tested.
- Data Provenance: Not applicable. This refers to testing of a physical medical device, not analysis of medical data. The tests would have been performed in a laboratory or simulated environment by the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This device is not an AI/ML diagnostic tool requiring expert ground truth for interpretation. Its performance is assessed through functional and biocompatibility tests.
4. Adjudication method for the test set
- Not Applicable. As above, no expert adjudication process is described or implied for this type of device testing.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- No. This is a physical device, not an AI/ML diagnostic tool. MRMC studies are not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This is a physical device, not an algorithm. Its performance is inherently "standalone" in that it performs its physical function without human intervention after placement.
7. The type of ground truth used
- Not Applicable/Implied by engineering standards. For a physical device, "ground truth" is typically defined by engineering specifications, material properties, and biological safety standards (e.g., ISO standards for biocompatibility, functional tests against design specifications). There isn't a "ground truth" derived from expert consensus, pathology, or outcomes data in the way an AI diagnostic would require.
8. The sample size for the training set
- Not Applicable. This is a physical device. There is no concept of a "training set" as it would apply to AI/ML.
9. How the ground truth for the training set was established
- Not Applicable. There is no "training set" for this type of device.
Summary Limitations: The provided 510(k) summary is a high-level overview intended to demonstrate substantial equivalence to predicate devices and adherence to general safety and effectiveness. It does not contain the detailed study protocols, specific acceptance criteria values (e.g., a specific pressure tolerance, a specific flow rate), or quantitative results that would be found in full test reports. This level of detail is typically reviewed by the FDA but is not always included in the public 510(k) summary document itself.
§ 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).