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The PneumRx Family of Biopsy Needles and Kits is intended for use in obtaining bone, vertebral body, and bone marrow biopsy specimens, and single and multiple tissue biopsy specimens of tissues or lesions, partial or complete removal of imaged abnormalities, in soft tissues, for applying radionuciide sources into the body, and for aspirating, or injecting various fluids or contents (e.g., sclerosing agents, vasoconstrictors, anesthetics, ethanol, saline, heparin, and other historically used, and/or generally accepted medical fluids in accordance with the judgment and training of the medical practitioner).

The PneumRx Family of Biopsy Needles and Kits is indicated for use in obtaining bone, vertebral body, and/or bone marrow biopsy using coring, cutting or aspiration, as well as providing and maintaining surgical site access with coaxial biopsy needle kits.

They are also indicated for use in percutaneous, open surgical, fine needle, tissue core, coaxial, and aspiration biopsy/ tissue sampling of soft tissues for:

• . Microscopic, histologic, diagnostic, evaluation
• Fluoroscopic, ultrasound (US), computed tomography (CT)/x-ray, mammographic imaging, . MRI (magnetic resonance imaging), and/or direct visualization
• . Guiding biopsy needles to the target lesion
• Avoiding punctures in non-penetrable anatomic obstacles (e.g., bone, spine) or vital structures (e.g., blood vessels, nerves)
• Obtaining multiple biopsy, core biopsy, and aspiration biopsy tissue samples with partial or . complete removal of the imaged abnormality
• Aspirating, draining, or injecting various fluids or contents in soft tissues, including . introduction of sclerosing agents or vasoconstrictors to control actual or potential bleeding
• Pericardiocentesis, transhepatic cholorangiography, and other applications requiring injection . or aspiration of fluids
• Lumbar puncture, spinal fluid sampling, local anesthetic injection to provide regional nerve . block/anesthesia, and amniocentesis
• Manual application of a radionuclide source into or on the body for radiation therapy .
• Including, but not limited to, the following anatomical locations and lesions; .
  • Pleural cavity
  • Lung
  • Lymph nodes
  • Thyroid
  • Adrenals
  • Soft tissue organs of the abdomen and thorax
  • Abdominal cavity/ abdominal soft tissue masses
  • Kidney
  • Liver
  • Spleen
  • Pancreas
  • Prostate
  • Tumors
  • Cysts
  • Fluid spaces
  • Soft tissue lesions or tissue spaces
  • Breast:
    • The PneumRx Family of Biopsy Needles and Kits is 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 a 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.

The PneumRx Family of Biopsy Needles and Kits are comprised of the following main components:

• Standard and steerable biopsy needles in a range of sizes;
• Standard straight and steering stylets compatible with a range of steerable and . standard biopsy needles;
• . Remote Control Steering Handle accessory:
• Procedure accessories including drapes, gauze sponges, syringes, scalpels, depth . markers, and prep tray.

The provided text is a 510(k) summary for the PneumRx Family of Biopsy Needles and Kits. This type of submission focuses on demonstrating substantial equivalence to predicate devices, rather than proving performance against specific acceptance criteria through a clinical study. Therefore, the document does not contain the detailed information requested regarding acceptance criteria, study design, sample sizes, expert involvement, or AI-specific performance metrics.

However, based on the context of a 510(k) summary for a biopsy needle, we can infer the nature of the acceptance criteria and the type of study that would have been performed, even if the specifics are not explicitly stated in this document.

Here's an analysis of the provided text in relation to your questions:

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

• Acceptance Criteria (Inferred): For a biopsy needle, acceptance criteria would typically revolve around:
  • Biopsy Yield/Quality: Ability to obtain adequate tissue samples for histological examination.
  • Mechanical Integrity/Functionality: Needle sharpness, rigidity, ease of penetration, absence of breakage, smooth operation of steering mechanisms (if applicable).
  • Biocompatibility: Absence of adverse reactions to materials.
  • Sterility: Maintenance of sterility.
  • Safety: Absence of sharp edges, proper disposal, minimal tissue trauma during deployment and retraction.
• Reported Device Performance: The document states:

  "In addition, comparative performance test data demonstrated adequate device performance."
  and
  "The review of the indications for use and technical characteristics provided demonstrates that the PneumRx Family of Biopsy Needles and Kits is substantially equivalent to the predicate devices."

  • Explanation: This is a high-level statement indicating that the device met the necessary performance characteristics to be deemed substantially equivalent to existing, legally marketed predicate devices. It does not provide specific metrics or raw data. For a biopsy device, "adequate performance" likely refers to successful tissue acquisition and mechanical function on in-vitro or in-vivo (animal) models, confirming it performs comparably to the predicates.

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

• The document does not provide details on the sample size for a test set, nor the data provenance (e.g., country of origin, retrospective/prospective).
• For a 510(k) of this nature (biopsy needle), performance testing often involves bench testing (mechanical strength, sharpness, fluid flow), and potentially animal studies for tissue yield, rather than large human clinical trials, unless a novel feature or indication warrants it.

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/Not mentioned. The 510(k) summary focuses on demonstrating substantial equivalence through technical characteristics and "comparative performance test data," which would primarily involve engineering and possibly animal model assessments. There is no indication of human expert review for establishing ground truth in a "test set" in the context of AI or diagnostic accuracy.

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

• Not applicable/Not mentioned. This concept is typically relevant for studies involving human interpretation or AI performance assessment, which is not the focus of this 510(k) summary.

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

• No. This is a conventional medical device (biopsy needle), not an AI diagnostic tool. Therefore, an MRMC study or AI-related effectiveness study was not performed or mentioned.

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

• No. As explained above, this is a physical medical device, not an algorithm, so standalone algorithm performance is not applicable.

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

• For a biopsy needle, the "ground truth" during performance testing would likely be:
  • Pathology: Confirmation of tissue type and quality from samples retrieved in animal models or bench test substitutes (e.g., gelatin, synthetic tissue).
  • Mechanical Measurement: Engineering specifications for strength, sharpness, bend resistance, etc.
• The document does not explicitly state the ground truth methodology but implies technical verification and potentially histological analysis of acquired tissue in performance testing.

8. The sample size for the training set

• Not applicable. This is a physical medical device, not an AI model requiring a training set.

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

• Not applicable. As above, this is a physical medical device.

In summary:

The provided 510(k) summary for the PneumRx Family of Biopsy Needles and Kits serves to demonstrate substantial equivalence to predicate devices. It relies on the inherent safety and effectiveness of similar devices already on the market and "comparative performance test data" to show that the new device performs adequately. It does not contain the detailed clinical study data, acceptance criteria, or AI-specific performance metrics that would be found in a submission for a novel diagnostic device or an AI-powered system.

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