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The Arrow™ Endurance™ Extended Dwell Peripheral Catheter System permits access to the patient's peripheral vascular system for short-term venous use (less than 30 days) to sample blood, administer fluids, and perform high pressure contrast injections at a maximum of 325 psi.

The Arrow™ Endurance™ Extended Dwell Peripheral Catheter System permits access to the patient's peripheral vascular system for short-term use (less than 30 days) to facilitate arterial blood pressure measurement and blood sampling.

The safety feature is intended to minimize the risk of sharps injuries.

The Arrow™ Endurance™ Extended Dwell Peripheral Catheter may be used for any patient population with consideration given to adequacy of anatomy and appropriateness of the procedure.

The Arrow™ Endurance™ Extended Dwell Peripheral Catheter may be used in hospitals, clinics, and other advanced clinical facilities.

The subject device, Arrow™ Endurance™ Extended Dwell Peripheral Catheter System, is a sterile, single use peripheral intravascular device designed to permit access to the peripheral vascular system. The Endurance catheter is intended to permit access to the patient's peripheral vascular system for short-term venous use to sample blood, administer fluids and for high pressure contrast injections at a maximum of 325 psi. The Arrow™ Endurance™ Extended Dwell Peripheral Catheter System permits access to the patient's peripheral vascular system for short-term arterial use to monitor arterial blood pressure and blood sampling. The safety feature is intended to minimize the risk of sharps injuries.

The Arrow™ Endurance™ Extended Dwell Peripheral Catheter System is available in a single lumen, 18 gauge configuration with usable length of 8 cm (3.15").

This document is a 510(k) summary for the Arrow™ Endurance™ Extended Dwell Peripheral Catheter System, seeking substantial equivalence to a predicate device. As such, it focuses on demonstrating equivalence through comparison of technological characteristics and nonclinical bench testing. It does not describe acceptance criteria and a study that proves the device meets those criteria in the context of an AI-powered medical device.

The information provided confirms that the device is a physical intravascular catheter, not an AI/software device. Therefore, the specific requirements listed in the prompt (e.g., sample size for test/training sets, expert ground truth establishment, MRMC studies, standalone algorithm performance) are not applicable to the content of this document.

The document highlights:

• Acceptance Criteria (Implied by equivalence): The "acceptance criteria" here are implicitly that the new device performs equivalently to the predicate device in relevant physical and functional characteristics, and that any differences do not raise new questions of safety or effectiveness.
• Reported Device Performance: This is demonstrated through a detailed comparison table (Section 7) and a list of "Nonclinical Testing" (Section 8).

Here's a breakdown of what is available and what is not relevant from your prompt:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a typical "acceptance criteria" table with numerical targets as would be seen for an AI device. Instead, it presents a comparison to a predicate device. The "acceptance" is based on demonstrating that the subject device is "substantially equivalent" to the predicate, meaning it performs similarly and does not introduce new safety or effectiveness concerns.

2. Sample sized used for the test set and the data provenance:

• This is not an AI/software device, so there isn't a "test set" in the sense of a dataset for algorithm evaluation.
• The performance is evaluated through bench testing (listed in Section 8). Details on the specific sample sizes for these physical and material tests are not provided in this summary.
• Data provenance: Not applicable as it's not clinical data. The tests are laboratory-based, performed on manufactured devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. This is not an AI/software device requiring expert labeling of data.
• The "ground truth" for a physical device is established through engineering specifications, material science, and performance standards.

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

• Not applicable. This concept is for resolving disagreements in expert annotations for AI datasets, not for physical device testing.

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 catheter, not an AI software intended to assist human readers.

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

• Not applicable. This is not an AI algorithm. Its performance is inherent in its physical properties and design.

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

• For physical devices like this, the "ground truth" for validating performance is typically derived from:
  • Engineering specifications and design requirements: Does it meet the intended physical dimensions, material properties, and functional outputs (e.g., flow rate, pressure limits)?
  • Recognized consensus standards: Compliance with ISO standards related to biocompatibility, sterilization, and general medical device safety.
  • Bench testing results: Data from rigorous laboratory tests simulating various use conditions.

8. The sample size for the training set:

• Not applicable. This is not a machine learning model.

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

• Not applicable. This is not a machine learning model.

In summary, this 510(k) pertains to a physical medical device (catheter), not an AI/software product. Therefore, most of the requested information regarding AI device evaluation (test/training sets, expert ground truth, MRMC studies) is not relevant to this document. The "study" proving the device meets acceptance criteria is the comprehensive nonclinical bench testing outlined in Section 8, which demonstrates that the device performs functionally and safely, and is substantially equivalent to its predicate.

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Reinforced Tube: Rusch Reinforced Endotracheal Tubes are designed for nasal intubation and are indicated for airway management. The correct designation (oral, nasal or oral/nasal) is printed on the tube and unit package. Reinforced Endotracheal Tubes may be used to reduce the potential for kinking whenever an unusual positioning of the head or neck is required following intubation. The Reinforced Endotrached to be used on all patients requiring ventilation, pediatric and adult.

Safety Clear and Safety Clear Pediatric Tubes: Rusch Endotracheal Tubes, Cuffed and Uncuffed, with or without Murphy Eye are for oral or nasal intubation. They are indicated for airway management. The Rusch Endotracheal Tubes are intended to be used on all patients requiring ventilation, pediatric and adult.

An endotracheal tube is a device that is inserted into the trachea via the nose or the mouth to establish a patent airway to allow ventilation. The proposed Teleflex Medical Rusch Endotracheal Tubes are sterile, single use devices that are made non made with DEHP. The tracheal tubes contain a compatible cuff, inflation line, pilot balloon and one-way valve. A radiopaque line is incorporated into the full length of the Safety Clear tracheal tube, while the Reinforced tube contains an embedded stainless-steel spiral that allows for X-ray visualization. Each tracheal tube is supplied with an appropriately sized 15mm connector.

The provided document is a 510(k) Premarket Notification from Teleflex Incorporated to the FDA regarding their Rusch Endotracheal Tubes. It details the device's characteristics, indications for use, and a comparison to predicate devices to establish substantial equivalence.

Crucially, this document does NOT describe a study that involves AI or machine learning, human readers, or image-based diagnostics. The "device" in question is an endotracheal tube, a physical medical device, not a software or AI-driven diagnostic tool.

Therefore, many of the requested criteria related to AI/ML model performance, such as sample size for test sets, number of experts for ground truth, MRMC studies, standalone algorithm performance, and training set details, are not applicable to this submission.

The "acceptance criteria" and "device performance" in this context refer to the physical and biological characteristics of the endotracheal tube, verified through standard bench testing and biocompatibility assessments, rather than diagnostic accuracy or reader improvement.

Here's an attempt to fill in the relevant information based on the provided text, while clearly stating when information is Not Applicable (N/A) due to the nature of the device:

Acceptance Criteria and Device Performance Study for Rusch Endotracheal Tubes

This submission focuses on establishing substantial equivalence for physical medical devices (endotracheal tubes), not software or AI-driven diagnostic tools. Therefore, many standard AI/ML study components are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the successful completion of the described bench testing and biocompatibility assessments, demonstrating that the device performs as intended and is safe for its indicated use. The "reported device performance" is the successful fulfillment of these tests, confirming substantial equivalence to the predicate devices.

| Acceptance Criteria Category | Specific Tests Performed | Reported Device Performance (as implied by acceptance) |
|------------------------------|----------------------------------------------------------------+|--------------------------------------------------------|
| Physical Performance | Visual inspection | Acceptable |
| | Dimensional testing | Within specifications |
| | Bonding strength (main tube to side arm, inflation tube, connector) | Acceptable |
| | Tube curvature | Acceptable |
| | Cuff restrained burst | Acceptable |
| | Bevel angle | Acceptable |
| | Cuff inflation | Acceptable |
| | Kink resistance | Acceptable |
| | Cuff herniation | Acceptable |
| | Cuff diameter | Acceptable |
| | Tube collapse | Acceptable |
| | Tracheal seal testing | Acceptable |
| Biocompatibility | Cytotoxicity (ISO 10993) | Pass |
| | Sensitization (ISO 10993) | Pass |
| | Irritation (ISO 10993) | Pass |
| | Acute Systemic Toxicity (ISO 10993) | Pass |
| | Material Mediated Pyrogenicity (ISO 10993) | Pass |
| | Implantation (ISO 10993) | Pass |
| | Subacute Systemic Toxicity (ISO 10993) | Pass |
| | Genotoxicity (ISO 10993) | Pass |
| | Chemical Characterization (Exhaustive & Simulated Use) | Pass (Toxicological Risk Assessment Related to Extractables and Leachables) |
| | Particulates and VOC | Pass (Toxicological Risks Related to Inhalation of VOCs and Particulates) |

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

• Sample Size for Test Set: The document does not specify the exact sample sizes (e.g., number of tubes) used for each bench test or biocompatibility test. It indicates that "testing performed verifies that the performance of the subject device is substantially equivalent." For biocompatibility, it states "Materials have been tested per ISO 10993-1" and lists the tests performed, implying standard sample sizes as per the ISO standard.
• Data Provenance: The data provenance is from internal testing conducted by Teleflex Medical, Inc. (the manufacturer). The type of data is physical testing and chemical/biological analysis of device materials. It is implicitly "prospective" in the sense that the testing was performed on newly manufactured devices for the purpose of this submission. Country of origin not specified, but likely where Teleflex manufactures or tests its products, or where the testing labs are located.

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

• Not Applicable (N/A): For a physical device like an endotracheal tube, "ground truth" is established through standardized engineering specifications, material science, and regulatory standards (e.g., ISO standards). It does not involve expert readers reviewing output in the same way an AI diagnostic tool would. The experts involved would be engineers, material scientists, and toxicologists conducting the testing and interpreting the results against established physical and biological acceptance criteria.

4. Adjudication Method for the Test Set

• Not Applicable (N/A): As there is no human interpretation or subjective assessment of "ground truth" images or data points (as in an AI diagnostic study), there is no adjudication method in the context of multiple expert readers. Compliance is determined by objective measurements against predefined engineering and biological limits.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No: This is a physical medical device; an MRMC study is not relevant.

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

• Not Applicable (N/A): This submission is for a physical medical device, not a software algorithm.

7. The Type of Ground Truth Used

• Engineering Specifications and Standardized Test Results: The "ground truth" for this medical device is based on established engineering specifications for physical characteristics (e.g., dimensions, bond strength, kink resistance, cuff performance) and adherence to recognized international standards for biocompatibility (ISO 10993 series). The device's performance is measured against these objective criteria rather than expert consensus on a diagnostic outcome.

8. The Sample Size for the Training Set

• Not Applicable (N/A): This is a physical medical device, not an AI/ML algorithm that requires a "training set."

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

• Not Applicable (N/A): As there is no training set, this question is not applicable.

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The Arrow™ Endurance™ Extended Dwell Peripheral Catheter System permits access to the patient's peripheral vascular system for short-term venous use (less than 30 days) to sample blood, administer fluids, and perform high pressure contrast injections at a maximum of 325 psi.

The Arrow™ Endurance™ Extended Dwell Peripheral Catheter System permits access to the patient's peripheral vascular system for short-term use (less than 30 days) to facilitate arterial blood pressure measurement and blood sampling.

The safety feature is intended to minimize the risk of sharps injuries.

The Arrow™ Endurance™ Extended Dwell Peripheral Catheter may be used for any patient population with consideration given to adequacy of anatomy and appropriateness of the procedure.

The Arrow™ Endurance™ Extended Dwell Peripheral Catheter may be used in hospitals, clinics, and other advanced clinical facilities.

The subject device, Arrow™ Endurance™ Extended Dwell Peripheral Catheter System, is a sterile, single use peripheral intravascular device designed to permit access to the peripheral vascular system. The Endurance catheter is intended to permit access to the patient's peripheral vascular system for short-term venous use to sample blood, administer fluids and for high pressure contrast injections at a maximum of 325 psi. The Arrow™ Endurance" Extended Dwell Peripheral Catheter System permits access to the patient's peripheral vascular system for short-term arterial use to monitor arterial blood pressure and blood sampling. The safety feature is intended to minimize the risk of sharps injuries.

The Arrow™ Endurance™ Extended Dwell Peripheral Catheter System is available in single lumen, 20 and 22 gauge configurations with usable lengths of 6 cm (2.36'') and 8 cm (3.15").

The provided text is a 510(k) Summary for the Arrow™ Endurance™ Extended Dwell Peripheral Catheter System, detailing its substantial equivalence to a predicate device. This document focuses on the physical and functional aspects of a medical device (intravascular catheter) and its comparison to a similar existing device. It does not contain information related to an AI/ML powered medical device, a multi-reader multi-case (MRMC) comparative effectiveness study, or details about ground truth establishment for a diagnostic algorithm.

Therefore, I cannot extract the specific information requested in your prompt regarding acceptance criteria and studies for an AI/ML device performance, as this information is not present in the provided document. The nonclinical testing listed relates to the physical performance and safety of the catheter itself, not to the diagnostic accuracy of an AI.

To elaborate on why the requested information cannot be found:

• Acceptance Criteria & Reported Device Performance (Table): The document provides a comparison of features, materials, and functional aspects of the subject device against a predicate device. It indicates "Same" or "Different" for many features and then lists various nonclinical bench tests in Section 8. However, it does not present quantitative acceptance criteria or reported performance for an AI/ML output. For example, it doesn't state "AI sensitivity > X%" or "AI accuracy > Y%" with corresponding actual performance.
• Sample Size (Test Set) & Data Provenance: This would be relevant for an AI study involving patient data. The document describes bench testing of a physical catheter, which does not typically involve a "test set" of patient data in the context of AI.
• Number of Experts, Qualifications & Adjudication Method: These points are critical for establishing ground truth in AI studies. Since this device is a physical catheter, there is no AI algorithm generating diagnostic outputs that would require expert adjudication for a ground truth.
• MRMC Comparative Effectiveness Study: This type of study assesses how AI affects human reader performance. As the device is not an AI, this study type is not applicable.
• Standalone Performance: This refers to the AI algorithm's performance without human intervention. Again, not applicable to a physical catheter.
• Type of Ground Truth: For an AI device, ground truth might be pathology, long-term outcomes, or expert consensus. For this physical catheter, "ground truth" is established through engineering specifications, material properties, and physical performance benchmarks.
• Sample Size for Training Set & How Ground Truth for Training Set was Established: These are fundamental elements of AI model development. Since this is not an AI device, there is no "training set" or corresponding ground truth establishment process in the context of machine learning.

In summary, the provided document describes the regulatory clearance for a physical medical device (intravascular catheter) through a substantial equivalence pathway, not an AI/ML-powered diagnostic or assistive device. Therefore, the information requested in your prompt is not available within this text.

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The Arrow(R) Pressure Injectable Midline Catheter is indicated for short-term (≤ 30 days) peripheral access to the venous system for intravenous therapy, blood sampling, infusion, and pressure injection of contrast media. The maximum pressure of pressure injector equipment used with the Arrow Pressure Injectable Midline Catheter may not exceed 300 psi (2068.4 kPa). The maximum pressure injection flow rate for the specific lumen being used for pressure injection is printed on the extension line hub.

The Arrow Pressure Injectable Midline Catheter is a non-coated, single use catheter designed to provide short-term peripheral access to the venous system. The midline catheter is a peripherally inserted intravenous catheter manufactured with medical grade, flexible polyurethane. It consists of a non-tapered, radiopaque polyurethane extruded catheter body with a single opening or double opening at the distal end and centimeter markings placed along its length to facilitate its positioning. The catheter is available in 4 Fr. Single lumen and 5 Fr. Double lumen configurations with a usable catheter length of 20 cm. Pinch clamps are an integral part of the catheter and are provided on the extension lines to occlude flow through the lumens, as needed. The catheters can be used for the injection of contrast media. The maximum recommended infusion rate is 5 mL/sec.

The catheters will be packaged sterile in kits that will include components to facilitate insertion.

The provided text is a 510(k) summary for a medical device (Arrow® Pressure Injectable Midline Catheter) and does not describe acceptance criteria for an AI/ML powered device or a study proving that an AI/ML device meets said criteria. It focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing, biocompatibility testing, and sterilization/packaging testing.

Therefore, most of the requested information regarding AI/ML device acceptance criteria, sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance simply does not apply to this document.

However, I can extract the information that is present about the device's characteristics and the types of non-clinical tests performed:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide specific numerical acceptance criteria (e.g., "Pass if flow rate >= X mL/s") or specific reported performance values resulting from the tests. Instead, it indicates that "Non-clinical testing related to the device changes has been completed to support the substantial equivalence." This implies that the device met the internal and standard-based requirements for these tests to demonstrate equivalence, but the precise thresholds and results are not detailed.

2. Sample size used for the test set and the data provenance: Not applicable. This document describes non-clinical engineering and biological performance testing, not AI/ML model testing with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for AI/ML models is not relevant here. The "ground truth" for these tests would be defined by the technical specifications of the standards (e.g., a specific pressure, flow rate, or biological response).

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.

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 not an AI/ML device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to an AI/ML device. For this device, the "ground truth" for testing is established by recognized international and national standards (e.g., ISO, ASTM, ANSI/AAMI) and internal company test methods, which define acceptable parameters for physical and chemical properties, functionality, and biocompatibility.

8. The sample size for the training set: Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

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The Arrow Stiffening Stylet is intended to be placed inside a catheter to stiffen the catheter for placement.

The Arrow Stiffening Stylet is a sterile, single use, percutaneous peripheral vasculature catheter stylet intended for transient use (up to 24 hours) to be placed within a catheter to render it stiff to aid in catheter placement. The proposed device will be delivered as a sterile accessory within a convenience kit for the Arrow Peripherally Inserted Central Catheter (PICC)s. The Stylet is a PTFE coated solid nitinol core wire with straight tip. The stylet is available in 0.015-0.017-inch diameters and in 29.5-inch length with distance markings along the stylet body.

The Arrow Stiffening Stylet is provided with an existing, commercially available flushable hub with side arm and slide clamp cleared under K790408. The flushable hub maintains the stylet position within the catheter during catheter placement, is intended to minimize blood loss during catheter introduction, and allows the clinician to flush through the catheter to aid in catheter placement, if needed. There is no change to the flushable hub cleared under K790408 introduced by this submission.

This document describes a 510(k) Pre-Market Notification for the Arrow Stiffening Stylet. The primary purpose of this submission is to demonstrate the substantial equivalence of the Arrow Stiffening Stylet to a legally marketed predicate device, the Galt Medical Corp's GaltTWS Stylet (K182660).

Acceptance Criteria and Device Performance (as derived from the provided document):

The document does not explicitly state "acceptance criteria" as a pass/fail threshold but rather lists the tests performed and implies that the device "passed all acceptance criteria" during non-clinical performance testing. The "reported device performance" is essentially that the device met the requirements of these tests.

Study Details:

1. Sample Size and Data Provenance:

   • Test Set Sample Size: The document does not specify the exact sample sizes for each test. It broadly states "testing conducted" without providing numerical details for the number of units or distinct test conditions evaluated.
   • Data Provenance: The data appears to be entirely from non-clinical performance testing conducted by Arrow International LLC. There is no indication of patient data or clinical trials. The country of origin for the data is not explicitly stated, but as Arrow International LLC is based in Morrisville, North Carolina, USA, the testing was likely performed there or in accordance with US regulatory standards. The data is not retrospective or prospective clinical data as no human clinical data was used.

2. Number of Experts and Qualifications for Ground Truth:

   • Not Applicable. This submission is for a medical device (stylet) that relies on physical and mechanical testing, not interpretation of data like images or patient records that would require expert consensus for ground truth. Therefore, there's no mention of experts establishing ground truth in the context of interpretation. Internal engineering and quality control experts at Arrow International LLC would have developed the test protocols and evaluated the results against internal requirements and relevant ISO standards.

3. Adjudication Method for Test Set:

   • Not Applicable. As this is non-clinical physical/mechanical testing, there isn't an "adjudication method" in the sense of resolving disagreements between human readers or experts. Test results would be objectively measured against predefined specifications.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No. An MRMC study was not conducted. This type of study is typically performed for AI or diagnostic imaging devices where human interpretation is involved. This submission is for a physical medical device.

5. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance):

   • Not Applicable. This is a physical medical device, not a software algorithm or AI.

6. Type of Ground Truth Used:

   • The "ground truth" for this device's performance is established by objective measurements against predefined engineering specifications and relevant international standards (e.g., ISO 11070, ISO 10993-1). It is based on physical and mechanical properties, not expert consensus, pathology, or outcomes data from a clinical setting.

7. Training Set Sample Size:

   • Not Applicable. There is no "training set" in the context of this device. This is not an AI/machine learning device. The testing described is verification testing against design specifications.

8. How Ground Truth for Training Set Was Established:

   • Not Applicable. As there is no training set, there is no ground truth established for one.

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The VPS Rhythm® DLX Device is indicated for the positioning of central venous catheters including PICCs. It provides real-time catheter tip location information by using the patient's cardiac electrical activity. The VPS Rhythm DLX® Device is indicated for use as an alternative method to chest x-ray or fluoroscopy for confirmation of central venous catheter tip placement in adult patients.

The TipTracker™ Technology is an optional accessory for use with the VPS Rhythm® DLX Device, indicated for visual navigation of a peripherally inserted catheter (PICC) as it is threaded through the vasculature. The TipTracker™ technology is used for catheter tip navigation purposes only; it is not used to determine final catheter tip placement.

For a catheter insertion procedure, ultrasound may optionally be used to assess the blood vessel to aid in selection of catheter size and visualize the blood vessel during initial insertion.

Note: In general, devices that utilize ECG technique to observe P-wave are limited, but not contraindicated, for patients where cardiac rhythms may change presentation of the P-wave: including

• Atrial fibrillation
• Atrial flutter
• Severe tachycardia
• Pacemaker-driven rhythm
• Chronic obstructive pulmonary disease (COPD)

Such patients are easily identified prior to central catheter insertion. In these specific cases, use of an additional confirmation method is necessary to confirm catheter tip location.

The VPS Rhythm® DLX Device with TipTracker™ Technology is a medical device system consisting of nonsterile, reusable electronic components and accessories, as well as single-use, sterile components. All of which are utilized together to facilitate the final confirmation of central venous catheter tip placement by using the patient's cardiac electrical waveform. The system features an electronic monitor with graphical user interface display, as well as connection cables and accessories which allow for the display of the patient's external and intravascular cardiac ECG waveforms. Interpretation - by the clinician - of changes in the patient's intravascular cardiac ECG waveform morphology, which are displayed in real-time on the VPS Rhythm® DLX Device monitor as the central venous catheter is inserted, is utilized for confirmation of the final position of the catheter tip as an alternative to radiographic confirmation.

The optional Tip TipTracker™ Technology includes the software algorithms and accessory components (the non-sterile, reusable TipTracker™ T-piece and sterile, single-use TipTracker™ and proposed NaviCurve™ Stylet) which facilitate the real-time visualization of a Peripherally Inserted Central Catheter's (PICC) track and direction as it is inserted by the clinician through the vasculature. The TipTracker™ T-piece consists of a magnetic emitter array that is connected to the VPS Rhythm® DLX Device monitor. In use, the TipTracker™ T-piece is placed externally on the patient's chest. When the sterile, single-use TipTracker™ Stylet or NaviCurve Stylet is assembled with the peripherally inserted central catheter (PICC) and inserted by the clinician, the VPS Rhythm® DLX Device with TipTracker™ Technology facilitates the visualization of the PICC's insertion track and direction relative to the location of the TipTracker™ T- piece. The TipTracker™ Technology is not intended as an indicator of specific catheter location nor is it intended to be utilized for confirmation of final catheter tip location.

The proposed VPS Rhythm® DLX Device introduces the ability to pair a commercially available Ultrasound probe (Interson Corporation: K163443) with the VPS Rhythm® DLX monitor to permit ultrasound visualization during the initial central catheter insertion procedure for vessel assessment and visualization on the display of the VPS Rhythm® DLX system. An optional catheter to vessel ratio tool can be used during vessel assessment.

As a new optional feature related to P-wave morphology changes, the DLX Software uses a time detected reference based on the R-Peak to show where the P-wave should exist in a patient with a normal sinus rhythm.

The provided text, a 510(k) summary for the VPS Rhythm® DLX Device with TipTracker™ Technology, describes the device and its demonstrated equivalence to a predicate device. However, it does not contain the specific details required to answer all parts of your request, particularly a table of acceptance criteria with reported performance, or details about patient sample sizes, expert adjudication, or MRMC studies.

The document focuses on demonstrating substantial equivalence to an existing predicate device (VPS Rhythm® Device with TipTracker™ Technology, K160925) by highlighting non-clinical performance data and the absence of new safety or effectiveness concerns due to the modifications.

Here's a breakdown of what can be extracted from the document regarding acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a specific table with numerical acceptance criteria and corresponding reported device performance values. Instead, it broadly states that "testing verifying the performance requirements of the subject VPS Rhythm® DLX Device with TipTracker™ Technology was conducted and included in this premarket notification and the results support substantial equivalence."

The types of testing performed can be inferred as fulfilling the acceptance criteria, as the document concludes that the testing "has passed all acceptance criteria to verify that the proposed VPS Rhythm® DLX Device with TipTracker™ Technology meets its design, physical integrity, functional, software, and safety requirements."

Inferred "Acceptance Criteria" based on tests mentioned:

2. Sample Size and Data Provenance:

• Test Set Sample Size: The document does not specify a sample size for the test set for any of the non-clinical performance tests. It refers to "Human Factors: A human factors and usability report assessing the usability of the subject VPS Rhythm® DLX Device with TipTracker™ Technology was conducted. The studies conducted utilized independent clinician participants to assess the primary operating functions of the proposed device against the predetermined usability criteria." However, it does not state the number of participants.
• Data Provenance: The document explicitly states: "No human clinical data was provided to support substantial equivalence." The data described is "Non-Clinical Performance Data," implying in-vitro and bench testing, as well as a human factors study which involves users, not patients. Therefore, information regarding "country of origin of the data," "retrospective or prospective," or "patient samples" is not applicable based on what is provided.

3. Number of Experts and Qualifications for Ground Truth:

• Number of Experts: Not applicable, as no human clinical data was provided and the human factors study involves participants for usability assessment, not for establishing medical ground truth for device accuracy.
• Qualifications of Experts: The human factors study used "independent clinician participants," but no specific qualifications (e.g., "radiologist with 10 years of experience") are provided.

4. Adjudication Method for the Test Set:

• Not applicable, as no clinical ground truth was established by experts for medical performance. The human factors study assessed usability against "predetermined usability criteria," implying internal validation, but no multi-expert adjudication process is described for device performance accuracy.

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

• No MRMC study was done. The document explicitly states: "No human clinical data was provided to support substantial equivalence." Therefore, there is no information on human readers improving with AI vs. without AI assistance.

6. Standalone (Algorithm Only) Performance:

• The document describes the device's overall performance in various non-clinical tests (e.g., "ECG Waveform Performance," "Tracking Display," "Ultrasound Display"). Since no human clinical data was presented, the "performance" described is effectively the "algorithm's" or device's inherent capability as measured in bench and engineering tests. However, it does not isolate "algorithm-only" performance as a separate study component distinct from the integrated device. The device itself uses the cardiac electrical activity and magnetic field technology for its functions.

7. Type of Ground Truth Used:

• For the non-clinical performance data, the ground truth is implicitly defined by the standards and specifications against which the device was tested (e.g., IEC 60601-1, IEC 60601-1-2, ANSI/AAMI EC53, ISO 11070, ISO 10993-1). These standards represent established engineering and safety benchmarks for medical devices.
• For the human factors study, the "ground truth" was predetermined usability criteria.

8. Sample Size for the Training Set:

• The document describes a 510(k) submission for a device that uses cardiac electrical activity and magnetic field technology, and mentions "software algorithms." However, it does not state that the device uses machine learning or AI that requires a "training set" in the typical sense of supervised learning. The software V&V refers to traditional software testing. Therefore, information on a training set size is not provided and likely not applicable in the context of this traditional medical device clearance.

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

• As a "training set" for AI/machine learning is not mentioned as part of the device's development or clearance, this information is not applicable and not provided. The device's functionality is based on known physiological principles (ECG changes to detect catheter tip location) and magnetic field-based tracking, rather than data-driven "learning" from a large dataset.

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For intraosseous access anytime in which vascular access is difficult to obtain in emergent, urgent, or medically necessary cases for up to 24 hours. Insertion sites: ADULTS (≥22 years old): proximal humerus, proximal tibia, distal tibia PEDIATRICS (≤21 years old): proximal humerus, proximal tibia, distal tibia, distal femur Use of the device may be extended for up to 48 hours when alternate intravenous access is not available or reliably established. Insertion sites: ADULTS (≥22 years): proximal humerus, proximal tibia, distal tibia PEDIATRICS (≥12 years through 21 years old): proximal humerus, proximal tibia, distal tibia, distal femur

The EZ-IO System previously cleared with K14117 is designed to allow the user to insert a needle set consisting of a stylet and catheter through the cortex of the bone to a desired depth within the bone marrow to facilitate intraosseous infusion of desired fluids and medications for vascular access. All system materials are biocompatible. Needle sets are single-use and composed of 304 stainless steel with polycarbonate hubs and available in 15 mm (for patients 3-39 kg); 25 mm (for patients 3 kg or over) and 45 mm (for patients 40 kg or over) lengths. Black lines on the needle set serve as depth markers. The reusable cordless driver/drill is powered by lithium batteries with a battery-power indicator light. An extension tubing set accessory, the EZ-Connect, is included with every needle set. The EZ-Connect contains a needleless connector system and Luer lock adapter. An optional dressing, the EZ-Stabilizer, is an accessory to the EZ-IO Vascular Access System. It is designed as a securement device with an adhesive backing that is placed over an EZ-IO Needle to keep the needle securely anchored to the patient; and is recommended in the Instructions for use (IFU).

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

The core change addressed by this submission is the expansion of the "EZ-IO Intraosseous Vascular Access System" indications for use from up to 24 hours to up to 48 hours. Therefore, the primary acceptance criteria revolve around demonstrating the safety and effectiveness of the device for this extended dwell time.

Study Details

1. Sample size used for the test set and the data provenance:

   • Sample Size (Test Set): 121 evaluable subjects.
     • 79 healthy volunteers
     • 39 with diabetes only
     • 3 with diabetes and renal insufficiency
   • Data Provenance: US single-site, prospective clinical IDE trial.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not explicitly stated. The study involved clinical trial procedures and observations, including physical examinations and x-rays, but the specific number or qualifications of "experts" establish ground truth in the sense of a diagnostic consensus is not detailed. The "ground truth" here is the clinical outcome (complications, pain, patency) observed in the subjects under the study protocol.

3. Adjudication method for the test set:

   • Not explicitly stated in detail for all events. However, adverse events were assessed for relatedness to the device, implying a review process. The primary endpoint was the "absence of serious complications," suggesting a clear definition of what constitutes a serious complication and its determination by the study team.

4. 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. This is not an AI/imaging device. It is a medical device for vascular access.

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

   • N/A. This is not an AI/algorithm device.

6. The type of ground truth used:

   • Clinical outcomes data: The ground truth was based on the presence or absence of serious complications, pain reports, patency, and other observed adverse events during the 48-hour indwelling period and subsequent 30-day follow-up of human subjects. This also included objective measures like IO aspirate cultures and x-rays.

7. The sample size for the training set:

   • N/A. This is a medical device approval, not an AI model requiring a training set. The "development" of the device was based on prior predicate devices and engineering principles, with the clinical study serving as a validation of the extended use.

8. How the ground truth for the training set was established:

   • N/A. As above, no training set in the AI sense was used.

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The ARROW Endurance catheter system permits access to the patient's peripheral vascular system for short-term use to sample blood, monitor blood pressure, or administer fluids. The catheter may be used for high pressure injection. The safety feature is intended to minimize the risk of sharps injuries.

The Arrow® Endurance™ Extended Dwell Peripheral Catheter System is a sterile, single use peripheral intravascular device designed to permit access to the peripheral vascular system. The insertion device consists of a handle with an integral needle, a passivelyactivated needle protection mechanism, guide wire with slider advancer, catheter release tab, and single-lumen catheter. The catheter is advanced over the needle and threaded over a guide wire into a peripheral vessel. The catheter system consists of a catheter body, juncture hub, integrated extension tubing with Luer hub, vent plug to prevent blood leakage during insertion, and a clamp. The catheter is intended for short-term use to permit delivery of infusion therapies. infusion of blood and blood products, pressure monitoring, high pressure injection at a maximum of 325 psi, and withdrawal of blood. The Arrow Endurance Extended Dwell Peripheral Catheter System is available in single lumen, 18 ga. 20 ga. and 22 ga. configurations with usable lengths of 6 cm (2.36") and 8 cm (3.15").

The provided document is a 510(k) summary for the Arrow Endurance™ Extended Dwell Peripheral Catheter System (K163513). It describes non-clinical testing performed to demonstrate substantial equivalence to predicate devices, but it does not include performance data typically found in clinical studies, nor does it define acceptance criteria in a quantifiable manner for device performance.

Therefore, many of the requested items cannot be answered from the provided text. The document focuses on demonstrating that modifications made to an existing device (guide wire design and catheter release colorant) do not raise new questions of safety or efficacy.

Here's a breakdown of what can and cannot be answered:

1. Table of acceptance criteria and reported device performance:

• Acceptance Criteria: Not explicitly stated in a quantifiable table format. The document implies acceptance criteria are met if the device performs comparably to the predicate and passes standard tests.
• Reported Device Performance: Not provided in quantifiable metrics. The document states that testing "verified that the changes presented no different questions of safety or efficacy" and that "the results of the risk assessment and resultant testing performed have demonstrated that the proposed guide wire design and catheter release colorant change present no different questions of safety or effectiveness."

2. Sample sized used for the test set and the data provenance:

• Sample Size: Not specified.
• Data Provenance: The testing is "Bench testing," meaning it's performed in a laboratory setting, not with human or animal subjects. Thus, data provenance in terms of country of origin or retrospective/prospective is not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. This is not a study involving ground truth established by human experts for a diagnostic or interpretative AI device.

4. Adjudication method for the test set:

• Not applicable. This is not a study involving human adjudication of results.

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 document describes a medical device (catheter system), not an AI imaging or diagnostic algorithm. No MRMC study was performed.

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

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

7. The type of ground truth used:

• Not applicable in the context of expert consensus, pathology, or outcomes data, as this is bench testing for a physical device. The "ground truth" for this type of testing is largely based on engineering specifications, material properties, and performance against established industry standards (e.g., ISO 10993-1, ISO 11070).

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device requiring a training set.

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

• Not applicable.

Summary of what can be extracted/inferred from the document:

• Device Name: Arrow Endurance™ Extended Dwell Peripheral Catheter System
• Purpose of the Submission: To demonstrate substantial equivalence for a modified version of an already marketed device (K152272 & K151513). The modifications are a guide wire design change (shortening flexible distal portion, removal of stainless steel coil/spring) and a catheter release colorant change.
• Nonclinical Testing Performed: Bench testing, including:
  • Biocompatibility (in accordance with ISO 10993-1)
  • Applicable requirements from ISO 11070 (Surface: Extraneous Matter and Defects, Surface: Lubricant, Guide wire Radio Detectability, Guide wire Fracture, Guide wire Flexure, Guide wire Tensile)
  • Guide wire Stiffness
  • Simulated Use Testing
• Conclusion of Testing: The testing verified that the changes presented no different questions of safety or efficacy, and the device is considered substantially equivalent to the cited predicate devices.

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The VPS Rhythm Device is indicated for the positioning of central venous catheters including PICCs. It provides catheter tip location information by using the patient's cardiac electrical activity. The VPS Rhythm Device is indicated for use as an alternative method to chest x-ray or fluoroscopy for confirmation of central venous catheter tip placement in adult patients. The TipTracker Technology is an optional accessory for use with the VPS Rhythm Device, indicated for visual navigation of a peripherally-inserted central catheter (PICC) as it is inserted through the vasculature. The TipTracker technology is used for catheter tip navigation purposes only; it is not used to determine final catheter tip placement.

Note: In general, devices that utilize ECG technique to observe P-wave are limited, but not contraindicated, for patients where cardiac rhythms may change presentation of the P-wave; including

• Atrial fibrillation
• Atrial flutter
• Severe tachycardia
• Pacemaker-driven rhythm
• Chronic obstructive pulmonary disease (COPD)
  Such patients are easily identified prior to central catheter insertion. In these specific cases, use of an additional confirmation method is necessary to confirm catheter tip location.

The VPS Rhythm Device with Optional TipTracker Technology is a medical device system consisting of nonsterile, reusable electronic components and accessories, as well as single-use, sterile components. All of which are utilized together to facilitate the final confirmation of central venous catheter tip placement by using the patient's cardiac electrical waveform. The system features an electronic monitor with graphical user interface display, as well as connection cables and accessories which allow for the display of the patient's external and intravascular cardiac ECG waveforms. Interpretation - by the clinician - of changes in the patient's intravascular cardiac ECG waveform morphology, which are displayed in real-time on the VPS Rhythm Device monitor as the central venous catheter is inserted, is utilized for confirmation of the final position of the catheter tip as an alternative to radiographic confirmation.

The optional TipTracker Technology includes software algorithms and accessory components (the TipTracker T-piece and Stylet) which facilitate the real-time visualization of the catheter's track and direction as it is inserted by the clinician through the vasculature. The TipTracker T-piece is a non-sterile, reusable component consisting of a magnetic emitter array that is connected to the VPS Rhythm Device monitor. In use, the TipTracker T-piece is placed externally on the patient's chest. When the sterile, singleuse TipTracker Stylet is assembled with the PICC which is to be inserted by the clinician, the VPS Rhythm Device with Optional TipTracker Technology facilitates the visualization of the catheter's insertion track and direction relative to the location of the TipTracker T-piece. The TipTracker Technology is not intended as an indicator of specific catheter location nor is it intended to be utilized for confirmation of final PICC tip location.

The provided document is a 510(k) premarket notification for the "VPS Rhythm™ Device with Optional TipTracker™ Technology." It indicates that no human clinical data was provided to support substantial equivalence (Section 8). Therefore, it is not possible to describe a study that proves the device meets acceptance criteria based on clinical performance.

However, the document does list non-clinical performance data that was submitted. This non-clinical data focuses on verifying the device's technical performance, electrical safety, electromagnetic compatibility, software, material properties, sterilization, biocompatibility, and usability.

Based on the provided information, I can address the available non-clinical performance data and the usability study.

Here's a breakdown of the requested information based on the non-clinical data and the usability study:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) and no clinical studies are reported, specific acceptance criteria for clinical performance (e.g., accuracy, sensitivity, specificity) for the device are not described in the document. The non-clinical testing, however, implies meeting industry standards and internal design requirements.

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

• Human Factors Study Test Set (Usability): The document mentions "independent clinician participants" but does not specify the sample size for this test set.
• Data Provenance for Human Factors Study: This was a prospective study conducted with clinicians. The country of origin is not explicitly stated, but given the context of a US FDA submission, it can be inferred to be a US-based study or following US regulatory guidelines.
• Other Non-Clinical Testing: Sample sizes for material integrity, electrical, EMC, and software testing are not specified. These are typically lab-based tests.

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

• For the Usability Study (Human Factors): The "ground truth" here would be the predefined usability criteria and the assessment of whether clinicians could successfully perform tasks. The "experts" would be the independent clinician participants, but their specific qualifications (e.g., years of experience) are not detailed. The study assessed the device's functions against predetermined usability criteria.
• For other non-clinical tests: Ground truth is established by engineering specifications, international standards (IEC, ISO, ASTM), and internal design requirements.

4. Adjudication Method for the Test Set

• For the Usability Study (Human Factors): An explicit adjudication method (e.g., 2+1) is not described. The document states that "The results of the human factors study were compiled and assessed," suggesting an analysis against predefined usability criteria rather than an expert consensus on a subjective outcome.
• For other non-clinical tests: Adjudication is typically against established engineering specifications and standards.

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

• No MRMC study was done. The document explicitly states "No human clinical data was provided to support substantial equivalence." An MRMC study would fall under clinical data.

6. Standalone Performance Study (Algorithm only without human-in-the-loop performance)

• Yes, in the context of the device's ECG technology and TipTracker navigation:
  • The "VPS Rhythm Device" as a standalone component uses software algorithms to acquire, process, and display ECG waveforms for catheter tip location. Its performance in this function relies on the algorithm interpreting cardiac electrical activity.
  • The "TipTracker Technology" also involves "software algorithms" to facilitate real-time visualization of the catheter's track and direction using magnetic field-based technology. This is also a standalone algorithmic function.
• The non-clinical testing, particularly "Software Verification and Validation Testing" and "TipTracker Stylet Performance," would evaluate these standalone algorithmic and system performances against specified requirements.

7. Type of Ground Truth Used

• For the Human Factors Study (Usability): "Predetermined usability criteria" established prior to the study, likely by device designers and regulatory/human factors experts.
• For TipTracker Stylet Performance and Physical Integrity: Engineering specifications, material science standards (e.g., ISO 11070), and internal design requirements.
• For Electrical Safety, EMC, Sterilization Residuals, Biocompatibility: International and national standards (e.g., IEC 60601 series, ISO 10993 series, ASTM F2096).

8. Sample Size for the Training Set

• The document does not mention a training set for any AI/machine learning models. The description of the device's technology points to signal processing and magnetic tracking algorithms rather than learnable AI models in the modern sense. Therefore, "training set" is not applicable in the context described.

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

• As no training set is mentioned (see point 8), this information is not applicable/provided.

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The Arrow® Pressure Injectable Midline Catheter with Chlorag+ard® Antimicrobial and Antithrombogenic Technology is indicated for short-term (

The Arrow Pressure Injectable Midline Catheter with Chlorag ard Antimicrobial and Antithrombogenic Technology is a single use catheter designed to provide short-term peripheral access to the venous system. It consists of a non-tapered, radiopaque polyurethane extruded catheter body with a softer, contoured Blue FlexTip (flexible distal tip). The catheter is available in 4.5 Fr. Single lumen and 5.5 Fr. Double lumen configurations with a usable catheter length of 15 cm. The catheters can be used for the injection of contrast media. The maximum recommended infusion rate is 5 mL/sec. The external catheter body and the entire internal fluid path of the device are treated with a Chlorhexidine-based solution technology. Studies have shown the technology to possess both antimicrobial and antithrombogenic properties.

The catheters will be packaged sterile in kits that will include components to facilitate insertion. The Chlorag+ard technology that is incorporated in the modified device's physical design is the same as the reference device.

The provided text is a 510(k) summary for the "Arrow Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology." This document is a premarket notification to the FDA to demonstrate that the new device is substantially equivalent to a legally marketed predicate device. It does not describe a study to prove a device meets acceptance criteria for an AI/algorithm-based medical device.

Instead, this document details the substantial equivalence of a physical medical device (a catheter) to existing predicate devices based on design characteristics, materials, and non-clinical performance testing. The "Chlorag+ard Technology" mentioned refers to a coating on the catheter that has antimicrobial and antithrombogenic properties, which were evaluated using in vitro and in vivo test methods. This is not an AI or algorithm.

Therefore, I cannot provide the requested information regarding acceptance criteria and studies for an AI device. The input document is for a physical medical device, not an AI/algorithm-based one.

If you can provide a different document that describes an AI/algorithm-based medical device, I would be happy to then attempt to answer the questions you've posed.

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