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For intraosseous access anytime in which vascular access is difficult to obtain in emergent, urgent or medically necessary cases up to 24 hours. For patients ≥ 12 years old, the device may be extended for up to 48 hours when alternate intravenous access is not available or reliably established.

The EZ-IO Intraosseous Vascular Access System previously cleared with K202492 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 biocompatible. 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 serve as depth markers. The reusable cordless driver/drill is powered by lithium batteries with a battery-power indicator light. An extension tubing set accessory, the EZ-Connect, is included with every needle set. The EZ-Connect contains a needleless connector system and Luer lock adapter. An optional dressing, the EZ-Stabilizer, is an accessory to the EZ-IO Vascular Access System. It is designed as a securement device with an adhesive backing that is placed over an EZ-IO Needle to keep the needle securely anchored to the patient; and is recommended in the Instructions for use (IFU).

The provided document is an FDA 510(k) clearance letter for the EZ-IO Intraosseous Vascular Access System. It describes a Special 510(k) submission, which means the device being submitted is very similar to a previously cleared predicate device, with only minor changes. In this case, the only change is the sterilization of the EZ-IO Power Driver.

Therefore, the document does not describe a study involving AI performance, human reader improvement with AI assistance, or the establishment of ground truth by expert consensus for an AI-based device. It focuses on demonstrating the substantial equivalence of the modified (now sterile) power driver to the existing non-sterile one through non-clinical performance testing.

Consequently, much of the requested information (related to AI acceptance criteria, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone AI performance, and ground truth for AI) is not applicable to this document.

However, I can extract the information relevant to the provided text:

Acceptance Criteria and Device Performance (for the change in sterility of the driver)

The acceptance criteria for this 510(k submission are not directly stated as clinical performance metrics for the device's indications for use. Instead, they are related to demonstrating that the change (sterilization of the power driver) does not negatively impact the safety and effectiveness compared to the predicate device. The performance is demonstrated through non-clinical testing.

Table 1: Acceptance Criteria (Implied) and Reported Device Performance

Detailed Information as per Request:

1. A table of acceptance criteria and the reported device performance: See Table above.

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

   • Sample Size: Not specified in terms of clinical patient numbers. The testing appears to be primarily bench/laboratory testing on physical devices and packaging.
   • Data Provenance: Not specified, but generally, such non-clinical testing for FDA submissions would be conducted in controlled laboratory environments, likely within the US or by certified labs adhering to international standards. The tests are prospective in nature as they evaluate the manufacturing process and design changes.

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):

   • Not applicable. Ground truth in the context of expert consensus for AI models is not relevant here. The ground truth for this submission is established through adherence to recognized international standards for sterilization, packaging, and functional performance testing, which are objectively measurable.

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

   • Not applicable. Adjudication methods are typically for subjective assessments by multiple human readers, often in the context of AI performance evaluation. Here, the "truth" is determined by objective measurements against established engineering and sterilization standards.

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 study was not done as this clearance is not for an AI-enabled device or one that involves human interpretation of medical images.

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

   • Not applicable. This submission is not for an algorithm.

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

   • The "ground truth" for this submission is based on engineering standards, validated sterilization processes, and functional performance specifications of the medical device components (specifically, the power driver). It is objective and measurable, rather than being derived from subjective expert consensus, pathology, or clinical outcomes data in the context of a diagnostic or treatment outcome.

8. The sample size for the training set:

   • Not applicable. This submission does not involve an AI model or a training set.

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

   • Not applicable. This submission does not involve an AI model or a training set.

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For intraosseous access anytime in which vascular access is difficult to obtain in emergent, urgent or medically necessary cases for up to 24 hours.

Insertion sites:

ADULTS (≥22 years old)

• Proximal humerus
• Proximal tibia
• Distal tibia

PEDIATRICS (≤21 years old)

• Proximal humerus
• Proximal tibia
• Distal tibia
• Distal femur

For patients ≥12 years old, use of the device may be extended for up to 48 hours when alternate intravenous access is not available or reliably established.

The EZ-IO Intraosseous Vascular Access System previously cleared with K180395 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 biocompatible. 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 serve as depth markers. The reusable cordless driver/drill is powered by lithium batteries with a battery-power indicator light. An extension tubing set accessory, the EZ-Connect, is included with every needle set. The EZ-Connect contains a needleless connector system and Luer lock adapter. An optional dressing, the EZ-Stabilizer, is an accessory to the EZ-IO Vascular Access System. It is designed as a securement device with an adhesive backing that is placed over an EZ-IO Needle to keep the needle securely anchored to the patient; and is recommended in the Instructions for use (IFU).

The provided text describes a 510(k) submission for the EZ-IO Intraosseous Vascular Access System. This submission is for a device that already has a predicate (K180395) and the only change is to its MR Safety Status labeling, from "MR Unsafe" to "MR Conditional."

The document does not describe a study involving "AI assistance" or "human readers" or "ground truth established by experts" in the context of diagnostic performance, as the device is a medical access system, not an imaging or diagnostic AI. Therefore, many of the requested points regarding AI/MRMC study details are not applicable to this submission.

However, I can extract information related to the non-clinical testing performed to justify the change in MR safety status.

Here's a breakdown of the requested information based on the provided text:

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

The document does not explicitly state "acceptance criteria" in a quantitative table for this specific update, as the change is primarily about MR compatibility, not a functional performance metric beyond its existing predicate. The "performance" being evaluated is its behavior in an MRI environment.

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

• Test Article Sample Size: The tests were conducted on the "45 mm needle" as the test article. It's common in such engineering studies to test a representative sample rather than a large clinical cohort. The exact number of 45mm needles tested is not specified, but it's implied to be a sufficient and representative sample for engineering testing.
• Data Provenance: The testing was conducted by "Exponent, 2020," which is a consulting firm specializing in engineering and scientific consulting. The location is not specified, but this is a laboratory/engineering study rather than a clinical data set. It is a prospective test specifically for this regulatory submission.

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

• Not applicable. This is a physical device MR compatibility test, not a diagnostic study requiring human expert interpretation or ground truth establishment in the typical clinical sense. The "ground truth" here is determined by the physical measurements and compliance with engineering standards.

4. Adjudication method for the test set

• Not applicable. This is a physical device test, not a study requiring adjudication of expert opinions.

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. This is not an AI-assisted diagnostic device study. It is a physical medical device.

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

• No. This is not an algorithm.

7. The type of ground truth used

• Engineering/Physical Measurements against established safety standards. The "ground truth" for MR compatibility is determined by the quantitative measurements of parameters like RF-induced heating (as per ASTM F2052, ASTM F2213, ASTM F2182, and ASTM F2119 standards) and ensuring these measurements fall within safe limits for MRI environments.

8. The sample size for the training set

• Not applicable. This is not a machine learning or AI device that requires a training set.

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

• Not applicable. As above, no training set was involved.

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For intraosseous access anytime in which vascular access is difficult to obtain in emergent, urgent, or medically necessary cases for up to 24 hours. Insertion sites: ADULTS (≥22 years old): proximal humerus, proximal tibia, distal tibia PEDIATRICS (≤21 years old): proximal humerus, proximal tibia, distal tibia, distal femur Use of the device may be extended for up to 48 hours when alternate intravenous access is not available or reliably established. Insertion sites: ADULTS (≥22 years): proximal humerus, proximal tibia, distal tibia PEDIATRICS (≥12 years through 21 years old): proximal humerus, proximal tibia, distal tibia, distal femur

The EZ-IO System previously cleared with K14117 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 biocompatible. 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 serve as depth markers. The reusable cordless driver/drill is powered by lithium batteries with a battery-power indicator light. An extension tubing set accessory, the EZ-Connect, is included with every needle set. The EZ-Connect contains a needleless connector system and Luer lock adapter. An optional dressing, the EZ-Stabilizer, is an accessory to the EZ-IO Vascular Access System. It is designed as a securement device with an adhesive backing that is placed over an EZ-IO Needle to keep the needle securely anchored to the patient; and is recommended in the Instructions for use (IFU).

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

The core change addressed by this submission is the expansion of the "EZ-IO Intraosseous Vascular Access System" indications for use from up to 24 hours to up to 48 hours. Therefore, the primary acceptance criteria revolve around demonstrating the safety and effectiveness of the device for this extended dwell time.

Study Details

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

   • Sample Size (Test Set): 121 evaluable subjects.
     • 79 healthy volunteers
     • 39 with diabetes only
     • 3 with diabetes and renal insufficiency
   • Data Provenance: US single-site, prospective clinical IDE trial.

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

   • Not explicitly stated. The study involved clinical trial procedures and observations, including physical examinations and x-rays, but the specific number or qualifications of "experts" establish ground truth in the sense of a diagnostic consensus is not detailed. The "ground truth" here is the clinical outcome (complications, pain, patency) observed in the subjects under the study protocol.

3. Adjudication method for the test set:

   • Not explicitly stated in detail for all events. However, adverse events were assessed for relatedness to the device, implying a review process. The primary endpoint was the "absence of serious complications," suggesting a clear definition of what constitutes a serious complication and its determination by the study team.

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. This is not an AI/imaging device. It is a medical device for vascular access.

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

   • N/A. This is not an AI/algorithm device.

6. The type of ground truth used:

   • Clinical outcomes data: The ground truth was based on the presence or absence of serious complications, pain reports, patency, and other observed adverse events during the 48-hour indwelling period and subsequent 30-day follow-up of human subjects. This also included objective measures like IO aspirate cultures and x-rays.

7. The sample size for the training set:

   • N/A. This is a medical device approval, not an AI model requiring a training set. The "development" of the device was based on prior predicate devices and engineering principles, with the clinical study serving as a validation of the extended use.

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

   • N/A. As above, no training set in the AI sense was used.

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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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The EZ-10 Intraosseous Infusion System provides intraosseous access in the proximal tibia, distal tibia and humeral head (proximal humerus) of adult and 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 including previously cleared K091140 EZ-MIO Distal Tibia, EZ-10 Distal Tibia; EZ-10 (formerly Vidaport) Intraosseous Infusion System ; EZ-IO Humeral Head and K101026 Powered PD IO Infusion System; EZ-IO Humeral Head; Powered PD-IO 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 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 (3-39 kg); 25 mm (40 kg or over) and 45 mm (40 kg or over). Black lines on the needle set catheter serve as depth markers. The needle sets connect to the driver/drill/ manual handle shaft with a magnetic disc. The reusable cordless driver/drill is powered by lithium batteries with a battery-power indicator light. The EZ-MIO consists of a manual handle device which is primarily used by the armed forces.

Clinicians locate anatomical landmarks and clean the insertion site. Using the cordless driver or manual handle 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 or manually inserting the needle set to ensure placement within the medullary space. If using the powered driver 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 medullary space; the catheter will not always be inserted to the hub. If using the manual handle, clinicians apply downward pressure and rotation through the bone until a change in pressure is felt as a "give" or "pop" or desired depth is reached. For both methods after insertion of the needle set, the driver unit is detached from the needle set, leaving the stylet and cannula 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 a label change only to the 25 mm needle set from "40 kg or over" to" 3 kg or over" utilizing the same technique and devices previously cleared via 510(k)s K091140 and K101026.

The provided text describes the EZ-IO Intraosseous Infusion System and a 510(k) submission for a label change. However, it does not contain information about acceptance criteria, specific studies proving the device meets those criteria, device performance metrics, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/ML device.

The submission is for a label change for a physical medical device (intraosseous needle) to expand its approved weight range, not for a software-as-a-medical-device (SaMD) or an AI/ML component. The "study" mentioned refers to cadaveric pediatric studies demonstrating safety for the expanded needle length, rather than performance metrics of an AI model.

Therefore, I cannot fulfill your request for the specific AI/ML related information (such as reported device performance, sample sizes for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or ground truth details) because this information is not present in the provided document.

The document states:

• "This submission requests a label change only to the 25 mm needle set from '40 kg or over' to '3 kg or over' utilizing the same technique and devices previously cleared via 510(k)s K091140 and K101026."
• "The labeling change requires no new technology to facilitate the safe application of the product."
• "There have been no changes to the design or components of the Vidacare devices..."

This indicates that no new performance studies (especially not for an AI/ML component) were conducted or are being presented here. The "performance data" mentioned in the summary refers to existing data and clinical observations supporting the expanded weight range of the physical needle.

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The Powered PD-IO provides intraosseous access in the distal tibia of pediatric patients as an alternative to IV access in emergent, urgent, or medically necessary cases for up to 24 hours.

The Humeral Head EZ-IO provides vascular access when standard venous access is not possible. Humeral head IO access is indicated in pediatrics in emergent, urgent, or medically necessary cases when intravenous access is difficult or impossible to obtain for up to 24 hours.

The Powered PD-IO Intraosseous Infusion System provides intraosseous access in the proximal tibia as an alternative to IV access in emergent, urgent, or medically necessary cases for up to 24 hours. The device is for use in pediatric patients (approximate weight range: 3kg-39kg).

This submission seeks to extend the indications for use for the Powered PD-IO Intraosseous Infusion System (K051992); EZ-IO Humeral Head (K052408) and Powered PD-IO (K063142) for emergent, urgent and medically necessary intraosseous vascular access for the delivery of drugs and fluids to pediatric patients. Vidacare manufactures all of these products. The expansion of indications for these products requires no new technology to facilitate the safe application of the product. There have been no changes to the design or components of the devices cleared under 510(k) K051992, K052408, K063142 and therefore the comparison of technological characteristics listed below are identical.

I am sorry, but the provided text is a 510(k) summary and FDA clearance letter for a medical device (Powered PD-IO Intraosseous Infusion System). This type of document describes the device, its intended use, and its substantial equivalence to previously cleared devices.

It does not contain information about acceptance criteria, specific device performance metrics, study designs (sample sizes, data provenance, ground truth establishment, adjudication methods), multi-reader multi-case (MRMC) studies, or standalone algorithm performance studies.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. This document is focused on regulatory clearance based on equivalence, not on detailed performance studies of the kind you are asking about.

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EZ-MIO and EZ-IO: The EZ-MIO manual driver and EZ-IO power driver provide intraosseous access in the distal tibia of adults when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases for up to 24 hours.

Vidaport Intraosseous Infusion System: The VidaPort provides intraosseous access in the proximal tibia, when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases for up to 24 hours. The device is for use in adult patients only.

EZ-IO Humeral Head: The Humeral Head EZ-IO provides intraosseous access in the Humeral Head, when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases for up to 24 hours.

The EZ-MIO manual driver and EZ-IO power driver provide intraosseous access in the distal tibia. The VidaPort provides intraosseous access in the proximal tibia. The EZ-IO Humeral Head provides intraosseous access in the Humeral Head. These devices are used when intravenous access is difficult or impossible to obtain.

The provided text is a 510(k) summary for the Vidacare® Needle for EZ-MIO and EZ-IO, Vidaport Intraosseous Infusion System, and EZ-IO Humeral Head. This document does not contain information about acceptance criteria or a study proving device performance in the manner requested. Instead, it focuses on demonstrating substantial equivalence to existing predicate devices.

The key points from the document are:

• Device: Intraosseous infusion systems (needles and drivers) for providing access in the distal tibia, proximal tibia, or humeral head.
• Purpose of Submission: Extends the indications for use to include usage for up to 24 hours.
• Method of Equivalence: The submission states, "There have been no changes to the design or components of the devices cleared under 510(k) K062956, K032885 and K052408, and therefore the comparison of technological characteristics listed below are identical." This means the product's performance is assumed to be equivalent to the predicate devices because its design and components are unchanged.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and performance studies because the provided text does not contain that information. The document is a regulatory submission focused on substantial equivalence, not a detailed performance study report.

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For Bone Marrow Aspiration of the Iliac Crest in pediatric patients.

The Powered EZ-IO® Pediatric Bone Marrow Aspiration System consists of a reusable battery powered driver [previously cleared for aspiration in adults via 510(k) K062833], and a 25mm intraosseous (IO) device fcleared under 510(k) K032885] connected to a disposable, single use intraosseous aspiration needle set assembly. Upon activation, the drill assists the operator with needle set insertion into the bone. The driver is then separated from the hub of the needle set assembly, leaving the needle set securely seated in the bone. The trocar/stylet is then removed from the needle set leaving the 15 gauge catheter. A standard Luer lock (part of the catheter hub) then permits attachment of standard syringe for aspirating bone marrow samples. The needle set is 25mm in length [previously cleared for IO use in adults via 510(k] number K032885). This submission does not include new devices; it only requests new indications for use of the 510(k) device listed above as an aspiration product for pediatric applications.

It seems there's a misunderstanding in the request or the provided document. The provided text is a 510(k) summary for the "Powered EZ-IO Pediatric Bone Marrow Aspiration System." A 510(k) submission generally focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria, test sets, ground truth establishment, or multi-reader multi-case studies, as would be expected for a novel AI/software-as-a-medical-device.

The document states: "This submission does not include new devices; it only requests new indications for use of the 510(k) device listed above as an aspiration product for pediatric applications." It further emphasizes that the device was compared to predicates and found to have "similar technological characteristics and to be equivalent" in several areas.

Therefore, the information requested in points 1-9 (acceptance criteria, study details, sample sizes, expert qualifications, etc.) is not present in the provided 510(k) summary because this type of detailed performance study is not typically required or included for a 510(k) seeking a new indication for an already cleared device through substantial equivalence.

Based on the provided text, I can extract the following relevant information, but I cannot fulfill the request for a detailed performance study description:

Summary of Device and Regulatory Status:

• Device Name: Powered EZ-IO® Pediatric Bone Marrow Aspiration System
• Submitter: Vidacare Corporation
• 510(k) Number: K070759
• Date Prepared: March 16, 2007
• Classification Name: Gastroenterology-urology biopsy instrument
• Regulatory Class: II
• Product Code: FCF
• Predicate Devices:
  • K062833: Powered EZ-IO® Bone Marrow Aspiration System (Vidacare Corp.)
  • K051506: MIELO-CAN® (Sterylab)
  • K032885: VidaPort Intraosseous Infusion System (Powered Adult IO) (Vidacare Corp.)
  • K51992: Powered Pediatric IO (PD-IO) (Vidacare Corp.)

Indications for Use:

• For Bone Marrow Aspiration of the Iliac Crest in pediatric patients.

Description of the Device:

• Consists of a reusable battery-powered driver (previously cleared for aspiration in adults via K062833) and a 25mm intraosseous (IO) device (cleared under K032885) connected to a disposable, single-use intraosseous aspiration needle set assembly.
• The driver assists with needle set insertion into the bone.
• Driver is separated, trocar/stylet removed, leaving a 15 gauge catheter.
• Standard Luer lock permits attachment of a syringe for aspirating bone marrow samples.
• The needle set is 25mm in length (previously cleared for IO use in adults via K032885).

Basis for Substantial Equivalence:

The technological characteristics of the Powered EZ-IO® Pediatric Bone Marrow Aspiration System were compared to the predicate devices and found to be similar and equivalent in the following areas:

• Indications for Use
• Target Population
• Driver Design Features
• Needle Design
• Technique
• Sterility
• Biocompatibility
• Anatomical Sites Where Used

In conclusion, for a 510(k) submission based on substantial equivalence for a new indication for an existing device, a detailed "study that proves the device meets the acceptance criteria" in the way you've described (with test sets, ground truth, experts, etc.) is not typically performed or presented. The primary evidence presented is the comparison to legally marketed predicate devices to demonstrate equivalent technological characteristics and safety/effectiveness.

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The EZ-MIO manual driver and EZ-IO power driver provide intraosseous access in the distal tibia of adults as an alternative to IV access during emergencies.

The EZ-MIO manual driver, previously cleared under 510(k) K052195, consists of a proprietary pentagon shaft permanently attached to an ergonomically designed handle. The manual driver is designed to allow the user to manually 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 the infusion of desired fluids. After insertion of the needle set, the manual driver is detached from the needle set, leaving the stylet and cannula 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 drugs and fluids (not supplied). The size needle that can be used in the distal tibia utilizing the MIO manual driver is identical to the predicate 15q X 25mm. The EZ-MIO system is approved for use in the proximal tibia under 510(k) K052195. This submission extends the indication for use of the manual device to include the distal tibia in adults utilizing the same technique and device previously cleared for the proximal tibia via 510(k) K052195.

The EZ-IO powered driver, previously cleared under 510(k) K032885 for adult use, consists of a reusable battery powered driver connected to a single use disposable intraosseous (IQ) needle assembly. Upon activation, the drill supplies power to the needle set in order to penetrate through the cortex of the bone to a desired depth within the bone marrow. After insertion of the needle set, the power driver is detached from the needle set, leaving the stylet and cannula 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 drugs and fluids (not supplied). The size needle that can be used with the EZ-IO powered driver is identical to the predicate 15g X 25mm. The EZ-IO powered intraosseous system is cleared for use in the proximal tibia under 510(k) K032885. This submission extends the indication for use of the powered device to include the distal tibia in adults utilizing the same technique and device previously cleared for the proximal tibia via 510(k) K032885.

This document is a 510(k) summary for the EZ-MIO and EZ-IO Intraosseous Infusion Systems, seeking to extend their indications for use to include the distal tibia in adults. The submission primarily relies on equivalence to previously cleared devices (K052195 and K032885) and does not describe a new study with specific acceptance criteria or performance metrics directly comparable to a table.

Therefore, many of the requested details about acceptance criteria, specific device performance, sample sizes, expert qualifications, and ground truth establishment for a new study validating the extended indication are not present in this summary. The submission argues that since there are "no changes to the design or components," the devices are substantially equivalent to their predicates for the new anatomical site based on existing technology.

However, based on the provided text, here's what can be extracted and inferred:

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

The document does not explicitly state acceptance criteria in a quantitative manner or present a new study with specific performance metrics for the distal tibia insertion that would traditionally be reported in such a table. The argument for expanded indication is based on the devices being identical to their cleared predicates and the technique being similar.

Inferred Acceptance Criteria:

• Substantial Equivalence: The primary "acceptance criterion" for this 510(k) is demonstrating substantial equivalence to the predicate devices (EZ-MIO, K052195; EZ-IO, K032885) for the new indication (distal tibia in adults). This implies that the device performs similarly in terms of safety and effectiveness as demonstrated by the predicate devices for their cleared indications.
• No Design Changes: The device must have no changes to its design or components compared to the cleared predicate devices.
• Same Technique: The insertion technique for the distal tibia must be the same as the technique cleared for the proximal tibia.

Reported Device Performance (Inferred from Substantial Equivalence):
Since no new performance data for the distal tibia is presented, the "reported device performance" is essentially that the EZ-MIO and EZ-IO systems, when used in the distal tibia with the specified 15g x 25mm needle, are expected to perform comparably to their performance in the proximal tibia, which was deemed safe and effective in their original 510(k) clearances. This includes:

• Successfully facilitating the infusion of desired fluids.
• Firmly seating the stylet and cannula in the bone.
• Allowing separation and removal of the stylet, leaving a standard Luer lock catheter.

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

The document does not describe a new "test set" or a new clinical study to evaluate performance in the distal tibia. The submission is based on the technological characteristics being identical to the predicate devices. Therefore, details like sample size, country of origin, or retrospective/prospective nature are not applicable to this specific submission for an expanded indication. The "data provenance" would refer to the original studies conducted for the predicate devices, which are not detailed here.

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

Not applicable, as no new test set or ground truth establishment for an expanded indication study is described in this summary.

4. Adjudication method for the test set

Not applicable, as no new test set requiring adjudication is described.

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 a medical device for intraosseous infusion, not an AI-assisted diagnostic or imaging device, and no MRMC study is mentioned.

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

Not applicable, as this is a medical device, not an algorithm.

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

For this particular 510(k) expanding the indication, the "ground truth" is implied to be the established safety and effectiveness of the predicate devices for their original indications, and the argument that the same principles apply due to identical device characteristics and technique. No new empirical "ground truth" for the distal tibia is presented.

8. The sample size for the training set

Not applicable, as no new training set or new study is described.

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

Not applicable, as no new training set or new study is described. The relevant "ground truth" in this submission pertains to the established performance of the predicate devices.

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For Bone Marrow Aspiration of the Iliac Crest.

The Powered EZ-IO Bone Marrow Aspiration System consists of a reusable battery powered driver connected to a disposable intraosseous (IO) needle assembly. Upon activation, the drill penetrates through the cortex of the bone to a desired depth within the bone marrow. The driver then is separated from the hub of the IO needle assembly, leaving the cannula securely seated in the bone. The trocar/stylet containing the drill bit is then removed. A standard Luer lock (part of the needle assembly) then permits attachment of standard syringe for aspiration. The needle is 15 gauge and 60mm long.

This document is a 510(k) summary for the Powered EZ-IO Bone Marrow Aspiration System. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a full study to establish performance against acceptance criteria. Therefore, much of the requested information regarding detailed study design, ground truth establishment, expert involvement, and statistical analyses (like MRMC studies or specific acceptance criteria performance) is not typically found in these types of submissions.

Based on the provided text, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a quantitative sense with performance metrics. Instead, it focuses on demonstrating substantial equivalence to predicate devices by comparing their "technological characteristics." The "performance" is implied through this equivalence, suggesting the device performs comparably to already approved devices.

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

The document does not describe a performance "test set" in the traditional sense involving human subjects or patient data. The evaluation is based on comparing design characteristics and intended use with predicate devices. Therefore, there is no information provided on sample size or data provenance for a test set.

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

Since no clinical or performance "test set" is described, there's no mention of experts establishing ground truth. The substantial equivalence assessment is typically conducted by the manufacturer and reviewed by regulatory bodies (like the FDA).

4. Adjudication Method for the Test Set:

Not applicable, as no test set or clinical study requiring adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, there is no mention of an MRMC comparative effectiveness study. This type of study is more common for diagnostic imaging AI devices where human reader performance is a key metric.

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

Not applicable. The device is a physical medical instrument, not a software algorithm, so the concept of "standalone performance" in that context does not apply. The performance is assessed based on its functional design and equivalence to existing devices.

7. The Type of Ground Truth Used:

Ground truth, in the context of substantial equivalence for a physical device like this, refers to the established safety and effectiveness of the predicate devices. The "ground truth" is that these predicate devices are already legally marketed and considered safe and effective for their intended use. The new device is then compared to this established "truth." No specific "pathology" or "outcomes data" is referenced for the comparison, but rather the functional and design characteristics.

8. The Sample Size for the Training Set:

Not applicable. This is a medical device (aspiration system), not an AI algorithm that requires a "training set."

9. How the Ground Truth for the Training Set was Established:

Not applicable, as there is no training set for this type of device.

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