Search Results

Indications for Use (Rx): Hemostatic Dressing is intended for the external, temporary control of severely bleeding wounds.

Indications for Use (OTC): Hemostatic Dressing is intended for temporary external use to stop bleeding of minor wounds, minor cuts and minor abrasions.

Hemostatic Dressing is a sterile non-woven fabric dressing composed of hydrophilic fiber (a mixture of chitosan and chitosan derivative). When applied directly over a wound with pressure, this soft and highly absorbent dressing quickly absorbs blood and turns into a gel to seal the wound. It promotes control of wound bleeding and exudates absorption and promotes coagulation.

The provided text describes a 510(k) premarket notification for a medical device called "Hemostatic Dressing." This document is from the FDA and focuses on demonstrating substantial equivalence to predicate devices, rather than a study proving the device meets specific performance criteria against a predefined acceptance table for a diagnostic or AI-driven device.

Therefore, many of the requested criteria for a study proving a device meets acceptance criteria, such as details on sample sizes for test and training sets, expert adjudication, MRMC studies, or ground truth establishment relevant to an AI/diagnostic device, are not applicable to this document. This document is a regulatory submission for a physical medical product (a dressing).

However, I can extract the information that is present and explain why other information is not included.

Here's an attempt to answer the questions based only on the provided text, recognizing its limitations for the requested specifics:

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

The document does not provide a table of acceptance criteria with specific quantitative performance metrics like sensitivity, specificity, or response times, which are typical for diagnostic or AI devices. Instead, it focuses on demonstrating substantial equivalence to a predicate device. The "performance" is demonstrated through a series of nonclinical tests to show safety and effectiveness comparable to the predicate.

Below is information regarding the types of tests conducted, which imply certain performance expectations, but not a direct acceptance criteria table with reported quantitative results.

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

The document does not specify sample sizes for the "test set" in terms readily comparable to an AI/diagnostic study (e.g., number of images or patient cases). It refers to "representative samples of Hemostatic dressing" for nonclinical tests.

• Sample Size: Not specified quantitatively (e.g., number of units, number of animal subjects for in-vivo). The text only states "representative samples."
• Data Provenance: Not explicitly stated (country, retrospective/prospective). The manufacturer is Jiangsu NewValue Medical Products Co., Ltd. in China, implying testing was likely conducted in China or by contracted labs. The tests are nonclinical, focusing on material properties and in-vitro/in-vivo animal models, not human patient data in the context of an AI study.

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)

Not applicable. This is a material hemostatic dressing, not a diagnostic or AI device that requires expert-established ground truth from images or clinical data. "Ground truth" for this device would relate to validated laboratory testing methods and established material standards.

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

Not applicable. Adjudication methods are relevant for subjective interpretations by multiple experts, typically in diagnostic imaging or clinical assessment studies. This document describes physical, chemical, and biological performance tests, which are objective and do not involve human adjudication in that sense.

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

Not applicable. This is a hemostatic dressing, not an AI-assisted diagnostic device. Therefore, no MRMC study involving human readers or AI assistance would be conducted.

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

Not applicable. This is a physical medical device, not an algorithm.

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

For this type of device, "ground truth" is established through:

• Standardized laboratory assays: For biocompatibility, sterility, pH, absorbency, etc.
• Validated animal models: For in-vivo hemostatic performance.
• Material and chemical property standards: Industry and regulatory standards for composition and purity.

No expert consensus, pathology, or outcomes data from human clinical trials is detailed in this 510(k) summary directly, as the primary goal is substantial equivalence through nonclinical data.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device; therefore, there is no "training set."

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

Not applicable. As there is no training set for an AI model, this question does not apply.

Ask a specific question about this device