Search Results

The Koala Vascular Clamps and Inserts are reusable, ring-handled stainless steel clamps for clamping delicate vessels during surgery. They are radiopaque, visualized under fluoroscopy. Designed for tip-first closure to prevent vessel roll-out. Applications include pulmonary, gastrointestinal procedures, peripheral clamping, thoracic procedures such as occlusion of the aorta and vena cave, cross-clamping of the aorta and aortic aneurysms, etc.

The Boss Instrument Koala Vascular Clamps and inserts are reusable, ring-handled stainless steel instruments which have inserts which reduce trauma to the tissue being clamped.

The provided text describes a 510(k) submission for the "Koala Vascular Clamps and Inserts," demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria and a detailed performance evaluation of the device itself.

Therefore, many of the requested details, such as specific acceptance criteria and a study proving those criteria were met, are not available in the provided document. The document focuses on comparing the new device to an existing predicate device to establish substantial equivalence for regulatory approval.

Here's a breakdown based on the available information:

1. A table of acceptance criteria and the reported device performance

This information is not present in the provided document. The document asserts substantial equivalence to a predicate device based on attributes such as indicated use, design, packaging, and materials.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not present in the provided document. The document describes a comparison to a predicate device, not a performance study of the Koala Vascular Clamps and Inserts with a test set.

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 present in the provided document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not present in the provided document.

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

This information is not present in the provided document. This type of study is more relevant for diagnostic AI devices, not for surgical instruments like vascular clamps.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not present in the provided document. This is not applicable to a physical surgical instrument.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not present in the provided document. The basis for comparison is the characteristics and intended use of the legally marketed predicate device.

8. The sample size for the training set

This information is not present in the provided document. This is not applicable to a physical surgical instrument.

9. How the ground truth for the training set was established

This information is not present in the provided document. This is not applicable to a physical surgical instrument.

Summary of what is available:

The document is a "Non-Confidential Summary of Safety and Effectiveness" for a 510(k) premarket notification. It aims to demonstrate that the "Koala Vascular Clamps and Inserts" are substantially equivalent to a legally marketed predicate device.

Predicate Device: Baxter V. Mueller - Fogarty Hydragrip Clamps and Inserts - K951413

Comparison to Predicate Devices (which serves as the "study" for substantial equivalence):

Differences between Other Legally Marketed Predicate Devices:
"The clamps are manufactured and supplied by the same manufacturer. The inserts are manufactured by different companies, but the base material is exactly the same. Therefore there are no significant differences between the intended device and the predicate - Baxter - V. Mueller - Fogarty -Hydragrip Vascular Clamps and inserts approved under K951413."

Conclusion of the FDA:
The FDA reviewed the 510(k) and determined that "the device is substantially equivalent... to legally marketed predicate devices."

This document does not provide a study with acceptance criteria for the Koala Vascular Clamps and Inserts themselves, but rather provides evidence for substantial equivalence to a known device, which is the basis for its regulatory clearance.

Ask a specific question about this device