(349 days)
The KSEA Deployable Vascular Clamp is intended for use by qualified surgeons for temporary cross-occlusion of arteries and veins ranging between 0.3 -1.6 cm in diameter during endoscopic surgery.
The KSEA Deployable Clamp is a manual surgical instrument for temporary cross occlusion of blood vessels. The body contact materials are surgical grade stainless steel.
The provided text is a 510(k) summary for the KSEA Deployable Vascular Clamp. This type of document focuses on establishing substantial equivalence to a predicate device rather than presenting detailed performance studies against specific acceptance criteria.
Based on the information provided, here's what can be extracted and what is not available:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state acceptance criteria in the form of numerical thresholds or performance targets. Instead, it relies on the concept of "substantial equivalence" to a predicate device. The performance is described in qualitative terms, asserting similarity to the predicate.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device in dimensions. | "dimensions... are similar." |
| Substantial equivalence to predicate device in performance. | "performance... are similar." |
| Substantial equivalence to predicate device in materials. | "stainless steel... are similar." |
| Substantial equivalence to predicate device in intended uses. | "intended uses are similar." |
| Device does not raise new issues of safety and effectiveness compared to predicate. | "The minor differences... raise no new issues of safety and effectiveness, as these differences have no effect on the performance, function or intended use of these devices." |
| Intended for temporary cross-occlusion of arteries and veins 0.3 - 1.6 cm in diameter. | The device is intended for this use. (This is an indication for use, not a performance metric directly, but implies the device can effectively occlude vessels within this range). |
| For use during endoscopic surgery. | The device is intended for this use. |
2. Sample Size Used for the Test Set and Data Provenance:
This information is not provided in the 510(k) summary. A 510(k) submission typically focuses on comparison with a predicate, and detailed clinical study data with specific test sets and provenance might not be included in the summary if the device is deemed substantially equivalent based on design, materials, and intended use.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
This information is not provided. As there's no mention of a formal clinical test set requiring expert adjudication for ground truth, this detail is absent.
4. Adjudication Method:
This information is not provided.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:
This information is not provided. The document makes no mention of a study involving human readers or AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance:
This is not applicable. The KSEA Deployable Vascular Clamp is a manual surgical instrument, not an AI/algorithm-driven device.
7. Type of Ground Truth Used:
Ground truth, in the context of device performance, would typically involve direct measurement or observation of the device's ability to occlude vessels within the specified diameter range. However, the document relies on comparison to a predicate device for establishing safety and effectiveness, rather than presenting novel ground truth data from new studies. The "ground truth" used for approval is the existing safety and effectiveness profile of the predicate device.
8. Sample Size for the Training Set:
This information is not applicable as the device is a manual surgical instrument and does not involve machine learning algorithms requiring a training set.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the same reason as point 8.
In summary: The provided 510(k) summary for the KSEA Deployable Vascular Clamp demonstrates that the device meets acceptance criteria through the principle of substantial equivalence to an existing predicate device. The "study" proving this involves a comparison of the new device's design, materials, and intended use with that of the predicate, concluding that any minor differences do not raise new issues of safety or effectiveness. Detailed clinical trials with specific performance metrics and ground truth establishment (as would be seen for a novel or AI-powered device) are not presented in this summary document.
§ 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).