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CoreLeader HEMO-Bandage is intended to be used as a topical dressing to temporarily control moderate to severe external bleeding resulted from traumatic or surgical wounds.

CoreLeader HEMO-Bandage is woven gauze made of chitosan fiber and rayon fiber. Chitosan is a type of organic polysaccharide carrying positively-charged ions. Appearing light yellow color and inheriting biodegradability and biocompatibility of chitosan. CoreLeader HEMO-Bandage achieves hemostasis by attracting erythrocytes to the injured sites and facilitates blood clot formation. CoreLeader HEMO-Bandage is sterilized by gamma-ray radiation to 10th SAL after packed in a foil bag. With the softness and flexibility, it is readily conformable to various wound shapes.

This document is a 510(k) summary for the CoreLeader HEMO-Bandage, a device intended to control bleeding. The primary purpose of this submission is to demonstrate substantial equivalence to legally marketed predicate devices. The study detailed focuses on non-clinical performance and safety rather than a clinical trial with human subjects for diagnostic accuracy.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria seem to be implicit in demonstrating equivalence to previously approved predicate devices, particularly regarding safety and certain aspects of performance. The performance data is presented in a table comparing the proposed device against predicate devices based on various tests.

2. Sample Size Used for the Test Set and Data Provenance

The provided document describes non-clinical tests, primarily in-vitro and animal studies, not human clinical trials.

• Sample Size for Biocompatibility (animal studies):
  • Skin Irritation Test: In vivo rabbit skin irritation test. (Specific number of rabbits not stated).
  • Skin Sensitization Test: In vivo guinea pig skin sensitization test. (Specific number of guinea pigs not stated).
  • Systemic Toxicity Test: In vivo systemic toxicity test. (Specific animal type and number not stated).
• Sample Size for Hemostasis Test: In vivo swine femoral arterial hemorrhage model. (Specific number of swine not stated).
• Data Provenance: The document does not explicitly state the country of origin for the non-clinical test data. However, the submitting company is CoreLeader Biotech Co., Ltd. from New Taipei City, Taiwan (R.O.C.), suggesting the studies were likely conducted or overseen in Taiwan. All tests are referred to as "non-clinical tests." These are prospective tests conducted on the device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as the described tests are non-clinical (laboratory and animal studies) and do not involve human diagnostic decisions or expert-established ground truth in the context of clinical accuracy.

4. Adjudication Method for the Test Set

This information is not applicable for the same reason as point 3.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A multi-reader multi-case (MRMC) comparative effectiveness study, which typically involves human readers assessing diagnostic performance with and without an AI device, was not performed or described. The device is a "topical hemostasis wound dressing," not a diagnostic AI tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This concept is not directly applicable as the CoreLeader HEMO-Bandage is a physical medical device (wound dressing) and not a software algorithm. The "standalone performance" presented here refers to the device's inherent physical, chemical, and biological properties and its ability to achieve hemostasis in an animal model, independent of human interaction beyond application.

7. Type of Ground Truth Used

The "ground truth" for the non-clinical studies was established by:

• Standardized laboratory protocols: For sterility, cytotoxicity, irritation, sensitization, systemic toxicity, heavy metal residue, fluid absorption, and tensile strength, the "ground truth" is defined by the results meeting or not meeting the specified international standards (e.g., AAMI/ANSI/ISO 11137-1, AAMI/ANSI/ISO 10993 series, EN 13726-1) or established methods (Journal of AOAC International).
• Physiological observation/measurement in animal models: For the in vivo hemostasis test in swine, the ground truth was the observable cessation of bleeding from a femoral artery hemorrhage within a specified time (<10 minutes).

8. Sample Size for the Training Set

This device is not an AI/machine learning algorithm, so there is no "training set" in the context of algorithm development. The non-clinical tests described are validation tests for the physical product.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no training set for an AI algorithm.

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