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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to the biopsy cannula and the driver is activated and advanced the desired depth to obtain the biopsy specimen and then withdrawn.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 EZ-IO Intraosseous Infusion System provides intraosseous access in the proximal tibia, distal tibia and humeral head (proximal humerus) of adult and pediatric patients, and the distal femur in pediatric patients when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases for up to 24 hours.

The EZ-IO Intraosseous Infusion System previously cleared with K132583 is designed to allow the user to insert a needle set consisting of a stylet and catheter through the cortex of the bone to a desired depth within the bone marrow to facilitate intraosseous infusion of desired fluids and medications for vascular access. All system materials are medical grade. Needle sets are single-use and composed of 304 stainless steel with polycarbonate hubs and available in 15 mm (for patients 3-39 kg); 25 mm (for patients 3 kg or over) and 45 mm (for patients 40 kg or over) lengths. Black lines on the needle set catheter serve as depth markers. The reusable cordless driver/drill is powered by lithium batteries with a battery-power indicator light.

Clinicians locate anatomical landmarks and clean the insertion site. Using the cordless driver with needle set attached, the needle set is pressed through the soft tissue to the outer cortex of the bone. Depth markers on the catheter must be visible prior to powering driver to ensure adequate needle length for proper placement within the medullary space. Clinicians then squeeze the driver trigger and apply moderate, steady pressure. Trigger is released when a sudden "give" or "pop" is felt, which indicates entry into the medullary space; the needle set will not always be inserted to the hub. After insertion of the needle set, the driver unit is detached from the needle set, leaving the stylet and catheter firmly seated in the bone. The stylet is then separated and removed from the catheter by turning the stylet hub counter clockwise leaving a standard Luer lock catheter securely seated in the bone. The catheter Luer lock permits attachment of standard syringes and IV tubing for administration of medications and fluids.

This submission requests the addition of the distal femur as an insertion site for the pediatric population utilizing the same insertion technique and devices previously cleared via 510(k) K132538, which includes the insertion sites of the proximal tibia, distal tibia and proximal humerus.

This document is a 510(k) premarket notification for the Vidacare EZ-IO Intraosseous Infusion System, specifically requesting an expanded indication to include the distal femur as an insertion site for pediatric patients.

Here's an analysis of the provided information regarding acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state acceptance criteria in a quantitative or numerical format, nor does it present device performance in such a table. Instead, the "acceptance criteria" are implied by the applicant demonstrating the safety and efficacy of the EZ-IO system for the new distal femur insertion site, with the key argument being its similarity to currently approved sites and the absence of reported complications from its use in other regions.

The document references:

• Safety: The device has been cleared in the EU since 2011 for pediatric femoral insertion with no reported complications. The target area is "relatively large" making correct insertion "easier."
• Efficacy: Anatomically and physiologically, any bone with a medullary cavity can be used for infusion. The distal femur is closer to the heart, potentially providing "quicker drug and fluid delivery." Multiple publications support the use of the distal femur in pediatric patients for intraosseous access.

2. Sample Size Used for the Test Set and Data Provenance

The document primarily relies on cadaveric studies and preclinical vascular flow studies, and references to existing literature.

• Test Set Description: "cadaveric studies" and "preclinical vascular flow studies" are mentioned. No specific sample sizes for these studies are provided in this summary.
• Data Provenance: Not explicitly stated for the cadaveric and preclinical studies. However, the document mentions that the device is cleared in 39 countries outside the US, suggesting international experience. The EU clearance for pediatric femoral insertion since 2011 implies real-world data from Europe, though details are not provided within this specific submission summary.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not provided in the given document. The summary only refers to "cadaveric studies" and "preclinical vascular flow studies."

4. Adjudication Method for the Test Set

This information is not provided in the given document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or described in the provided summary. This submission focuses on expanding the indications for an existing device, primarily by demonstrating the safety and efficacy of a new anatomical insertion site, rather than comparing human reader performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The EZ-IO Intraosseous Infusion System is a physical medical device (a needle set and driver) for intraosseous access, not an AI algorithm. Therefore, the concept of a "standalone (algorithm only)" performance study is not applicable to this device. Human interaction is central to its intended use (clinicians performing the insertion).

7. The Type of Ground Truth Used

The ground truth implicitly used for the studies mentioned appears to be a combination of:

• Anatomical/Physiological Feasibility: The statement, "Anatomically and physiologically any bone that has a medullary cavity can be used to safely infuse drugs and fluids...", establishes a fundamental biological ground truth.
• Direct Observation/Measurement: Implied by "cadaveric studies" (demonstrating physical insertion and placement) and "preclinical vascular flow studies" (demonstrating fluid delivery).
• Clinical Outcomes/Absence of Complications: The lack of reported complications from EU use since 2011 serves as a form of clinical ground truth for safety.
• Expert Consensus/Literature Review: The document cites multiple publications and notes that the distal femur IO insertion site is "noted to be an option and has been used with success in pediatric patients." This relies on established medical knowledge and expert consensus in the field.

8. The Sample Size for the Training Set

The concept of a "training set" typically applies to machine learning algorithms. Since the EZ-IO Intraosseous Infusion System is a physical medical device, there is no training set in the context of an algorithm.

9. How the Ground Truth for the Training Set Was Established

As there is no training set (see point 8), this question is not applicable.

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