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Disposable Biopsy Needle is intended for use in soft tissue biopsies such as liver, kidney, breast, thyroid, prostate, spleen, pancreas, lymph nodes, lung and various soft tissue tumors. It is not intended for use in bone.

Disposable Biopsy Needle is intended for use in obtaining an aspirate for cytology. Disposable Biopsy Needle has five models: BN-MAR-1, BN-MAR-2, BN-MAR-3, BN-MAR-4, BN-MAR-8. The Disposable Biopsy Needle consists of operating handle of Inner stylet, operating handle of cutting cannula, cutting cannula, inner stylet, depth stopper and protective sheath. The models differ as follows:

• Cutting cannula tip type: The cannula tip type of BN-MAR-1, BN-MAR-2, BN-MAR-3 is chiba. The cannula tip type of BN-MAR-4, BN-MAR-8 is greene.
• Operating handle designs:
  • BN-MAR-1, BN-MAR-3, BN-MAR-4 Models:
    a. BN-MAR-1, BN-MAR-3, and BN-MAR-4 have the same operating handle, including the operating handle of inner stylet and operating handle of cutting cannula.
    b. The Operating handle of Inner stylet connector connects to the Operating handle of cutting cannula connector via a straight snap-fit design, allowing for easy disconnection with one hand to remove the Inner stylet.
  • BN-MAR-2, BN-MAR-8 Models:
    a. The Operating handle of Inner stylet of BN-MAR-2 connects to the Operating handle of cutting cannula via a straight snap-fit design connector, allowing easy disconnection with one hand to remove the Inner stylet.
    b. The Operating handle of inner stylet of BN-MAR-8 connects to the Operating handle of cutting cannula via a female Luer taper and male Luer thread taper, which can meet the sealing performances in clinical applications.
• Bevel Angle of the Cutting cannula tip: There are three kinds of bevel angle of the Cutting cannula tip, which are α, β, δ. The bevel angle of the cutting cannula tip of BN-MAR-1 and BN-MAR-2 is α. The bevel angle of the needle tip of BN-MAR-3 is β. The bevel angle of the Cutting cannula tip of BN-MAR-4 and BN-MAR-8 is δ.

Each model has various specifications depending on different sizes such as needle lengths, needle diameters, etc. The cutting cannula has numerically ordered centimeter markings on it to provide reference for depth placement. In the distal area of the cutting cannula, an ultrasound enhancement is available to promote accurate placement under ultrasound or X-ray guidance.

An adjustable depth stopper allows the user to restrict forward movement, localizing the needle tip to the biopsy site.

The Operating handle of Inner stylet is color-coded, which indicates gauge size of the needle. It is available in several needle gauge sizes and lengths.

The Disposable Biopsy Needle is a single-use device, supplied in a sterile state sterilized by EO gas. Re-sterilization by users is forbidden. The shelf life is defined for 3 years, which is verified.

The provided document is a 510(k) clearance letter for a Disposable Biopsy Needle. It is a physical device, not an AI/software device. Therefore, the questions regarding acceptance criteria and studies related to AI performance, such as human-in-the-loop, standalone performance, ground truth establishment for training sets, multi-reader multi-case studies, and effect size of AI assistance, are not applicable.

The document discusses non-clinical tests to demonstrate the safety and effectiveness of the device as a physical product.

Here's a breakdown of the relevant information provided:

1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a formal table of acceptance criteria with reported performance values in a side-by-side comparison. Instead, it describes various performance tests conducted. The acceptance criteria are implied by successful completion of these tests as per relevant standards.

• Appearance
• Basic dimensions
• Sample collection space and accessibility
• Luer connection
• Connection firmness
• Stiffness
• Toughness
• Corrosion resistance
• Leakage
• Ultrasound detectability
• X-ray detectability
• Protective sheath
• Puncture force
• Chemical Characteristics
• EO and ECH Residual
• Sterility test
• Bacterial endotoxin |
  | Comparative Performance (Sampling) | No significant difference in sampling weight or cell integrity compared to predicate devices across various tissues (liver, kidney, breast, thyroid, prostate, spleen, pancreas, lymph nodes, lungs). |

2. Sample size used for the test set and the data provenance
The document details testing conducted on the device itself and does not refer to a "test set" in the context of diagnostic data. The tests performed are for physical and functional properties of the biopsy needle.

• Sample size: Not explicitly stated for each test, but standard testing practices involve a sufficient number of samples to ensure representativeness and statistical validity.
• Data provenance: Not applicable in the context of patient data; the data is generated directly from testing manufactured devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a physical device. Ground truth refers to diagnostic accuracy in AI/imaging studies.

4. Adjudication method for the test set
Not applicable. Adjudication methods are used to establish ground truth in diagnostic studies, typically involving disagreements between expert readers.

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 physical device, 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 a physical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the "Comparative study" mentioned in section 4 (Non-Clinical Tests), the ground truth for evaluating sampling performance would inherently be pathology-based assessment of the collected tissue samples (e.g., measuring sampling weight and assessing cell integrity). While not explicitly stated as "ground truth," this is the objective measure used to compare the device's performance against predicates.

8. The sample size for the training set
Not applicable. This is a physical device, not an AI model requiring a training set.

9. How the ground truth for the training set was established
Not applicable. This is a physical device, not an AI model.

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