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HydroPICC Single Lumen: Indicated for short-or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to the administration of fluids, medications, and nutrients; the sampling of blood; central venous pressure monitoring; and power injection of contrast media. Rated for maximum power injection flow rate of 5.0 ml/s

HydroPICC Dual Lumen: Indicated for short- or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to the administration of fluids, medications, and nutrients; the sampling of blood; central venous pressure monitoring; and power injection of contrast media. Rated for a maximum power injection flow rate of 5.0 ml/s

HydroMID Single Lumen: Indicated for short term access(< 30 days) to the peripheral venous access system for intravenous therapy, including but not limited to, the administration of fluids, medications, and the sampling of blood and blood products. Maximum Power Injection Flow Rate: 4Fr Single Lumen, 20cm: 6 ml/sec

The HydroMID catheters are a family of midline catheters comprised of a radiopaque, hydrophilic catheter with a suture wing, Luer lock hub, and extension tubing made from materials commonly used in the manufacture of catheters. Catheters are provided packaged in kit configurations with the appropriate accessories for placement in the respective clinical environments. The maximum power injection flow rate for the lumen is indicated on the extension tube clamp. HydroMID has been shown to be effective in reducing thrombus accumulation and thrombotic occlusions. Reduction of thrombus accumulation and thrombotic occlusions were evaluated using an in vitro model. Pre-clinical in vitro evaluations do not necessarily predict clinical performance with respect to thrombus formation.

The HydroPICC catheters are a family of peripherally inserted central catheter (PICC) comprised of a radiopaque hydrophilic catheter material with a suture wing, Luer lock hub, and extension tubing made from materials commonly used in the manufacture of catheters. Catheters are provided packaged in kit configurations with the appropriate accessories for placement in the respective clinical environments. The maximum power injection flow rate for the lumen is indicated on the extension tube clamp. HydroPICC has been shown to be effective in reducing thrombus accumulation and thrombotic occlusions. Reduction of thrombus accumulation and thrombotic occlusions were evaluated using an in vitro model. Pre-clinical in vitro evaluations do not necessarily predict clinical performance with respect to thrombus formation.

The purpose of this 510(k) is to add an additional statement to the indications for use.

The provided FDA 510(k) clearance letter (K243458) details the HydroPICC and HydroMID catheters. The focus of this submission is to add a statement to the indications for use regarding the anti-thrombogenic properties of the MIMIX® Technology incorporated into these catheters. The acceptance criteria and supporting studies are described below:

Acceptance Criteria and Reported Device Performance

The core acceptance criterion for this 510(k) submission is to demonstrate that the expanded Indications for Use statement, specifically concerning the anti-thrombogenic properties of the MIMIX® Technology, does not introduce new questions of safety or effectiveness and is supported by non-clinical data. The reported device performance is based on in vitro studies.

Note: The FDA letter explicitly states: "The clinical impact has not been evaluated in human clinical trials. This device is not intended for the treatment of existing vein thrombosis." This indicates that the acceptance criteria are based solely on in vitro performance for the anti-thrombogenic claims, not on in vivo clinical outcomes.

Study Details for Acceptance Criteria

The provided document does not fully delineate separate "test sets" for the in vitro studies in the way one might for an AI/algorithm-based device. Instead, the "studies" themselves are the performance evaluations for the stated acceptance criteria.

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

   • The document lists several in vitro tests.
   • Sample Size: The specific number of devices or experimental replicates used in each in vitro test is not explicitly stated in the provided text.
   • Data Provenance: All studies are indicated as "in vitro" (meaning conducted in a test tube, culture dish, or other controlled environment outside of a living organism). The country of origin is not specified but is presumably where Access Vascular Inc. conducts its research and development or contracts with testing facilities.

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

   • For in vitro studies of this nature (evaluating properties like thrombus accumulation), the "ground truth" is typically established by the experimental setup, validated measurement techniques, and potentially statistical analysis.
   • No specific number of experts or their qualifications are mentioned as having established "ground truth" for these in vitro tests in the context of expert consensus, as might be the case for image-based diagnostic devices. The results are based on objective physical or biological measurements.

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

   • Not applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies or studies involving subjective expert review (e.g., radiology image interpretation) to resolve discrepancies in independent assessments. As these are in vitro physical/biological tests, such adjudication methods are not relevant or mentioned.

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:

   • Not applicable. This device is a medical catheter, not an AI software/algorithm requiring human reader interpretation. No MRMC study was conducted or is relevant for this device.

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

   • Not applicable. This device is a physical medical device (catheter) with a material technology, not an AI algorithm. Therefore, "standalone" algorithm performance is not a relevant concept for this submission.

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

   • The ground truth for the in vitro studies described (e.g., "Assessment of PICC Catheter Thrombosis," "Thrombosis Accumulation Report") is based on objective measurements of physical and biological phenomena (e.g., quantification of thrombus accumulation, pressure required to remove occlusions) within controlled laboratory environments. This is a form of empirical scientific measurement, rather than expert consensus, pathology, or outcomes data.

7. The sample size for the training set:

   • Not applicable. There is no mention of a "training set" because this is a physical medical device, not an AI/machine learning model that requires training data.

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

   • Not applicable. As no training set is mentioned, the method for establishing ground truth for it is also not applicable.

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Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM): Indicated for short-or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to the administration of fluids, medications, and nutrients; the sampling of blood; central venous pressure monitoring; and power injection of contrast media. Rated for maximum power injection flow rate of 4.0ml/s.

Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM): Indicated for short-or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to the administration of fluids, medications, and nutrients; the sampling of blood; central venous pressure monitoring; and power injection of contrast media. Rated for maximum power injection flow rate of 5.0ml/s.

The HydroPICC catheters are a family of peripherally inserted central catheters (PICC) made of radiopaque hydrophilic material with a suture wing, Luer lock hub, and extension tubing made from materials commonly used in catheter manufacturing. The catheters are provided in kit configurations with the necessary accessories for placement in clinical environments. The maximum power injection flow rate for the lumen is indicated on the extension tube clamp.

HydroPICC has been shown to be effective in reducing thrombus accumulation and thrombotic occlusions. These reductions were evaluated using in vitro and in vivo models. Pre-clinical evaluations do not necessarily predict clinical performance with respect to thrombus formation. HydroPICC 5F Dual Lumen Catheter Components include: HydroPICC 5Fr Dual Lumen Catheter Assembly, Dispensing Tube, 2 Channel Clip, and Guidewire Introducer and Straightener.

The provided FDA 510(k) clearance letter pertains to a medical device (PICC catheter), not an AI/Software as a Medical Device (SaMD) product. Therefore, the content of the letter does not contain the information requested in your prompt regarding acceptance criteria and studies for AI/SaMD, such as:

• A table of acceptance criteria and reported device performance (for AI metrics like sensitivity, specificity, etc.)
• Sample sizes used for test sets and data provenance (for image/data-driven AI)
• Number of experts and their qualifications for ground truth establishment
• Adjudication method for ground truth
• MRMC comparative effectiveness study results or effect sizes
• Standalone algorithm performance
• Type of ground truth used (e.g., pathology, outcomes data)
• Sample size for training set
• How ground truth for the training set was established

The 510(k) summary for the HydroPICC Catheter focuses on physical device performance characteristics. It mentions:

• Acceptance Criteria/Performance (Implied through testing): The device was tested to demonstrate acceptable performance for the modified power injection ratings and device length.
• Study Type: Non-clinical tests were performed, specifically "Power injection Cyclical and Static Burst testing as well as dimensional verification testing."
• Conclusion: These tests demonstrated that "the modifications to the power injection rating and the length do not adversely impact product performance."

In summary, this document does not contain the specific information you requested relating to the acceptance criteria and study proving performance for an AI/SaMD device. The information provided is for a physical medical device clearance based on engineering and performance bench testing.

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The HydroMID 5F Dual Lumen Midline Catheter is indicated for short term access (< 30 days) to the peripheral venous access system for intravenous therapy, including but not limited to, the administration of fluids, medications, and the sampling of blood and blood products.

Rated for maximum power injection flow rate of 6ml/s.

The HydroMID catheter is a 5 French, dual lumen, midline catheter comprised of a radiopaque, hydrophilic catheter with a suture wing, Luer lock hub, and extension tubing made from materials commonly used in the manufacture of catheters. Catheters are provided packaged in kit configurations with the appropriate accessories for placement in the respective clinical environments.

HydroMID has been shown to be effective in reducing thrombus accumulation and thrombotic occlusions. Reduction of thrombus accumulation and thrombotic occlusions were evaluated using in vitro and in vivo models. Pre-clinical in vivo evaluations do not necessarily predict clinical performance with respect to thrombus formation.

Catheter and accessories are supplied sterile. Product is sterilized by ethylene oxide (EO) except where labeled otherwise. Product should be stored in a cool, dry, dark place. The HydroMID Catheter is supplied in a dry state and must be hydrated before use.

The provided text describes a 510(k) summary for the HydroMID 5F Dual Lumen Midline Catheter. It focuses on demonstrating substantial equivalence to a predicate device through bench testing. The document does not contain information about a study proving the device meets acceptance criteria in the context of an AI/human reader study or clinical performance with ground truth established by experts/pathology/outcomes data.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this document refer to engineering and performance bench testing of a physical medical device (a catheter), not a medical device software or AI algorithm. Therefore, many of the requested categories in the prompt (e.g., number of experts for ground truth, adjudication methods, MRMC study, standalone algorithm performance, training set details) are not applicable to this type of device submission.

However, I can extract the information relevant to the device's performance and the "acceptance criteria" as described in the 510(k) summary for this physical medical device.

1. Table of Acceptance Criteria and Reported Device Performance (Bench Testing):

The document states: "All tests passed the acceptance criteria specified for both the subject and predicate devices." It does not provide specific numerical acceptance criteria or numerical reported performance values for each test. Instead, it lists the types of tests conducted.

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

• Sample Size: The document states: "Testing was identical to the predicate in standard conformance, sample size, methods, and acceptance criteria." However, the specific numerical sample size for each test is not provided.
• Data Provenance: The tests are described as "Bench Data" conducted internally by the manufacturer, Access Vascular Inc. The country of origin for the data is not explicitly stated, but the company address is Billerica, MA, which implies the testing was conducted in the United States. The data is prospective in the sense that it was generated for this 510(k) submission to demonstrate the performance of the new device design.

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

• Not Applicable. This is a physical medical device. Ground truth for its performance is established by engineering and material science testing against predefined specifications, not by human expert review of images or clinical outcomes in the typical sense of AI/image analysis.

4. Adjudication Method for the Test Set:

• Not Applicable. See point 3. Testing results are objective measurements against established engineering standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs. without AI assistance:

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

7. The Type of Ground Truth Used:

• Engineering Specifications and Standardized Test Methods: The "ground truth" for this device's performance revolves around its physical and functional properties meeting predetermined engineering specifications and validated test methods (e.g., pressure resistance, flow rates, dimensional accuracy, material properties like tensile strength and kink resistance, sterility, and MRI compatibility). These are objective criteria, not based on expert consensus, pathology, or outcomes data in a clinical trial sense.

8. The Sample Size for the Training Set:

• Not Applicable. This is a physical medical device; there is no "training set" in the context of machine learning. The device design and materials are based on established engineering principles and prior device iterations.

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

• Not Applicable. See point 8.

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Indicated for short-or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to the administration of fluids, medications, and nutrients; the sampling of blood; central venous pressure monitoring; and power injection of contrast media. Rated for maximum power injection flow rate of 5.0ml/s

The HydroPICC 4F Single Lumen Catheter is comprised of a radiopaque hydrophilic catheter material with a suture wing, Luer lock hub, and extension tubing made from materials commonly used in the manufacture of catheters are provided packaged in kit configurations with the appropriate accessories for placement in the respective clinical environments. The maximum power injection flow rate for the lumen is indicated on the clamp. HydroPCC has been shown to be effective in reducing thrombus accumulation and thrombotic occlusions f thrombus accumulation and thrombotic occusions were evaluated using in vitro and in vivo models. Pre-clinical in vivo evaluations do not necessarily predict clinical performance with respect to thrombus formation.

The provided text is a 510(k) summary for the HydroPICC 4Fr Single Lumen Marked catheter, where the purpose of the submission is to modify the power injection ratings in the indications for use. As such, it focuses on demonstrating substantial equivalence to a predicate device rather than providing details of a study against specific acceptance criteria for a new device's performance.

Therefore, the document does not contain the information requested regarding acceptance criteria, a specific study proving device meets acceptance criteria, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details.

The document discusses "comprehensive data demonstrating the safety and efficacy" and "rigorous testing protocols" including "in vitro" data to support the modified power injection rating, and states that "the form, fit, and function of these devices have not changed from their previous clearances." However, it does not provide specific details of these tests or their results in a measurable, quantifiable way that would allow for the completion of the requested table and study breakdown.

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The HydroMID is indicated for short term access (< 30 days) to the peripheral venous access system for intravenous therapy, including but not limited to, the administrations, and the sampling of blood and blood products.

Maximum Power Injection Flow Rate: -4Fr Single Lumen, 20cm: 6 mL/sec

The HydroMID catheter is a 4 French, single lumegemidfifie catheter comprised of a radiopaque, hydrophilic catheter with a suture wing, Luer lock hub, and extension tube made from materials commonly used in the manufacture of catheters. Catheters are provided packaged in kit configurations with the appropriate accessories for placement in the appropriate clinical environments. The maximum power injection flow rate for the lumen is indicated on the extension tube clamp.

HydroMID has been shown to be effective in reducing thrombus accumulation and thrombotic occlusions. Reduction of thrombus accumulation and thrombotic occlusions were evaluated using in vitro and in vivo models. Pre-clinical in vivo evaluations do not necessarily predict clinical performance with respect to thrombus formation.

The provided text describes the 510(k) summary for the HydroMID 4F Single Lumen Midline Catheter. It focuses on demonstrating substantial equivalence to a predicate device (HydroMID 4F Single Lumen Catheter, K203069) rather than presenting a performance study with specific acceptance criteria and reported device performance in the format requested.

Therefore, for aspects like "Table of acceptance criteria and the reported device performance," "Sample size used for the test set and data provenance," "Number of experts used to establish ground truth," "Adjudication method," "MRMC comparative effectiveness study," "Standalone performance," "Type of ground truth," "Sample size for the training set," and "How the ground truth for the training set was established," the document does not provide the requested quantitative information typically found in clinical or AI algorithm performance studies.

Instead, the document primarily addresses the following:

1. Acceptance Criteria and Device Performance (Qualitative Description):

The device is deemed to meet its intended purpose and be substantially equivalent to the predicate device based on various bench tests and biocompatibility testing. The "acceptance criteria" are implied to be adherence to various consensus standards and FDA guidance.

The document states, "All necessary performance testing has been conducted on the HydroMID to assure substantial equivalence to the predicate devices and to demonstrate the device performs as intended. All testing was performed on test units representative of finished devices."

Regarding the other requested information:

• Sample size used for the test set and the data provenance: Not specified. The document mentions "test units representative of finished devices" for bench testing.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or not specified. This type of information is typically for AI/diagnostic device studies.
• Adjudication method: Not applicable or not specified.
• 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 diagnostic device.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical catheter, not an algorithm.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the physical characteristics, the ground truth would be engineering specifications and measurements. For biocompatibility, it's the results of standardized biological assays.
• The sample size for the training set: Not applicable. This is a physical medical device, not an AI model requiring a training set.
• How the ground truth for the training set was established: Not applicable.

Summary of what the document focuses on instead:

The document focuses on demonstrating substantial equivalence to a predicate device (HydroMID 4F Single Lumen Catheter, K203069) by highlighting:

• Identical intended use, principle of operation, and similar technological characteristics.
• Minor differences (e.g., removal of certain warnings for midline therapies, addition of Copper Phthalocyanine Blue 15:1 material for catheter markings, addition of catheter markings) are addressed and supported by bench testing and biocompatibility data.
• Adherence to various international and FDA consensus standards for medical devices (ISO 10555, ISO 11135, AAMI TIR28, ISO 15223, ISO 10993).

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HydroPICC is indicated for short- or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to; the administration of fluids, medications, and nutrients; the sampling of blood; central venous pressure monitoring; and power injection of contrast media.

HydroPICC is rated for a Maximum Power Injection Flow Rate of 3.5mL/sec.

The HydroPICC is a peripherally inserted central catheter (PICC) intended for short or long-term use. The HydroPICC is a 4Fr, 55cm long catheter suitable for periodic access to the superior vena cava (SVC) while maintaining a reduced level of thrombus accumulation. HydroPICC is supplied in a kit with the necessary accessories to insert and maintain the catheter.

This document is a 510(k) K193015 Premarket Notification for the HydroPICC (Model 142) intravascular catheter, asserting its substantial equivalence to a previously cleared predicate device, HydroPICC (Model 141, K172885).

The submission focuses heavily on demonstrating equivalence and does NOT include a study involving AI assistance for human readers, nor a standalone AI algorithm performance study. Therefore, most of the requested information regarding AI study design, ground truth establishment for AI, expert involvement, and MRMC studies is not present in this document.

The document describes performance testing for a medical device (intravascular catheter), not an AI algorithm. The acceptance criteria and performance data described relate to physical and mechanical properties of the catheter, as distinct from the performance metrics (e.g., sensitivity, specificity, AUC) typically associated with AI/ML medical devices.

Here's the breakdown of the information that CAN be extracted, followed by a clear statement of what is NOT in the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "The subject devices met all predetermined acceptance criteria derived from the applicable guidance documents, standards and in-house protocols," but it does not provide a specific table with numerical acceptance criteria and reported performance values. Instead, it lists the types of tests performed and the standards followed.

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

The document does not specify the sample size used for the test set for each individual test. It merely states that "The subject devices met all predetermined acceptance criteria." The provenance of the data (e.g., country of origin, retrospective/prospective) is not mentioned for this engineering/performance testing.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. This document describes the testing of a medical device (catheter), not the performance of an AI algorithm based on expert-labeled data.

4. Adjudication Method for the Test Set

Not applicable. This is for medical device performance (physical, mechanical, safety), not for AI algorithm evaluation requiring expert consensus/adjudication.

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

No MRMC comparative effectiveness study was done because this submission is not for an AI/ML medical device and does not involve human readers interpreting images with or without AI assistance.

6. Standalone Algorithm Performance

No standalone algorithm performance study was done relevant to AI/ML, as this is not an AI/ML device.

7. Type of Ground Truth Used

The "ground truth" for this device's performance testing is established by engineering standards and specifications (e.g., ISO, ASTM standards, FDA guidance documents, and internal protocols) for physical and mechanical properties, not expert consensus on medical images, pathology, or outcomes data in the context of an AI study.

8. Sample Size for the Training Set

Not applicable. This document describes testing for a manufactured 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 for the same reason as point 8.

Summary of what is NOT in the document regarding acceptance criteria and studies for an AI/ML device:

The provided document is a 510(k) premarket notification for a physical medical device (intravascular catheter). It details the substantial equivalence to a predicate device and describes the various engineering and performance tests conducted to ensure the device meets safety and performance standards. It does not contain any information about an AI/ML device, its acceptance criteria, expert consensus, ground truth establishment, or any studies related to its performance (standalone or human-in-the-loop). Therefore, the specific requirements of the prompt regarding AI are not addressed by this document.

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HydroPICC is indicated for short- or long-term peripheral access to the central venous system for intrapy, including but not limited to; the administration of fluids, medications, and nutrients; the sampling of blood; central venous pressure monitoring; and power injection of contrast.

HydroPICC is rated for a Maximum Power Injection Flow Rate of 3.5ml/sec.

The HydroPICC is a peripherally inserted central catheter (PICC) intended for short or long-term use. The HydroPICC is a 4Fr, 55cm long catheter suitable for periodic access to the superior vena cava (SVC). HydroPICC has been shown to be effective in reducing thrombosis accumulation. Reduction of thrombosis accumulation was evaluated using in vitro and in vivo models. Preclinical in vitro and in vivo evaluations do not necessarily predict clinical performance with respect to thrombosis formation.. HydroPICC is supplied in a kit with the necessary accessories to insert and maintain the catheter.

The provided text describes the 510(k) premarket notification for the HydroPICC device, focusing on its substantial equivalence to predicate devices rather than providing detailed acceptance criteria and study results in the format requested for an AI/algorithm-based device.

The HydroPICC is a medical device (a peripherally inserted central catheter), and the performance data presented relates to its physical and biological properties. This document does not describe an AI or algorithm-driven device. Therefore, it does not contain the information required to answer the prompt regarding acceptance criteria and studies for an AI/algorithm.

Specifically, the document focuses on:

• Biocompatibility Testing: Cytotoxicity, intracutaneous reactivity, sensitization, intramuscular implant, pyrogenicity, chemical extractables, in vivo thrombogenicity.
• Mechanical Testing: Power Injection Flow Rate, Static Burst Strength, Lifecycle Power Injections, Gravity Flow Rate, Catheter Length, Priming Volume, Dimensional Verification, Catheter Kink/Flex Resistance, Alcohol Compatibility, Catheter Marking & Identification/Radio Detectability Testing, Tensile Testing, Catheter Compatibility with Medications, Catheter Thrombus Accumulation Evaluation Using in Vitro Blood Loop, Catheter Collapse Resistance, Central Venous Pressure Monitoring, Pyrogens testing.
• Sterilization: Validated overkill Ethylene Oxide (EO) method.

These are standard tests for a physical medical device and do not involve AI/algorithm performance metrics such as sensitivity, specificity, AUC, or the involvement of expert readers for ground truth establishment.

Therefore, I cannot fulfill the request as the provided text does not contain information about an AI/algorithm-driven device or its associated acceptance criteria and study proving its performance.

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