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The Disposable Pre-calibrated Biopsy Needle for brain biopsy is a single-use device intended for use in stereotactic and other guided biopsy of brain tissue, for example brain tumors. The Disposable Pre-calibrated Biopsy Needle is provided in a set.

Device Description

The Disposable Pre-calibrated Biopsy Needle is a dual cannula device made from stainless steel. The cannula requires vacuum suction provided by a syringe to draw the tissue into the needle. The inner cannula is then rotated against the outer cannula to cut the tissue.
Biopsy needles are used to perform a biopsy of brain tissue. In the area of the blunt tip, they have a lateral biopsy window (Sedan Type) on which the biopsy is obtained.
Through navigation systems or a stereotactic frame, the biopsy window is brought to the place of interest.
Brainlab cranial navigation allows the tracking and calculation of the position of instruments with attached reflective tracking marker. It is one possible method of navigation.
There are different versions of the Disposable Brain Biopsy Needle 2.0 for following use-cases:
Guide: In the use case "Guide" the Biopsy Needle shall be used with Brainlab optical cranial navigation system with Brainlab VarioGuide. Brainlab Frameless Biopsy System or Brainlab VarioGuide Robotics. Therefore, a tracking marker array attached to Biopsy Needle shall allow the depth tracking of the instrument and calculation of the cutting window position.
Frame: In the use case "Frame" the Biopsy Needle shall be used with the Elekta Leksell stereotactic frame. A defined length and exact stop shall allow the precise inserting of the Biopsy Needle in the stereotactic frame.

AI/ML Overview

Based on the provided text, the document is a 510(k) Premarket Notification from the FDA to Pajunk GmbH Medizintechnologie regarding their Disposable Pre-calibrated Brain Biopsy Needle 2.0. The core of the information provided for acceptance criteria and device performance relates to MRI conditional labeling.

Here's an analysis of the provided information, structured to address your questions. Please note that many of your points (e.g., sample size for training set, number of experts for ground truth, multi-reader multi-case studies) are not applicable to this specific submission because it pertains to a physical medical device (a biopsy needle) and not an AI/ML algorithm or software as a medical device (SaMD). The acceptance criteria here are for the device's physical safety and compatibility, specifically in an MRI environment.

Acceptance Criteria and Device Performance for Disposable Pre-calibrated Brain Biopsy Needle 2.0

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Test	Test Method Summary	Reported Device Performance / Result
MRI Safety: Magnetically Induced Displacement	According to ASTM F2052-15 "Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment". The medical device is suspended by a string in an MR system near the bore entrance. The angular deflection of the string from the vertical is measured. Acceptance Criterion (implicit based on ASTM F2052-15): If the device deflects less than 45°, then the deflection force induced by the MR System's magnetic field is less than the force on the device due to gravity (its weight). This is generally considered acceptable for "MR Conditional" labeling.	No magnetically induced displacement was detectable for the test object "Disposable Pre-calibrated Biopsy Needle 2.1 x 257 mm" used within this test and in the described MR environment of a 3 Tesla Siemens Magnetom Vida MR scanner. This result meets the implicit acceptance criterion of ASTM F2052-15.
MRI Safety: Usage within 5 Gauss line marking	Testing was conducted to demonstrate the device is safe to be used in an MR environment if a 5 Gauss line (0.5 mTesla) is clearly marked on the floor around the MR scanner. This likely implies that the device does not pose a significant hazard when brought into proximity of an MR scanner, provided appropriate safety zones are respected.	The document states that testing was conducted to demonstrate safety under these conditions. The "Conclusion" section indirectly confirms this by stating the device is "as safe and effective as the legal predicate devices" due to this testing. No specific quantitative result is provided beyond the statement of safety.
Biocompatibility	(Implied) Evaluation against ISO 10993-1.	ISO 10993-1 compliant material & set components. Result: Identical to predicate device, indicating compliance.

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

Sample Size: The document does not specify a numerical sample size for the MRI testing. It refers to "the test object 'Disposable Pre-calibrated Biopsy Needle 2.1 x 257 mm'". This wording suggests that the testing was performed on at least one representative unit of the device. For physical device testing, particularly for magnetic properties, often a single, representative sample is sufficient if the manufacturing process ensures consistency.
Data Provenance: The testing was conducted in a laboratory setting, likely in Germany (where Pajunk GmbH Medizintechnologie is located), using a Siemens Magnetom Vida MR scanner. This is a controlled, prospective laboratory study to assess device properties. It is not patient or clinical data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

N/A. This submission is for a physical medical device (biopsy needle), not an AI/ML or diagnostic software. Ground truth in this context refers to physical properties tested in a lab, not expert interpretation of medical images or patient outcomes.

4. Adjudication Method for the Test Set

N/A. As above, this is laboratory testing of a physical device, not an interpretation task requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This is not a study involving human readers or diagnostic interpretation. It is a study on the physical properties of a medical device (MRI compatibility).

6. Standalone (Algorithm Only) Performance

N/A. This is a physical medical device, not a software algorithm.

7. Type of Ground Truth Used

The ground truth for the device's MRI compatibility testing was established by physical measurement against a recognized standard (ASTM F2052-15) using a 3 Tesla MR scanner. The "truth" is whether the device exhibits magnetic displacement, as defined by the standard's criteria (e.g., deflection less than 45 degrees).

8. Sample Size for the Training Set

N/A. There is no "training set" as this is a physical device, not an AI/ML model.

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

N/A. As above, there is no training set.

In summary, the provided document focuses on demonstrating the substantial equivalence of a physical medical device (a brain biopsy needle) to a predicate device, with a specific emphasis on the addition of "MR Conditional" labeling. The "study" in question is a performance test (specifically, magnetic displacement) conducted under lab conditions, adhering to an ASTM standard, to prove the device's safety in an MRI environment.

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