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The Power Acute Triple Lumen Hemodialysis Catheter is indicated for short term central venous access for hemodialysis, apheresis, infusion, central venous pressure monitoring and pressure injection of contrast media. The maximum recommended infusion rate is 5 mL/sec for power injection of contrast media.

The Power Acute Triple Lumen Hemodialysis Catheter is manufactured from a thermally reactive polyurethane material known for its rigidity at room temperature and softness at body temperature. This reactivity allows bedside insertion, while minimizing the risk of vein perforation and providing an overall improvement of patient comfort after insertion. The catheter cannula is radiopaque and incrementally marked to indicate the effective insertion length of the device in centimeters (cm). This cannula is extruded with three independent, non-communicating inner lumens. The lumens are made accessible within the cannula via luer-fitted silicone extension legs on the proximal end of the device, alongside a rigid polyurethane hub marked with the catheter's size in French (Fr) and effective insertion length that is fitted with a freely rotating suture wing. The clear outer extension legs are fitted with red and blue occlusion clamps, which are marked on either face with the lumen's priming volume in milliliters (mL), and respectively identify arterial and venous lumens. The medial, colored, extension leg is fitted with a purple occlusion clamp that is similarly marked with priming volume on its dorsal face, and marked with the maximum flow rate (in cubic centimeters [cc]) and injection pressure (in pounds per square inch [psi]) recommended for power-injected fluids on its ventral face. The distal end of the device is thermally bonded to a flexible, symmetrically tapered tip, which allows for direct outflow, and is skived on the radial and ulnar sides of the cannula.

The provided text is a 510(k) Premarket Notification Submission for a medical device: the "Power Acute Triple Lumen Hemodialysis Catheter." This document is primarily focused on demonstrating "substantial equivalence" of the new device to existing predicate devices, rather than proving the device meets specific acceptance criteria through a clinical study or a study directly assessing AI performance.

Therefore, many of the specific details requested in your prompt regarding acceptance criteria, AI performance, ground truth establishment, expert adjudication, and MRMC studies are not available in this document because it describes a traditional medical device submission, not an AI/ML-enabled medical device submission.

However, I can extract information related to the device's performance testing and validation as described for a non-AI/ML device.

Here's an analysis based on the provided text, addressing what can be found and noting what is not applicable/present:

Acceptance Criteria and Study for Power Acute Triple Lumen Hemodialysis Catheter

This submission pertains to a traditional medical device (hemodialysis catheter), not an AI/ML-enabled device. As such, the "acceptance criteria" discussed are primarily related to general device performance and safety benchmarks, rather than specific AI performance metrics like sensitivity, specificity, or AUC, or human reader improvement with AI assistance. The "study" refers to bench testing and biocompatibility testing to ensure the device performs as intended and is safe.

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

The document lists various tests performed to ensure the device's safety and performance, demonstrating "substantial equivalence" to a predicate device. The acceptance criteria are implicitly the successful completion of these tests in accordance with recognized standards, showing that the new device performs comparably to or better than the predicate. The "reported device performance" is that it "met the minimum requirements" for these tests.

2. Sample size used for the test set and the data provenance

The document describes bench testing and biocompatibility testing. This type of data does not typically involve a "test set" in the context of patient data for AI model validation. The sample sizes for these engineering and biological tests (e.g., number of catheters tested for flow rate, number of samples for chemical tolerance) are not specified in this summary document.

• Data Provenance: Not applicable in the sense of country of origin for clinical data. The tests are laboratory-based and conducted on the manufactured device.
• Retrospective or Prospective: Not applicable for bench/biocompatibility testing.

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

This is not applicable as the document describes a traditional medical device, not an AI/ML device relying on expert-established ground truth from medical images or clinical data. Ground truth for these tests is established by standardized measurements and laboratory methods (e.g., measuring flow rates, observing material reactions).

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

Not applicable. This concept applies to human expert review of medical data, typically for AI model validation, not for the engineering and biocompatibility testing described.

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 is not applicable. This document describes a traditional hemodialysis catheter, not an AI-assisted device. Therefore, no MRMC study, human reader improvement, or AI effect size would be relevant or performed.

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

No. This is not applicable. There is no algorithm mentioned in this device submission.

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

The "ground truth" for the device's performance is established by physical and chemical measurements conducted according to internationally recognized standards (e.g., ISO standards) and FDA-recognized consensus standards. This includes:

• Measured flow rates
• Measured burst pressures
• Observational results of material integrity (kinking, clamping)
• Biological reactions in biocompatibility tests (e.g., cell culture, animal studies for toxicity, hemolysis)

8. The sample size for the training set

Not applicable. This document describes the testing of a physical medical device, not an AI/ML model that requires a "training set" of data.

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

Not applicable. As there is no training set mentioned, there is no ground truth establishment for it.

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The Acute Dual Lumen Hemodialysis Catheter is indicated for short-term central venous access for hemodialysis, apheresis, and infusion.

The Acute Dual Lumen Hemodialysis Catheter is manufactured from thermal reactive polyurethane material known for its rigidity at room temperature which allows bedside insertion, and softness at body temperature minimizing the risk of vein perforation and improving patient comfort after insertion. The catheter shaft is made of radiopaque polyurethane with two independent, non-communicating inner lumens, where the distal end of the catheter, with arranged outflow eyelets, extends to a symmetrical tip configuration. The proximal end of the catheter shaft joins to a polyurethane hub assembly having each inner lumen connected to individual extension tubes. The extension tubes are made of silicone material and are identified by color coded occlusion clamps. The red clamp identifies the lumen which provides "arterial" outflow from the patient, the blue clamp identifies the lumen which provides "venous" inflow return when used for hemodialysis, apheresis and infusion. Lumen priming volume is printed on each ID tag clamp insert, and catheter size and length are printed in the hub. Centimeter markings are placed along the length of the indwelling portion of the catheter body to facilitate proper positioning.

Here's a breakdown of the acceptance criteria and study information for the Acute Dual Lumen Hemodialysis Catheter, based on the provided document:

1. Table of Acceptance Criteria and the Reported Device Performance:

The document lists various performance characteristics that were tested. While specific numerical acceptance criteria (e.g., "flow rate must be > X mL/min") are not explicitly detailed in the summary, the general statement indicates the device "met the minimum requirements that are considered adequate for its intended use." This implies that for each test, there was an established benchmark or range that the device successfully achieved.

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

The document does not specify the exact sample sizes used for each individual performance test (e.g., how many catheters were tested for flow rate or tensile strength). It only states that "Bench testing was conducted."

Regarding data provenance:

• Country of Origin: Not specified.
• Retrospective or Prospective: The testing described is prospective, as it involves the evaluation of the subject device's performance before market approval.

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

This information is not provided in the document. The document describes bench testing and biocompatibility testing against established standards (FDA recognized standards, ISO standards), rather than studies involving human experts establishing "ground truth" on clinical cases. The "ground truth" here is the adherence to these engineering and biocompatibility standards.

4. Adjudication Method for the Test Set:

This is not applicable as the described testing does not involve human expert adjudication of clinical cases. The "adjudication" is essentially the determination by a testing facility or qualified personnel that the device either passed or failed the specified test criteria based on the relevant standard.

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 MRMC comparative effectiveness study was mentioned. The device is a physical medical device (catheter), not an AI algorithm or a diagnostic tool that would typically involve human readers.

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

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

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the performance evaluation of this medical device is based on established engineering standards, international standards (ISO), and regulatory requirements for the safety and performance of such devices. For example:

• Bench Testing: Engineering specifications and performance limits for properties like flow rate, tensile strength, leakage, etc.
• Biocompatibility Testing: Standards outlined in ISO 10993-1, which define acceptable levels of biological response to medical devices.
• Sterilization and Shelf Life: Standards like ISO 11135 and ISO 11607-1.

8. The Sample Size for the Training Set:

Not applicable. This document describes the evaluation of a physical medical device, not a machine learning algorithm that would have a "training set."

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

Not applicable. As above, no training set is relevant for this type of device submission.

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The HEALTH LINE CT MIDLINE CATHETER is indicated for short term (less than 30 days) access to the peripheral venous system for infusion, intravenous therapy and blood sampling. The HEALTH LINE CT MIDLINE CATHETER is suitable for use with power injectors.

The HEALTH LINE CT MIDLINE CATHETER is a family of peripherally inserted peripheral catheters made from specially formulated biocompatible medical grade materials. Catheters are packaged in a tray with accessories necessary for a percutaneous micro introducer introduction (Modified Seldinger or Seldinger technique). The device is intended for short term (less than 30days) vascular access.

The HEALTH LINE CT MIDLINE CATHETER is indicated for dwell times shorter than 30 days. The HEALTH LINE CT MIDLINE CATHETER product line will have catheters in 3Fr, 4 Fr and 5 Fr single lumen, and 4 Fr and 5 Fr dual lumen. The HEALTH LINE CT MIDLINE CATHETER's are supplied in two lengths, approximately 10 and 20 cm long. All catheters are attached to an injectionmolded polyurethane hub that has extension legs with Luer lock fittings for access attachment.

This document is a 510(k) summary for the Health Line CT Midline Catheter (K200263). The core argument for its substantial equivalence relies on its technological identity to a predicate device, the NEXUS MIDLINE CT CATHETER (K140270). Therefore, the "acceptance criteria" here refers to the equivalence to the predicate device, especially in performance, rather than a separate set of numerical thresholds for a new, independent study.

Here's a breakdown of the requested information based on the provided text:

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

The acceptance criterion for this device is substantial equivalence to the predicate device (NEXUS MIDLINE CT CATHETER, K140270). The "reported device performance" is the claim of identity or sameness with the predicate device for all critical performance aspects.

The document states changes only include a name change, added priming instructions in the IFU, and a catheter trim tool in the kit, none of which impact the core functional characteristics used for demonstrating substantial equivalence to the predicate product.

2. Sample size used for the test set and the data provenance

This FDA 510(k) summary does not describe a specific "test set" in the context of an AI/algorithm performance study. Instead, it relies on the "technological identity" of the new device to an already cleared predicate device.

Therefore:

• Sample size for test set: Not applicable, as there was no independent clinical/performance test set for this device beyond demonstrating it is identical to the predicate. Performance data was "leveraged from the predicate device."
• Data provenance: Not applicable in the context of a new test set. The provenance of the predicate device's data would be from its original clearance. The changes made to this device were assessed through a risk analysis, which found "no risks... identified with these changes."

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

Not applicable. This is not a study involving expert-established ground truth for an AI/algorithm-based diagnostic device. It's a medical device clearance based on substantial equivalence to an existing device.

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

Not applicable. No test set requiring adjudication was performed as this is a substantial equivalence submission for a physical medical catheter, not an AI/diagnostic algorithm.

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-assisted diagnostic device.

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

Not applicable. This is a physical medical device (catheter), not an algorithm.

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

Not applicable. The "ground truth" for this submission is the established performance and safety of the legally marketed predicate device (NEXUS MIDLINE CT CATHETER, K140270), to which the new device is claimed to be technologically identical. The assessment relies on a comparison of specifications, materials, and intended uses.

8. The sample size for the training set

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

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

Not applicable.

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The HEALTH LINE CT CVC is indicated for short term (less than 30 days) access to the central venous system for intravenous administration of fluids, medications, blood products, and/or nutritional therapy solutions when prescribed. Blood sampling and power injection of contrast media may also be conducted with the HEALTH LINE CT CVC.

The HEALTH LINE CT CVC is a family of central venous catheters designed to perform infusion, intravenous therapy, blood sampling and also power injection of contrast media studies. The catheters, made of radiopaque polyurethane tubing, are inserted in a central vein. Each HEALTH LINE CT CVC has a kink resistant, gradual tapered catheter design. The HEALTH LINE CT CVC kit includes a catheter and introduction components. The catheter is supplied sterile and nonpyrogenic in a variety of kit configurations.

The HEALTH LINE CT CVC is indicated for dwell times shorter than 30 days. The HEALTH LINE CT CVC catheter assemblies have been tested to withstand power injection of worst-case viscosity injection media at 5 ml/sec with a maximum power injector pressure of 300 psi.

The HEALTH LINE CT CVC product line has catheters in 16 G and 14 G single lumen, 5 Fr and 7 Fr dual lumen and 7 Fr triple lumen. Catheters range from approximately 13-30 cm long. The catheters are attached to an injection-molded polyurethane hub that has extension legs with Luer lock fittings for access attachment. All HEALTH LINE CT CVC products have a maximum recommended infusion rating is 5 ml/sec. The maximum pressure or pounds per square inch (psi) of the power injector utilized should not exceed 300 psi.

The provided text describes a 510(k) summary for the "Health Line CT CVC" device. This device is a central venous catheter (CVC).

Important Note: The document states that the device is identical to the predicate device (Orion™ II CT CVC, K113622) in its final finished form, with only minor changes to labeling, instructions for use, and the addition of an optional suture wing component. These changes are explicitly stated to not impact the performance or safety and effectiveness of the device compared to the predicate. Therefore, the "study that proves the device meets the acceptance criteria" for this specific 510(k) is primarily based on the demonstration of substantial equivalence to the legally marketed predicate device, leveraging the predicate's existing performance and biocompatibility data.

This is not a typical AI/ML-based device submission that would involve ground truth establishment, reader studies, or detailed algorithm performance metrics. Instead, it's a traditional medical device submission relying on established equivalence principles.

Given this context, I will address the requested points, noting where the information is not applicable due to the nature of this 510(k) submission for a non-AI/ML device.

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

Since this is a substantial equivalence submission for a physical device, the "acceptance criteria" are primarily met through demonstrating equivalence to the predicate device and compliance with relevant standards. The performance is demonstrated through in vitro testing and biocompatibility.

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The ARTLINE Device is intended to permit access to the peripheral arterial circulation system for short term access (less than 30 days).

The ARTLINE is a single lumen peripherally inserted catheter device designed to perform short term access to the peripheral arterial circulatory system for less than 30 days. The catheter, made of radiopaque polyurethane tubing, echogenic needle, guidewire with slide advancer. Each ARTLINE has a kink resistant catheter design. The catheter is inserted over the needle into the peripheral arterial vessel, the guide wire is advanced and the catheter is threaded over the guide wire. The catheter is supplied sterile and non-pyrogenic. The ARTLINE is indicated for dwell times shorter than 30 days. The ARTLINE is a 20ga single lumen catheter. The catheter is approximately 4.45 cm long. The catheters are attached to an injectionmolded polyurethane hub with Luer lock fittings for access attachment.

The provided document is a 510(k) premarket notification for a medical device called ARTLINE, a percutaneous catheter. It describes the device, its intended use, and a comparison to a predicate device. The document also lists performance tests conducted.

Here's the breakdown of the information requested, based on the provided text:

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

The document states, "The ARTLINE met all established acceptance criteria for performance testing and design verification testing." However, the specific numerical acceptance criteria for each test are not provided in this document. Only the types of tests performed are listed. Therefore, a complete table with criteria and performance cannot be generated from the given text.

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

The document does not specify the sample size used for the performance tests, nor does it provide information about the data provenance (country of origin, retrospective or prospective nature).

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)

This information is not provided in the document. The performance tests described are engineering/material tests, not clinical studies requiring expert ground truth establishment in the medical sense.

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

This information is not provided in the document. As these are physical performance tests, an adjudication method for "ground truth" in a clinical context is 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

The document does not mention an MRMC comparative effectiveness study, nor does it refer to any AI assistance. The ARTLINE is a physical medical device (catheter), not an AI-powered diagnostic tool.

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

This is not applicable as the ARTLINE is a physical medical device, not an algorithm.

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

For the performance tests listed, the "ground truth" would be established by engineering and industry standards for medical device components and materials (e.g., ISO standards for conical fittings, established methods for tensile strength or flow rate measurement). The document implies adherence to these standards by stating "met all established acceptance criteria." However, it does not detail which specific standards were used as the "ground truth."

8. The sample size for the training set

This is not applicable. The ARTLINE is a physical medical device, not a machine learning algorithm that requires a training set.

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

This is not applicable for the same reason as point 8.

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The NEXUS™ MIDLINE CT CATHETER is indicated for short term (less than 30 days) peripheral access to the peripheral venous system for infusion, intravenous therapy and blood sampling. The NEXUS™ MIDLINE CT CATHETER is suitable for use with power injectors.

The NEXUS™ MIDLINE CT Catheter is a family of peripherally inserted central catheters made from specially formulated biocompatible medical grade materials. Catheters are packaged in a tray with accessories necessary for a percutaneous microintroducer introduction (Modified Seldinger or Seldinger technique). The device is intended for short term (less than 30days) vascular access. The NEXUS™ MIDLINE CT Catheter is indicated for dwell times shorter than 30 days. The NEXUS™ MIDLINE CT Catheter product line will have catheters in 3Fr, 4 Fr and 5 Fr single lumen, and 4 Fr and 5 Fr dual lumen. The NEXUS™ MIDLINE CT Catheters are supplied in two lengths, approximately 10 and 20 cm long. All catheters are attached to an injectionmolded polyurethane hub that has extension legs with Luer lock fittings for access attachment.

The provided text describes the Nexus Midline CT Catheter and its substantial equivalence to predicate devices, but it does not contain details of a clinical study or a multi-reader multi-case (MRMC) comparative effectiveness study. The information focuses on non-clinical bench testing to demonstrate performance and substantial equivalence.

Here's an analysis based on the provided text, addressing the points where information is available and indicating where it is not:

1. Table of Acceptance Criteria and Reported Device Performance

The document mentions that various bench tests "met predefined acceptance criteria" and "demonstrated equivalence." However, it does not provide the specific numerical acceptance criteria or the numerical reported device performance for each test. It only lists the tests performed and states they were successful.

A qualitative summary of the performance claims based on the text:

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: The document does not specify the sample size for any of the bench tests (e.g., number of catheters tested for tensile strength, burst pressure, etc.).
• Data Provenance: The data is described as "Nonclinical tests" and "bench test data" performed for "design verification testing." This suggests it's laboratory-based testing of the device itself, not data from human subjects or clinical settings. There is no mention of country of origin as it pertains to clinical data, as this is bench testing. The data is not described as retrospective or prospective clinical data.

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 as the document describes non-clinical bench testing. There is no mention of human experts being involved in establishing "ground truth" for these engineering and material performance tests. The "ground truth" for such tests would typically be defined by engineering specifications and direct physical measurements.

4. Adjudication method for the test set

This question is not applicable as the document describes non-clinical bench testing. Adjudication methods like 2+1 or 3+1 typically refer to expert consensus in interpreting images or clinical outcomes, which is not relevant here.

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 MRMC comparative effectiveness study was done or mentioned. The submission describes non-clinical bench testing for a physical medical device (catheter), not an AI algorithm or a diagnostic tool that would involve human readers.

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

No standalone algorithm performance study was done or mentioned. The device is a physical catheter, not a software algorithm.

7. The type of ground truth used

For the non-clinical bench testing, the "ground truth" refers to engineering specifications, direct physical measurements, and adherence to relevant international standards (e.g., ISO 11135:2007 for sterilization, ISO-10993 for biocompatibility). The document states that testing was performed "according to protocols based on the above-referenced guidance document recommendations and additional standards."

8. The sample size for the training set

This question is not applicable as the document describes non-clinical bench testing for a physical medical device. There is no mention of a "training set" in the context of an algorithm.

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 CASCADE™ Hemodialysis/Apheresis Catheter is intended for use in attaining long-term vascular access for Hemodialysis therapy and Apheresis. It may be inserted percutaneously and is primarily placed in the internal jugular vein. Alternate insertion sites include the subclavian vein and femoral vein, as required.

Indications For Use:

• The CASCADE™ Hemodialysis/Apheresis Catheter is indicated for use in attaining . Long-Term (greater than 30 days) vascular access for Hemodialysis therapy and Apheresis.
• It may be inserted percutaneously and is primarily placed in the internal jugular vein ● of an adult patient.
• Alternate insertion sites include subclavian vein as required. .
• Catheters greater than 40 cm are intended for femoral vein insertion. .
• . The curved CASCADE™ Hemodialysis/Apheresis Catheter is intended for internal jugular vein insertion.

The CASCADE™ Hemodialysis/Apheresis Catheter is a family of percutaneously inserted catheters designed to perform Hemodialysis therapy and Apheresis. The catheters are manufactured from medical grade radiopaque silicone material, which provides increased patient comfort while offering excellent biocompatibility. The CASCADE™ Hemodialysis/Apheresis Catheter Kit includes a catheter and introduction components. The catheter is supplied sterile and non-pyrogenic in a variety of kit configurations.

The CASCADE™ Hemodialysis/Apheresis Catheter is indicated for dwell times greater than 30 days. The CASCADE™ Hemodialysis/Apheresis Catheter product line has catheters in 12.5 Fr dual lumen sizes. Catheters range from approximately 13 - 55 cm long and are offered in straight or curved catheter configurations with cuffs for long-term implantation. The catheters are attached to an injection-molded silicone hub that has a suture wing and extension legs with Luer lock fittings for access attachment.

The provided text describes a 510(k) premarket notification for the CASCADE™ Hemodialysis/Apheresis Catheter. This document focuses on demonstrating substantial equivalence to a predicate device for this medical device. It does not contain information about an AI/algorithm-driven device, nor does it detail a study proving the device meets acceptance criteria related to AI performance, human reader improvement with AI, or standalone AI performance.

Therefore, I cannot fulfill most of your request regarding AI-specific criteria and studies.

However, I can extract information related to the device itself and its regulatory approval process, which includes mentions of acceptance criteria as they relate to the substantial equivalence determination for a medical device.

Here's what I can provide based on the given text:

Acceptance Criteria and Device Performance (as related to substantial equivalence for a medical device, not AI):

The following points cannot be addressed as the provided text is for a physical medical device (catheter) and does not involve AI or algorithms:

• Sample size used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts
• Adjudication method for the test set
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
• The sample size for the training set
• How the ground truth for the training set was established

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The UNI-PICC™ is intended to be used by medical professionals for short-term or long-term peripheral access to the central venous system for infusion, intravenous therapy and for blood sampling.

The UNI-PICC™ Peripherally Inserted Central Catheter is indicated for short or long term access to the central venous system for intravenous administration of fluids, medications and/or nutritional therapy when prescribed. Blood sampling may also be conducted with UNI-PICC™.

The 3F UNI-PICC™ Peripherally inserted Central Catheter is indicated for short or long term access to the central venous system via peripheral insertion in neonates, infants and children. It may be used for administration of fluids, medications and/or nutritional therapy when prescribed.

The UNI-PICC™ is a family of peripherally inserted central venous catheters designed to perform infusion, intravenous therapy and blood sampling. The catheters, made of radiopaque polyurethane tubing, are inserted peripherally. Each UNI-PICC™ has a kink resistant catheter design. The UNI-PICC™ kit includes a catheter and introduction components. The catheter is supplied sterile and non-pyrogenic in a variety of kit configurations.

The UNI-PICC™ is indicated for dwell times shorter or greater than 30 days. The UNI-PICC™ product line has catheters in 3Fr, 4 Fr and 5 Fr single lumen, 4 Fr, 5 Fr and 6 Fr dual lumen and 5 Fr and 6 Fr triple lumen. All catheters range from approximately 30 - 60 cm long. The catheters are attached to an injection-molded polyurethane hub that has extension legs with Luer lock fittings for access attachment.

The provided 510(k) summary for the UNI-PICC™ focuses on demonstrating substantial equivalence to predicate devices, primarily through technological comparison and performance testing that adheres to established guidance documents and standards. It does not detail specific acceptance criteria in quantitative terms nor the performance of a device against such criteria in a tabular format as you've requested for typical AI/ML medical devices.

Instead, the submission states:
"The UNI-PICC™ met all established acceptance criteria for performance testing and design verification testing. This testing demonstrated that the UNI-PICC™ is safe and effective for its intended use, and based on FDA's decision tree is substantially equivalent to the SYNERGY™ CT PICC (K101329), 2.6F Vascu-PICC® (K102966) and Vascu-PICC® and Midline Catheters, Single, Double and Triple Lumen (K091586)."

The study described is a design verification testing based on FDA guidance and international standards, aiming to show that the UNI-PICC™ performs comparably to pre-existing, legally marketed predicate devices.

Given the nature of the information provided in the K130034 submission, I cannot create the requested table of acceptance criteria and reported device performance with quantitative metrics. The document confirms that all established acceptance criteria were met, but it does not list them or the specific performance values achieved.

Furthermore, this submission describes a traditional medical device (a catheter), not an AI/ML powered device. Therefore, questions related to test set sample size, data provenance, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, and training set details are not applicable to this document.

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The ORION™ II CT CVC is intended to be used by medical professionals for short-term access to the central venous system for infusion, intravenous therapy, blood sampling and for power injection of contrast media. All ORION™ II CT CVC products have a maximum · recommended infusion rating of 5 ml/sec.

The ORION™ II CT CVC is indicated for short term (less than 30 days) access to the central venous system for intravenous administration of fluids, medications, blood products, and/or nutritional therapy solutions when prescribed. Blood sampling and power injection of contrast media may also be conducted with the ORION™ III CT CVC.

The ORION™ II CT CVC is a family of central venous catheters designed to perform infusion, intravenous therapy, blood sampling and also power injection of contrast media studies, The catheters, made of radiopaque polyurethane tubing, are inserted in a central vein. Each ORION™ II CT CVC has a kink resistant, gradual tapered catheter design. The ORION™ II CT CVC kit includes a catheter and introduction components. The catheter is supplied sterile and non-pyrogenic in a variety of kit configurations.

The ORION™ II CT CVC is indicated for dwell times shorter than 30 days. The ORION™ II CT CVC catheter assemblies have been tested to withstand power injection of worst-case viscosity injection media at 5 ml/sec with a maximum power injector pressure of 300 psi.

The ORION™ II CT CVC product line has catheters in 16 G single lumen, 5 Fr and 7 Fr dual lumen and 7 Fr triple lumen. Catheters range from approximately 13-30 cm long. The catheters are attached to an injection-molded polyurethane hub that has extension legs with Luer lock fittings for access attachment. All ORION™ II CT CVC products have a maximum recommended infusion rating is 5 ml/sec. The maximum pressure or pounds per square inch (psi) of the power injector utilized should not exceed 300 psi.

The provided text describes the 510(k) Premarket Notification Submission for the ORION™ II CT CVC. It details the device, its intended use, a technological comparison to a predicate device, and the conclusion regarding its safety and effectiveness.

However, the document does not contain specific acceptance criteria in a tabular format, nor does it provide a detailed study report with performance metrics like sensitivity, specificity, or AUC, or information about sample sizes for test and training sets, data provenance, number or qualifications of experts, adjudication methods, or MRMC study results (which are typically relevant for AI/radiology devices).

The document is for a Central Venous Catheter (CVC), which is a medical device for infusion, not an AI or imaging device with performance metrics related to diagnostic accuracy. Therefore, many of the requested points, particularly those related to a multi-reader multi-case study, ground truth establishment for AI, and advanced performance metrics, are not applicable to this type of submission.

Based on the provided information, I can extract the following:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that "The ORION™ II CT CVC met all established acceptance criteria for performance testing and design verification testing." However, the specific numerical acceptance criteria are not detailed in the provided text. The performance reported is in terms of the device's ability to withstand certain conditions.

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

• Sample size: Not specified in the provided text. The document refers to "Verification testing" and "design verification testing" being performed but does not state the number of devices tested.
• Data provenance: Not applicable in the context of clinical data for a diagnostic device. The testing conducted would be bench testing/engineering verification, not clinical data from patients.

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

• Not applicable. This device is a catheter, not a diagnostic imaging device that requires expert-established ground truth for a test set. Ground truth would relate to physical and chemical properties and performance under stress, established by engineering and quality assurance standards.

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

• Not applicable. Adjudication methods are typically used in clinical studies for diagnostic accuracy, not for performance testing of a catheter.

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-assisted diagnostic device.

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

• Not applicable. This is not an algorithm.

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

• For this device, "ground truth" would be established by objective measurements and scientific standards in engineering and materials testing. For example, pressure measurements, flow rates, material composition analysis, and sterility testing according to established international standards (ISO). The document references:
  • FDA's Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, dated 3/16/95.
  • ISO 11135-1:2007 for Sterilization.
  • ISO-10993, Part 1 for Biocompatibility.

8. The sample size for the training set:

• Not applicable. This is not a machine learning or AI-based device that requires a training set.

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

• Not applicable.

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The HLIC Needle-Less Valve is intended to allow access to IV administration sets, medication vials, blood donor collection bags, and solution bags with one convenient device without the use of needles or blunt cannulas.

The HLIC Needle-Less Valve is a needle free valve that allows the user to add medication into IV sets without the use of a needle. When the valve is in the closed position, it has a flat, smooth surface for cleaning. When the male connector of a syringe or secondary line is pushed into the valve, the silicone stem opens in the middle creating a fluid path. When the male connector is removed from the valve, the body of the valve forces the stem shut and maintains a sealed fluid path. A cap is not required to seal the valve or to maintain sterility.

The provided text describes a 510(k) Premarket Notification for the HLIC Needle-Less Valve, a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting new clinical studies to establish diagnostic performance against specific acceptance criteria like those common for AI/ML devices. Therefore, much of the requested information regarding acceptance criteria, study design, ground truth, and expert involvement is not directly applicable to this SSEA (Summary of Safety and Effectiveness Analysis) for a non-diagnostic, non-AI medical device.

However, I can extract the relevant information pertaining to the device's performance testing and the conclusion regarding its safety and effectiveness.

Here's a breakdown based on the provided text, indicating where information is not available or not applicable for this type of device submission:

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

The document states that the device "met all established acceptance criteria for performance testing and design verification testing." While the specific acceptance criteria are not detailed in this public summary, the device passed them.

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