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The UR0-1 SUREcore Prime Device is a reusable system for histological core biopsies. It is used to obtain tissue from transrectal or transperineal biopsy of the prostate. It has a throw (advancement) of 25 mm and is used in conjunction with a single use SUREcore biopsy needle.

The SUREcore Prime Biopsy Instrument facilitates collection of tissue for analysis by pathology in order to assist with a diagnosis of a disease condition in a patient. The SUREcore Prime device consists of two elements: (1) a handle and (2) a needle set. The handle contains springs that energize the biopsy needles and when used will cause rapid advance of the needles into target tissue. This action causes tissue to be held within a component of the needle (the core collector) intact from the body. The tissue samples are removed from the needle set and prepared for transfer to a pathologist or lab. The user can reenergize the springs by pulling back on the cocking slide so that multiple tissue samples can be collected from different locations within the target tissue.

This document is a 510(k) summary for the URO-1 SUREcore Prime Biopsy Instrument. It focuses on demonstrating substantial equivalence to a predicate device, the Cook BX Biopsy Device, rather than presenting a study proving that the device meets specific acceptance criteria based on diagnostic performance metrics (like sensitivity, specificity, or AUC) as one might expect for an AI/software as a medical device (SaMD) product.

Therefore, many of the requested elements regarding acceptance criteria and study design for diagnostic performance (such as sample size, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable to this submission, as it is for a mechanical biopsy instrument.

However, the document does describe performance testing relevant to the function of a mechanical biopsy device.

Here's a breakdown based on the provided text, addressing the points where information is available or indicating when a point is not applicable to this type of device submission:

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

The document doesn't explicitly list "acceptance criteria" in a quantitative diagnostic sense with target thresholds (e.g., "sensitivity > 90%"). Instead, the performance testing described is functional and safety-related for a mechanical device. The "performance" is implicitly demonstrated by passing these tests and showing similarity to the predicate.

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not specified in terms of a "test set" of patient cases for diagnostic performance, as this is a mechanical device. For mechanical testing, the number of units tested (e.g., prostate models, individual needles) is not detailed.
• Data Provenance: Not applicable in the context of clinical data for diagnostic performance. The mechanical testing was described as "bench testing."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. This submission does not involve diagnostic interpretation studies requiring expert ground truth for imaging or similar data. The "ground truth" for mechanical testing would be the physical properties and functionality of the device itself (e.g., did it puncture, did it collect tissue).

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

• Not applicable. No expert adjudication was needed for this type of mechanical device testing.

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. This is a mechanical biopsy instrument, not an AI/SaMD product. Therefore, MRMC studies and human reader improvement with AI assistance are not relevant.

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

• No. This is a mechanical device, not an algorithm.

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

• For biocompatibility: Laboratory testing against ISO standards (Cytotoxicity, Sensitization, Irritation, Systemic toxicity).
• For mechanical function: Physical observation in a prostate model and force measurement for deformation. There isn't a "ground truth" in the diagnostic sense; it's about meeting pre-defined mechanical specifications.

8. The sample size for the training set

• Not applicable. This is a mechanical device and does not involve AI or machine learning algorithms that require training data.

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

• Not applicable. As above, no training set or ground truth in this context is relevant.

In summary, this FDA submission for the URO-1 SUREcore Prime Biopsy Instrument focuses on demonstrating "substantial equivalence" to a predicate mechanical device through design comparisons and basic functional/safety bench testing, rather than through complex clinical studies evaluating diagnostic performance or AI algorithms. The "acceptance criteria" are implicitly met by passing the described biocompatibility and mechanical tests, and by showing equivalence to a legally marketed predicate.

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