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The Cassi Rotational Core Biopsy 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 Cassi Device is also indicated to provide breast tissue sampling of breast abnormalities. It is designed to provide breast tissue for histological examination with partial or complete removal of the imaged abnormality. The extent of a histological 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 histological 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 proposed CASSI II Rotational Core Biopsy System consists of the following primary components: a fully integrated CASSI biopsy handle, a valve block, battery, cryogen, a Cassi biopsy needle (CASSI biopsy needle comprised of a sticking needle and cutting cannula/piston assembly), and a sample collection tray. The sticking needle is operated by CASSI biopsy handle 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 is available in two sizes (10 and 12 gauge).

The proposed CASSI biopsy handle are minor design evolution of the predicate CASSI II biopsy handle. The proposed CASSI II biopsy needle unit assembly remains unchanged from the predicate CASSI II biopsy needle unit assembly.

The proposed CASSI II system uses one control unit handle and allows for multiple, single patient use, biopsy needle units to operate with the handle, in the very same manner as the predicate CASSI II device. The principles of operation for the proposed CASSI™ II Rotational Core Biopsy System and the predicate CASSI II system remain unchanged.

The provided text is a 510(k) summary for the CASSI™ II Rotational Core Biopsy System, which focuses on changes to manufacturing and minor design evolutions rather than a study demonstrating clinical performance against acceptance criteria. Therefore, I cannot extract information related to clinical studies from this document.

However, based on the information provided, I can infer the following about the device's technical specifications and aspects addressed in the submission:

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

Since this submission is for manufacturing and minor design changes, it does not present a table of clinical acceptance criteria and device performance in that context. The "performance" discussed relates to maintaining equivalence to the predicate device.

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

Not applicable to this 510(k) submission. This document describes manufacturing and minor design changes, not a clinical test set.

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 to this 510(k) submission. No clinical test set requiring expert ground truth establishment is described.

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

Not applicable to this 510(k) submission. No clinical test set is described.

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 to this 510(k) submission. This device is a biopsy system, not an AI-assisted diagnostic tool.

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

Not applicable to this 510(k) submission. This device is a biopsy system, not an algorithm.

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

Not applicable to this 510(k) submission. The document focuses on demonstrating that design and manufacturing changes do not alter fundamental performance or safety, rather than evaluating clinical accuracy against a ground truth.

8. The sample size for the training set:

Not applicable to this 510(k) submission. This device is not an AI/machine learning system.

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

Not applicable to this 510(k) submission. This device is not an AI/machine learning system.

In summary, this 510(k) submission (K161234) for the CASSI™ II Rotational Core Biopsy System focuses on demonstrating substantial equivalence to a previously cleared predicate device (K123606) following changes in contract manufacturers, sterilizer, and minor design evolutions to the biopsy handle, rather than presenting a clinical study and acceptance criteria for its diagnostic performance. The document confirms that the device's intended use and principles of operation remain unchanged and that the modifications do not raise new questions of safety or efficacy.

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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.q., 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 proposed CASSI II Rotational Core Biopsy System consists of the following primary components: a fully integrated control unit handle (the CASSI II handle), a valve block, battery, cryogen, a biopsy needle (CASSI QuadPoint comprised of a sticking needle and cutting cannula/piston assembly), and a 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.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the CASSI™ II Rotational Core Biopsy System, addressing your requested points:

The provided document is a 510(k) summary for a medical device. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

Instead, this 510(k) submission is for an updated branding and packaging configuration, along with minor modifications, of an already cleared predicate device (Sanarus CASSI™ II Rotational Core Biopsy System K051581). Therefore, the regulatory decision is based on substantial equivalence to that predicate device, not on new performance studies establishing new acceptance criteria.

The core argument in this 510(k) is that the modified device "do[es] not raise any new or significant questions of safety and efficacy and are substantially equivalent to the predicate Sanarus CASSI II Rotational Core Biopsy System." This implies that the original predicate device would have had studies and acceptance criteria to demonstrate its safety and efficacy, but those details are not present in this document.

Therefore, I cannot populate most of your requested information based on the provided text. However, I can explain why for each point:

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: Not applicable. No new performance study data is described in this 510(k) summary.
• Data provenance: Not applicable. No new performance study data is described in this 510(k) summary.

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. No new performance study requiring ground truth establishment is described in this 510(k) summary.

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

• Not applicable. No new performance study requiring adjudication is described in this 510(k) summary.

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 device is a biopsy system, 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 device is a biopsy system, not an algorithm, and the submission does not describe a standalone performance study.

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

• Not applicable. No new performance study requiring ground truth is described in this 510(k) summary.

8. The sample size for the training set

• Not applicable. No training set is mentioned as this is not an AI/algorithmic device and no new performance study data is presented.

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

• Not applicable. No training set or associated ground truth establishment is mentioned.

Summary of what the document does indicate:

• Device: CASSI™ II Rotational Core Biopsy System with the CASSI QuadPoint™ Disposable
• Purpose of Submission: Seek clearance for updated branding and packaging, and summarize minor modifications to the predicate device (Sanarus CASSI™ II Rotational Core Biopsy System, K051581).
• Conclusion: The manufacturer believes the modified device is substantially equivalent to the predicate and does not raise new safety or efficacy questions.
• Indications for Use: Obtaining biopsies from soft tissues (liver, kidney, prostate, spleen, lymph nodes, various soft tissue tumors, and breast abnormalities). Not intended for use in bone.
• Classification: Class II, 21 CFR 876.1075 (Gastroenterology-urology biopsy instrument).

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