(28 days)
The V. Mueller Cosgrove™ Flex Clamps are indicated 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.
Each V. Mueller Cosgrove™ Flex Clamp device consists of a ring handle, flexible shaft and jaw. The design of the flexible shaft allows the end user to bend the shaft following clamping of the blood vessel providing the user a clear field of visualization to the surgical site.
The proposed device and the predicate device have a similar design, the same materials and the same manufacturing and fabrication methods/processes. The main difference between the subject device and the predicate device is a change to the wire configuration of the cable. In addition, the cleaning and sterilization instructions in the instructions for use were updated in accordance with current guidance. These changes do not raise different questions of safety or effectiveness.
The provided text describes a 510(k) premarket notification for a medical device called "V. Mueller Cosgrove Flex Clamps." This device is a vascular clamp used to temporarily occlude blood vessels.
Based on the provided text, there is no information about a study proving the device meets acceptance criteria related to an AI or algorithm-driven system. The document, K210324, is for a physical medical device (vascular clamps) and its substantial equivalence to previously marketed predicate devices. The "Performance Data" section explicitly states: "N/A - No clinical tests were conducted for this submission." and "The results of the non-clinical tests demonstrate the V. Mueller Cosgrove™ Flex Clamps meet all performance requirements and are substantially equivalent to the predicate devices."
Therefore, I cannot provide the requested information regarding acceptance criteria and studies for an AI/algorithm-driven device, as this document is not about such a device. The "acceptance criteria" and "performance data" discussed in the document relate to the physical properties, reusability, sterilization, and biocompatibility of the vascular clamp itself, as demonstrated by non-clinical tests.
If you intended to ask about a different document or a different type of device, please provide that information.
However, I can extract and present the existing acceptance criteria and performance data for the V. Mueller Cosgrove Flex Clamps as presented in the document, though it won't match the format for an AI/algorithm study:
Acceptance Criteria and Device Performance for V. Mueller Cosgrove Flex Clamps (K210324)
1. Table of Acceptance Criteria and the Reported Device Performance (Non-Clinical)
| Acceptance Criteria (Characteristic) | Standard / Test / FDA Guidance | Reported Device Performance (Summary of Results) |
|---|---|---|
| Instrument strength | Strength Tests, Life Cycle Test | PASS |
| Device must be reusable | Cleaning and Sterilization Tests | PASS |
| Device is able to be cleaned and sterilized | AAMI TIR12, AAMI TIR30, ANSI AAMI ST79, ISO 11138, ISO 17664, ISO 17665 | PASS |
| Device materials are biocompatible | ISO 10993 | PASS |
Note: These criteria pertain to the physical characteristics and functionality of the vascular clamp, not to an AI or algorithm.
Regarding the other points you requested for an AI/algorithm study, they are not applicable to this document as it concerns a physical medical device:
- Sample size used for the test set and the data provenance: Not applicable. The performed tests are non-clinical (e.g., strength tests, material biocompatibility tests), not involving data sets like those for AI.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI validation (e.g., expert consensus on medical images) is not relevant here. Device testing would be performed by qualified engineers/technicians according to established protocols.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 not an AI.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is not an AI.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For this physical device, "ground truth" would be the engineering specifications and performance standards (e.g., tensile strength, sterilization efficacy), which are determined by established scientific methods and industry standards. It's not a "truth" derived from human interpretation of data in the AI sense.
- The sample size for the training set: Not applicable. This device is not an AI.
- How the ground truth for the training set was established: Not applicable. This device is not an AI.
§ 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).