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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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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 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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