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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 Zenysis™ Short-Term Dialysis Catheter, is indicated for use in attaining short-term (less than 30 days) vascular access for hemodialysis, hemoperfusion, and apheresis treatments. The catheter is intended to be inserted in the jugular, femoral, or subclavian vein as required.

Zenysis™ Short-Term Dialysis Catheters are made of thermosensitive polyurethane, which softens when exposed to body temperature. The catheter is divided into two separate lumens permitting continuous blood flow. Both the venous (blue) and the arterial (red) lumens may be used for hemodialysis, hemoperfusion, and apheresis treatments. The Attachable Suture Wing and Attachable Suture Wing Fastener will be used to support the Zenysis™ Short-Term Dialysis Catheter, as securement devices to fixate the exposed portion of the catheter shaft to the patient's skin. The subject device included in this submission will be offered in varying French size and catheter configuration types, as summarized in the table below: Straight Extension Legs and Precurved Extension Legs with Insertion Lengths of 12.5 cm, 15 cm, 20 cm, and 24 cm. The subject catheters will be packaged with legally marketed components used in the placement procedure.

The provided text describes the Zenysis™ Short-Term Dialysis Catheter and its substantial equivalence to a predicate device. However, it does not contain a study that proves the device meets specific acceptance criteria in the way a clinical or performance study with detailed statistical results would.

Instead, the document outlines the acceptance criteria by referencing various guidance documents and standards that the device was tested against. The study itself is a series of verification tests performed in accordance with Design Controls (21 CFR §820.30) and the listed standards. The "reported device performance" is simply stated as "The subject device met all predetermined acceptance criteria".

Here's the information extracted and formatted to answer your request, with "N/A" for information not present in the document.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that the "subject device met all predetermined acceptance criteria derived from the above listed references and demonstrated substantially equivalent performance as compared to the cited predicate device." It does not provide specific numerical results for each test.

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

• Sample Size: Not specified.
• Data Provenance: Not specified (e.g., country of origin). The testing would typically be performed in a laboratory setting by the manufacturer (Bard Access Systems, Inc. in Salt Lake City, UT).
• Retrospective or Prospective: N/A (these are bench tests, not clinical studies on patients).

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

• Number of Experts: N/A. Ground truth for these types of bench tests is established by adhering to widely accepted engineering and medical device standards (e.g., ISO, ASTM) and internal protocols, rather than expert consensus on medical images or diagnoses.
• Qualifications of Experts: N/A.

4. Adjudication Method for the Test Set

• Adjudication Method: N/A. The evaluation methods for these bench tests are typically predefined by the relevant standards and protocols, not requiring an adjudication process like clinical expert review.

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

• N/A. This document describes a medical device (dialysis catheter), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

• N/A. This document describes a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

• Type of Ground Truth: Established definitions and metrics based on engineering principles and international standards (e.g., ISO 10555, ASTM F640, ISO 10993-1) for device performance, safety, and material properties.

8. The Sample Size for the Training Set

• N/A. This is a physical medical device; there is no "training set" in the context of machine learning or AI.

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

• N/A. As there is no training set, this is not applicable.

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The Zenysis™ Short-Term Dialysis Catheter, is indicated for use in attaining short-term (less than 30 days) vascular access for hemodialysis, hemoperfusion, and apheresis treatments. The catheter is intended to be inserted in the jugular, femoral, or subclavian vein as required.

Zenysis™ Short-Term Dialysis Catheters are made of thermosensitive polyurethane, which softens when exposed to body temperature. The catheter is divided into two separate lumens permitting continuous blood flow. Both the venous (blue) and the arterial (red) lumens may be used for hemodialysis, hemoperfusion, and apheresis treatments. The Attachable Suture Wing and Attachable Suture Wing Fastener will be used to support the Zenysis™ Short-Term Dialysis Catheter, as securement devices to fixate the exposed portion of the catheter shaft to the patient's skin. The subject device included in this submission will be offered in varying French size and catheter configuration types, as summarized in the table below: Straight Extension Legs with Insertion Lengths of 15 cm, 20 cm, 24 cm and Precurved Extension Legs with Insertion Lengths of 12.5 cm, 15 cm, 20 cm, 24 cm. The subject catheters will be packaged with legally marketed components used in the placement procedure.

The provided document is a 510(k) premarket notification for the Zenysis™ Short-Term Dialysis Catheter. It does not describe a study involving an AI/algorithmic device or human readers. Instead, it focuses on demonstrating substantial equivalence to a predicate device through technological characteristic comparisons and performance testing to ensure safety and effectiveness.

Therefore, most of the information requested in your prompt (acceptance criteria tables, sample sizes for test/training sets for AI, expert qualifications, adjudication methods, MRMC studies, standalone AI performance, type of ground truth used for AI) is not applicable to this document.

However, I can extract the acceptance criteria and performance related to the device itself from the safety and performance testing section.

Here's the relevant information that can be extracted from the provided document:

Study Type: This is a medical device substantial equivalence submission (510(k)), not a study on an AI/algorithmic medical device. It involves bench testing of the physical catheter, not evaluation of a diagnostic algorithm's performance with human readers.

Acceptance Criteria and Device Performance for Zenysis™ Short-Term Dialysis Catheter

Details from the document that are not applicable to the AI prompt but are included for context:

• Sample size used for the test set and the data provenance: Not applicable to an AI device. The testing here refers to physical product testing (bench tests) on the Zenysis™ catheter. The document does not specify the number of catheters tested for each metric, but mentions "Verification tests were designed and performed in accordance with Design Controls as per 21 CFR §820.30."
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for AI and expert consensus are not relevant here.
• Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
• 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 device.
• If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI device.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to an AI device. For this physical medical device, "ground truth" would be established by physical measurements, material properties, and functional performance testing against established engineering and medical standards.
• The sample size for the training set: Not applicable. This is not an AI device that requires a training set.
• How the ground truth for the training set was established: Not applicable.

Relevant Guidance Documents and Standards Used for Testing:

• Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, March 16, 1995
• Draft Guidance for Industry and Food and Drug Administration Staff: Implanted Blood Access Devices for Hemodialysis, June 28, 2013
• ISO 10555-1:2013, Sterile, single-use intravascular catheters – Part 1: General requirements
• ISO 10555-3:2013, Sterile, single-use intravascular catheters – Part 3: Central Venous catheters
• ASTM F640:2012, Standard Test Methods for Determining Radiopacity for Medical Use
• ASTM F756:2013, Standard Practice for Assessment of Hemolytic Properties of Materials
• ASTM F1841:1997 (R2013), Standard Practice for Assessment of Hemolysis in Continuous Flow Blood Pumps
• ISO 10993-1 CORR1:2010. Biological Evaluation of Medical Devices: Part 1 - Evaluation and Testing
• ISO 14971:2012, Medical Devices - Risk Management for Medical Devices (for Risk Management/FMEA)

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