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The Ranfac Bone Marrow Biopsy Needles are indicated for use in aspirating bone marrow and for use in obtaining core biopsy samples of bone marrow.

The Ranfac Bone Marrow Biopsy Needles subject of this premarket notification (RTN-114, RTN-116, RTN-84, RTN-86, RTN-114-T, RTN 116-T, RTN-84-T, RTN-86-T, RJN -114, RJN -116, RJN-84, RJN-86) are manual, sterile disposable needles intended for the purpose of harvesting bone marrow specimens. The device is comprised of an outer cannula with handle and an inner stylet. The cannula has graduated etched markings spaced in 1 cm intervals. The product is provided with a probe guide and marked probe to assist with the extraction of the bone marrow specimen from the needle. The probe guide facilitates the insertion of the marked probe through the distal end of the needle. The marked probe is introduced into the probe guide at the distal tip of the needle and advanced forward to move and expel the specimen out through the needle handle. Specific models of the Ranfac Bone Marrow Biopsy Needles are also provided with a stainless steel marrow extraction cannula (either Canoe or Tweezer design) which fit inside the needle to facilitate capture and retrieval of bone marrow samples. The specimen is contained within the extraction cannula during withdrawal from the needle. The Ranfac Bone Marrow Biopsy Needles are provided with a luer cap to prevent back flow of blood during needle insertion and product with the optional extraction cannula are provided with two needle vices to cap the needle and stylet tip prior to disposal.

I am unable to provide the details you requested regarding acceptance criteria and study data for the device. The provided text is an FDA 510(k) clearance letter for Ranfac Bone Marrow Biopsy Needles, not a study report or clinical trial summary.

While the document states that "Performance testing and comparison of characteristics between the subject and predicate devices have demonstrated that the Ranfac Bone Marrow Biopsy Needles are substantially equivalent to the predicate devices...", it does not include specific acceptance criteria, detailed performance data, sample sizes, information on ground truth establishment, or any of the other specific study parameters you requested.

The document only generally mentions:

• Biocompatibility Testing: Passing results for Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic toxicity, and Material-Mediated Pyrogenicity.
• Bench Testing:
  • Structural integrity testing (tensile/torque) with all samples meeting or exceeding acceptance criteria.
  • Comparative performance testing using the Jamshidi Bone Marrow Biopsy/Aspiration Needle demonstrating suitability for bone marrow sampling.
  • Simulated use testing to validate design output met design input requirements.
• Clinical Studies: "No clinical studies were conducted for this submission."

Therefore, I cannot extract the information required to populate the fields in your request, such as a table of acceptance criteria and reported performance, sample sizes, expert qualifications, or details on ground truth for training or test sets.

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