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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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The Cartilage Biopsy Needle is intended to obtain a sample of articular cartilage tissue during arthroscopy.

The Ranfac Cartilage Biopsy Needle is a manual, sterile disposable needle intended to obtain a sample of cartilage during arthroscopy. The device is comprised of an outer cannula with handle and an inner stylet. The product is provided with probe guide and probe to assist with the extraction of the cartilage from the needle. The probe guide facilitates the insertion of the probe through the distal end of the needle. The 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. This premarket notification is for both an 8-gauge and 11-gauge needle (product catalog numbers: CBN-84 and CBN-114, respectively).

The provided document is a 510(k) Summary for the Ranfac Cartilage Biopsy Needle. It includes some performance data (bench testing) but does not describe acceptance criteria, a specific study proving it meets those criteria, or details regarding sample sizes for training/test sets, expert ground truth establishment, or MRMC studies. The document indicates "No clinical studies were conducted for this submission."

Here's an analysis of the available information based on your request:

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

The document does not explicitly present a table of acceptance criteria or detailed performance metrics. It provides qualitative statements about bench testing results:

2. Sample size used for the test set and the data provenance

The document does not specify a sample size for the bench testing beyond "All samples." It states that articular cartilage was harvested from "ex vivo bovine knees." This indicates the data provenance is ex-vivo animal tissue (bovine), and the nature of the test is prospective in the sense that the testing was conducted for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document mentions "histological analysis" for evaluating sample integrity but does not specify the number or qualifications of experts involved in this analysis for the bench testing.

4. Adjudication method for the test set

The document does not describe any adjudication method for the bench testing results.

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, an MRMC comparative effectiveness study was not done. The device described is a physical biopsy needle, not an AI-powered diagnostic tool. The document explicitly states: "No clinical studies were conducted for this submission."

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

Not applicable. This device is a physical biopsy needle. There is no algorithm or AI component.

7. The type of ground truth used

For the bench testing, the ground truth for "sample integrity" was established via histological analysis of the cartilage samples acquired.

8. The sample size for the training set

Not applicable. The device is a physical biopsy needle, not a machine learning model. There is no training set mentioned or implied.

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

Not applicable. As there is no training set, there is no ground truth for a training set to be established.

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