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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 are intended for use as an alternative to intravenous access during pediatric emergencies, permitting infusion of drugs and fluids. Intraosseous Infusion Needles consist of two basic components - the needle (composed of a knob, a stylet luer-lock, and a beveled stylet) and the cannula (comprised of a hub, a base plate, and a cannula shaft). The cannula attaches to the needle by the stylet luer-lock and is supplied attached and ready to use. The Intraosseous Infusion Needles are available in the following configurations:

Intraosseous Infusion Needle (with Dieckmann Modification – Standard Hub Design)

Cannula Gauge: 14, 16, 18
Cannula/Stylet Length (cm): 14 Gauge: 3.0; 16 Gauge: 2.5, 3.0, 4.0; 18 Gauge: 2.5, 3.0
Stylet Length (cm): 14 Gauge: 4.6; 16 Gauge: 4.2 (for 2.5cm cannula), 4.65 (for 3.0cm cannula), 5.65 (for 4.0cm cannula); 18 Gauge: 4.2 (for 2.5cm cannula), 4.65 (for 3.0cm cannula)
Stylet Bevel Style: Trocar
Hub Material: Clear Polycarbonate (for 14 and 16 Gauge), Pink Polycarbonate (for 18 Gauge)

The provided FDA 510(k) clearance letter and summary for the Intraosseous Infusion Needles does not contain the detailed information necessary to answer most of the questions you've posed regarding acceptance criteria and study particulars.

This document focuses on justifying "substantial equivalence" to a predicate device, primarily by demonstrating that changes to the sterilization process do not negatively impact safety or effectiveness. It explicitly states that "No additional performance testing was conducted because the design of the subject device is identical to the predicate, K160887."

Therefore, I can only provide limited information based on the text.

Here's what can be inferred and what cannot:

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

The document does not explicitly state acceptance criteria or performance metrics for the device's primary function (intraosseous infusion). The "performance testing" described is related only to the sterilization process.

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

• Test Set Sample Size: Not specified for any performance testing related to the device's functional use or even for the sterilization validation beyond general statements of "performance testing was conducted."
• Data Provenance: Not specified.

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. The document does not describe studies requiring expert ground truth for device performance related to patient outcomes or imaging. The testing focuses on sterilization process validation.

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

Not applicable. The document does not describe studies 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

Not applicable. This device is a physical medical needle, not an AI-assisted diagnostic tool.

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

Not applicable. This device is a physical medical needle, not an algorithm.

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

For the sterilization validation, the "ground truth" would be objective laboratory measurements and adherence to international standards (e.g., ANSI/AAMI/ISO 11135 and ISO 10993-7) for sterility and residuals. It's not related to clinical "ground truth" like pathology or outcomes.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI model requiring a training set.

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

Not applicable.

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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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