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The device is indicated for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone.

The device 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 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 Sanarus InCore Rotational Core Biopsy System consists of a fully integrated control unit, sticking needle, cutting cannula and sample collection tray. The sticking needle is operated by the control unit and uses cold temperatures at its tip to engage the tissue to be sampled. The cutting cannula is coaxially mounted around the sticking needle and is used to core the tissue specimen. The cutting cannula will be available in several gauge sizes and lengths.

The provided text describes a 510(k) summary for the Sanarus InCore Rotational Core Biopsy System. It states that the device is substantially equivalent to a predicate device and includes a "Performance Testing Summary" that confirms the quality of samples obtained with the new device is equivalent to that of the predicate device. However, the document does not provide specific acceptance criteria, detailed study results, sample sizes, ground truth establishment, or expert qualifications for performance testing. It only makes a general statement about equivalence.

Therefore, many of the requested details cannot be extracted from this document.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. Table of acceptance criteria and the reported device performance

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

• Sample size for test set: Not specified.
• Data provenance: Not specified (e.g., country of origin, retrospective/prospective).

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)

• Number of experts: Not specified.
• Qualifications of experts: Not specified.

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

• Not specified.

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 device is a biopsy system, 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

• Not applicable. This device is a biopsy system, not an algorithm.

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

• The performance testing summary mentions "quality of samples." This implies that the ground truth would likely involve histologic examination of the tissue samples, which is a form of pathology. However, the specific method for establishing a "ground truth" for sample quality (e.g., against a gold standard or expert assessment) is not detailed.

8. The sample size for the training set

• Not applicable. This device is a physical biopsy system, not a machine learning algorithm that requires a training set.

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

• Not applicable. This device is a physical biopsy system, not a machine learning algorithm that requires a training set.

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