Search Results

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.

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

This information is not available in the provided text. The document refers to "Performance Testing" which includes comparison testing with a predicate device and specific tests for biocompatibility, sterility, shelf-life, and mechanical function. However, details about the sample sizes of devices tested, the origin of the samples (e.g., if tissue samples were used), or whether the data was retrospective or prospective are not provided.

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/available. As a biopsy needle, the device itself does not establish a "ground truth" in a diagnostic sense (e.g., identifying disease from an image). Its function is to obtain tissue samples. The "ground truth" for the effectiveness of the biopsy sample, once acquired, would typically be established by a pathologist examining the tissue. This document does not detail any studies involving expert interpretation of collected biopsy samples.

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

This information is not applicable/available. Adjudication methods are typically relevant for diagnostic studies where expert consensus is needed to establish a ground truth for imaging or other diagnostic interpretations. For a physical device like a biopsy needle, this concept does not directly apply to the reported performance testing.

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

This information is not applicable. This device is a biopsy needle, an instrument used for tissue sampling, not an AI/ML-driven diagnostic tool. Therefore, an MRMC study or an assessment of human reader improvement with AI assistance is not relevant to this submission.

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

This information is not applicable. This is a medical instrument (biopsy needle), not an algorithm or AI system.

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

This information is partially applicable but not explicitly detailed for the performance testing.

• For Biopsy Sample Testing, the "ground truth" would implicitly be the histological examination of the tissue samples. The text states "Comparison of samples obtained by predicate and proposed devices to prove equivalency." This suggests that the quality or characteristics of the obtained tissue (which would be assessed via pathology) were compared. However, details on how this comparison was quantified or what specific metrics were used are not provided.
• For other tests (biocompatibility, sterility, mechanical performance), the "ground truth" is adherence to established international standards and comparable performance to the predicate device.

8. The sample size for the training set

This information is not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.

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

This information is not applicable. As above, this device does not utilize a training set.

Ask a specific question about this device