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Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5) is indicated for external temporary use as a topical dressing on minor bleeding wounds such as minor cuts, minor lacerations and minor abrasions.

The Polysaccharide Hemostatic Powder (HP-2, HP-5) are sterile, topical wound dressings comprised of plant base polysaccharides. The hemostatic particles contained in powder absorb the water in the blood through physical adsorption, so that the blood components are concentrated to form a stable clot and achieve the purpose of hemostasis.

The information provided pertains to the regulatory submission for a medical device (Polysaccharide Hemostatic Powder) and does not describe acceptance criteria for a study showing device performance in the way typically associated with AI/ML-based diagnostic devices. The document focuses on demonstrating substantial equivalence to a predicate device for regulatory clearance, primarily through non-clinical testing.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, training set information) are not applicable or not explicitly detailed in this type of submission.

However, I can extract the non-clinical testing performed and the conclusions drawn to fulfill the spirit of the request regarding "acceptance criteria" and "study proving the device meets the acceptance criteria" in the context of this regulatory document.

Here's a breakdown based on the provided text:

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

2. Sample size used for the test set and the data provenance

• Sample Size: Not specified in terms of numerical size for the animal model or other non-clinical tests. The document only mentions "a porcine animal model."
• Data Provenance: The animal study was performed (implied as part of the manufacturer's testing). No country of origin for the data is specified, nor is it classified as retrospective or prospective (animal studies are typically prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable. This information is typically required for studies involving human clinicians interpreting data or images. The current submission describes non-clinical and animal testing.

4. Adjudication method for the test set

• Not Applicable. Again, this is relevant for studies involving human interpretation and disagreement resolution, which is not described here.

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. No MRMC study was conducted, as this device is a physical hemostatic powder, not an AI-assisted diagnostic tool.

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

• Not Applicable. This is not an algorithm or software device.

7. The type of ground truth used

• For the animal study ("safety and effectiveness study on a porcine animal model"), the "ground truth" would likely be derived from direct observation of hemostasis and potentially histological examination of the wound site, compared to the performance of the predicate device. For other non-clinical tests (sterilization, shelf-life, biocompatibility, design verification), the ground truth is established by meeting predefined scientific and regulatory standards (e.g., bioassay results meeting specified limits, physical tests meeting design specifications).

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device requiring a training set.

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

• Not Applicable. This is not an AI/ML device requiring a training set.

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The Biopsy Needle is intended for use in obtaining core biopsy samples from soft tissue such as kidney, liver, prostrate, spleen, lymph nodes, and various soft tissue masses. Not intended for use in bone.

The Biopsy Needle is also indicated to provide breast tissue sampling of breast abnormalities. It is designed to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.

The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality (e.g., malignancy). When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.

The Biopsy Needle are used to remove, by cutting, a specimen of tissue for microscopic evaluation. The organs in which the device may be used include but are not limited to breast, kidney, liver, prostate, spleen and lymph nodes plus various soft tissue masses. As the device is single use device, which is individually packaged sterile devices. In the package, there is a whole device with the structure shown in the picture above without any accessories. The packaging is compatible with the product's EO sterilization method. The sterilization validation confirms the packaging is qualified bacterial film to maintain the sterilization condition of the device.

This document describes the Ushare Medical Inc. Biopsy Needle (K191472) and its substantial equivalence to a predicate device. It primarily focuses on comparing technical characteristics and performance testing. However, it does not contain information about the device's diagnostic performance or any studies related to human-in-the-loop performance, as it is a medical instrument (biopsy needle) and not a diagnostic AI/ML device.

Here's a breakdown of the requested information based on the provided text, with clear indications where the information is not available for this type of device submission:

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

The document does not specify formal "acceptance criteria" for diagnostic performance, as the device is a biopsy needle and not a diagnostic tool. Instead, it outlines performance testing to demonstrate substantial equivalence to the predicate device in terms of mechanical, biological, and sterilization characteristics.

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