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The Stiletto Extended Dwell Catheter is inserted into a patient's vascular system for short-term use (<28 days) to sample blood or administer fluids intravenously. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of the procedure. The Stiletto Extended Dwell Catheter is suitable for use with power injectors.

The Stiletto Extended Dwell Catheter (EDC) is a sterile, single use device designed to allow users to sample blood and/or administer fluids over a short duration (<28 days) through a peripherally inserted catheter. The Stiletto EDC utilizes an introducer needle and sheathing cannula to support advancement of a single lumen, power-injectable, catheter into peripheral vasculature. Unique catheter tip geometry is employed that works in conjunction with a sheathing cannula to provide support as the catheter advances into the vessel, providing a reliable method of insertion without need of a guidewire. The catheter, hub and insertion components are integrated into a single housing to enhance ease of use.

The Stiletto EDC will be available in 8 cm and 10 cm lengths with a 20 gauge catheter, and 10 cm and 12 cm lengths with an 18 gauge catheter.

Here's a breakdown of the acceptance criteria and study information for the "Stiletto Extended Dwell Catheter" based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text details bench testing and biocompatibility testing. It does not describe a clinical test set in the traditional sense of patient data.

• Bench Testing: The specific sample sizes for each bench test are not provided in the document. The provenance is implied to be laboratory testing of the device itself.
• Biocompatibility Testing: The sample sizes for these tests are not explicitly stated, but they would typically involve material samples of the device components. The provenance is implied to be laboratory testing in accordance with ISO 10993 standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. The study relies on objective bench test measurements and established biological safety protocols, not subjective expert assessment of a test set in the context of diagnostic or interpretive performance.

4. Adjudication Method for the Test Set

Not applicable. There is no expert adjudication method described as the performance is based on objective measurements against 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

Not applicable. This is a medical device (catheter) and the provided documentation focuses on its physical and biological performance, not an AI or imaging diagnostic tool. Therefore, an MRMC study is not relevant.

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

Not applicable. This document is about a physical medical device (catheter), not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by:

• International Standards: Adherence to various ISO and ASTM standards (e.g., ISO 10555-1, ISO 10555-5, ISO 9626, ISO 7864, ISO 80369, ASTM F640, ANSI/AAMI HE75, ISO 23908).
• FDA Guidance Documents: Compliance with specific FDA guidance.
• Internal Requirements: Company-defined performance specifications.
• Biocompatibility Standards: Adherence to ISO 10993 series and USP <788> for particulate matter.
• Predicate Device Comparison: Performance is often benchmarked against the "PowerGlide Pro™ Midline Catheter" (K162377) to demonstrate substantial equivalence, particularly in terms of flow rates and other functional characteristics.

8. The Sample Size for the Training Set

Not applicable. There is no mention of a training set as this is a physical medical device, not a machine learning model.

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

Not applicable, as there is no training set involved. The evaluation is based on direct physical and biological testing of the device itself.

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The Piper GO-IO® Intraosseous Infusion System provides intraosseous access in the proximal tibia, distal tibia and humeral head (proximal humerus) of adult 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 Piper GO-IO® Intraosseous Infusion System provides clinicians and emergency personnel with access to the intraosseous space for resuscitation and lifesaving fluid delivery for up to 24 hours. The Piper GO-IO® Intraosseous Infusion System consists of the following:

• a single use hypodermic needle (with needle safety cap), ●
• a powered or manual driver to assist with needle insertion, ●
• an extension set, and;
• an adhesive-backed securement dressing.

For insertions using the powered driver, the hypodermic needle hub that mates with a stylet connected to a drive adapter hub. The drive adapter hub includes a magnetic insert that attaches to the powered driver prior to needle insertion. The Piper GO-IO® Powered Driver is a hand-held, batterypowered device with a rechargeable lithium battery used to assist in the insertion of the subject device needle through the bone cortex. The assembly of the hypodermic needle and stylet with connected drive adapter hub is referred to as the needle set.

For insertions using the manual driver, the needle and the needle hub mate with a stylet in the same way as the needle set that is used with the powered driver, except the stylet is integrated into the handle of the manual driver instead of a drive adaptor hub (i.e. the manual driver needle assembly does not include a drive adapter hub).

The stylet was designed to include a passive safety feature to protect the placer from sharps injury. After the needle is inserted, the stylet is separated from the needle and needle hub. Upon separation of the stylet from the needle hub, the passive safety feature is released onto the stylet tip and can be safely discarded into a sharps container. Following needle insertion, the securement dressing can be applied to secure the needle hub to the skin. An extension set is available for access to the needle hub to support fluid exchange.

The subject device Piper GO-IO® Intraosseous Infusion System will be offered in needle set (for use with the powered driver) and manual driver needle kit configurations. Each kit configuration will include a securement dressing and an extension set.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document details various performance tests conducted on the Piper GO-IO® Intraosseous Infusion System. For most entries, the "acceptance criteria" are implied by the standard followed (e.g., ISO 9626:2016 for Needle Outer Diameter) and the "reported device performance" is stated as "met all predetermined acceptance criteria" within the "Summary of Substantial Equivalence" section. Specific quantitative acceptance criteria or detailed performance results are not provided in this document for individual tests.

Therefore, a table cannot be constructed with explicit quantitative acceptance criteria and reported device performance for each test. However, a summary table indicating the tests performed and the general outcome can be presented:

2. Sample Size for Test Set and Data Provenance

The document does not provide specific sample sizes for the test sets (e.g., number of needles, drivers, or tests performed on each). The provenance of the data is not specified; it refers to "performance tests completed on the subject device system" and implies the data was generated internally as part of the regulatory submission. There is no information regarding country of origin or whether the studies were retrospective or prospective beyond the stated date of preparation of the summary (November 8, 2019).

3. Number of Experts and Qualifications for Ground Truth

This information is not applicable. The device is a medical instrument (intraosseous infusion system), and the performance testing described is engineering and biological in nature, evaluating physical and material properties, and adherence to established standards. It does not involve diagnostic interpretation or human reader performance that would require experts to establish ground truth in the context of image analysis or similar AI/algorithm-driven tasks.

4. Adjudication Method for Test Set

This information is not applicable, as the performance tests are objective engineering and biological assessments against established standards, not subjective interpretations requiring adjudication.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. The document describes premarket notification for a medical device, which typically involves demonstrating substantial equivalence to a predicate device through engineering, biocompatibility, and performance testing, rather than comparative effectiveness studies with human readers and AI.

6. Standalone (Algorithm Only) Performance Study

No standalone (algorithm only) performance study was done. The device is a physical medical instrument, not an AI or software algorithm.

7. Type of Ground Truth Used

The "ground truth" for the performance tests outlined in the document is established by adherence to recognized international and national standards (e.g., ISO, ASTM, FDA guidance, USP) and internal protocols. These standards define the methods, parameters, and acceptable ranges for various tests related to material properties, mechanical performance, electrical safety, biocompatibility, and sterilization.

8. Sample Size for Training Set

This information is not applicable. The device is a hardware medical device, not an AI or machine learning model that requires a training set.

9. How Ground Truth for Training Set Was Established

This information is not applicable, as there is no training set for a hardware medical device.

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