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The ZIEN IO Intraosseous Access System provides intraosseous access in the proximal tibia, distal tibia and humeral head (proximal humerus) of adults 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 ZIEN IO Intraosseous Access System consists of a single use disposable intraosseous (IO) needle assembly (the ZIEN IO Needle Set) that connects to a reusable manually powered drill (the ZIEN IO Driver). Upon manual activation, the Driver penetrates through the cortex of the bone to a desired depth within the bone marrow by means of rotary cutting action along with force applied axially by the operator. The Driver can then be separated from the hub of the IO needle assembly, leaving the cannula securely seated in the bone. The stylet containing the driver connection is then removed. The needle insertion can also be performed by hand, without the use of the Driver, as per the user's discretion. A standard Luer lock (part of the needle assembly) permits attachment of standard syringes and IV lines for administration of drugs and fluids.

The ZIEN IO Intraosseous Access System is a medical device designed to provide intraosseous access when intravenous access is difficult or impossible. The provided document, a 510(k) premarket notification, indicates that no clinical testing was performed for this submission. The substantial equivalence to a predicate device (SAM IO™ Intraosseous Access System, K191488) was established through non-clinical bench and simulated use testing.

Therefore, information regarding acceptance criteria and performance derived from a study involving human subjects or AI effectiveness studies is not available in the provided text. The following sections will address the available information based on the non-clinical testing detailed in the document.

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

The document primarily refers to "applicable design and performance requirements" and "conformity to applicable standards" as the acceptance criteria for non-clinical testing. The device's performance is reported as "Fulfilled" or "Passed-Fulfilled" against these standards.

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

The document does not specify the sample sizes used for the non-clinical bench testing or simulated use testing. It also does not provide details on the data provenance such as the country of origin or whether the data was retrospective or prospective, as these terms are typically relevant for clinical studies, which were not performed.

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)

This information is not applicable and therefore not provided in the document. The testing was non-clinical (bench and simulated use) and did not involve expert establishment of ground truth in a clinical context.

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

This information is not applicable as the testing was non-clinical and did not involve human-based assessment requiring adjudication.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is an intraosseous access system, not an AI-assisted diagnostic tool.

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

This question is not applicable. The ZIEN IO Intraosseous Access System is a physical medical device, not an algorithm, and therefore does not have "standalone" algorithm performance in the sense of AI. Its performance was tested as a standalone physical system in bench and simulated use.

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

For the non-clinical testing, the "ground truth" was established by conformity to established international and industry standards (e.g., ISO, ASTM) and the successful completion of specified performance tests. For instance, mechanical properties were tested against standard specifications, and sterility against validated sterilization processes. The "simulated use" testing implies a simulated environment, rather than a clinical ground truth.

8. The sample size for the training set

This information is not applicable as the device is a physical medical device and does not involve a "training set" in the context of machine learning or AI.

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

This information is not applicable as the device is a physical medical device and does not involve a "training set" for AI.

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The LANDMARK REBOA Catheter is intended for temporary occlusion of large vessels including patients requiring emergency control of hemorrhage.

The LANDMARK REBOA Catheter is a 67cm, 59cm working length, 6.5 Fr (2.2mm), single lumen balloon catheter for temporary intravascular vessel occlusion in patients requiring emergency control of hemorrhage. Radio-opaque markers are provided on the catheter shaft at the proximal and distal ends of the balloon for radiological location of the device is additionally provided with depth markings referenced from the balloon to provide positioning information similar to the predicate device prior to confirmation of placement through radiological means. The device is intended to be deployed through a 7F introducer sheath placed into the femoral artery through normal vascular access procedures.

The LANDMARK REBOA Catheter consists of five elements:

• . Occluder Balloon Inflation Lumen with female luer (DEHP free PVC)
• Catheter Handle (PA 12)
• Catheter Shaft (polyimide and stainless steel) with Marker Bands (stainless steel)
• Occluder Balloon (polyurethane)
• Guide J-tip (stainless steel, nitinol, acrylic) ●

The provided text is a 510(k) summary for the LANDMARK REBOA Catheter. While it outlines non-clinical testing performed to establish substantial equivalence to a predicate device, it does not contain information about studies involving human readers, AI assistance, or the use of expert consensus for ground truth. This device, a physical medical catheter, is evaluated based on its physical performance characteristics and biocompatibility, not on diagnostic accuracy derived from image analysis or human interpretation.

Therefore, many of the requested points regarding acceptance criteria and studies would not be applicable in this context. The document focuses on demonstrating that the new device performs comparably to a legally marketed predicate device through bench testing and an animal model, rather than validating a diagnostic algorithm's performance.

Here's an attempt to answer the applicable points based on the provided text, with an explanation for the missing information:

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

The document doesn't present a specific table of "acceptance criteria" with quantitative performance metrics for each test in the way one might for a diagnostic AI. Instead, it states that "Performance bench testing was conducted to ensure that the LANDMARK REBOA Catheter met the applicable design and performance requirements throughout its shelf life, verify conformity to applicable standards, and demonstrate substantial equivalence to the predicate system."

The tests performed and implicitly, the criteria for passing them, are:

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