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The Lateral Access Bone Marrow Aspiration Needle is intended for use for aspiration of bone marrow or autologous blood using a standard piston syringe.

The Ranfac Lateral Access BMA Needle subject of this premarket notification is a manual, sterile disposable needle intended for the purpose of aspirating bone marrow or autologous blood. The device consists of an Access Needle for bone marrow penetration and an Aspirator Cannula through which the aspirate is obtained. The Access Needle is comprised of a 7-gauge outer cannula and an 11-gauge inner cannula with an overall length of 6.5 inches when the inner cannula is fully extended. The outer cannula has an adjustable grip, and a blunt tip that rests on the surface of the bone. The inner cannula has a ground point for bone/bone marrow penetration and side ports for marrow aspiration. When the molded grip of the Access Needle is turned clockwise the inner cannula is withdrawn into the outer cannula exposing the tip to a different location within the needle tract allowing for additional bone marrow aspiration acquisition without having to reposition the needle. During use, the Access Needle is inserted into bone with the aid of a sharp or drillable stylet. Once the needle is properly positioned and the stylet removed, a 14-gauge Aspiration Cannula is inserted into the Access Needle. The distal tip of the Aspiration Cannula is closed and provided with side holes to allow the physician to aspirate from the sides of the needle (to minimize blood within the aspirate). A white indicator on both the Access Needle and the Aspiration Cannula is provided in order to allow for alignment of the two components' side ports (for aspiration of bone marrow). An exchangeable Drillable Stylet is provided for use with the device which can mate to a standard surgical drill to aid bone penetration if needed. The device is also packaged with a commercially available, 510k cleared standard 10mL luer lock hypodermic syringe for collection of bone marrow aspirate.

The provided document is a 510(k) Premarket Notification for the Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA). It describes the device, its intended use, and a comparison to a predicate device. However, it does not contain information about the acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML algorithm or diagnostic performance study. The document focuses on demonstrating substantial equivalence to a predicate device primarily through comparison of design, materials, and functional characteristics for a physical medical device (a needle), and basic performance testing for structural integrity and sterility.

Therefore, I cannot provide the detailed information requested regarding acceptance criteria and study data for an AI/ML device, as it is not present in the provided text.

Specifically:

• 1. A table of acceptance criteria and the reported device performance: Not provided. The document mentions "All samples met or exceeded acceptance criteria" for structural integrity testing, but does not detail these criteria or performance metrics. This is for the physical device's robustness, not diagnostic performance.
• 2. Sample sized used for the test set and the data provenance: Not applicable in the context of an AI/ML device's test set. For the physical device, it mentions "All samples" for structural integrity testing, without specifying the number of samples or data provenance (e.g., country of origin, retrospective/prospective).
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this is a physical medical device (a needle), not an AI/ML algorithm or diagnostic tool where ground truth would be established by experts.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
• 8. The sample size for the training set: Not applicable.
• 9. How the ground truth for the training set was established: Not applicable.

The "Performance Testing" section states: "Structural integrity testing was conducted on the Ranfac LA BMA Needle demonstrating robustness and appropriateness of the design. All samples met or exceeded acceptance criteria. Strength specifications (resistance to breakage and torque) are similar to those of the predicate Ranfac Marrow Cellution Bone Marrow Aspiration Needle. Additionally, simulated use testing was performed to validate that the design output of the Ranfac LA BMA Needle met design input requirements." This refers to mechanical and design performance, not diagnostic accuracy or AI/ML performance.

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The Ranfac FLEX Bone Marrow Aspiration (BMA) Needle is intended for aspiration of bone marrow or autologous blood using a standard piston syringe.

The Ranfac FLEX BMA Needle subject of this premarket notification is a manual, sterile disposable needle intended for the purpose of aspirating bone marrow or autologous blood. The device consists of an Access Needle for bone marrow penetration and an Aspirator Cannula through which the aspirate is obtained. The Access Needle is provided with an integral threaded Adjustable Guide which acts as a depth stop for control of needle penetration depth and when turned counterclockwise allows for the Aspiration Cannula to be withdrawn backwards through the bone marrow needle tract in a controlled manner (as opposed to manually pulling back the needle or Aspiration Cannula). The distal tip of the Aspiration Cannula is closed and provided with side holes to allow the physician to aspirate from the sides of the needle (to minimize blood within the aspirate). The Aspiration Cannula has a flexed tip which will redirect if the tip encounters the wall of the marrow cavity. The Access Needle is 8 gauge with an effective length of 3 inches. An exchangeable Drillable Stylet is provided for use with the device which can mate to a standard surgical drill to aid bone penetration if needed.

The provided text describes the 510(k) submission for the Ranfac FLEX BMA Needle, asserting its substantial equivalence to a predicate device. However, this submission does not contain information about a study that assesses AI/algorithm performance or human reader performance with AI assistance.

Therefore, I cannot fill in the table or provide details for most of the requested points related to AI/algorithm performance, multi-reader multi-case studies, or the specifics of training and test sets and their ground truth.

The document focuses on demonstrating the device's physical and functional equivalence through engineering and biological testing, not through clinical performance data relevant to AI model validation.

Here's a breakdown of what can be extracted from the document based on your request, and where information is missing:

Acceptance Criteria and Device Performance (as far as applicable to this document)

Detailed Study Information (Based on Document Content)

This document describes the 510(k) submission for a physical medical device (a bone marrow aspiration needle), not an AI-powered diagnostic or assistive tool. Therefore, most of the requested information, which pertains to AI/algorithm development and validation, is not present in the provided text.

1. Sample size used for the test set and data provenance:

   • Not applicable for AI/algorithm testing. The document mentions "Structural integrity testing," "simulated use and cadaver testing," "biocompatibility testing," "sterility validation," and "shelf life studies." Specific sample sizes for these engineering and biological tests are not detailed beyond "All samples" for structural integrity.

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

   • Not applicable for AI/algorithm testing. Ground truth, in the context of an AI model, typically refers to expert labels on a dataset. This concept does not apply to the validation of a physical medical device as described here.

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

   • Not applicable for AI/algorithm testing. Adjudication is a process to resolve disagreements among human labelers, which is not relevant to the physical device validation described.

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. Not applicable. This document pertains to clearances for a physical device, not an AI system that assists human readers.

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

   • Not applicable. This device is a manual, physical instrument. There is no algorithm to test in standalone mode.

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

   • Not applicable for AI/algorithm testing. For the physical device, "ground truth" would be the success of a mechanical test, sterility validation result, or biocompatibility outcome. These are defined by established standards (e.g., ISO 11135 for sterility).

7. The sample size for the training set:

   • Not applicable for AI/algorithm training. There is no AI model being trained for this physical device.

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

   • Not applicable for AI/algorithm training. There is no AI model being trained for this physical device.

Summary: The provided FDA 510(k) submission describes the substantial equivalence of a physical medical device (bone marrow aspiration needle) to a predicate device. The performance data shared relates to the manufacturing, material, and mechanical properties of the needle, and does not involve AI algorithms or human reader performance studies. Therefore, most of the requested details concerning acceptance criteria and studies for AI-based devices cannot be extracted from this document.

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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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