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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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