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The SUREcore Plus Biopsy Instrument is intended for use in obt tissue such as liver, kidney, and prostate. It is not intended for use in bone.

The SUREcore Plus 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 Plus 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 re-energize the springs by pulling back on the cocking slide so that multiple tissue samples can be collected from different locations within the target tissue. When the user has determined that sufficient amount of tissue has been obtained, the SUREcore Plus device is disposed in accordance with local and facility policies and procedures. The device is single-use only and is not to be resterilized by the user.

This document is a 510(k) Premarket Notification from Uro-1, Inc. for their SUREcore Plus Biopsy Instrument. It focuses on demonstrating substantial equivalence to a predicate device, the Max-Core Biopsy Instrument. Therefore, the information provided primarily addresses the comparison between the proposed and predicate device, and the performance data presented is related to mechanical testing and biocompatibility of the device itself, not a study evaluating human reader performance with or without AI (MRMC study) or standalone AI algorithm performance.

Based on the provided text, a detailed answer to all parts of your request regarding acceptance criteria and a study proving an AI device meets these criteria cannot be fully generated. This document describes a traditional medical device (biopsy instrument), not an AI/ML medical device.

However, I can extract the relevant information regarding the performance data that was collected for this specific device (SUREcore Plus Biopsy Instrument) and how it addresses safety and effectiveness in the context of a 510(k) submission.

Here's an attempt to answer your questions based only on the provided document, highlighting what is present and what is absent due to the nature of the device:

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

The document does not present "acceptance criteria" in the typical sense for an AI/ML device (e.g., target specificity, sensitivity, AUC). Instead, it focuses on demonstrating that the mechanical and biological performance of the subject device is comparable to the predicate device and safe for its intended use.

The "performance" of the device is assessed through the following:

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

• Test Set Sample Size: Not explicitly stated in numerical terms for the mechanical capacity testing. It mentions "ex vivo models of liver, kidney & prostate tissue." The number of samples or trials performed is not specified.
• Data Provenance: The document does not provide details on the country of origin of the ex vivo models or whether the data collection was retrospective or prospective. It is primarily bench testing.

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. This device is a mechanical biopsy instrument, not an AI diagnostic tool that requires expert annotation for ground truth. Ground truth for its performance would be assessed by physical measurements, material properties, and tissue collection efficacy.

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

• Not applicable. See point 3. This is not a study involving human interpretation of medical images or data.

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 not an AI/ML device. Therefore, no MRMC study or AI assistance evaluation was conducted or is relevant.

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

• No. This is not an AI/ML device. Therefore, no standalone algorithm performance study was conducted.

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

• For the biocompatibility testing, the ground truth is established by standards (e.g., ISO 10993) and the results of the specific biological tests (cytotoxicity, sensitization, irritation, systemic toxicity).
• For mechanical testing, the ground truth involves physical measurements and observations of the device's ability to collect tissue in ex vivo models (e.g., macroscopic assessment of collected tissue integrity/size, consistency of penetration depth).

8. The sample size for the training set

• Not applicable. This is not an AI/ML device that requires a training set.

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

• Not applicable. See point 8.

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