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The Uramix Curaway Automatic Core Biopsy Instrument is intended for use in obtaining biopsies from soft tissues such as liver, kidneys, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone, or breast.

The URAMIX CuraWay Automatic Core Biopsy Instrument is a single use only core biopsy device and is individually packaged and sterilized. The packaging is compatible with the product's EO sterilization method. The sterilization validation confirms the packaging is qualified to maintain the sterilization condition of the device. It is available in several needle gauge sizes and lengths. The side and rear actuator buttons are color coded according to the various gauge sizes. The 18 gauge is the one used for current intended marketing, for prostate and kidney biopsies.

The URAMIX CuraWay Automatic Core Biopsy Instrument is a medical device intended for obtaining biopsies from soft tissues. The provided text outlines a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study of the device's diagnostic performance against specific acceptance criteria. Therefore, several of the requested sections (e.g., effect size of human readers, standalone performance, training set details) are not applicable or cannot be extracted from the given document as it primarily covers non-clinical engineering and design comparisons.

Here's an analysis of the provided information:

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

The document does not explicitly state "acceptance criteria" in the traditional sense of diagnostic performance metrics (like sensitivity, specificity, or AUC). Instead, it provides a comparison of engineering and functional characteristics to a predicate device, aiming to show substantial equivalence. The "performance" reported is primarily in relation to these comparative metrics.

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

The document mentions "ex-vivo tissue studies (porcine muscle, liver)" which suggests an experimental test set. However, it does not specify the sample size for these ex-vivo studies beyond stating "equivalent tissue samples." The data provenance is implied to be laboratory testing rather than human clinical data. No country of origin for this specific testing data is given, but the manufacturer is based in China. This is not a clinical study on patient data.

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. The comparisons and tests described are for physical and material characteristics of the device, not diagnostic performance requiring expert interpretation of results.

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

Not applicable. This device is not an imaging or diagnostic AI device requiring adjudication of human expert interpretations. The testing focuses on mechanical and material properties.

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 URAMIX CuraWay Automatic Core Biopsy Instrument is a physical medical instrument (a biopsy needle), not an AI device or an imaging/diagnostic AI software. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to this device.

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

Not applicable. This is not an algorithm or AI-driven device.

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

For the ex-vivo tissue studies, the ground truth was implied by the objective measurements of sample length and weight taken from the porcine tissues. For other non-clinical tests (biocompatibility, sterility, etc.), the ground truth is compliance with recognized international standards (e.g., ISO, ASTM).

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable. No training set is relevant for this device.

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