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CELSTAT is indicated for topical external use in the management of topical wounds and to temporarily control moderate to severe bleeding from the skin.

CELSTAT is a topical hemostatic dressing made of oxidized cellulose. It is a sterile, biocompatible, biodegradable hemostatic material designed to temporarily control moderate to severe bleeding from the skin.

The provided document is a 510(k) summary for the CELSTAT Topical Hemostatic Dressing. It categorizes the device as unclassified and specifies its product code as FRO (later updated to QSY). The document asserts the device's substantial equivalence to a predicate device based on technological characteristics, performance, and intended use.

Here's an analysis based on the information provided, specifically addressing the requested points:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with numerical targets. Instead, it states that "Device performance has been demonstrated according to a porcine liver square model animal study and biocompatibility testing." The conclusion further asserts that the device is "as safe and effective as the predicate device" based on testing against established standards and guidelines.

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

• Test Set Sample Size: The document mentions a "porcine liver square model animal study" but does not specify the sample size (e.g., number of animals, number of liver squares).
• Data Provenance: The study was an animal study (porcine liver model). It is a preclinical study, not a human retrospective or prospective study. The country of origin of the data is not specified.

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

This information is not provided in the document. As an animal study, the "ground truth" would likely be objective measurements of hemostasis (e.g., time to hemostasis, blood loss) rather than expert consensus on interpretative data.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given it's an animal study, a formal adjudication process by multiple humans is unlikely to be relevant in the same way as an imaging study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret medical images with and without AI assistance. The CELSTAT device is a topical hemostatic dressing, a therapeutic device, for which MRMC studies are not applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone "algorithm only" performance would not be relevant for this device. The CELSTAT device is a physical dressing, not an AI algorithm. Its performance is inherent to its physical and chemical properties and how it interacts with biological tissue.

7. The Type of Ground Truth Used

The ground truth for the "porcine liver square model animal study" would likely be objective physiological measurements related to blood clotting, such as:

• Time to hemostasis
• Volume of blood loss
• Observed cessation of bleeding

This is based on the nature of a hemostatic dressing. The document does not explicitly detail the specific measurements.

8. The Sample Size for the Training Set

The concept of a "training set" is primarily applicable to machine learning or AI algorithms. Since the CELSTAT Topical Hemostatic Dressing is a physical medical device and not an AI-driven product, there is no training set in the context of an algorithm. The development of the device would involve materials science, engineering, and in vitro/in vivo testing, but not an algorithmic training process.

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

As there is no training set for this device, the question of how its ground truth was established is not applicable.

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