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510(k) Data Aggregation
(73 days)
K2 MEDICAL VASCULAR CLAMPS
K2 Medical Vascular Clamps are devices intended for temporary or partial occlusion of blood vessels during vascular surgical procedures.
The K2 Medical Vascular Clamps are reusable surgical instruments. To ensure the multi-purpose use of this device, many different models are available. The differences can be as follows: - Some have ring handles with a ratchet closure to adjust the amount of tension applied to . the vessel for occlusion or partial occlusion. - Bulldog style Vascular Clamps are another type of vascular cross clamp that use a spring or cross . action mechanism to apply tension to the vessel for occlusion. - The choice of iaw style depends on the surgeon's preference, based on the type and delicacy of . the vessel to be occluded. The surgeon chooses the vascular clamp based on the anatomy of the site and the type of occlusion desired, based on the type and size of the blood vessels, and surgical techniques. Clamps are either fully or partially occluding an artery or vein with correct tension to produce minimal trauma to vessels. Full occlusion clamps stops blood flow entirely by covering the full vessel. Partial occlusion clamps are placed on part of the vessel to isolate the area to be worked on while allowing blood flow to continue in the rest of the vessel. K2 Medical vascular clamps are made of the following standardized materials Stainless Steel ASTM F 899-07 or Titanium Alloy. The instruments are offered in non-sterile condition.
The provided text describes a 510(k) summary for the K2 Medical Vascular Clamp, which is a reusable surgical instrument. The submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing a study proving specific acceptance criteria for a novel device or AI algorithm.
Therefore, many of the requested categories related to proving device meets acceptance criteria through a study (especially those concerning AI, ground truth, expert readers, and specific performance metrics like sensitivity/specificity) are not applicable to this document.
Here's the information that can be extracted or deduced from the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or a direct performance study with numerical results. Instead, it relies on demonstrating substantial equivalence to an existing predicate device. The "performance" assessment is qualitative, stating:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical properties & safety (e.g., proper occlusion, minimal trauma to vessels) | "The results of non-clinical and bench testing indicates that the new device is completely comparable to the predicate devices." |
| Biocompatibility | "Biocompatibility and sterilization studies were successfully completed." |
| Sterilization suitability | "Biocompatibility and sterilization studies were successfully completed." |
| Technical characteristics | "The K2 Medical product is similar to the predicate device in terms of technical characteristics..." |
| Design | "...design..." |
| Indications for Use | "...Indications for Use..." |
| Target population | "...Target population..." |
| Place of use | "...where it is used..." |
| Sterilization method | "...sterilization method..." |
| Sizes and configurations | "...as well as sizes and configurations." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This document describes a 510(k) submission for a physical medical device (vascular clamp) and relies on bench testing and comparison to a predicate device, not a "test set" of clinical data in the context of an AI or diagnostic device.
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)
Not applicable. "Ground truth" in this context would likely refer to engineering specifications or material standards, rather than expert interpretation of medical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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 instrument, not an AI or diagnostic imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For a device like a vascular clamp, the "ground truth" for performance would be established through engineering standards, material specifications (e.g., Stainless Steel ASTM F 899-07 or Titanium Alloy), and bench testing against established performance parameters for temporary occlusion of blood vessels. It is not externally defined clinical ground truth.
8. The sample size for the training set
Not applicable.
9. How the ground truth for the training set was established
Not applicable.
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