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AprioCore plus is intended for use in obtaining core biopsy specimens from soft tissue such as breast, kidney, liver, lung, thyroid, lymph nodes and various soft tissue masses performed under image guidance techniques for soft tissue biopsy.

AprioCore plus is a manually operated, sterile, single use, semi-automatic, spring-loaded biopsy needle. AprioCore plus is provided in a variety of sizes (gauge and length) and is compatible with AprioMed devices Gangi-SoftGuard Coaxial Needle and Gangi-HydroGuard Coaxial Needle.

The provided document is a 510(k) summary for the AprioCore plus, a semi-automatic, spring-loaded biopsy needle. The purpose of this summary is to demonstrate substantial equivalence to a predicate device (Quick-Core Biopsy Needle, K973565). The document primarily focuses on non-clinical and bench testing to establish this equivalence, rather than clinical studies involving human subjects or AI algorithms.

Therefore, many of the requested elements regarding acceptance criteria for AI performance, sample sizes for test sets in clinical studies, expert qualifications, adjudication methods, MRMC studies, standalone AI performance, and training set details are not applicable to this submission.

Here's a breakdown of the requested information based on the provided text:

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

The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail format alongside reported performance for each criterion. Instead, it states that "Conformity has been demonstrated" for various performance characteristics by comparing the subject device (AprioCore plus) to the predicate device (Quick-Core Biopsy Needle). The acceptance for each test appears to be that the subject device performs "equivalent to" or "equal or lower" or "equivalent or higher" than the predicate, or that it successfully meets a functional goal (e.g., "will not extend over the stylet tip", "can successfully retrieve biopsy specimen").

Table: Acceptance Criteria and Reported Device Performance (as inferred from the text)

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

The document describes bench testing, not a clinical study with a "test set" in the context of diagnostic accuracy. Therefore, information about human subject sample size, data provenance, retrospective/prospective nature, or country of origin is not applicable. The "test set" refers to the physical devices and materials used in the bench tests. The specific number of devices or test repetitions for each bench test is not explicitly stated in the summary, though it notes that testing confirms the device meets design requirements.

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)

This is not applicable as the document describes bench testing for a physical medical device, not a diagnostic device requiring expert interpretation or ground truth establishment by clinical experts for a test set.

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

This is not applicable as the document describes bench testing for a physical medical device, not a diagnostic study requiring adjudication of expert readings.

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

This is not applicable. The device is a physical biopsy needle, not an AI-assisted diagnostic tool.

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

This is not applicable. The device is a physical biopsy needle, not an AI algorithm.

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

For the bench tests, the "ground truth" or reference for comparison was primarily the predicate device performance and recognized consensus standards (e.g., ISO 9626, ISO 10993). For example:

• Activation force, Penetration force, Loading force, Specimen size: Comparison was directly against the predicate device.
• Sterilization, Biocompatibility, Metal tubing: Compliance with international standards (ISO 11607-1, ISO 10993, ISO 9626).
• Visibility, Depth projection, Mechanical durability, Tissue sample extraction, Compatibility: Demonstrated functional success against predefined requirements, likely derived from engineering specifications and predicate device characteristics.

8. The sample size for the training set

This is not applicable. The device is a physical medical device, not an AI algorithm that requires a training set.

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

This is not applicable. The device is a physical medical device, not an AI algorithm.

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As a guiding needle in obtaining core biopsy samples from soft tissue such as liver, kidney, spleen, lymph nodes and various soft tissue lesions.

Gangi-SoftGuard Coaxial Needle together with Gangi-HydroGuard Coaxial Needle forms the Gangi Coaxial Needle family. Gangi-SoftGuard Coaxial Needle and Gangi-HydroGuard Coaxial Needle are manually operated, sterile, single use coaxial guiding needles with a spring loaded blunt-tip stylet, to be used as a guiding needle for biopsy instruments in procedures in soft tissue. Gangi-SoftGuard Coaxial Needle and Gangi-HydroGuard Coaxial Needle has the same intended use.

Coaxial Needle and Gangi-SoftGuard Gangi-HydroGuard Coaxial Needle are gastroenterological, manually operated, sterile, single use coaxial introducer needles. Both Gangi-SoftGuard Coaxial Needle and Gangi-HydroGuard Coaxial Needle consists of three parts: a needle (cannula) provided with a trocar stylet, and a spring-loaded blunt tip stylet. The difference from Gangi-SoftGuard Coaxial Needle is that Gangi-HydroGuard Coaxial Needle has a Luer hub located on the blunt stylet housing and the blunt stylet is hollow and has a distal tip hole. This enables injection of fluid without the need to remove the blunt stylet.

The provided text describes a medical device submission (K181756) for the Gangi-SoftGuard Coaxial Needle and Gangi-HydroGuard Coaxial Needle. This submission is for a traditional medical device (biopsy needle) and does not involve an Artificial Intelligence/Machine Learning (AI/ML) powered device. Therefore, many of the requested categories related to AI/ML device studies (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, training set sample size, ground truth for training set) are not applicable.

However, I can extract information regarding the acceptance criteria and the studies performed for this traditional medical device.

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a non-AI/ML medical device, the "acceptance criteria" are not reported as specific performance metrics like sensitivity/specificity for clinical outcomes. Instead, they are related to compliance with recognized standards and design requirements for a biopsy needle. The "reported device performance" refers to the successful verification against these standards and requirements.

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

• Not Applicable (N/A) for an AI/ML device. For this traditional medical device, testing involved bench testing of components and the final device against engineering and biocompatibility standards. The document does not specify exact sample sizes for each test unless it's inherent in the standard (e.g., number of units tested for mechanical performance or biocompatibility). Data provenance is not described as country of origin, but rather as "bench testing." These were likely performed in a controlled laboratory setting by the manufacturer (AprioMed AB, Sweden). The nature of these tests is prospective for the device evaluation.

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 (N/A): This is not an AI/ML device or a diagnostic device requiring expert interpretation for ground truth. Ground truth for the tests performed (biocompatibility, mechanical strength, dimensional conformity) is established by adherence to recognized international standards and engineering specifications, verified by testing laboratories or internal qualified personnel.

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

• Not Applicable (N/A): This concept primarily applies to AI/ML or diagnostic studies where human experts disagree on findings. For bench testing, results are typically objective measurements against set specifications.

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 (N/A): This is a traditional medical device (biopsy needle), not an AI/ML system. No MRMC study was performed.

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

• Not Applicable (N/A): This is a traditional medical device, not an algorithm.

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

• For this traditional medical device, the "ground truth" for its performance is:
  • Adherence to recognized international standards: e.g., ISO 10993 (biocompatibility), ISO 9626 (metal tubing), ISO 7864 (hypodermic needles), ISO 594 (conical fittings).
  • Compliance with internal design requirements: for mechanical performance, penetration force, and spring force. These are objective engineering specifications.

8. The sample size for the training set:

• Not Applicable (N/A): This is a traditional medical device, not an AI/ML system, so there is no "training set."

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

• Not Applicable (N/A): As there is no training set for an AI/ML model, this question is irrelevant to the provided document.

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The Morrison Steerable Needle is intended for percutaneous injection and aspiration procedures, and tissue sampling in kidney, liver, muscle and subcutaneous tissue.

The sterile, single use, Morrison Steerable Needle consists of the housing, a rotating lever which controls the deflection of the needle tip, the slide, the collar which transfers tensile force from the slide to the core wire; the tendon wire (core wire) which transfers tensile force from the collar to distal tip of the tubing; the stainless steel tubing which ends in a Menghini like needle tip on the distal end and a luer lock fitting on the proximal end.

The provided text describes the 510(k) premarket notification for the Morrison Steerable Needle, asserting its substantial equivalence to previously marketed predicate devices. It covers the device's description, indications for use, comparison with predicate devices, and performance data, but it does not contain the specific information requested in the prompt regarding acceptance criteria for an AI/CAD/software device, or a study proving that the device meets such criteria.

The document is for a physical medical device (a steerable needle), not an AI/CAD/software product. Therefore, it does not discuss topics such as:

1. Acceptance criteria for an AI/CAD/software device: The document focuses on regulatory equivalence based on design, materials, intended use, and performance of a physical needle, not performance metrics like sensitivity, specificity, or F1-score for an algorithm.
2. Study proving the device meets AI/CAD/software acceptance criteria: There is no mention of such a study. The performance testing described is for biocompatibility, needle advancement, injection/aspiration, tissue sampling, and animal safety for a physical needle.
3. Sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC comparative effectiveness study, standalone performance, type of ground truth, training set size, or how ground truth for training set was established: These are all concepts relevant to the evaluation of AI/CAD/software devices, which are not applicable to the physical device described in this document.

In summary, the provided text does not contain any of the information requested in the prompt as it pertains to an AI/CAD/software device.

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