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The Humeral Head, Manual Driver is for emergency vascular access when standard venous access is not possible. Humeral head IO access is indicated when rapid fluid or pharmacological resuscitation is required and intravenous access is not possible.

The Humeral Head, Manual Driver consists of a proprietary pentagon shaft permanently attached to an ergonomically designed handle. The Humeral Head, Manual Drivers are designed to allow the user to manually insert a needle set consisting of a stylet and catheter into 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 with the Humeral Head, Manual Driver, is 15g X 25mm.

This document is a 510(k) summary for the Humeral Head, Manual Driver device, submitted by VidaCare Corporation in 2006. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study with acceptance criteria and performance metrics for a novel medical device. Therefore, much of the requested information regarding acceptance criteria and study details demonstrating performance for a new algorithm/AI device is not available in the provided text.

The device described is a physical medical instrument (a manual driver for intraosseous infusion), not a digital or AI-powered diagnostic/treatment system. As such, the concept of "acceptance criteria" and "device performance" in the context of sensitivity, specificity, or reader improvement with AI assistance, as typically applied to AI/ML devices, is not directly applicable here. Instead, the "acceptance criteria" for a 510(k) submission for this type of device revolve around demonstrating substantial equivalence to legally marketed predicate devices in terms of intended use, technological characteristics, and safety/effectiveness.

Here's an attempt to answer the questions based on the provided text, while highlighting what is not applicable or not explicitly stated:

Acceptance Criteria and Study to Prove Device Meets Criteria (Based on Provided Text)

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

For this 510(k) submission, the "acceptance criteria" are implied by the regulatory standard for substantial equivalence, which requires demonstrating that the new device has the same intended use and similar technological characteristics to a predicate device, and does not raise new questions of safety or effectiveness. The "performance" is implicitly deemed acceptable if substantial equivalence is established.

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

• Not applicable / Not explicitly stated. This device is a physical instrument for medical procedures, not a diagnostic algorithm that processes data. Therefore, there's no "test set" of data in the sense of patient images or clinical records for an algorithm's performance evaluation. The submission relies on comparison to predicate devices, not on a new clinical study with a specific data set.

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. As above, there is no "test set" driven by expert ground truth for this type of device submission. The substantial equivalence relies on regulatory review and engineering/design comparisons.

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

• Not applicable. No test set or adjudication method 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

• No, a MRMC comparative effectiveness study was not done. This device is an intraosseous infusion system and does not involve "human readers" or "AI assistance" in the context of interpretation of medical images or data.

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

• Not applicable. This is a mechanical medical device, not an algorithm.

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

• Not applicable. The "ground truth" for this 510(k) submission is the established safety and effectiveness of the predicate devices based on their prior regulatory clearance and market experience. The new device is deemed acceptable if it is substantially equivalent to these already accepted devices.

8. The sample size for the training set

• Not applicable. There is no "training set" for an algorithm associated with this device.

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

• Not applicable. As there is no training set mentioned.

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