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· SemiCut Semi-Automatic 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.

· Themy Automatic Biopsy Needle is intended for obtaining core biopsy samples from soft tisues such as kidney, liver, prostate and various soft tissue masses. The device is not intended for use in bone.

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

· Palium Automatic Reusable Biopsy Device is intended for use in obtaining core biopsies from soft tissues such as liver, kidney, prostate, breast, spleen, lymph nodes and various soft tissue tumors. The device is not intended for use in bone.

· Easy Cut Semi-Automatic Biopsy Needle is intended for soft tissue biopsy or aspiration. The device is not intended for use in bone.

· MDL Biopsy Needle is intended for soft tissue core biopsy with Palium Reusable Automatic Biopsy Device. The device is not intended for use in bone.

· Coaxial Introducer Needle is intended for use with biopsy devices cannula 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 M.D.L. S.r.l. Soft Tissues Biopsy Devices and Accessories include semi-automatic spring powered guns (disposable and reusable). Biopsy needle and cannula accessories are provided in a variety of sizes, designed to work with the manufacturer's semi-automatic guns to obtain and deliver a soft tissue core or aspirate sample, facilitate skin and tissue penetration, sample retention and / or expulsion depending on the sample sites.

The provided text details the 510(k) premarket notification for M.D.L. S.r.l. Soft Tissue Biopsy Devices and Accessories. This document demonstrates substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a clinical study for an AI/algorithm-based device.

Therefore, most of the requested information (regarding expert ground truth, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, training set details, etc.) is not applicable to this document as it describes a clearance for a physical medical device (biopsy needles and devices), not a software or AI-driven diagnostic system.

However, I can extract information related to the acceptance criteria for the physical device performance and the tests performed to prove it, as presented in the document.

Here's the breakdown of what can be extracted and what is not applicable:

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

The document provides a "Performance Testing Summary" table (Table 2 on page 10) and describes the criteria and results in section 6.3 "Performance Testing".

2. Sample sized used for the test set and the data provenance:

• Sample Size: The document states, "Samples of each device product family (subject device) were selected at the extremes of device design for needle length and gauge sizes for comparative testing to predicate devices for device performance." For specific tests like mechanical durability, penetration, activation force, and extraction, it notes that "Each tested subject and predicate device was activated 50 times" or "comparable over 50 shots per use," or "tested in triplicate" for shelf-life. There are no overall sample sizes for a "test set" in the context of clinical data for an AI model.
• Data Provenance: Not applicable as this is laboratory/bench testing of physical devices. The testing was conducted by M.D.L. S.r.l. in Italy, as indicated by the company's address. The data is from prospective bench testing performed specifically for 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)

Not applicable. Ground truth, in the context of AI, refers to expert-annotated clinical data. This document describes the performance testing of physical biopsy devices, not a diagnostic AI algorithm. The "ground truth" here is the objective measurement of physical properties (e.g., force, distance, weight) performed by engineering testing.

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

Not applicable. This is not a clinical study involving human readers or interpretation of medical images.

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 not an AI-assisted diagnostic device.

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

Not applicable. This is not an AI algorithm.

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

The "ground truth" for the performance testing of these physical devices was established through objective engineering measurements against predefined physical criteria, often compared to predicate devices. For example:

• Depth Projection: Measured movement of the needle.
• Penetration Force: Measured force using a dynamometer and certified testing foil.
• Sample Extraction: Measured weight of collected samples.
• Biocompatibility/Sterility/Pyrogenicity: Laboratory tests against international standards (ISO, USP).

8. The sample size for the training set

Not applicable. This device does not use a training set as it's a physical device, not an AI/ML model.

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

Not applicable. See point 8.

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