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Pajunks soft tissue biopsy, puncture and aspiration cannulas and needles listed above are intended for obtaining biopsies from soft tissues, for use in puncturing and for aspiration. They are not appropriate for bone biopsies.

Pajunks soft tissue puncture and aspiration Kit acc. Steinhoff is intended for use in puncturing and aspiring for soft tissue biopsy.

Pajunks breast localization cannulas/ needles can be used in Mammographic procedures to obtain breast lesion tissue. Pajunks Breast localization cannulas/ needles are intended for diagnostic sampling of breast tissue during breast biopsy procedures. They are to be used for diagnostic purposes only and are not intended for therapeutic uses. The Breast localization cannulas/ needles are indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is designed to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality (e.g., malignancy). When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures. This device is not indicated for use under MR based imaging technologies, such as MRI.

The cannulas and needles consist of medical grade steel, plastic luer hub and stylet (stabilizing mandrin inside cannula). For safety reasons, the graduated puncture cannula also has an additional depthstop installed at the shaft of the cannula.

The cannula Type Chiba Special has been developed by PAJUNK® with an approx. 1 cm matted finish of the cannula tip and three additional ring-markings.

For safety reasons, the graduated puncture cannula/ needle has an additional depth-stop installed at the shaft. As a standard, the cannulas/ needles with beveled tip are normally equipped with a handle plate and a depth stop.

This universally usable puncture cannula/ needle made of high-grade stainless steel is suitable for all percutaneous punctures with guidance wires. It is available in a 2-parted and in a 3-parted version, with and without graduation. The outer cannula has a rounded, blunt tip, and it is designed to match the inside stylet-cannula.

This cannula with a Special Sprotte tip is intended for obtaining biopsies from soft tissues, for use in puncturing and for aspiration. It is an EO-sterilized, latex-free device for single use.

For better depth control, the interventional micro-cannula features graduated collars at intervals of 1 cm.

The puncture kit according Dr. Steinhoff contains a Chiba-type puncture cannula/ needle with a cannula rider and a flexible tube. The millimeter-precise introduction of the puncture needle by means of the cannula rider is facilitated with the aid of the centimeter-graduation and the corresponding markings at intervals of 5 mm. Thereby, the needle can be quided safely, without lacking the necessary flexibility.

Pajunks breast localization cannulas can be used in Mammographic procedures to obtain breast lesion tissue.

The provided document is a 510(k) Premarket Notification Submission for various soft tissue biopsy, puncture, and aspiration cannulas and needles. It is a submission seeking substantial equivalence to a predicate device, rather than a study demonstrating that a device meets specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, ground truth, and expert involvement is not present in this type of regulatory document.

However, based on the information provided, here's what can be inferred and what is explicitly stated:

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

This document does not specify quantitative acceptance criteria or a performance study with reported metrics. The submission is a claim of "substantial equivalence" to a predicate device, meaning it asserts that the new device is as safe and effective as a legally marketed device.

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

Not applicable. This is a 510(k) premarket notification for substantial equivalence, not a clinical study. The submission relies on a comparison to a predicate device and bench testing (e.g., sterilization, biocompatibility, packaging) rather than a clinical trial with a test set of 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. No clinical test set requiring expert ground truth is mentioned.

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

Not applicable. No clinical test set is mentioned.

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. This device is a physical medical instrument (cannulas and needles), not an AI-powered diagnostic system.

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

Not applicable. This is a physical medical instrument.

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

Not applicable in the context of a clinical performance study. The "ground truth" for this 510(k) submission is typically the established safety and effectiveness of the predicate device (K980211 Manan MRI Chiba, spinal, breast localization etc.). The new device aims to be substantially equivalent to this standard.

8. The sample size for the training set

Not applicable. This is a physical medical instrument, not an AI model.

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

Not applicable.

Summary based on the provided document:

The submission explicitly states its approach:

• Acceptance Criteria (Implied): The primary "acceptance criterion" for this 510(k) submission is demonstrating substantial equivalence to the predicate device (Manan Medical's cannulas and needles, cleared under K980211). This means showing the new device is as safe and effective as the predicate.
• Study Proving Device Meets Acceptance Criteria: The "study" is a comparative analysis documented in Section 12 of the submission (not provided here).
  • Basis of Comparison: The submission states, "The comparison between the predicate devices and the proposed device in section 12 of this submission demonstrates that the proposed device is safe and effective, as well as substantially equivalent to the predicate devices."
  • Key points of the comparison for substantial equivalence:
    • Identical Indications for Use: The predicate device and the proposed device share "identical indications for use" for their respective categories (e.g., breast localization, soft tissue biopsy).
    • Same Technical Specification: The proposed device has the "same technical specification in materials and grinding" as the predicate device.
    • Biocompatibility: All materials are medical grade steel and plastic, which have been cleared in previous 510(k) applications (K040965 for Anesthesia conduction, spinal and epidural) and are "deemed to be biocompatible." Testing according to ISO 10993 has been conducted successfully using identical materials.
    • Sterilization: The device uses Ethylene Oxide (EO) sterilization to a Sterility Assurance Level (SAL) of

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