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The PAJUNK DeltaCut blopsy system is intended for obtaining biopsies from soft tissues ans soft tissue tumors. It is not appropriate for bone blopsies. The single use, sterile, seperately packaged DeltaCut cannulas are available seperately.

The PAJUNK DeltaCut blopsy system consists of a gun and a disposable cannula. It is intended for obtaining biopsies from soft tissues and soft tissue turnors. It is not appropriate for bone biopsies.

The Pajunk DeltaCut blopsy cannulas are single use sterile devices. They are intended for obtaining biopsies from soft tissues and soft tissue tumors. They are only to be used in combination with the DeltaCut biopsy gun, but they are available seperately. It is not appropriate for bone biopsies.

DeltaCut consist of a non-sterile biopsy gun and a sterile biopsy cannula. The PAJUNK DettaCut biopsy gun is a reusable, spring-loaded, core biopsy device. It features adjustable penetration depths of 15 mm to 22 mm and is sold non-sterlie (see directions for cleaning, sterilization and lubrication). The Pajunk DeltaCut biopsy needle is a disposable needle intended for single use with the Pajunk DeltaCut biopsy gun. The DeltaCut biopsy needle is packaged individually and sterile. It is available in various diameters and lengths. For single patient use. Do not reuse. Do not resterilize. DeltaCut is a cannula system made by Pajunk®, which was developed specifically for the extraction of biopsies from soft tissue. The device is equipped with a visual and mechanical safety-system. Two triggers permit ergonomic handling for right and lefthanded application, regardless of the position of the extraction location. The puncture depth can be adjusted variable on a scale from 15 to 22 mm. The biopsy extraction is carried out in two steps and takes only seconds: 1. First, the inner cannula shoots out forwards and is filled with tissue. 2 Then the cutting cannula instantaneously sildes over it, thereby closing the biopsy chamber and protecting the biopsy material from contamination,

The provided submission for the DeltaCut Biopsy system does not contain specific acceptance criteria or a study that evaluates the device's performance against such criteria. The document is a 510(k) Premarket Notification Submission, focusing on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria.

The submission confirms the device's intended use, describes its components (biopsy gun and cannula), and highlights its similarity to the Bard® Magnum Biopsy system (K883469), which is the predicate device. It discusses sterilization, packaging, labeling, biocompatibility, and applicable standards (or lack thereof for specific standards for this type of device). The conclusion states that the comparison to predicate devices demonstrates the proposed device is safe, effective, and substantially equivalent.

Therefore, the tables and information requested below cannot be extracted from the provided text as the document does not contain this type of performance study data.

1. A table of acceptance criteria and the reported device performance:
Not available in the provided document. The submission focuses on substantial equivalence to a predicate device, not on meeting specific quantitative performance acceptance criteria in a study.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not available in the provided document. There is no performance study described with a 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 available in the provided document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not available in the provided 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:
Not applicable. The DeltaCut Biopsy system is a physical medical device (biopsy gun and cannula), not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. The DeltaCut Biopsy system is a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not available in the provided document. There is no performance study described. The document relies on equivalence to a predicate device which is implicitly considered "ground truth" for safety and effectiveness.

8. The sample size for the training set:
Not applicable. This is a physical medical device, not a machine learning algorithm that requires a training set.

9. How the ground truth for the training set was established:
Not applicable. This is a physical medical device.

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