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Spire Biomedical, Inc.'s Decathlon™ Twin Lumen Chronic Hemodialysis Catheter with Separated Tips is designed for chronic hemodialysis and apheresis. It is a radiopaque polyurethane catheter designed for percutaneous insertion via cutdown. Catheters longer than 40cm are intended for femoral vein insertion.

The Decathlon™ Twin Lumen Chronic Hemodialysis Catheter with Separated Tips is constructed of radiopaque medical grade polyurethane. To reduce recirculation during hemodialysis. the arterial lumen of the catheter is shorter than the venous lumen at the catheter's distal end. The catheter has a felt cuff and dual extensions. Each extension has a color coded luer lock adaptor, red for arterial and blue for venous lumen determination. Additionally, each extension has a clamp.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Decathlon™ Kuhle Twin Lumen Chronic Hemodialysis Catheter:

Summary of Device and Context:

The "Decathlon™ Kuhle Twin Lumen Chronic Hemodialysis Catheter with Separated Tips" is a radiopaque polyurethane catheter designed for chronic hemodialysis and apheresis. It is intended for percutaneous insertion. This 510(k) submission seeks to demonstrate substantial equivalence to a predicate device (15.5Fr Decathlon™ Twin Lumen Hemodialysis Catheter with Separated Tips, K032061, K042858). The key difference in the proposed device is a "small angle" divergence of the lumens at the distal end, compared to the predicate's "substantially parallel" lumens.

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The acceptance criteria are largely implied by the claim of substantial equivalence to the predicate device. The core argument is that the single design change (angle of distal lumen divergence) is minor enough not to alter the established safety and effectiveness characteristics of the predicate.

Study Information:

The provided document describes a comparison study to a legally marketed predicate device, rather than a de novo clinical or extensive performance study.

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

  • Test Set Sample Size: Not explicitly stated as a separate test set. The submission relies on data from the predicate device. If "test set" refers to the new device itself, there's no mention of a specific number of new devices being tested for this submission.
  • Data Provenance: The data provenance is from the predicate device (Spire Biomedical, Inc.'s 15.5Fr Decathlon™ Twin Lumen Hemodialysis Catheter with Separated Tips, K032061, K042858). It appears to be retrospective in the sense that existing data from a previously cleared device is being leveraged. The country of origin of the data is not specified, but the submitter is based in the USA.

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

  • Not applicable. This was not a study requiring expert-established ground truth in the typical sense (e.g., for diagnostic accuracy). The comparison is against engineering specifications and existing regulatory clearance of a predicate device.

• 4. Adjudication Method for the Test Set:

  • Not applicable. There was no specific "adjudication" (e.g., expert consensus on clinical cases) for a test set. The review process was a regulatory submission evaluated by the FDA.

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

  • No, an MRMC comparative effectiveness study was not done. This device is a physical medical device, not an AI or diagnostic imaging tool that would typically involve human readers.

• 6. Standalone (Algorithm Only) Performance Study:

  • No, a standalone performance study in the context of an algorithm or AI was not done. This is not an algorithmic device.

• 7. Type of Ground Truth Used:

  • The "ground truth" for this submission is the established safety and effectiveness profile of the predicate device, as demonstrated through its mechanical, physical, and biocompatibility tests that led to its previous FDA clearance (K032061, K042858). The manufacturer is asserting that the minor design change in the new device does not alter this established ground truth.

• 8. Sample Size for the Training Set:

  • Not applicable. There is no "training set" in the context of an AI/machine learning model for this physical medical device submission.

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

  • Not applicable, as there is no training set for an AI/machine learning model. The underlying "ground truth" for the predicate device would have been established through a combination of engineering specifications, material testing, mechanical testing, and biocompatibility studies conducted according to relevant standards at the time of its original clearance.

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Spire Biomedical, Inc.'s Decathlon Coated Twin Lumen Chronic Hemodialysis Catheter with Separated Tips is designed for chronic Hemodialysis and apheresis. It is a radiopaque polyurethane catheter with a heparin coating, designed for percutaneous insertion or insertion via a cutdown. The ability of the Carmeda® End-Point Bonded heparin coating to reduce clotting is supported by in-vitro and animal testing. Catheters longer than 40cm are intended for femoral vein insertion.

The Decathlon™ Coated Twin Lumen Chronic Hemodialysis Catheter with Separated Tips is constructed of radiopaque medical grade polyurethane. To reduce recirculation during hemodialysis, the arterial lumen of the catheter is shorter than the catheter's distal end. The catheter has a felt cuff and dual extension has a color coded luer lock adaptor, red for arterial and blue for venous lumen determination. Additionally, each extension has a clamp.

Here's a summary of the acceptance criteria and the studies related to the Decathlon Gold Kuhle Twin Lumen Chronic Hemodialysis Catheter, based on the provided text:

Acceptance Criteria and Reported Device Performance

Study Information

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

   • 90-day durability tests (Heparin Coating Bioactivity): The sample size isn't explicitly stated for this particular part. It mentions "coated catheters" in saline, with measurements at "7 regular intervals." The study type appears to be prospective (in-vitro). No country of origin is mentioned.
   • In-vitro thromboresistance study: One coated and one uncoated catheter per test. The study involved circulation of bovine blood. This is an in-vitro, prospective study. No country of origin is mentioned.
   • Animal study (Ovine Model): "One coated and one uncoated catheter was evaluated in each of three animals (ovine)." This is an animal study, prospective. No country of origin is mentioned.

2. 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)

   • The document does not mention the use of human experts to establish ground truth for the performance studies. The ground truth appears to be objective laboratory measurements (heparin bioactivity, thrombus accumulation via radiolabeled measurements and weight measurements, visual evaluation, pressure increase).

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

   • Not applicable, as human expert adjudication is not mentioned for establishing ground truth in these performance studies.

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

   • No MRMC comparative effectiveness study was done. This device is a medical catheter, not an AI-assisted diagnostic tool.

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

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

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

   • The ground truth used for performance evaluation was based on objective laboratory measurements and animal study observations/measurements:
     • Heparin bioactivity (in pmol/cm').
     • Total thrombus accumulation (radiolabeled measurements, thrombus weight measurements).
     • Pressure increase in the arterial lumen (in-vitro).
     • Visual evaluation of catheters (in-vitro and animal study).
     • Optical and scanning electron microscopy (animal study).

7. The sample size for the training set

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

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

   • Not applicable.

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Spire Biomedical Inc's Alta Gold, Coated Twin Lumen Chronic Indications for Use: Hemodialysis Catheter with fixed tips is designed for chronic hemodialysis and apheresis. It is a radiopaque polyurethane with a heparin coating, designed for percutaneous insertion or insertion via cutdown. The ability of the Carmeda End point Bonded Heparin Coating to reduce clotting is supported by in-vitro testing. Catheters longer than 40cm are intended for femoral vein insertion.

Spire Biomedical, Inc.'s 15.5Fr Alta Gold, Twin Lumen Fixed Tip Coated Chronic Hemodialysis Catheter is processed with a proprietary Carmeda® BioActive Surface (CBAS®) coating technology that attaches a functionally active heparin to the surfaces of the device. The coating counteracts thrombus from forming on the catheter. Spire's 15.5Fr Alta Gold, Heparin Coated Catheter is fully coated with CBAS® on the internal surface and on the external surface of the catheter body (from 2cm distal to the ends of the distal tips; the cuff is not coated).

The coating is essentially non-leaching. Additionally, the maximum amount of heparin on the surface is only 1mg. Therefore; the effects of the entire coating on a patient's coagulation status would be insignificant.

Acceptance Criteria and Study for K063441: 15.5Fr Alta Gold, Twin Lumen Fixed Tip Coated Chronic Hemodialysis Catheter

This document describes the acceptance criteria and the study that proves the Spire Biomedical, Inc.'s 15.5Fr Alta Gold, Twin Lumen Fixed Tip Coated Chronic Hemodialysis Catheter meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

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

The primary performance studies for the Alta Gold catheter leveraged data from previously cleared devices, particularly the 15.5Fr Decathlon Coated Twin Lumen Chronic Hemodialysis Catheter (K060155), due to identical material, outside dimensions, and coating.

• In-vitro durability test (90-day bioactivity): Not explicitly stated, but performed on "coated catheters in saline."
• In-vitro thromboresistance study (2-hour blood loop): Involved "circulation of bovine blood" through an outer loop with "coated or uncoated catheter." The number of catheters tested is not specified but it's a comparative study. This study was performed on the Alta Gold catheters, while other tests were performed on the predicate Decathlon Gold catheters.
• Biocompatibility Testing: Conducted on the 15.5Fr Decathlon coated catheter. Number of samples not explicitly stated but implied to be sufficient for ISO 10993 compliance.

Data Provenance:
All studies mentioned are in-vitro laboratory studies, and thus the concept of "country of origin of the data" or "retrospective/prospective" does not apply in the same way as for clinical trials with human subjects. The studies were conducted by Spire Biomedical, Inc. (or their contractors) in support of regulatory submission in the United States.

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

This submission does not involve a standard clinical study with expert interpretation of cases. The "ground truth" for the performance claims is established through objective, quantitative, in-vitro scientific measurements and validated international standards (e.g., ISO 10993). Therefore, there were no "experts" in the traditional sense establishing a diagnostic ground truth for a test set of medical images or patient data. The scientists and technicians conducting the laboratory tests provided the data.

4. Adjudication Method for the Test Set

No adjudication method (e.g., 2+1, 3+1) was used as this was not a study involving human interpretation of medical data requiring consensus or arbitration. The performance data was derived from laboratory measurements.

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

No MRMC comparative effectiveness study was done. This device is a medical device (catheter) and not an AI or imaging diagnostic tool that would typically involve human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is a chronic hemodialysis catheter, not an algorithm or AI system. Its performance is inherent to the device's material properties and coating, not dependent on an algorithm.

7. Type of Ground Truth Used

The ground truth used for performance validation was based on:

• Quantitative In-vitro Measurements: Direct measurements of heparin bioactivity (pmol/cm²), thrombus accumulation (radiolabeled measurements), pressure increase, and visual evaluation in controlled laboratory settings.
• Adherence to Standards: Compliance with established physical and mechanical test methods, and international biocompatibility standards (ISO 10993).

8. Sample Size for the Training Set

Not applicable. This device does not use machine learning or AI, and therefore no "training set" was used. The device's design and performance are based on engineering principles and established biological interactions, not data training.

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

Not applicable, as there was no training set.

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Spire Biomedical Inc's Decathlon Gold, Coated Twin Lumen Chronic Hemodialysis Catheter with separated funnel tips is designed for chronic hemodialysis and apheresis. It is a radiopaque polyurethane with a heparin coating, designed for percutaneous insertion or insertion via cutdown. The ability of the Carmeda® End point Bonded Heparin Coating to reduce clotting is supported by invitro testing. Catheters longer than 40cm are intended for femoral vein insertion.

Spire Biomedical, Inc.'s 15.5Fr Decathlon Gold, Coated catheters are processed with a proprietary Carmeda® BioActive Surface (CBAS®) coating technology that attaches a functionally active heparin to the surfaces of the coating counteracts thrombus from forming on the catheter. Spire's 15.5Fr Decathlon Gold. Coated catheters are fully coated with CBAS® on the internal surface and on the external surface of the catheter body (from 2cm distal to the cuff to the ends of the distal tips; the cuff is not coated). The distal ends of this catheter have the arterial and venous tips rounded and "funneled" for easier over the wire insertion. It has one elliptical side hole placed on the distal ends of the arterial and venous lumens. A stylet will be preloaded in the arterial lumen for ease of guidewire placement.

The coating is essentially non-leaching. Additionally, the maximum amount of heparin on the surface is only 1mg. Therefore; the effects of the entire coating on a patient's coagulation status would be insignificant.

The provided text describes a 510(k) summary for a medical device, the 15.5Fr Decathlon Gold, Coated Catheters with funnel tips. However, it does not contain the specific information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria, especially in the context of an AI/human reader study.

The document focuses on:

• Device Description: Details about the catheter's design, material (polyurethane with Carmeda® BioActive Surface (CBAS®) coating), and the "funneled" distal tips.
• Product Claims:
  • Maintains heparin's bioactive properties for a minimum of 90 days (demonstrated in two in-vitro studies).
  • Coating reduces total thrombus accumulation by 51% compared to uncoated catheters (demonstrated in an in-vitro thromboresistance study).
• Technological Characteristics Comparison to Predicate Devices: States that the device is identical to a predicate device (K060155) in materials, dimensions, and coating, with the only difference being the funneled distal tips.
• Performance Data: Refers to in-vitro blood loop testing and catheter flow bench testing as additional tests performed specifically for this device (Decathlon Gold with funnel tips), while other tests (stability, durability, mechanical properties) were performed on the predicate device and not duplicated.
• Predicate Devices: Lists several legally marketed devices that use the same Carmeda® BioActive Surface (CBAS®) coating.

Based on the provided text, I cannot answer the specific questions about acceptance criteria and a study proving the device meets those criteria, particularly in the context of AI assistance, sample sizes for training/test sets, ground truth establishment, or multi-reader multi-case studies.

The "studies" mentioned are in-vitro studies demonstrating the coating's properties (bioactivity duration, thrombus reduction) and do not involve human readers, AI, or clinical outcomes that would typically have acceptance criteria in the format requested. The document does not provide a table of acceptance criteria or specific performance against such criteria.

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The 55cm Pourchez RetrO Twin Lumen Chronic Hemodialysis Catheter with Separated Tips is designed for chronic (long-term) hemodialysis and apheresis. It is designed for percutaneous insertion or insertion via cutdown. Catheters longer than 40cm can be used for femoral insertion.

55cm Pourchez RetrO™ Silicone Twin Lumen Chronic Device Hemodialysis Catheter with Separated Tips. The 55cm Pourchez RetrO catheter uses the exact same materials of construction.

The provided text is a 510(k) summary for a medical device, the "55cm Pourchez RetrO Kit" or "Pourchez RetrO Twin Lumen Chronic Hemodialysis Catheter with Separated Tips." This document focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria in a study involving human-in-the-loop or standalone AI performance.

Therefore, many of the requested details about acceptance criteria, study design, and AI performance metrics are not applicable or cannot be extracted from this type of regulatory submission. The 510(k) process primarily relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, often through engineering and bench testing, rather than extensive clinical trials with human readers or AI.

Here's an attempt to answer the questions based only on the provided text, indicating where information is not available:

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

   This document does not specify quantitative acceptance criteria. Instead, it asserts that "A series of mechanical and physical tests, including tensile and flow, were performed to demonstrate substantial equivalence to predicate devices or conformation to established ISO standards for hemodialysis catheters." The "reported device performance" is essentially that these tests did demonstrate substantial equivalence or conformance.

   Acceptance Criteria	Reported Device Performance
   Substantial equivalence to predicate devices (K022000) for mechanical and physical properties.	Demonstrated via mechanical and physical tests (tensile and flow).
   Conformance to established ISO standards for hemodialysis catheters.	Demonstrated via mechanical and physical tests (tensile and flow).

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

   Not applicable. The "tests" mentioned are mechanical and physical bench tests, not clinical studies with patients or data sets in the typical sense for AI/human performance. No sample size for a test set (e.g., patient data) is provided, nor is data provenance.

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

   Not applicable. Ground truth for device performance in this context would be physical measurements from the aforementioned mechanical and physical tests, not expert consensus on medical images or diagnoses.

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

   Not applicable. This is not a study involving human interpretation or subjective assessment that would require adjudication.

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

   Not applicable. No MRMC study was performed, as this device (a catheter) is not an AI-assisted diagnostic tool.

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

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

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

   The "ground truth" for the performance claims appears to be derived from objective measurements from mechanical and physical bench tests, and conformance to ISO standards for hemodialysis catheters.

8. The sample size for the training set

   Not applicable. This is a physical medical device; there's no "training set" in the context of an AI algorithm.

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

   Not applicable, as there is no training set mentioned in the context of AI. For the manufacturing and quality control of the physical device, ground truth would be established through engineering specifications and industry standards.

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The 15.5Fr Alta LR Twin Lumen Fixed Tip Hemodialysis Catheter is designed for chronic (long-term) hemodialysis and apheresis. It is designed for percutaneous insertion or insertion via cutdown.

The polyurethane 15.5Fr Alta LR Twin Lumen Fixed Tip Chronic Hemodialysis Catheter is a product line extension of Spire Biomedical, Inc.'s Decathlon ™ radiopaque polyurethane catheters with similar catheter tip-to-hub lengths of 24cm, 28cm, 32cm, 36cm and 40cm.

This document is a 510(k) summary for the 15.5Fr Alta LR Twin Lumen Fixed Tip Chronic Hemodialysis Catheter by Spire Biomedical, Inc. It describes the device, its intended use, and claims substantial equivalence to predicate devices based on performance data.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with specific numerical targets. Instead, it states that the device's performance was evaluated against standards and predicate device performance.

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

The document does not specify the sample sizes used for the mechanical and physical tests. It also does not provide information on the data provenance (e.g., country of origin, retrospective or prospective) for these tests. The tests were likely conducted in a laboratory setting by Spire Biomedical, Inc.

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

This information is not applicable to this submission. The "ground truth" here relates to engineering performance specifications and existing standards, not clinical diagnoses requiring expert interpretation.

4. Adjudication Method for the Test Set

This information is not applicable to this submission as it relates to clinical studies or interpretations, not the mechanical testing described.

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

No MRMC comparative effectiveness study was done. This type of study is relevant for imaging or diagnostic algorithms where human readers are involved in interpretation. The device in question is a physical medical device (catheter), and its evaluation relies on mechanical and physical performance tests, not AI-assisted human reading.

6. Standalone (Algorithm Only) Performance Study

No standalone performance study for an algorithm was done. This device is not an AI algorithm. Its performance is evaluated through physical and mechanical testing of the device itself.

7. Type of Ground Truth Used

The ground truth used for evaluating the device's performance was:

• Comparison to the performance of the predicate device (Spire Biomedical, Inc.'s Decathlon™).
• Conformance to established ISO standards for hemodialysis catheters.
  These are objective, established criteria for evaluating physical device performance.

8. Sample Size for the Training Set

This information is not applicable. The device is not an AI model, therefore, there is no "training set."

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

This information is not applicable, as there is no training set for an AI model.

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Spire Biomedical, Inc.'s Pourchez RetrO™ Silicone Twin Lumen Chronic Hemodialysis Catheter with Separated Tips is designed for chronic hemodialysis and apheresis. It is a radiopaque silicone catheter designed for percutaneous insertion or insertion via a cutdown.

The Pourchez RetrO™ Twin Lumen Chronic Hemodialysis Catheter with Separated Tips is a flexible radiopaque silicone catheter. The distal end has two tips separated over a predetermined distance. The distal arterial and venous lumens are round and are staggered to reduce recirculation. The body is oval, and the proximal end, which is connected to the catheter body by color-coded extension adapters, has two distinctive lumens with color-coded adapters (red for arterial and blue for venous). The catheter is available in five different implant lengths. It is also available with and without side holes on the distal ends. The catheter has a polyester cuff located at one of five different implant lengths from the distal end. A RetrO catheter repair kit will also be offered to replace damaged extensions and/or extension adapters.

The provided text is a 510(k) Summary for a medical device (Pourchez RetrO™ Twin Lumen Chronic Hemodialysis Catheter) and a subsequent FDA clearance letter. It does not describe or refer to any algorithm, AI, or software.

Therefore, I cannot provide information on acceptance criteria and a study proving device conformance based on the input text for an AI/algorithm-based device as requested in the prompt.

The document states: "A series of tests were performed to demonstrate substantial equivalence to predicate devices or conformation to established ISO standards for hemodialysis catheters. In all cases, the Pourchez RetrO™ catheter demonstrated equivalent performance to the predicate devices and acceptance criteria established by the appropriate standard." However, it does not provide specific details about these tests, acceptance criteria, reported performance, sample sizes, or ground truth establishment relevant to an AI/algorithm study.

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The Pourchez XpressO™ is a silicone twin lumen catheter with separated tips designed for chronic (long-term) hemodialysis and apheresis. It is designed for percutaneous insertion or insertion via cutdown.

The 24cm tip to hub length Pourchez XpressO™ Twin Lumen Chronic Hemodialysis Catheter with Separated Tips is a product line extension of Spire Biomedical, Inc.'s the Pourchez XpressO™ flexible radiopaque silicone catheters. The 24cm catheter supplements the other four tip to hub length catheters (28cm, 32cm, 36cm and 40cm) catheters. The 24cm is also available with and without side holes on the distal ends.

The provided text describes a 510(k) summary for a medical device, the 24cm Pourchez XpressO™ Twin Lumen Chronic Hemodialysis Catheter with Separated Tips. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance data from a standalone study or a multi-reader, multi-case (MRMC) comparative effectiveness study.

Therefore, many of the requested items (acceptance criteria, specific reported performance metrics, sample sizes, ground truth details, expert qualifications, adjudication methods, and MRMC study details) are not explicitly present in the provided document.

However, based on the furnished text, here's what can be extracted:

Acceptance Criteria and Device Performance

The document states that the 24cm Pourchez XpressO™ Catheter demonstrated equivalent or superior performance to the predicate devices or exceeded the minimum acceptance criteria established by the appropriate standard.

Study Details

Given the nature of a 510(k) summary for a product line extension, the "study" referred to is a series of tests to demonstrate substantial equivalence, rather than a clinical trial with human subjects.

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

   • Sample Size: Not specified in the provided text.
   • Data Provenance: Not specified. The tests were performed to compare against predicate devices or ISO standards, implying laboratory-based testing rather than clinical data from a specific country. This is likely retrospective in the sense that the predicate device data is pre-existing, and the new device's performance is measured against it.

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

   • Not applicable as this is a device performance test against predicate devices and ISO standards, not a diagnostic or AI-assisted study requiring human expert ground truth.

3. Adjudication method for the test set:

   • Not applicable for a device performance test.

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:

   • No. This is a medical device (catheter) and not an AI/software-as-a-medical-device (SaMD) or diagnostic imaging product that would typically involve human readers.

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

   • Yes, device performance "tests were performed" on the catheter itself, in a standalone manner, to demonstrate its characteristics. However, this is not a software algorithm, but a physical medical device.

6. The type of ground truth used:

   • Predicate Device Performance Data: Performance characteristics of legally marketed predicate devices (Medical Components, Inc. Ash Split Cath™ and MedComp Pourchez XpressO™) served as a benchmark.
   • Established ISO Standards for Hemodialysis Catheters: Compliance with these standards formed another part of the "ground truth" or acceptance criteria.

7. The sample size for the training set:

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

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

   • Not applicable.

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The Pourchez XpressO™ Catheter is designed for chronic (longterm) hemodialysis and apheresis. It is designed for percutaneous insertion or insertion via cutdown into the jugular or subclavian vein.

The Pourchez Xpresso™ is a silicone twin lumen catheter with separated tips designed for chronic (long-term) hemodialysis and apheresis. It is designed for percutaneous insertion or insertion via cutdown.

The Pourchez XpressO™ Twin Lumen Chronic Hemodialysis Catheter with Separated Tips is a flexible radiopaque silicone catheter. The distal end has two tips separated over a predetermined distance. The distal arterial and venous lumens are round and are staggered to reduce recirculation. The body is oval, and the proximal end has two distinctive lumens with color-coded adapters (red for arterial and blue for venous). The catheter is available in four different tip-to-hub lengths. It is also available with and without side holes on the distal ends. The catheter has a polyester cuff located at one of four different locations from the distal end.

The provided text describes a 510(k) submission for a medical device, the Pourchez XpressO™ Twin Lumen Chronic Hemodialysis Catheter with Separated Tips. The submission focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and conducting a primary study to prove those criteria.

Therefore, the following information is not present in the provided text:

• A table of acceptance criteria and reported device performance specific to novel criteria (the document focuses on comparison to predicates or established ISO standards).
• Sample size used for a dedicated test set.
• Data provenance (country of origin, retrospective/prospective).
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for a test set.
• Information on a multi-reader multi-case (MRMC) comparative effectiveness study or human reader improvement with AI assistance.
• Information on a standalone (algorithm only) performance study.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for a primary study.
• Sample size for a training set.
• How the ground truth for the training set was established.

Based on the provided text, here is what can be extracted regarding performance and "acceptance criteria" through equivalence:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that performance was evaluated against predicate devices and ISO standards. The "acceptance criteria" were implied to be equivalent or superior performance to the predicates or exceeding minimum acceptance criteria of appropriate standards.

2. Study Description and Details:

The document describes "A series of tests were performed to demonstrate substantial equivalence to predicate devices or conformation to established ISO standards for hemodialysis catheters." This implies a bench testing approach comparing the new device against predicate devices and relevant industry standards.

• Sample size used for the test set and the data provenance: Not specified. This would typically be determined by the specific ISO standards or internal company protocols for bench testing.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for this type of technical performance testing. Ground truth would be based on validated measurement methods and instrumentation.
• Adjudication method for the test set: Not applicable for this type of technical performance testing.
• If a multi reader multi case (MRMC) comparative effectiveness study was done: No. This is a technical performance assessment, not a clinical reader study.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an AI algorithm.
• The type of ground truth used: For characteristics like flow rates, lumen area, priming volumes, and material compatibility, ground truth would be established through objective physical measurements using calibrated equipment and methods defined by engineering standards or internal validation protocols. For comparison to predicate devices, the documented specifications and performance of those predicate devices serve as the reference.
• The sample size for the training set: Not applicable as this is not an AI/machine learning study.
• How the ground truth for the training set was established: Not applicable.

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