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The Shengwei Biopsy needle consist of Model 121 Biopsy Needle, Model 111/112 Biopsy Needle, and Model 13 1 Disposable Coaxial Biopsy Needle. These devices are indicated for use as follows:

Model 121 Biopsy Needle is intended for obtaining percutaneous or surgical histological core samples from soft tissues such as breast, kidney, liver, lung and various soft tissue masses. The device is not intended for use in bone.

Model 111/112 Biopsy Needle is intended for obtaining core biopsy from samples soft tissues such as kidney, liver, prostate and various soft tissue masses. The device is not intended for use in bone.

Model 111/112 Biopsy Needle is also indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is designed to provide breast tissue for histologic examination with partial or complete removal of the abnormality.

Model 131 Disposable Coaxial Biopsy Needle is intended for use with biopsy needle during soft tissue core biopsy procedures. The device is not intended for use in bone.

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

The Shengwei Biopsy needle include semi-automatic and automatic spring powered guns (disposable). Cannula accessory is provided in a variety of sizes, designed to work with the manufacturer's semi-automatic and automatic guns to obtain and deliver a soft tissue core sample, facilitate skin and tissue penetration, sample retention and / or expulsion depending on the sample sites.

The provided document describes the acceptance criteria and the study that proves the device meets the acceptance criteria for the Shengwei Biopsy Needles (Model 121, Model 111/112, and Model 131 Disposable Coaxial Biopsy Needle).

Here's a breakdown of the requested information:

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

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

• Sample Size: For performance testing (Depth Projection, Penetration Force, Activation Force, Mechanical Durability, Extraction), "Samples of each device product family (subject device) were selected at the extremes of device design for needle length and gauge sizes." For Depth Projection, Activation Force, and Extraction, testing was performed "over 50 shots per use." For Penetration Force, "Each tested subject and predicate device was activated 50 times." For Shelf-life, "Three lots of aged and non-aged subject devices were tested in triplicate."
• Data Provenance: The document does not explicitly state the country of origin of the data for these performance tests. It also does not explicitly state whether the tests were retrospective or prospective, but given they are laboratory performance tests, they are inherently prospective for the purpose of this submission.
• Clinical Data: No clinical data was included in this submission.

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)

• This information is not applicable as the studies described are laboratory performance tests focusing on mechanical and biological properties of the device, not clinical performance requiring expert interpretation or ground truth establishment in a medical context.

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

• This information is not applicable as the studies described are laboratory performance tests measuring quantifiable physical properties of the device, not clinical studies involving interpretation or adjudication.

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

• No MRMC study was done. This document is for a medical device (biopsy needle), not an AI-assisted diagnostic tool for human readers.

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

• No standalone (algorithm only) performance study was done. This document is for a physical medical device (biopsy needle), not a diagnostic algorithm.

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

• For biocompatibility, the ground truth is established by recognized international standards (ISO 10993 series and USP tests) which define acceptable biological responses.
• For performance testing, the ground truth is established by specific criteria outlined in the testing protocols (e.g., "Needle Advancement > 20 mm," "Breakage Force (SHENGWEI) > FPredicate") and comparison to legally marketed predicate devices. Quantitative measurements are taken against these predefined standards or predicates.

8. The sample size for the training set

• This information is not applicable as the document describes laboratory performance and biocompatibility testing for a physical medical device, not a machine learning model that would require a training set.

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

• This information is not applicable for the same reason as point 8.

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