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The Stiletto Extended Dwell Catheter is inserted into a patient's vascular system for short-term use (

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 (

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 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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The 5 FR DL Piper PICC Catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy, power injection of contrast media, and prolonged exposure to intraluminal solutions containing up to 70% ethanol. The maximum recommended infusion rate is 5mL/sec for power injection of contrast media.

The 5 French (FR) Dual Lumen (DL) Piper PICC is a single use peripherally inserted central catheter made from a specially-formulated medical grade polyurethane material.

The Piper PICC is designed to perform infusion, intravenous therapy, blood sampling and power injection of contrast media, and is compatible with intraluminal solutions containing up to 70% ethanol. The maximum recommended infusion rate is 5 mL/sec.

The Piper PICC is a 5 French catheter with two 18-gauge lumens and will be provided with 55cm of effective length. The catheter has a reverse-tapered design. The catheter is inserted peripherally by the clinician and is trimmable to fit different patient sizes. It is inserted with a Seldinger or modified-Seldinger technique with compatibility to guidewires up to 0.019" in outer diameter. The catheter distal tip is positioned in the lower 1/3 of the Superior Vena Cava (SVC). The effective length of the catheter including the distal end is radiopaque, which allows for catheter tip visualization.

The Piper PICC catheter includes an extruded polyurethane catheter shaft molded to an injection molded polyurethane hub with extruded extension legs molded to luer-lock fittings, which provide attachments for IV administration. The junction has suture wings to allow for securement to the patient. Clamps are attached to both extension legs on the catheter.

The distal end of the catheter shaft is a dual lumen symmetrical D-shape design that does not differ in material from the remainder of the shaft. With the exception of the reverse-tapered section of the shaft, the distal end is also dimensionally identical to the remainder of the shaft.

The proximal end of the catheter consists of two power injectable extension legs, which each have a luer lock style connection depicting gage size, thumb clamp, ID tag. The catheter has an average priming volume is 0.61 mL

The Piper PICC is packaged in a catheter only kit and provided sterile to the end user. There are no additional components in the kit.

The provided text describes a 510(k) submission for a medical device, the 5 FR DL Piper PICC, and details the non-clinical performance testing conducted to demonstrate its substantial equivalence to a predicate device. This submission focuses on the safety and performance aspects rather than a study on diagnostic accuracy or AI performance. Therefore, many of the requested categories related to AI studies, ground truth, and expert evaluation are not applicable or cannot be extracted from this document.

Here's the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The document states, "The 5 FR DL Piper PICC met all of the predetermined acceptance criteria derived from the standards and guidance listed above." It lists the standards and guidance used, and all the tests performed. However, it does not provide a specific table detailing each acceptance criterion and the quantitative reported device performance for each test. It only gives a general statement that all criteria were met.

A list of guidelines and standards employed:

• Guidance on Premarket Notification [510(k)] Submission for Short- Term and Long-Term Intravascular Catheter, March 16, 1995
• Design Control Guidance for Medical Device Manufacturers, March 11, 1997
• ISO 10555-1: 2013, Sterile, single-use intravascular catheters, Part 1: General requirements
• ISO 10555-3: 2013, Intravascular catheters--Sterile and single-use catheters, Part 3: Central venous catheters
• ISO 594-1: 1986, Conical fittings with 6% luer taper for syringes, needles and certain other medical equipment - Part 1: General Requirements
• ISO 594-2: 1998, Conical fittings with 6% luer taper for syringes, needles and certain other medical equipment - Part 2: Lock Fittings
• ASTM F640-79 (reapproved 2000): 2012, Standard Test Methods for Radiopacity of Plastics for Medical Use
• ISO 11135:2014, Medical Devices Validation and Routine Control of Ethylene Oxide Sterilization
• ISO 11607-1: 2006, Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
• ISO 11607-1 AMD 1: 2014, Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
• ISO 10993-7: 2008. Biological Evaluation of Medical Devices Part 7: Ethylene Oxide Sterilization Residuals
• ANSI/AAMI ST72:2011, Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing
• FDA Guidance for Industry Pyrogen and Endotoxins Testing: Questions and Answers, 2010
• ISO 10993 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing for externally communicating, blood contacting, permanent devices and FDA Guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
• ISO 14971:2007, Medical Devices – Risk Management for Medical Devices.

List of tests performed:

• Dimensional Analysis
• Ink Permanence
• Radiopacity
• Leak Testing
• Extension Leg Leak w/ Clamp
• Pump Flow
• Priming Volume
• Gravity Flow
• Kink Diameter
• Catheter Collapse
• Tip Stability
• Suture Wing Integrity
• Assembly Tensile
• Shaft Tensile
• Catheter Elongation
• Catheter Modulus
• Catheter Fatigue
• Power Injection
• Assembly Burst
• Extension Leg Burst
• ISO Luer Gauging
• ISO Luer Testing
• Sterilization
• Packaging Validation
• Residuals. EO and ECH
• Pyrogenicity Bacterial Endotoxin Test (LAL)
• Cytotoxicity
• Sensitization
• Irritation/Intracutaneous Reactivity
• Acute Systemic Toxicity
• Material Mediated Pyrogenicity
• Hemolysis (indirect/direct)
• Complement Activation
• Partial Thromboplastin Time
• Sheep Thrombogenicity
• Implantation 13 weeks
• Chemical Characterization
• Subacute/ Sub-chronic Toxicity
• Genotoxicity
• Chronic Toxicity
• Carcinogenicity

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

The document does not explicitly state the sample sizes for each specific test mentioned (e.g., how many catheters were tested for leak testing, power injection, etc.). The study is a non-clinical performance evaluation, likely involving bench testing and some in-vivo animal testing (sheep thrombogenicity, 13-week implantation). No human patient data is mentioned; thus, data provenance in terms of country of origin is not applicable for this type of testing, nor is the retrospective/prospective nature as it's a verification and validation study.

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

Not applicable. This is a non-clinical device performance study, not an AI diagnostic study requiring expert ground truth for interpretation of images or patient data.

4. Adjudication Method for the Test Set

Not applicable. This is a non-clinical device performance study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size of Human Reader Improvement with AI vs Without AI Assistance

Not applicable. This document describes the performance testing of a physical medical device (PICC catheter), not an AI-powered diagnostic tool. No human-in-the-loop study with AI assistance was performed.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done

Not applicable. This document is for a physical medical device, not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device, in essence, is established by adherence to the performance requirements outlined in the referenced national and international standards (e.g., ISO, ASTM, FDA Guidance). The tests performed (e.g., dimensional analysis, leak testing, tensile strength, biocompatibility, sterilization validation) are designed to objectively verify that the device meets these pre-defined engineering and safety specifications. No pathology, outcomes data, or expert consensus in the diagnostic sense is mentioned as ground truth.

For thrombogenicity evaluations, a legally marketed comparative device (LMCD), the Bard 5F Dual Lumen PowerPICC, was used as a reference for in vivo thrombogenicity evaluations to meet ISO 10993-4 requirements. This served as a comparative benchmark rather than a "ground truth" derived from patient outcomes or pathology.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI algorithm that requires a training set.

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

Not applicable. There is no training set for a physical medical device.

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