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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to the biopsy cannula and the driver is activated and advanced the desired depth to obtain the biopsy specimen and then withdrawn.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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