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PAJUNK®s soft tissue biopsy, puncture and aspiration cannulas and needles are intended for obtaining biopsies from soft tissues, for use in puncturing and for aspiration.

They are not appropriate for bone biopsies.

Chiba SONO cannulas/ needles enhanced for ultrasound visibility are single use sterile and nonpyrogenic devices used to gain entry or puncture the tissue and aspirate soft tissue for biopsy purposes. The needles/ cannulas may be used during all biopsy and puncturing procedures according to the physician´s indication. Additionally fluids for example for fluoroscopy may be injected.

Cannulas/ needles enhanced for ultrasound visibility are standard cannulas/ needles equipped with CornerStone reflectors (cleared in K111374 - SonoPlex STIM) in order to significantly enhance ultrasound visibility.

The cannulas basically consist of stainless steel tubing and an epoxy glued polycarbonate hub.

In order to enhance ultrasound visibility the cannulas are equipped with a special reflector pattern named "CornerStone" imprinted to the cannulas surface. These reflectors are designed to optimally reflect ultrasound waves.

Here's an analysis of the provided text regarding the acceptance criteria and study for the device:

Important Note: The provided document is a 510(k) Summary of Safety and Effectiveness for a medical device (Chiba SONO cannulas/needles). This type of document primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed, rigorous study proving new performance claims against explicit acceptance criteria in the way one might expect for a novel, high-risk AI-powered device. Therefore, some of the requested information (especially around AI-specific elements like MRMC studies, training set details, or complex ground truthing) is not applicable or not provided in this type of submission.

Acceptance Criteria and Device Performance

The document does not explicitly list numerical "acceptance criteria" and "reported device performance" in a quantitative table for, for example, diagnostic accuracy (sensitivity, specificity, etc.), because it's a submission for a biopsy needle based on substantial equivalence to existing devices, not a new diagnostic algorithm.

Instead, the "acceptance criteria" are implied by the requirements for substantial equivalence and the performance of the predicate devices. The "reported device performance" is a qualitative affirmation that the device meets these implied criteria by being substantially equivalent and passing standard industry tests.

Here's an interpretation based on the provided text:

Study Details

1. Sample size 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" for mechanical properties and "bench marking" for general performance. It does not specify a "test set" in the context of patient data or images.
   • The "CornerStone" reflectors' efficacy is stated to be "demonstrated for each type of cannula" based on "clinical evaluation, the biocompatibility testing and the bench testing." However, details of this "clinical evaluation" (e.g., sample size, design) are not provided in this summary. Instead, the focus is on the device's technical and material equivalence to previously cleared devices.
   • Data provenance: Not specified for any "clinical evaluation." Bench testing would be internal to the manufacturer (Germany).

2. 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 as no specific "test set" requiring expert ground truth in a diagnostic sense is described. The evaluation is based on engineering tests and comparison to predicates.

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

   • Not applicable.

4. 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:

   • No. This device is a physical medical instrument (a biopsy needle), not an AI-powered diagnostic system. Therefore, an MRMC study is not relevant or described.

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

   • No. This is not an algorithm; it's a physical device.

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

   • For biocompatibility, the ground truth is compliance with ISO 10993-1 and material composition identical to cleared devices.
   • For sterility, the ground truth is an SAL of 10^-6 and compliance with specific limits, validated by standard methods.
   • For mechanical properties, the ground truth is adherence to internal "standard testing" requirements for bending stability, breaking resistance, and hub-to-needle bonding.
   • The primary "ground truth" for marketing clearance is substantial equivalence to an existing predicate device based on material composition, intended use, and similar technological characteristics.

7. The sample size for the training set:

   • Not applicable. There is no AI model or "training set" for this physical device.

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

   • Not applicable.

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