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510(k) Data Aggregation
(30 days)
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 Cassi Rotational Core Biopsy System consists of a sticking needle, cutting cannula, fully integrated control unit and specimen container. 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 information is for device premarket submission and describes the Sanarus Cassi Rotational Core Biopsy System. This document does not contain details about acceptance criteria or a study proving that the device meets specific performance criteria related to AI or algorithm-only performance.
Instead, this submission is a Special 510(k) for a medical device that aims to demonstrate substantial equivalence to a previously legally marketed device (predicate device). In such submissions, the primary "acceptance criterion" is proving that the new device is as safe and effective as the predicate, often through shared technological characteristics and performance testing that confirms equivalence.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Equivalent Indications for Use to Predicate Device | Same indications for use as the predicate device. |
| Equivalent Technological Characteristics to Predicate Device | Same technological characteristics as the predicate device. |
| Equivalent Patient Contact Components/Materials to Predicate Device | Same patient contact components and materials as the predicate device. |
| Equivalent Packaging Materials/Configurations/Sterilization Methods/Sterility Assurance Level to Predicate Device | Equivalent packaging materials, configurations, sterilization methods, and sterility assurance level to the predicate device. |
| Quality of samples obtained is equivalent to Predicate Device | Performance testing confirms the quality of samples obtained with the Sanarus Cassi Rotational Core Biopsy System is equivalent to the predicate device. |
| Does not raise significant new questions of safety and effectiveness | Based on the above points, the device does not raise significant new questions of safety and effectiveness. |
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 provided in the document. The submission states "Performance testing confirms...", but does not detail the nature of this testing, sample sizes, or data provenance.
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 provided in the document. As this is a mechanical biopsy device, "ground truth" would likely refer to histopathological analysis of obtained tissue samples. However, no details on how this was established for test purposes are given.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
There is no mention of an MRMC study or AI in this submission. The device is a physical biopsy system, not an AI software/diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical biopsy system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The document implies that the performance testing for the new device compared the "quality of samples obtained" to the predicate device. For a core biopsy device, the ground truth would typically be histopathology/pathology of the tissue samples. However, the document does not explicitly state this or provide details of the pathology assessment.
8. The sample size for the training set
This information is not provided and is not applicable as this is not an AI/ML device.
9. How the ground truth for the training set was established
This information is not provided and is not applicable as this is not an AI/ML device.
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