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• The Hemodialysis Catheter is indicated for use in attaining short-term or long-term vascular access for Hemodialysis therapy and apheresis.

• It may be inserted percutaneously and is primarily placed in the internal jugular vein of an patient.
• Alternate insertion sites include subclavian vein as required.
• Catheters greater than 40 cm are intended for femoral vein insertion.
• The curved Hemodialysis Catheter is intended for internal jugular vein insertion.
• 8-10Fr Hemodialysis Catheters can be used in pediatric patients.

The Hemodialysis Catheter is indicated for use in attaining vascular access for Hemodialysis and Apheresis therapy. The catheter tubing is made of radiopaque polyurethane with a dual D cross-sectional design, providing independent arterial and venous lumens. The proximal end of the catheter features two luer connectors. The luer connectors are connected to extension legs. The extension legs are made of silicone material. Each extension leg has a catheter clamp, which is durable and can effectively ensure timely closure of the extension leg. The lumen with the red catheter clamp, which is called arterial lumen, is used for blood outflow; The lumen with the blue catheter clamp, which is called venous lumen, is used for blood return. The arterial and venous lumen priming volumes are printed directly on the ID ring of the clamp. Catheters range from approximately 13-55 cm long and are offered in straight or curved catheter configurations with cuff for long-term implantation. The Hemodialysis Catheter is packaged in a tray with legally marketed accessories intended for use during catheter placement. The Hemodialysis Catheter Kit is provided sterile, single use.

The provided FDA 510(k) clearance letter and associated documentation for the Hemodialysis Catheter (K241581) primarily detail the regulatory approval process, comparison to predicate devices, and non-clinical performance testing. It does not contain information about acceptance criteria for device performance based on clinical study data, nor does it describe a study that validates the device performance against such criteria in a clinical setting.

The document specifically states: "Clinical test: Clinical testing is not required." This indicates that the clearance was based on non-clinical performance data and substantial equivalence to legally marketed predicate devices, not on direct clinical evidence of the device's performance in patients.

Therefore, I cannot provide the requested information regarding:

• A table of acceptance criteria and reported device performance from a clinical study.
• Sample sizes used for the test set and data provenance from a clinical study.
• Number of experts used to establish ground truth and their qualifications from a clinical study.
• Adjudication method for a clinical study.
• Multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone (algorithm only without human-in-the-loop performance) study.
• Type of ground truth used in a clinical study.
• Sample size for the training set from a clinical study.
• How ground truth for the training set was established in a clinical study.

The provided document focuses on the following types of performance data, which are non-clinical in nature:

1. Acceptance Criteria and Reported Device Performance (Non-Clinical)

While not presented in a table with specific pass/fail metrics, the document implies that the device met the requirements of the following standards and guidance:

• FDA guidance "Implanted Blood Access Devices for Hemodialysis, issued on January 21, 2016"
• ISO 10555-1:2013 (Sterile, single-use intravascular catheters - Part 1: General requirements)

The following non-clinical tests were performed to demonstrate compliance:

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

• Not Applicable for Clinical Data: The document explicitly states "Clinical testing is not required."
• For Non-Clinical Data: Specific sample sizes for each non-clinical test (e.g., tensile testing, leakage testing) are not detailed in this summary document. Data provenance is implied to be from internal lab testing conducted by Haolang Medical USA Corporation, in compliance with the cited ISO standards and FDA guidance.

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

• Not applicable as clinical testing with expert-established ground truth was not performed or required for this 510(k) clearance.

4. Adjudication Method for the Test Set

• Not applicable as clinical testing with an adjudication method was not performed or required.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• Not applicable. This type of study is typically for AI/imaging device performance evaluation, not for a physical device like a hemodialysis catheter, and certainly not for a clearance that states "Clinical testing is not required."

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

• Not applicable. This is not a software/AI device.

7. The Type of Ground Truth Used

• For Non-Clinical Testing: The "ground truth" for the non-clinical tests is adherence to the specified performance requirements as outlined in the referenced ISO standards (e.g., ISO 10555-1) and FDA guidance documents for hemodialysis catheters (e.g., "Implanted Blood Access Devices for Hemodialysis"). This involves objective, measurable physical, mechanical, and biological properties.

8. The Sample Size for the Training Set

• Not applicable. This refers to training data for AI/ML algorithms, which is not relevant to this device's clearance.

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

• Not applicable.

In summary, the FDA 510(k) clearance for the Hemodialysis Catheter (K241581) was granted based on a substantial equivalence determination supported by comprehensive non-clinical performance testing (physical, mechanical, biocompatibility, sterilization, and shelf-life) against recognized industry standards and FDA guidance, rather than a clinical study with patient data and expert-derived ground truth.

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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 GlidePath™ Retro Long-Term Hemodialysis Catheters are indicated for use in attaining short-term or long-term vascular access for hemodialysis, hemoperfusion or apheresis therapy. Access is attained via the internal jugular vein, subclavian vein, or femoral vein. Catheters longer than 40 cm are intended for femoral vein insertion.

The GlidePath™ Retro Long-Term Hemodialysis Catheter features a dual-lumen polyurethane catheter shaft with optimized double-D cross-sectional design providing separate arterial and venous lumens, an external bifurcation hub with SwiftClick connector assembled by physician upon placement, and arterial and venous extension legs that connect to an external dialysis machine or blood cleansing device. The arterial (red) luer connector secures to the blood intake on the dialysis machine and the venous (blue) luer connector secures to the blood return line on the dialysis machine. Each extension leg has an atraumatic occlusion clamp which closes access to the lumen. The symmetrical catheter tip contains holes that aid in the distribution of blood flow or aid in over-the-guidewire placement. The dialysis catheter is offered in various lengths.

This document describes the GlidePath™ Retro Long-Term Hemodialysis Catheter. It addresses the performance data and comparison to predicate devices, but does not describe a study involving an AI medical device or clinical performance data that would typically include acceptance criteria and reporting on sensitivity, specificity, or other performance metrics for an AI algorithm.

Therefore, I cannot provide the information requested in your prompt regarding AI device acceptance criteria and study details because the provided text is for a traditional medical device (a catheter) and does not contain information about an AI-powered device or its performance study.

The document focuses on demonstrating substantial equivalence of the catheter to a predicate device through non-clinical testing of various physical and functional characteristics.

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The GlidePath™ 13F long-term hemodialysis catheters are indicated for use in attaining short-term or long-term vascular access for hemodialysis, hemoperfusion or apheresis therapy. Access is attained via the internal jugular vein, subclavian vein, or femoral vein. Catheters longer than 34 cm are intended for femoral vein insertion.

The GlidePath™ 13F Long-Term Hemodialysis Catheter is a vascular access device, intended for use in attaining short-term or long-term vascular access for hemodialysis, hemoperfusion or apheresis therapy and features a dual-lumen, optimized double-D cross-sectional catheter shaft with a fixed symmetrical tip design. The catheter has separate arterial and venous lumens, a molded bifurcation and, extending from the bifurcation, arterial (red) luer and venous (blue) luer and extension legs which connect to an external dialysis machine or blood cleansing device. Each extension leg has an atraumatic occlusion clamp which closes access to the lumen. The symmetrical catheter tip contains holes that aid in the distribution of blood flow and aid in overthe-guidewire placement. The GlidePath™ 13F Long-Term Hemodialysis Catheters are packaged in a tray with legally marketed accessories intended for use during catheter placement. The device is intended for single patient use only.

The provided text describes a 510(k) premarket notification for a medical device, the GlidePath™ 13F Long-Term Hemodialysis Catheter. This submission aims to demonstrate substantial equivalence to a legally marketed predicate device, the GlidePath™ Long-Term Hemodialysis Catheter (K190527).

The document details various performance tests conducted to support this claim, but it does not describe a study involving an AI/Machine Learning algorithm or human reader improvement with AI assistance. Therefore, many of the requested items related to AI device performance and clinical studies are not applicable or cannot be answered from the provided text.

The acceptance criteria mentioned are general ("met all predetermined acceptance criteria for design verification activities as specified by applicable standards, guidance, test protocols and/or customer inputs") rather than specific quantitative metrics for an AI model's performance.

Here's an analysis based on the provided text, addressing the applicable points:

Acceptance Criteria and Device Performance

The document states that the device "met all predetermined acceptance criteria for design verification activities as specified by applicable standards, guidance, test protocols and/or customer inputs." However, a specific table of quantitative acceptance criteria and reported numerical performance values is not provided in the text. The performance data section lists the types of tests conducted:

Note: The text explicitly states that "The results from these tests performed in accordance with standards and FDA guidance, demonstrate that the technical characteristics and performance criteria of the GlidePath™ 13F Long-Term Hemodialysis Catheter is substantially equivalent to the predicate..."

Study Details (Applicable to Non-AI Device Testing)

This document describes a submission for a traditional medical device (a catheter), not specifically an AI/Machine Learning device. Therefore, many of the questions related to AI study design (like training/test sets, ground truth establishment for AI, expert consensus for AI interpretation, MRMC studies) are not directly applicable to this premarket notification. The "performance data" refers to physical and functional performance testing of the catheter itself, not diagnostic or clinical accuracy.

1. Sample sizes used for the test set and the data provenance: The document does not specify the number of units tested for each characteristic (e.g., how many catheters were subjected to tensile testing). It also does not discuss "data provenance" in the context of clinical data for an AI model, as this is a physical device.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth in this context would be objective physical measurements or established engineering standards, not expert clinical interpretation.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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, as this is not an AI-powered device under review.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI-powered device under review.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the performance tests listed, the "ground truth" would be the established engineering and medical device standards (e.g., ISO standards, FDA guidance on non-clinical testing) against which the catheter's physical/functional properties were measured.
7. The sample size for the training set: Not applicable, as this is not an AI device that requires a training set.
8. How the ground truth for the training set was established: Not applicable, as this is not an AI device.

In summary, the provided document is a 510(k) premarket notification for a physical medical device (a hemodialysis catheter) and details its engineering and physical performance testing to demonstrate substantial equivalence to a predicate device, rather than the performance of an AI/ML algorithm.

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The Pristine™ Long-Term Hemodialysis Catheters are indicated for use in attaining short-term vascular access for hemodialysis, apheresis and infusion. Access is attained via the internal jugular vein, or femoral vein. Catheters longer than 40 cm implant length are indicated for femoral vein insertion. Catheters may be inserted percutaneously.

The Pristine™ Long-Term Hemodialysis Catheter is a chronic hemodialysis catheter consisting of a dual lumen radiopaque shaft with a pre-formed split tip, which enables long-term vascular access for hemodialysis, apheresis, and infusion. The proximal end of the catheter features two color-coded luer adapters. The luer adapters are connected to clear extension tubes. Each extension tube contains a clamp and is connected to the catheter bifurcation and suture wings (hub). The distal end of the catheter hub is connected to the dual lumen catheter shaft. The shaft contains a cuff and extends to a symmetrical split tip. The design of the catheter's distal tip includes a split, symmetric Y-Tip™ with notches and without side-holes or slots. The symmetric Y-Tip™ design allows a spatial separation between the distal ends of the two lumens. The Pristine™ Long-Term Hemodialysis Catheter is provided as a sterile, single use device, and is sterilized using a validated ethylene oxide process. The dialysis catheters are offered in various implant lengths, varying from 19 cm to 55 cm as depicted below.

Acceptance Criteria and Device Performance Study for Pristine™ Long-Term Hemodialysis Catheter (K203767)

The information provided describes the substantial equivalence determination for the Pristine™ Long-Term Hemodialysis Catheter (K203767) by comparing it to a predicate device, the Pristine™ Hemodialysis Catheter (K182443). The regulatory submission focuses on demonstrating that the new device meets the same performance criteria as the previously cleared predicate device, with additional testing for specific design changes.

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that the subject device met "all of the design verification and validation requirements previously reported for the predicate device. Pristine™ Hemodialysis Catheter (K182443, cleared May 31, 2019)."

For the specific design changes in the subject device, the verification testing was performed to the "exact same acceptance criteria as K182443."

The following table summarizes the acceptance criteria categories mentioned and the general reported performance. Specific numerical acceptance values are not provided in this document but are implied to be identical to those established for the predicate device.

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

The document states: "All samples used for final testing of each product attribute were representative of finished products." However, specific numerical sample sizes for each test are not provided.

The data provenance is implied to be from internal laboratory testing conducted by the manufacturer, C. R. Bard, Inc. The document does not specify country of origin for the data nor explicitly state if it was retrospective or prospective, but given the context of design verification and validation, it would be considered prospective testing of newly manufactured devices.

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

This information is not applicable and not provided in the document. The study described is a device performance verification and validation study against established engineering and performance criteria, not a study involving human interpretation of medical images or expert consensus for ground truth.

4. Adjudication Method for the Test Set:

This information is not applicable and not provided in the document. As this is a physical device performance study, there's no "adjudication" in the sense of reconciling multiple expert opinions. Test results are compared against pre-defined engineering acceptance criteria.

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

No, an MRMC comparative effectiveness study was not done. The document describes a design verification and validation study for a medical device against pre-defined engineering acceptance criteria, not a study evaluating human reader performance with or without AI assistance.

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

No. This document pertains to a physical medical device (catheter), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used:

The "ground truth" in this context is the pre-established engineering and performance specifications and acceptance criteria for the device's physical and functional attributes. These criteria are derived from applicable standards, guidance documents, test protocols, and customer inputs, which would have been established internally by the manufacturer and validated during the predicate device's clearance.

8. The Sample Size for the Training Set:

This information is not applicable and not provided. This is a device performance study, not a machine learning model development or validation study; therefore, there is no "training set."

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

This information is not applicable and not provided. As there is no training set, the establishment of ground truth for it is irrelevant to this document.

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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 GlidePath™ Long-Term Hemodialysis Catheters are indicated for use in attaining short-term vascular access for hemodialysis, hemoperfusion or apheresis therapy. Access is attained via the internal jugular vein, subclavian vein, or femoral vein. Catheters longer than 40cm are intended for femoral vein insertion.

The HemoStar™ and HemoStar™ XK Long-Term Hemodialysis Catheters are indicated for use in attaining short-term or long-term vascular access for hemodialysis, hemoperfusion or apheresis therapy. Access is attained via the internal jugular vein, subclavian vein or femoral vein. Catheters greater than 40 cm are intended for femoral vein insertion.

The GlidePath™, HemoStar™, and HemoStar™ XK Long-Term Hemodialysis Catheters feature a dual-lumen shaft with double-D cross-sectional designs providing separate arterial and venous lumens, a molded bifurcation and, extending from the bifurcation, arterial and venous extension legs that connect to an external dialysis machine or blood cleansing device. The arterial (red) luer connector connects to the blood intake on the dialysis machine and the venous (blue) luer connector connects to the blood return line on the dialysis machine. Each extension leg has an atraumatic occlusion clamp which closes access to the lumen. Long-term dialysis catheters are packaged in a tray with legally marketed accessories intended for use during catheter placement. Both the staggered and symmetrical catheter tips contain holes that aid in the distribution of blood flow or aid in over-the-quidewire placement. The dialysis catheters are offered in various lengths in straight or Alphacurve™ configurations. Alphacurve™ configurations feature a pre-formed, ~225 ° curve. Long-term dialysis catheters are tunneled to provide greater distance between the skin and entry site into the vein and provide a physical barrier to the migration of skin organisms.

The HemoStar™ and HemoStar™ XK Long-Term Dialysis Catheters feature a fixed, staggered distal tip. This tip design is identical to that of the predicate devices, HemoGlide™ Star Series and HemoGlide™ Star Series XK Long-Term Dialysis Catheters, cleared August 12, 2005 under K051748.

The GlidePath™ Long-Term Dialysis Catheters, launched in February 2013, are a modification of the HemoStar™ Long-Term Dialysis Catheters. GlidePath™ catheters feature an optimized catheter shaft extrusion profile and a modified tip which is fixed and symmetrical, allowing for reduced luminal pressure during use. The GlidePath™ catheters also include a preloaded stylet for ease of placement. This accessory was previously cleared under K090101. The changes to the catheter were documented via internal note to file prior to launch in 2013.

The provided text describes the 510(k) summary for the Bard Access Systems' GlidePath, HemoStar, and HemoStar XK Long-Term Hemodialysis Catheters. It details performance testing conducted to demonstrate substantial equivalence to predicate devices, but does not provide specific acceptance criteria values or detailed reported device performance in a table format. It also does not include information on sample sizes for test sets, data provenance, expert involvement for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or training set details as these are not relevant for a medical device clearance focused on physical and fluid dynamics performance instead of AI/software performance.

Therefore, I cannot populate all the requested sections. However, I can summarize the information related to device performance and the study that "proves" the device meets acceptance criteria, based on the provided text.

Acceptance Criteria and Device Performance for GlidePath, HemoStar, and HemoStar XK Long-Term Hemodialysis Catheters

The provided 510(k) summary indicates that the devices underwent a series of bench tests to demonstrate substantial equivalence to predicate devices. The "study" mentioned here refers to these non-clinical bench tests. The report states that the devices met all predetermined acceptance criteria, implying that the performance observed during these tests was within acceptable limits established for each test. However, the specific quantitative acceptance criteria values and the reported device performance measurements are not detailed in this summary document.

1. Table of Acceptance Criteria and Reported Device Performance

Summary of Device Performance:
The document concludes that the subject devices "met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs." This statement indicates that all tests listed above were successfully passed according to their respective acceptance criteria.

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

• Sample Size: Not specified in the provided summary.
• Data Provenance: The tests were "bench tests" performed by Bard Access Systems, Inc. The data is non-clinical. No country of origin is specified, but the company is located in Utah, USA. The data is non-clinical and would be considered prospective in the context of device development and testing, meaning the tests were designed and executed to evaluate the new/modified devices.

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 is not applicable as the study involves bench testing of physical device characteristics, not interpretation of medical images or patient outcomes. The "ground truth" for these tests is established by engineering specifications, recognized standards, and established test protocols.

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

• This is not applicable for bench testing. Test results are typically objective measurements against predefined specifications.

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 is not applicable. The devices are physical hemodialysis catheters, not AI software or diagnostic imaging aids.

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

• This is not applicable. The devices are physical hemodialysis catheters.

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

• For bench testing, the "ground truth" is defined by engineering specifications, recognized industry standards (e.g., ISO, ASTM relevant to medical devices), and internal test protocols that establish the functional and safety requirements for the catheter's physical properties, fluid dynamics, and material integrity.

8. The sample size for the training set:

• This is not applicable. There is no machine learning or AI component to this device.

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

• This is not applicable. There is no machine learning or AI component to this device.

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The Pristine™ Hemodialysis Catheter is indicated for acute and chronic hemodialysis, apheresis and infusion. It may be inserted percutaneously or by cut down. Catheters with greater than 40cm implant length are indicated for femoral placement.

Pristine™ Hemodialysis Catheter is a chronic hemodialysis catheter consisting of a dual lumen radiopaque shaft with a pre-formed split tip, which enables a long-term vascular access for hemodialysis and apheresis. The proximal end of the catheter features two color-coded luer adapters. The luer adapters are connected to clear extension tubes. Each extension tube contains a clamp and is connected to the catheter junction and suture wings (hub). The distal end of the catheter hub is connected to the dual lumen catheter shaft. The shaft contains a cuff and extends to a symmetrical split tip. The design of the catheter's distal tip includes a split, symmetric tip with notches and without side-holes nor slots. The symmetric tip design allows a spatial separation between the distal ends of the two lumens. The Pristine™ Hemodialysis Catheter is packed along with a Tunneler and two sealing caps in a vented blister tray and lid, sealed within a Tyvek pouch. The packed catheter and accessories set is provided as a sterile, single-use device, and is sterilized using a validated ethylene oxide process.

The provided text describes a 510(k) premarket notification for the Pristine™ Hemodialysis Catheter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that the device meets specific acceptance criteria in a clinical study against a defined ground truth.

Therefore, many of the requested points, such as detailed acceptance criteria with reported device performance numbers, sample sizes for test and training sets, expert qualifications, adjudication methods, multi-reader multi-case studies, and standalone algorithm performance, are not applicable or not provided in this type of regulatory document.

However, based on the information given, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "All tests passed and met the predefined acceptance criteria," but it does not provide the specific numerical acceptance criteria or the quantitative reported performance for most of the tests. It only lists the tests performed.

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

• Sample Size for Test Set: Not specified. The document refers to "testing" and "performance data" without detailing the number of devices or components tested for each bench or biocompatibility test.
• Data Provenance: Not explicitly stated as retrospective or prospective clinical data. The tests performed are laboratory/bench tests and biocompatibility studies, not clinical studies on human subjects. The data would be generated in a lab setting.

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

• Not applicable in the context of this document. The "ground truth" for the tests mentioned (biocompatibility, bench testing) is defined by established engineering and biological standards (e.g., ISO, ASTM). These are objective measurements against specified criteria, not subjective expert interpretations that require consensus.

4. Adjudication Method for the Test Set

• Not applicable. As described above, the tests are objective measurements against defined standards, not subjective assessments requiring an adjudication process.

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

• No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices, especially those involving human interpretation of images, to assess the impact of AI on reader performance. The Pristine Hemodialysis Catheter is a physical medical device, not a diagnostic AI system.

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

• No, a standalone performance assessment (in the context of an algorithm) was not done. This device does not involve an algorithm for performance, but rather physical and biological performance characteristics.

7. The Type of Ground Truth Used

• The "ground truth" for the performance data in this submission is based on adherence to international and national standards (e.g., ISO, ASTM, ANSI/AAMI) for medical device performance and biocompatibility. For bench testing, this means meeting predefined engineering specifications and functional requirements. For biocompatibility, it means demonstrating that the materials are safe for biological contact as per established protocols.

8. The Sample Size for the Training Set

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

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

• Not applicable. No training set is used for this type of device submission.

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The Symetrex™ Long Term Hemodialysis Catheter with Sideholes is a symmetric tip dual lumen catheter designed for chronic hemodialysis and apheresis. It may be inserted percutaneously or by cut down. Catheters with greater than 37cm implant length are indicated for femoral placement.

Long term, greater than 30 days, vascular access for Hemodialysis and Apheresis treatments.

The Symetrex™ Long Term Hemodialysis Catheter with Sideholes is a chronic, 15.5 French, dual lumen, radiopaque catheter made of polyurethane. It has a polyester retention cuff and two female luer adapters. The retention cuff promotes tissue ingrowth to anchor the catheter in the subcutaneous tunnel. The luer adapters are identical in color to indicate the reversibility of this catheter. This catheter features symmetrical side channels with a distal tip configuration designed to separate the intake flow from the output flow in both directions.

Here's a breakdown of the acceptance criteria and study information for the Symetrex™ Long Term Hemodialysis Catheter with Sideholes, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily demonstrated through equivalence to the predicate device and compliance with various ISO and ASTM standards. The document doesn't explicitly state quantitative acceptance criteria in all cases, but rather reports the device performance against established standards through "performance testing."

Key performance aspects are outlined in the comparison to the predicate device and in the performance standards section.

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

The document does not specify the sample sizes used for the performance testing (test set) for the device. It also does not provide information on data provenance (e.g., country of origin, retrospective/prospective). The studies mentioned are primarily in vitro (Recirculation) or bench/laboratory testing (physical, mechanical, packaging, luer fittings, biocompatibility).

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

This information is not provided in the document. The studies described are non-clinical, benchtop, and in vitro tests governed by engineering and scientific standards, rather than clinical trials requiring expert-established ground truth in the medical diagnostic sense.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This information is not applicable and therefore not provided in the document. The studies are non-clinical hardware tests.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This document pertains to a physical medical device (catheter), not an AI-powered diagnostic system. Therefore, the concept of "human readers improve with AI" is not relevant here.

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

This information is not applicable as the device is a physical catheter, not an algorithm or AI system.

7. The Type of Ground Truth Used

For the non-clinical performance testing and biocompatibility studies, the "ground truth" is established by:

• Engineering and Scientific Standards: Compliance with relevant ISO and ASTM standards (e.g., ISO 10555-1 for intravascular catheters, ISO 11607-1 for packaging, ISO 594-1/2 for luer fittings, and various ISO 10993 parts for biocompatibility).
• Measurement and Comparison: Direct measurement of physical properties (e.g., priming volumes) and comparison to the predicate device.
• Established Test Methods: In vitro testing for recirculation rates.

8. The Sample Size for the Training Set

This information is not applicable as there is no "training set" in the context of this physical medical device. The device is not learning-based.

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

This information is not applicable as there is no "training set" for this physical medical device.

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The Symetrex™ Long Term Hemodialysis Catheter is a symmetric tip dual lumen catheter designed for chronic hemodialysis and aphersis. It may be inserted percutaneously or by cut down. Catheters with greater than 37cm implant length are indicated for femoral placement.

The Symetrex™ Long Term Hemodialysis Catheter is a chronic, 15.5 French, dual lumen, radiopaque catheter made of polyurethane. It has a polyester retention cuff and two female luer adapters. The retention cuff promotes tissue ingrowth to arochr the catheter in the subcutaneous tunnel. The luer adapters are identical in color to indicate the reversibility of this catheter. This catheter features symmetrical side channels with a distal tip configuration designed to separate the intake flow from the output flow in both directions.

The provided document is a 510(k) premarket notification for a medical device called the Symetrex Long Term Hemodialysis Catheter. This document is a regulatory submission to the FDA, demonstrating substantial equivalence to a predicate device, and thus does not contain information about an AI/ML powered medical device. As such, the requested information regarding acceptance criteria, study details, ground truth, and training data for an AI/ML device cannot be extracted.

The document discusses the substantial equivalence of the new device to a predicate device (K140884), focusing on design, materials, manufacturing, and performance testing against established medical device standards (e.g., ISO, ASTM) for safety and basic functionality.

Therefore, I cannot provide the answer in the requested format because the input document does not pertain to an AI/ML medical device.

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