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Cook Intraosseous Infusion Needles are sterile, disposable devices used primarily during pediatric emergencies as an alternative to unsuccessful intravenous access to allow for effective infusion of resuscitative drugs or fluids.

The Intraosseous Infusion Needles consist of a two-part assembly with a needle and a cannula. The device is pre-assembled with the hub of the cannula attached to the needle by a luer-lock connection. The cannula shaft is made of stainless steel and is available in 14, 16, or 18 Gauge, with shaft lengths of 2.5, 3.0, or 4.0 cm. The hub and base plate of the cannula are constructed of either nickel-plated brass or polycarbonate. The stylet of the needle is constructed of stainless steel. For placement, the needle assembly is inserted into the bone with firm, downward pressure using a clockwise rotation, with the needle tip directed away from the joint space and epiphyseal plate; the needle orientation should always be maintained in line with the long axis of the bone. The stylet of the needle can then be removed by stabilizing the base plate of the cannula and turning the knob of the needle counterclockwise to disengage the needle from the cannula. Once access to the intramedullary space is confirmed, infusion of drugs and fluids can be initiated through the cannula. Five different versions of Cook Intraosseous Infusion Needles, with the same basic design, will be made available:

• Dieckmann Intraosseous Infusion Needle High Density Hub/Brass Design
• Dieckmann Intraosseous Infusion Needle Standard Hub/Polycarbonate Design
• Intraosseous Infusion Needles Standard Tip Design
• Intraosseous Infusion Needle with Adjustable Flange
• Sussmane-Raszynski Intraosseous Infusion Needle

Here's an analysis of the provided text regarding the acceptance criteria and study information for the Cook Intraosseous Infusion Needles:

Note: The provided document is a 510(k) Summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than providing exhaustive details of standalone performance studies or extensive clinical trial data. Therefore, some of the requested information (e.g., number of experts, specific effect sizes for MRMC studies, detailed training set information) is not present in this type of submission.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't provide a direct table with explicit quantitative acceptance criteria alongside specific numerical performance results. Instead, it describes modifications and the types of tests conducted, stating that "The results of all tests met their predetermined acceptance criteria." The acceptance criteria are implicitly defined by the standards referenced (e.g., ISO 14971, BS EN ISO 11070, ISO 594-2).

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

• Sample Size: The document does not specify the exact sample sizes used for each of the listed tests (e.g., how many needles were tested for tensile strength or leakage). This level of detail is typically found in the full test reports, not the 510(k) summary.
• Data Provenance: The studies are likely prospective benchtop and in-vitro tests conducted by Cook Incorporated, as described in the "Design Control Activities" table. There is no mention of human clinical data, animal studies, or specific geographical origins of the data beyond "Cook Incorporated" being an Indiana, USA-based company.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable/not provided in this type of submission. The studies described are engineering/performance bench tests, not studies requiring expert review of medical images or patient outcomes for ground truth establishment.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. Adjudication methods (like 2+1 or 3+1 consensus) are relevant for studies involving human interpretation or subjective assessments, typically in clinical or image-based studies. The studies here are objective performance tests against pre-defined engineering standards.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices where human readers' performance with and without AI assistance is compared. The Cook Intraosseous Infusion Needles are physical medical devices, not diagnostic software.

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

No, a standalone algorithm performance study was not done. This concept also applies to diagnostic algorithms. The performance testing described is of the physical device itself.

7. Type of Ground Truth Used

The "ground truth" for the tests described is based on the requirements and specifications within the referenced international standards (e.g., ISO 10993-1, BS EN ISO 11070, ISO 594-2). For instance, for tensile strength, the ground truth is a specific force threshold that the bond must withstand. For biocompatibility, the ground truth is the absence of a toxic, allergenic, or irritant response as defined by the standard.

8. Sample Size for the Training Set

This information is not applicable/not provided. The device is a physical medical device, not an AI/ML algorithm that requires a "training set." The materials and manufacturing processes are controlled and tested, not "trained."

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

This information is not applicable/not provided for the same reasons as above.

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