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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stop for control of needle penetration depth and when turned counterclockwise allows for the Aspiration Cannula to be withdrawn backwards through the bone marrow needle tract in a controlled manner (as opposed to manually pulling back the needle or Aspiration Cannula).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 OnControl™ Bone Marrow Biopsy System is intended for bone marrow aspiration and biopsy in adult and pediatric patients age 2 and older.

The OnControl Bone Marrow Biopsy System by Vidacare® consists of a reusable Power Driver and a disposable sterile needle set in a sealed procedure tray. The procedure tray contains 1 driver connector with sterile sleeve, 1 biopsy needle set with depth guide, an ejector rod and alignment quide. The OnControl Bone Marrow Biopsy System Needle Set consists of a cannula made of 304 stainless steel, with a beveled cutting tip and stylet. The needle sets are 11 gauge, 102 mm and 152 mm with an internal core capturing thread at the distal tip of the cannula. The proposed device will utilize identical needle sets (gauge, length and materials) as currently utilized in the predicate device K072045 The OnControl Bone Marrow Biopsy System by Vidacare®. The proposed device will also utilize the power rotary driver technology as used for the predicates K072045, The OnControl Bone Marrow Biopsy System by Vidacare® and K070759 Powered EZ-10® Pediatric Bone Marrow Aspiration System (new trade name, OnControl Bone Marrow Aspiration System).

Upon activation, the power rotary driver assists the clinician in inserting the needle set through the cortex of the bone. The driver is then separated from the hub of the needle set by retracting the OnControl Connector release mechanism. The inner stylet is used only to penetrate the cortex and is then removed. The standard Luer lock hub on the cannula permits attachment of a syringe for aspiration. The depth guide which slides up and down the cannula is moved to the desired depth marking. The power rotary driver is then reattached to the biopsy cannula and the driver is activated and advanced the desired depth to obtain the biopsy specimen and then withdrawn. The driver is then separated from the needle assembly for specimen removal.

This submission requests the addition of the pediatric population, age 2 and older, as an expanded indication to previously cleared K072045. The OnControl Bone Marrow Biopsy System with the same Indication For Use, for bone marrow aspiration and biopsy utilizing the same insertion technique and devices as the predicate.

The provided text is a 510(k) summary from the FDA, and it describes a medical device, "The OnControl™ Bone Marrow Biopsy System by Vidacare®," which is intended for bone marrow aspiration and biopsy. The submission requests an expanded indication for use in pediatric patients aged 2 and older. The document references a study to support this expanded indication, but it does not contain the detailed acceptance criteria or extensive study results that would allow for a complete answer to all parts of your request.

Here's an attempt to answer your questions based solely on the information provided in the given text:

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

The document does not explicitly state quantitative acceptance criteria in a table format. However, it discusses the outcomes of a study, implying certain performance goals.

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

• Sample Size: The study referenced for pediatric patients is described as "a recent randomized controlled trial with pediatric patients (ranging from 2-18 years old)." The exact sample size is not provided in this document.
• Data Provenance:
  • The study is a "randomized controlled trial with pediatric patients." This indicates it was a prospective study.
  • The "tactile feedback study" compared three devices in "simulated bone," so this was a non-clinical study or a phantom study.
  • The country of origin for the pediatric patient study is not specified in the provided text. The reference for this study is "Falcon-Cantrill M. Thomas P. Saldivar V. Assanasen C. Comparison of a rotary powered bone marrow aspiration and biopsy device to the traditional manual device in children. Pediatr Blood Cancer 2013;60(S2);S8. Doi:10.1002/pbc.24509 (Full manuscript pending publication)".

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)

The document does not provide details on the number or qualifications of experts used to establish ground truth for the pediatric patient study. It only mentions that the study concluded the device was safe and effective.

For a related detail (not for the specific pediatric study but general context on core biopsy length): "In a study by the European Neuroblastoma Study Group, 139 of 822 (17%) biopsy specimens were inadequate; containing less than 0.5 cm of well-preserved bone marrow as assessed by two central reviewers." This mentions "two central reviewers" but their qualifications are not specified.

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

The document does not describe any specific adjudication method for the test set of the pediatric study.

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

This document describes a medical device, not an AI software. Therefore, an MRMC comparative effectiveness study involving AI assistance for human readers is not applicable to this submission.

The study referenced is a "randomized controlled trial" comparing the OnControl system to "traditional manual biopsy retrieval methods."

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

This document describes a medical device, not an AI algorithm. Therefore, a standalone algorithm performance study is not applicable to this submission. The device is a "Bone Marrow Biopsy System," which is a physical tool used by clinicians.

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

For the pediatric study, the "ground truth" or primary outcomes implicitly relate to:

• Safety: Absence of complications.
• Effectiveness: Time taken for the procedure, quality of the biopsy specimens (implicitly assessed by pathology), and patient pain levels.
  • The text frequently refers to "adequate specimens," implying histological or pathological evaluation of the biopsy cores. For example, "Core biopsy length has been found to be critical in diagnoses..." and "The larger the amount of marrow obtained the greater chance of finding a focal lesion."

8. The sample size for the training set

This is a medical device for biopsy, not an AI algorithm that requires a training set. Therefore, this question is not applicable.

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

This is a medical device for biopsy, not an AI algorithm that requires a training set. Therefore, this question is not applicable.

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The Vertebral Access System by Vidacare® is intended for use with a standard cement delivery system for the fixation of fractures of the vertebral body using vertebroplasty. This system does not contain cement.

The Vertebral Access System by Vidacare® consists of a reusable Power Driver and a disposable sterile needle set in a sealed tray. The sealed tray contains 1 coupler with driver sterile sleeve, 1 beveled needle set and 2 sharps protectors. The Vertebral Needle Set is an 11 gauge, 152 mm cannula made of 304 stainless steel, with beveled cutting tip and stylet. The 11 gauge, 152mm needle set is identical in gauge and length to the predicate devices: OnControl™ Bone Marrow Biopsy System (cleared via K072045) and the Parallax EZFlow Cement Delivery System (cleared via K051820). The powered driver is identical to the predicate driver cleared via K072045.

This document describes a 510(k) submission for the "Vertebral Access System by Vidacare®". This submission is for substantial equivalence to existing devices, not for demonstrating new clinical effectiveness. Therefore, the typical "acceptance criteria" and "study that proves the device meets the acceptance criteria" as might be seen for a novel device demonstrating performance metrics are not directly applicable in the terms you've presented for medical imaging AI.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices. This means showing that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness compared to legally marketed devices.

Based on the provided text, here's a breakdown in relation to your questions:

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

For a 510(k) focusing on substantial equivalence, the "acceptance criteria" are not performance metrics like sensitivity/specificity for a diagnostic device. Instead, the acceptance criteria are met by demonstrating that the new device is as safe and effective as predicate devices. The "reported device performance" is essentially that the new device shares similar technological characteristics and indications for use with the predicate devices.

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

There is no "test set" in the context of an AI/diagnostic device study. This 510(k) is for a medical instrument (Vertebral Access System). Device performance is demonstrated through comparison of specifications and design features, not clinical data from a "test set" analyzing patient outcomes in the way a diagnostic AI would.

• Sample size: Not applicable in this context.
• Data provenance: Not applicable.

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

Not applicable. "Ground truth" in the context of AI refers to expert-labeled data. For a hardware medical device submission like this, there isn't a "ground truth" to establish for a test set.

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

Not applicable. There is no test set or adjudication process for clinical outcomes described in 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

Not applicable. This is not an AI device. No MRMC study was performed or required for this type of medical instrument submission.

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

Not applicable. This is not an algorithm or AI device.

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

Not applicable. The "ground truth" for this submission would be the established safety and effectiveness of the predicate devices based on their prior FDA clearances. The new device demonstrates substantial equivalence to these predicates. This is a technical comparison of specifications and intended use, not an evaluation against a clinical ground truth for diagnostic accuracy or outcomes.

8. The sample size for the training set

Not applicable. This is not an AI device.

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

Not applicable. This is not an AI device.

In summary: The provided document is a 510(k) premarket notification for a medical instrument, not a diagnostic AI system. Therefore, the questions related to acceptance criteria, test sets, ground truth, experts, and AI performance metrics are not relevant to this specific regulatory submission type. The "study" proving the device meets its "acceptance criteria" is the detailed comparison of its technological characteristics and indications for use against legally marketed predicate devices, which led to the FDA's finding of "substantial equivalence."

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