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MedTrade Products CELOX Topical Hemostatic Granules in Soluble Bag are intended to be used to achieve hemostasis in emergency situations for the temporary control of severe topical bleeding.

MedTrade Products CELOX Topical Hemostatic Granules OTC are indicated for the local management of bleeding such as lacerations, minor cuts and abrasions.

MedTrade Products CELOX Topical Hemostatic Granules and MedTrade Products CELOX Topical Hemostatic Granules in Soluble Bag are essentially the same product. In that the CELOX Topical Hemostatic Granules are exactly as in our 510(k) K061079 and the Soluble Bag prevents any accidental spillage of the granules whilst opening the sachet and provides a controlled and accurate delivery System to ensure that the CELOX Topical Hemostatic Granules are applied directly onto the wound site as quickly and efficiently as possible. On contact with liquid the soluble bag will dissolve in 30 to 70 seconds

MedTrade CELOX Topical Hemostatic Granules in Soluble Bag are intended as a temporary external wound treatment for the control of severely bleeding wound for emergency use and are intended for emergency use as an external temporary traumatic wound treatment to achieve Hemostatis and prevent blood loss. The product is designed and packaged to be easily packed, carried and applied using only one hand. It is well suited for moderate to large eviscerating wounds, to create hemolysis by coagulation.

The provided document is a 510(k) premarket notification letter from the FDA for MedTrade Products CELOX Topical Hemostatic Granules. It primarily discusses the substantial equivalence of the device to previously marketed predicates and its regulatory classification. It does not contain information about specific acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC studies for AI/device performance.

Therefore, I cannot provide details on those points based on the given text. The document focuses on regulatory approval rather than clinical study results or performance metrics in the way your request frames it (e.g., acceptance criteria for a diagnostic AI device).

The only relevant information that can be extracted is:

• Device Name: MedTrade Products CELOX Topical Hemostatic Granules OTC; MedTrade Products CELOX Topical Hemostatic Granules in Soluble Bag
• Intended Use (CELOX Topical Hemostatic Granules in Soluble Bag): Intended to be used to achieve hemostasis in emergency situations for the temporary control of severe topical bleeding.
• Intended Use (CELOX Topical Hemostatic Granules OTC): Indicated for the local management of bleeding such as lacerations, minor cuts and abrasions.
• Predicate Devices mentioned:
  • MedTrade Products CELOX Topical Hemostatic Granules (K061079)
  • Z-Medica Corporation QuikClot ACS (K051955)

Summary of what cannot be provided from the document:

• Table of acceptance criteria and reported device performance: This document does not describe specific performance metrics or acceptance criteria for the device's hemostatic capabilities.
• Sample sizes used for the test set and data provenance: No clinical study details (including sample sizes, country of origin, retrospective/prospective nature) are provided.
• Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable as no such test set or ground truth establishment is described.
• Adjudication method: Not applicable.
• MRMC comparative effectiveness study: Not mentioned.
• Standalone (algorithm only) performance: Not applicable, as this is a physical medical device, not an algorithm.
• Type of ground truth used: Not applicable.
• Sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

The document states that biocompatibility testing was conducted, including: Dermal Irritation, Dermal Sensitisation, Cytotoxicity, Acute Systemic Toxicity, and Hemolysis for the CELOX Granules. Dermal Irritation, Dermal Sensitisation, and Cytotoxicity were conducted on the Soluble Bag. Cytotoxicity and Systemic injection were conducted on the CELOX Granules in the Soluble Bag. However, it does not provide acceptance criteria or specific results for these tests.

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