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The disposable Corvocet Biopsy System is intended for use in obtaining core biopsy samples from soft tissues such as liver, kidney, prostate, spleen, breast, lung, lymph nodes and various soft tissue tumors. It is not intended for use in bone.

Merit's Corvocet Biopsy System is a core needle biopsy device intended to obtain core biopsy samples from soft tissues. It is an automatic device that uses a spring coupled to a cutting needle to obtain full core soft tissue specimens. It has an echo-enhanced tip to aid with visibility under ultrasound, fully adjustable throw length (10-25mm) and depth markings on the needle. The device also features a light wright design, ergonomic grip, dual firing triggers, a ready indicator, and an optional safety interlock. The Corvocet Biopsy System is available in several needle gauge sizes and lengths to accommodate soft tissue biopsy needs. The top and rear firing triggers are color coded according to the various gauge sizes (e.g. yellow = 20G, pink = 18G, purple = 16G, and green = 14G). The Corvocet Biopsy System will be offered as a stand-alone as well as paired with the Corvocet™ Coaxial Introducer. The Merit Corvocet Biopsy System is supplied sterile and is intended for single use only.

The provided text describes a 510(k) summary for the Corvocet Biopsy System. It outlines the device description, indications for use, comparison to a predicate device, and performance data. However, the document primarily focuses on bench testing (mechanical and functional performance of the device itself), biocompatibility testing, and sterilization validation, rather than clinical performance (e.g., diagnostic accuracy) involving human or simulated human-in-the-loop studies.

Therefore, many of the requested points related to acceptance criteria for AI/clinical performance, sample sizes for test sets, expert involvement, adjudication, MRMC studies, standalone performance, and ground truth establishment for diagnostic purposes are not applicable or available in this specific document, as the device is a mechanical biopsy instrument, not an AI or imaging diagnostic tool.

I will address the relevant points based on the provided text, and explicitly state when information is not present or not applicable.

Acceptance Criteria and Device Performance for the Corvocet Biopsy System

Based on the provided 510(k) summary for the Corvocet Biopsy System (K180450), the acceptance criteria and performance data primarily revolve around the mechanical and functional aspects of the biopsy instrument, rather than a clinical diagnostic performance (e.g., of an AI algorithm).

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

The document states that "The results of the testing demonstrated that the subject Corvocet Biopsy System met the predetermined acceptance criteria applicable to the safety and efficacy of the device." However, no specific quantitative acceptance criteria or detailed numerical results are provided in a table format for performance testing, only the types of tests performed are mentioned.

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

• Sample Size: Not explicitly stated for each test. The performance tests (Simulate Use – Biopsy Sample, Simulate Use – Multiple Samples, Cycle / Fatigue, Device Diameter Compatibility) are bench tests performed on the physical device. The "sample size" here would refer to the number of devices or biopsy cycles tested. This detail is not provided in the summary.
• Data Provenance: Not applicable in the context of clinical data for a diagnostic device. The tests are bench tests performed on the physical device. The location of the testing laboratories is not specified, nor is there any mention of retrospective or prospective data collection as it pertains to patient data.

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

• Not Applicable: This device is a mechanical biopsy instrument, not a diagnostic imaging or AI algorithm. There is no mention of experts establishing a "ground truth" for diagnostic accuracy. The tests performed are engineering and functional performance tests for the device itself.

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

• Not Applicable: Not relevant for bench testing of a mechanical device. Adjudication methods are typically used in clinical studies involving interpretation of medical images or patient outcomes, especially with multiple readers or challenging cases.

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: No MRMC study was performed or is relevant to this type of device. The Corvocet Biopsy System is a biopsy tool, not an AI-assisted diagnostic system that aids human readers.

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

• Not Applicable: This is a physical medical device (biopsy system), not an algorithm. There is no "standalone performance" in the sense of an algorithm. Its "performance" is its mechanical function and ability to obtain tissue samples.

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

• Not Applicable in the clinical diagnostic sense: Given that this is a mechanical biopsy device, the "ground truth" for its performance would involve whether it successfully obtains a tissue core, the quality and integrity of that core (as observed in a lab setting, "clinically acceptable" aspect mentioned), and the device's mechanical durability and safety. The document states that the "aspect of the biopsy sample is clinically acceptable," implying some form of physical assessment, but no specific "ground truth" methodology (e.g., comparing to pathology slides from a human patient) is detailed as this is a device performance study, not a diagnostic accuracy study.

8. The sample size for the training set:

• Not Applicable: This device is a mechanical product, not a machine learning model. Therefore, there is no "training set."

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

• Not Applicable: As there is no training set for a machine learning model, this question is not relevant.

In summary: The provided document is a 510(k) summary for a mechanical biopsy instrument. The "study that proves the device meets the acceptance criteria" refers to a series of bench tests and validations concerning the device's mechanical function, material safety (biocompatibility), and sterilization. It does not involve clinical performance studies, AI algorithms, or diagnostic accuracy assessments typical for AI-powered medical devices. Therefore, most of the questions pertaining to those aspects are not addressed in this document.

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