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The Semi-automatic Biopsy-Needle - BIM and Automatic Biopsy Needle - BAM are sterile, spring loaded, disposable percutaneous soft tissue biopsy systems. It consists of the following major components: handle, spring, cannula, stylet, trigger and spring guide. It is used to obtain multiple core biopsy samples from soft tissue such as breast, kidney, liver and prostate. The needle has to be inserted by a qualified physician under MR image guidance.

AI/ML Overview

The FDA 510(k) summary for the Automatic Biopsy Needle BAM and Semi-Automatic Needle BIM provides details of non-clinical tests conducted to demonstrate substantial equivalence to a predicate device (K222462). This report focuses on the performance of the device itself rather than a software AI or human-in-the-loop system. Therefore, some of the requested information regarding AI-specific criteria (like MRMC studies, training set details, or number of experts for AI ground truth) is not applicable to this submission.

Here's a breakdown of the acceptance criteria and study results based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance
1) Penetration of the needle (Stylet perforation capacity)	Stylet tip could easily and effortlessly penetrate tissue (muscle, liver, kidney) without causing tears or lacerations to create a good entry path for the cannula.	"For all tested biopsy devices the insertion was appropriate and conducted effortlessly with no difficulties at all. The acceptance criteria were met. This demonstrates that the device works as intended."
2) Shot of the needle (Release mechanism)	Device spring has sufficient power for the cannula to completely cover the tip of the stylet that contains the notch.	"The test showed that the device spring has sufficient power for the cannula to cover the tip of the stylet that contains the notch completely." (Tested for 10mm and 18mm notch).
3) Quantity of the sample taken (Length of collected samples)	≥ 5 mm for the 10 mm notch and ≥ 9 mm for the 18 mm notch.	"The results showed that the device met the acceptance criteria (e.g., ≥ 5 mm for the 10 mm notch and ≥ 9 mm for the 18 mm notch) and the dimensions of the samples were comparable to the dimensions of the sample acquired using the predicate."
4) Quality/integrity of the sample taken	Samples are cylindrical, intact, and abundant.	"All samples were cylindrical, intact and abundant. The acceptance criteria were met. The samples collected using the subject device were comparable to the samples acquired using the predicate."
5) MRI Safety Evaluation	Conditions of safe use established.	"MRI safety evaluation was performed to develop conditions of safe use." (Details of specific safety criteria not fully elaborated in this section, but stated as being performed).

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document mentions that for the penetration, shot, and sample quantity/quality tests, "different Semiautomatic Biopsy Needles - BIM and Automatic Biopsy Needles - BAM has been used. 18G and 16G biopsy needles were used. Two lengths were used: 150 mm and 200 mm." It also states, "The testing was conducted after the validated EO sterilization of all devices. Therefore the tests were conducted on final finished devices." However, specific numerical sample sizes for each test are not provided (e.g., how many needles of each size/length, or how many biopsy samples were collected).
Data Provenance: The tests were conducted using various tissue types (muscle, liver, kidney) and optionally "animal tissue" for the shot test. Given the nature of these tests for a physical device, the data provenance is likely prospective wet lab/bench testing. The country of origin for the data is not specified, but the applicant, ITP Innovative Tomography Products GmbH, is based in Germany.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The ground truth for these performance tests (e.g., visual inspection for penetration, measurement with a ruler for sample length, video microscopy for sample quality) was established through direct observation and measurement during the non-clinical testing. There is no mention of external human experts (like radiologists or pathologists) being used to establish a "ground truth" as would be the case for image-based diagnostic AI. These are engineering and functional performance tests.

4. Adjudication Method for the Test Set

Not applicable. The tests are direct measurements and observations of the device's physical performance, not subjective assessments requiring adjudication by multiple individuals.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is typically performed for AI-powered diagnostic devices to assess the impact of AI assistance on human reader performance. This submission is for a physical biopsy needle, not an AI or imaging device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

While the device operates without AI, the tests describe its physical function in relation to a "human-in-the-loop" application (a physician inserting and triggering the needle). The provided tests are "standalone" in the sense that they assess the device's functional characteristics independently of a diagnostic interpretation loop that characterizes AI.

7. The Type of Ground Truth Used

The ground truth used was empirical / physical measurement and observation. For example:

Penetration: Visual confirmation of effortless penetration and lack of tears.
Shot: Visual confirmation that the cannula completely covered the stylet tip.
Sample Quantity: Direct measurement of sample length with a ruler.
Sample Quality: Observation under video microscope for cylindrical shape, intactness, and abundance.

8. The Sample Size for the Training Set

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

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this physical device.

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