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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 Provena™ Midline Catheters are indicated for short term access to the peripheral venous system for selected intravenous therapies, blood sampling, and power injection of contrast media. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of the procedure. The Provena™ Midline Catheters are suitable for use with power injectors.

Provena™ Midline Catheters are a family of peripherally placed catheters made from radiopaque body-softening polyurethane materials. Each Provena™ Midline Catheter is designed with kink-resistant, reverse taper design. Catheters are packaged in a tray with accessories for reliable short term (less than 30 days) vascular access. The Provena™ Midline Catheters are suitable for use with power-injectors.

The provided FDA 510(k) summary for the Provena™ Midline Catheter does not describe a study involving an AI/Machine Learning device or an analysis of clinical images. Instead, it details a traditional medical device submission focused on demonstrating substantial equivalence to a predicate device through material, dimensional, and performance characteristic comparisons.

Therefore, many of the requested details regarding acceptance criteria and study design for an AI/ML device (e.g., sample size for test set, number of experts, MRMC studies, ground truth establishment) are not applicable to the content provided.

However, I can extract and present the device performance characteristics and the type of testing performed to demonstrate substantial equivalence, which serves as a form of "acceptance criteria" for a non-AI/ML device in this context.

Here's a breakdown based on the provided document, addressing the applicable points:

Device: Provena™ Midline Catheter (Non-AI/ML Device)

1. A Table of Acceptance Criteria and the Reported Device Performance (as demonstrated by testing against the predicate):

This table compares the characteristics of the subject device (Provena™ Midline Catheter) to the predicate device (PowerMidline™ Catheter) to demonstrate substantial equivalence, rather than defining specific statistical performance metrics against a clinical ground truth as would be done for an AI/ML device. The "reported device performance" is the equivalency shown through these characteristics and the results of specified performance tests.

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

The Stiletto Extended Dwell Catheter (EDC) is a sterile, single use device designed to allow users to sample blood and/or administer fluids over a short duration (

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

1. Table of Acceptance Criteria and Reported Device Performance

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

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

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

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

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

4. Adjudication Method for the Test Set

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

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

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

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

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

7. The Type of Ground Truth Used

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

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

8. The Sample Size for the Training Set

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

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

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

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The primeMIDLINE™ Catheters are indicated for short term access to the peripheral venous system for selected intravenous therapies, blood sampling and power injection of contrast media. These catheters are indicated for patients older than 28 days and that weigh more than 10 kg, with consideration given to adequacy of vascular anatomy and appropriateness of the procedure. The primeMIDLINE™ Catheters are suitable for use with power injectors.

The 4F DL primeMIDLINE™ Catheter is a peripherally placed midline catheter designed to provide access to the vascular system. The catheter lumen is an open-ended design comprised of radiopaque polyurethane. The 4F DL primeMIDLINE ™ Catheter is packaged sterile in a tray with the accessories necessary to establish short-term (less than 30 days) vascular access. The 4F DL primeMIDLINE Catheter is suitable for use with power injectors.

The provided text describes a 510(k) submission for a medical device (4F Dual Lumen primeMIDLINE™ Catheter) and focuses on demonstrating its substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria based on a study with a test set, expert ground truth, and statistical performance metrics commonly seen in studies for AI/ML-enabled devices.

Therefore, the requested information regarding a table of acceptance criteria and reported device performance, sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, type of ground truth, training set size, and training set ground truth establishment is not present in the provided document.

This document details the regulatory pathway for a conventional medical device, emphasizing its similarity to a previously cleared predicate device through comparisons of intended use, technological characteristics, and performance testing (e.g., tensile strength, flow rate). These tests are typically engineering/bench tests rather than clinical studies with human "ground truth" and reader performance metrics.

Here's a breakdown of what is provided and why it doesn't fit the requested AI/ML study format:

1. Acceptance Criteria and Reported Device Performance: Instead of performance in terms of diagnostic accuracy or reader improvement, the document lists various non-clinical performance tests conducted on the device (e.g., Visual Inspection, Tensile Strength, Catheter Elongation, Radiopacity, Lifecycle Performance, Static Burst Pressure, Power Injection Flowrate, Biocompatibility tests). The acceptance criteria for these tests are stated as having been "met all predetermined acceptance criteria as defined in the referenced Standards, FDA Guidance Document or PFM Medical, Inc. Internal Standards." Specific numerical results are not provided in this summary but would be in the full submission.

2. Sample Size for Test Set and Data Provenance: Not applicable in the context of the reported performance testing. These are bench tests on manufactured units, not a dataset of patient cases.

3. Number of Experts & Qualifications for Ground Truth: Not applicable. Ground truth for these tests would be objective measurements (e.g., a caliper for dimensional characteristics, a flow meter for flow rate).

4. Adjudication Method: Not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This is for evaluating changes in human reader performance, typically with AI assistance.

6. Standalone Performance: Not applicable. This device is a physical catheter, not an algorithm.

7. Type of Ground Truth Used: For non-clinical tests, "ground truth" refers to the objectively measured values compared against specifications derived from standards or internal requirements.

8. Sample Size for Training Set & How Ground Truth for Training Set was Established: Not applicable. This device does not involve machine learning or training a model.

In summary, the provided document describes the regulatory clearance of a physical medical device (a catheter) based on its substantial equivalence to an existing device and a series of engineering and biocompatibility tests. It does not contain information about an AI/ML-based device study with a "test set" in the diagnostic sense, expert ground truth, or human reader performance metrics.

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The catheters are indicated for short term access to the peripheral venous system intravenous therapies, blood sampling, and power injection of contrast media. These catheters may be used for any patient with consideration given to adequacy of vascular anatomy and appropriateness of the catheters are suitable for use with power injectors.

The Vygon Midline Catheters are EO sterilized, single-use, polyurethane, reverse taper, short-term, peripheral venous system access catheters. They include materials containing barium sulfate for radiopacity.

The provided text is a 510(k) Summary for the Vygon Midline Catheters. It details the device's characteristics, intended use, and a comparison to a predicate device to demonstrate substantial equivalence. However, it does not describe a study involving an AI/Machine Learning device.

Therefore, I cannot extract information regarding:

• Sample sizes for test or training sets
• Data provenance (country of origin, retrospective/prospective)
• Number of experts or their qualifications for ground truth establishment
• Adjudication methods
• MRMC comparative effectiveness studies or effect sizes
• Standalone algorithm performance
• Type of ground truth (expert consensus, pathology, outcomes)
• How ground truth for the training set was established

The document explicitly states under "Clinical Testing": "No Clinical Testing was performed." This further confirms that the type of study you are asking about (related to AI performance, human reader improvement, and ground truth establishment) was not conducted for this medical device.

The study described is primarily bench testing and biocompatibility testing to demonstrate that the Vygon Midline Catheters are substantially equivalent to a previously cleared predicate device.

Here's the relevant information that can be extracted, pertaining to acceptance criteria and performance for this non-AI medical device:

1. A table of acceptance criteria and the reported device performance

The document lists various bench tests and biocompatibility tests along with their results. The "Acceptance Criteria" are implied by the "Result" column consistently stating "Passed" or specific equivalent findings.

Table of Acceptance Criteria (Implied) and Reported Device Performance

2. Sample sizes used for the test set and the data provenance
The document does not explicitly state the sample sizes (number of devices tested) for each bench or biocompatibility test, nor does it specify data provenance as this is not a study involving human data or image data as typically seen with AI devices. The testing is laboratory-based "bench testing" of the physical devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as this is a physical medical device clearance, not an AI/ML device where expert ground truth is established. Performance is determined by standardized laboratory tests adhering to ISO standards and internal requirements.

4. Adjudication method
Not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, this type of study was not performed. The document explicitly states "No Clinical Testing was performed."

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable, as this is a physical medical device, not an algorithm.

7. The type of ground truth used
Not applicable for the reasons stated above. The "ground truth" for this device's performance is compliance with international and national standards for medical devices (e.g., ISO, ASTM, FDA guidance) and internal requirements, demonstrated through bench and biocompatibility testing.

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 primeMIDLINE™ Catheters are indicated for short term access to the peripheral venous system for selected intravenous therapies, blood sampling and power injection of contrast media. These catheters are indicated for patients older than 28 days and that weigh more than 10kg, with consideration given to adequacy of vascular anatomy and appropriateness of the procedure. The primeMIDLINE™ Catheters are suitable for use with power injectors.

The primeMIDLINE™ Catheters are a family of peripherally placed midline catheters designed to provide access to the vascular system. These catheters are offered in 3F, 4F and 5F Single Lumen and 5F Dual Lumen configurations with 20cm lengths. The catheter lumen is an open-ended design comprised of radiopaque polyurethane. Each primeMIDLINE™ Catheter is packaged sterile in a tray with the accessories necessary to establish short-term (less than 30 days) vascular access. The primeMIDLINE™ Catheters are suitable for use with power injectors.

The document provided describes the primeMIDLINE™ Catheters and their substantial equivalence to a predicate device, PowerMidline Catheters. It outlines verification testing performed to demonstrate that the device performs as intended and meets established acceptance criteria.

However, the document does not contain information about a study comparing the device's performance against specific acceptance criteria in the format requested. While it lists various performance testing categories, it does not provide:

• A table of specific quantitative acceptance criteria for each test (e.g., "Tensile Strength should be > X N") and the reported device performance against those criteria.
• Details on sample sizes for a "test set" in the context of device performance, data provenance, or the number/qualifications of experts for ground truth.
• Information on adjudication methods, MRMC comparative effectiveness studies, or standalone algorithm performance, as these are typically relevant to AI/diagnostic imaging devices, not direct hardware performance.
• The type of ground truth used for performance validation.
• Training set sample size or how ground truth was established for a training set (again, this points more towards AI/ML studies).

Instead, the document states: "The subject devices met all predetermined acceptance criteria as defined in the referenced Standards, FDA Guidance Documents or PFM Medical, Inc. Internal Standards." This is a general statement that the device passed all tests, but without quantifying the criteria or the results.

Therefore, based on the provided text, I cannot complete the table or answer most of the requested questions because the specific data is not available.

Summary of available information:

• Device: primeMIDLINE™ Catheters
• Predicate Device: PowerMidline Catheters (K153393)

1. Table of Acceptance Criteria and Reported Device Performance:

Study Information (based on available text):

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Not specified. The document states "design verification testing" was conducted but does not provide sample sizes for individual tests or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Not applicable/Not specified. The testing described is performance testing of a physical device against standards, not expert-adjudicated diagnostic performance.

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

• Not applicable/Not specified.

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:

• No. This type of study is for diagnostic tools, typically AI-powered. The device is a physical catheter.

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

• No. This is not an algorithm.

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

• "Predetermined acceptance criteria as defined in the referenced Standards, FDA Guidance Documents or PFM Medical, Inc. Internal Standards." This refers to objective measurements against established engineering and safety standards.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device that requires a training set.

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

• Not applicable.

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The Arch-Flo CT Midline is indicated for Short-Term peripheral venous system for selected intravenous therapies, blood sampling, and power injection of contrast media. This catheter may be inserted via basilic, cephalic, or median cubital vein.

The Arch-Flo'™ CT Midline is available in a 4F Single Lumen configuration. The catheter lumen terminates through an extension to a female luer-lock connector. The extension has an in-line clamp to control fluid flow and is marked POWER INJECTABLE MIDLINE along with the lumen gauge size. The transition between lumen and extension is housed within a molded hub. The hub is marked MIDLINE to identify that the catheter is not centrally placed. The tip of the lumen is notched to increase the exposed area of the lumen. The outside diameter of the lumen increases gradually near the hub to aid in kink resistance and to provide a mechanical obstruction to bleeding from the venotomy. The lumen is marked with depth marks every centimeter.

The provided text describes a 510(k) premarket notification for a medical device called "Arch-Flo CT Midline." This document primarily focuses on establishing substantial equivalence to a predicate device through comparison and performance testing. It does not contain information about acceptance criteria and studies related to the performance of an AI/algorithm-based device.

The device in question is an "Intravascular Catheter," which is a traditional medical device, not an AI or software-based application. Therefore, the specific questions regarding AI device performance (like the number of experts for ground truth, MRMC studies, standalone performance with AI, training set details, etc.) are not applicable to the content provided.

However, I can extract the general "acceptance criteria" (or performance data) for the physical device based on the bench/performance data and comparison to the predicate device.

Here's the information that can be extracted, interpreted based on the context of a traditional medical device submission:

1. A table of acceptance criteria and the reported device performance:

The document describes performance data for the Arch-Flo CT Midline and compares it to the predicate device, CT Midline (K141151). The "acceptance criteria" are implied by the standards the device was tested against and by demonstrating similar or superior performance to the predicate device.

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The CT Midlines are indicated for Short-Term peripheral access to the peripheral venous system for selected intravenous therapies, blood sampling, and power injection of contrast media. The maximum recommended infusion rate varies by catheter French size and is printed on the catheter.

The CT Midline Catheter is designed for peripheral vein catheterization and power injection of contrast media. The lumen is an open-ended design comprised of a soft radiopaque polyurethane material with barium sulfate for radiopacity. The lumen is connected to the extensions via a soft pliable hub with suture wing for secure placement. Clamps are provided on the extension tubes to prevent air/fluid contamination. Female luer connectors provide the connection for intravenous administration.

The CT Midline Catheter is available in a 4Fx20cm single-lumen, or 5Fx20cm double-lumen configuration. The outside diameter of the lumen has a reverse taper increasing gradually near the hub to aid in kink resistance and to provide a mechanical obstruction to bleeding from the venotomy. The lumen has depth marks every centimeter and numerical marks every fifth centimeter. The CT Midline is packaged sterile with the necessary accessories to facilitate insertion.

The provided document is a 510(k) premarket notification for a medical device (CT Midline) and primarily discusses its substantial equivalence to a predicate device, rather than presenting a study of the device's performance against specific acceptance criteria.

The submission states that the purpose of this particular 510(k) is to "remove a contraindication that was once cited in the Journal of Infusion Nursing but has since been revised." This is a change to the labeling, not a new performance claim or a new device design that would necessitate a comprehensive performance study with acceptance criteria and reported results.

Therefore, the document does not contain the detailed information requested regarding acceptance criteria and a study proving the device meets those criteria.

Here's a breakdown of why each point cannot be thoroughly answered from the provided text:

1. A table of acceptance criteria and the reported device performance:

   • The document implies that the device's performance (e.g., flow rates for power injection) is identical to the predicate device K141151.
   • Table 5.1 "Design Comparison Matrix" lists "Performance Testing" with "Power Injection: 5cc/sec (4F), 7cc/sec (5F)" for both the proposed and predicate devices, stating "Identical, no change." This indicates the expected performance, but not explicit acceptance criteria, nor the results of a new study designed to meet those criteria for this specific submission. It's a statement of equivalence.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • No test set is described for evaluating new performance. The comparison is based on the predicate device's existing performance data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • Not applicable as no new performance test set requiring expert ground truth is described.

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 device is an intravascular catheter, not an AI-powered diagnostic tool.

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

   • Not applicable.

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

   • Not applicable. The "ground truth" here is the established performance of the predicate device, against which the proposed device is declared equivalent.

8. The sample size for the training set:

   • Not applicable as this is a physical medical device, not an algorithm requiring a training set.

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

   • Not applicable.

Summary from the document:

The submission explicitly states under "Bench / Performance Data / Non-Clinical Testing":
"No performance testing was required for the revision to the instructions in conjunction with the substantial equivalence claims, effectively demonstrate the proposed device, CT Midline, is equivalent to the predicate device, CT Midline (K141151)."

The basis for equivalence is that the "Proposed CT Midline is substantially equivalent to the predicate device. CT Midline (K141151), in all aspects, including but not limited to, indications for use, intended use, anatomical location, basic design, dimensions, lengths performance, biocompatibility, materials, manufacturing process and method of sterilization." The only difference is a "revision to the instructions for use (labeling)" to remove a contraindication.

Therefore, for this specific 510(k) submission (K170770), no new study was conducted to prove the device meets performance acceptance criteria, because the device itself and its performance characteristics are deemed identical to a previously cleared predicate device. The change is solely in the labeling information, specifically removing a contraindication.

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The PowerGlide ST™ Midline Catheter is inserted into a patient's vascular system for short term use to sample blood or administer fluids intravenously. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of the procedure. The PowerGlide ST™ Midline Catheter is suitable for use with power injectors.

Bard Access Systems, Inc.'s PowerGlide ST™ Midline Catheter is a sterile, single use device designed to provide access to the patient's vascular system. The device is intended for short term use (

This document describes the premarket notification for a medical device, the PowerGlide ST™ Midline Catheter. It focuses on demonstrating substantial equivalence to a predicate device, not on proving clinical effectiveness through novel AI or diagnostic algorithms. Therefore, many of the requested criteria related to AI performance, ground truth establishment, expert readers, and MRMC studies are not applicable to this type of regulatory submission.

Here's an analysis based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document lists performance tests and states that the "subject device met all predetermined acceptance criteria". However, the specific quantitative acceptance criteria values and the exact reported performance results for each test are not disclosed in this summary. It only indicates that the device passed.

Biocompatibility Tests:

2. Sample size used for the test set and the data provenance
The document does not specify the sample sizes used for the described physical and biological performance tests. It also does not discuss data provenance (e.g., country of origin, retrospective/prospective) as these are non-clinical, in-vitro/bench tests on device components, not clinical data sets.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable. The "ground truth" for this medical device submission is based on engineering specifications, physical/chemical properties, and biological safety standards (ISO standards). It does not involve expert interpretations of medical images or diagnoses that would require human expert consensus.

4. Adjudication method for the test set
This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for diagnostic accuracy, where there's a need to resolve discrepancies between human readers or between AI and human reads. This document describes bench testing and biocompatibility assessments which do not involve this type of adjudication.

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
This question is not applicable. This submission is for a physical medical device (catheter) and does not involve AI or human readers for diagnostic purposes. Therefore, an MRMC study and effects on human reader performance are irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. This device is a physical medical catheter, not an algorithm.

7. The type of ground truth used
The "ground truth" for this device's acceptance is based on:

• Engineering design specifications: The physical dimensions and properties of the dilator and catheter.
• Industry Standards (ISO/BS EN ISO): Established international and national standards for medical devices, specifically for intravascular catheters, luer connectors, and biocompatibility.
• Bard internal standards and procedures: Proprietary testing methods and acceptance criteria used by the manufacturer.

8. The sample size for the training set
This question is not applicable. This is not an AI/machine learning device, so there is no concept of a "training set."

9. How the ground truth for the training set was established
This question is not applicable for the same reason as point 8.

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The PowerMidline™ Catheters are indicated for short term access to the peripheral venous system for selected intravenous therapies, blood sampling, and power injection of contrast may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of the procedure. The PowerMidline™ Catheters are suitable for use with power injectors.

The dual lumen PowerMidline™ catheters are a family of peripherally placed catheters made from radiopaque body-softening polyurethane materials. Each dual lumen PowerMidline™ catheter is designed with kink-resistant, reverse taper design. The dual lumen PowerMidline™ catheters are offered in a 4 F dual lumen (DL) and 5 F dual lumen (DL) configuration for reliable short term (less than 30 days) vascular access. These catheters are offered in 20 cm trimmable lengths. The dual lumen PowerMidline™ catheters are suitable for use with power injectors.

This document is a 510(k) summary for the PowerMidline Catheter (K162900) by Bard Access Systems, Inc. It describes the device, its intended use, indications for use, and a comparison to its predicate device (K153393). The document primarily focuses on demonstrating substantial equivalence to a previously cleared device, rather than defining and proving new acceptance criteria for an innovative device feature or algorithm.

Therefore, the requested information about acceptance criteria and a study proving a device-specific, newly established acceptance criteria cannot be fully extracted from this document in the way it's usually applied to a new AI/medical device. The document explicitly states: "The performance tests completed on the subject device were limited to those tests required to support a determination of substantial equivalence to the predicate device." and "when technological characteristics between the subject and predicate device were found to be identical, results of the performance testing conducted on the predicate device were applied to the subject device."

The "acceptance criteria" here are essentially "meets the performance requirements of the predicate device" or "meets the requirements of the specified ISO/FDA guidance documents."

However, I can extract the types of performance tests conducted and the standards/guidances used, which implicitly define what was considered acceptable performance.

1. Table of Acceptance Criteria and Reported Device Performance

Instead of explicit numerical acceptance criteria, the document states that the device "met all predetermined acceptance criteria" derived from various performance tests. The "reported device performance" is the confirmation that these implicit criteria were met, leading to a determination of substantial equivalence.

• 4 F DL = 4 mL/s
• 5 F DL = 7 mL/s
  (as implied by the statement "the subject device met all predetermined acceptance criteria" and the values provided in the comparison table.) |
  | Biocompatibility: The device materials must be biocompatible as per ISO 10993-1:2009. (Implicit criterion: The device must not cause adverse biological reactions when in contact with the body). | "Per ISO 10993-1:2009, Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process, a biocompatibility evaluation was performed based upon the modifications made to develop the subject device." - Met. |
  | Risk Management: The device must comply with risk management procedures as per BS EN ISO 14971:2012. (Implicit criterion: Identified risks must be acceptably managed and mitigated). | "Risk management, including a failure modes and effects analysis (FMEA), of the subject device was conducted in accordance with BS EN ISO 14971:2012, Medical Devices – Application of Risk Management to Medical Devices." - Met. |

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

The document does not specify an exact "sample size" for the performance tests in terms of number of catheters tested for each criterion. It simply states that "performance tests completed on the subject device were limited to those tests required to support a determination of substantial equivalence."

• Sample Size: Not explicitly stated as a numerical count for each test. The tests were performed on "the subject device" which includes 4 F DL and 5 F DL configurations.
• Data Provenance: The tests were conducted internally by Bard Access Systems, Inc. ("BAS Internal Protocols/Procedures"). This implies the data is prospective in nature, generated specifically for this submission, rather than retrospective clinical data. The country of origin is implicitly the USA, where the manufacturer is located.

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

Not applicable in the context of this device. This is a physical medical device (catheter), and the "ground truth" for its performance is established through objective engineering and biological performance testing against recognized standards (ISO, FDA guidance). There is no "ground truth" derived from expert interpretation of data in the way one would for an AI diagnostic algorithm.

4. Adjudication Method for the Test Set

Not applicable. This concept is relevant for studies involving human interpretation or clinical outcomes where discrepancies need to be resolved. Performance testing of a physical device against standards does not typically involve adjudication in this sense. The acceptance relies on the measured performance meeting the predefined (or implicitly defined by the standard) thresholds.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a physical medical device (catheter), not an AI algorithm intended for interpretation by human readers. Therefore, an MRMC study and analysis of human reader improvement with AI assistance is not relevant.

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 (expert consensus, pathology, outcomes data, etc.)

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

• Compliance with recognized international standards (e.g., ISO 10555-1:2013, ISO 10993-1:2009, BS EN ISO 14971:2012).
• Compliance with FDA Guidance documents (e.g., "Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, March 16, 1995").
• Internal protocols and procedures developed by the manufacturer, which would be designed to ensure the device meets its design specifications and is safe and effective for its intended use.

Essentially, the "ground truth" is adherence to established engineering, materials, and biological performance specifications and regulatory requirements.

8. The sample size for the training set

Not applicable. This is a physical device submission; there is no "training set" in the context of machine learning or AI models. The design and manufacturing processes are analogous to a training process, leading to the final device design.

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

Not applicable. As there is no training set in the AI sense, there is no ground truth establishment for it. The development of the device's design (analogous to "training") is guided by medical necessity, engineering principles, material science, regulatory requirements, and feedback from previous predicate devices. The "ground truth" for the predicate device would have been its demonstrated safety and effectiveness in previous clearances.

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