Search Results

The Covidien Acute and Chronic Catheter Repair Kit is intended to repair the external extension tubing, luer adapter or clamp of a hemodialysis catheter manufactured by Covidien. Do not use this kit to repair a catheter if the damaged portion of the extension tubing is more than 0.5 cm away from the distal end of the luer adapter. Specific hemodialysis catheters that can be repaired using this kit include: Palindrome ™ Chronic Care Catheters, Palindrome TM Emerald™ Chronic Care Catheters, Palindrome ™ Ruby™ Chronic Care Catheters, Palindrome™ Sapphire™ Chronic Care Catheters, MAHURKAR™* Maxid™ Chronic Care Catheters, MAHURKAR™* 8 Fr. (2.67mm) Single Lumen Acute Care Catheters, MAHURKAR™* 8 Fr. (2.67mm) Dual Lumen Acute Care Catheters, MAHURKAR™* 10 Fr. (3.33mm) Dual Lumen Acute Care Catheters, MAHURKAR™* 11.5 Fr. (3.83mm) Dual Lumen Acute Care Catheters, MAHURKAR™* 13.5 Fr. (4.50mm) High Flow Dual Lumen Acute Care Catheters, MAHURKAR™* 12 Fr. (4.00mm) Triple Lumen Acute Care Catheters. (Note: do not use this kit to repair the infusion lumen.)

The Covidien™ Acute and Chronic Catheter Repair Kit is intended to be used for the repair of a broken luer adapter, clamp, or extension tubing (only the most proximal 0.5-cm of tubing) of an existing catheter. When one of these components is damaged the implanted catheter will be clamped off using the existing clamp and a slide clamp that will be provided as apart of the catheter repair kit. Then the damaged extension tube will be cut off and the existing clamp will be removed while the slide clamp will provide the stasis of the catheter. After removing the existing clamp a threaded repair collar will be placed over the remaining extension tube. The barbed connector will then be inserted barb end first into the extension tube. Once in place the repair collar will be threaded onto the new repaired back end to secure the placement

Here's an analysis of the acceptance criteria and study information based on the provided text, using the requested format:

Acceptance Criteria and Device Performance Study for Covidien™ Acute and Chronic Catheter Repair Kit

The provided documentation details the performance testing conducted for the Covidien™ Acute and Chronic Catheter Repair Kit.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that testing was performed to "evaluate the performance" in these areas. Specific numerical acceptance thresholds and quantitative results are not provided in the extracted text.

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

The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions that "Testing was performed to evaluate the performance."

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

This information is not applicable and not provided. The study conducted was a technical performance evaluation of a physical repair kit, not an assessment requiring expert interpretation of data or images to establish a ground truth.

4. Adjudication Method for the Test Set

This information is not applicable and not provided, as the study does not involve expert interpretation or subjective assessments that would require adjudication.

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

No MRMC comparative effectiveness study was mentioned. The study described is a technical performance evaluation of the repair kit itself, not a study involving human readers or AI assistance.

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

This information is not applicable. The device is a physical catheter repair kit, not an algorithm or AI system. The performance evaluation is inherently a "standalone" assessment of the physical repair's integrity and function.

7. Type of Ground Truth Used

The "ground truth" for this study was established through objective engineering and physical testing against established industry and regulatory standards (FDA and ISO guidance for Tensile Strength, Dynamic Flow, Leak, and Burst). There is no "expert consensus," "pathology," or "outcomes data" in the typical sense for this type of device performance evaluation. The "ground truth" refers to whether the repaired catheter meets predefined physical and functional specifications.

8. Sample Size for the Training Set

This information is not applicable. The device is a physical repair kit, not a machine learning model, so 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 this device.

Ask a specific question about this device

The Kendall 14.5 Fr Chronic Hemodialysis Catheter with Heparin Coating and Silver Impregnated Sleeve (Palindrome™ Sapphire™) is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by cutdown.

The performance of the heparin coating on this catheter in reducing platelet adhesion on the catheter surface for up to 720 hours of dialysis treatment is supported by bench and animal testing.

The performance of the silver impregnated sleeve in reducing colonization on the catheter surface for up to 30 days is supported by bench and animal testing.

The proposed Kendall 14.5 Fr Chronic Hemodialysis Catheter with Heparin Coating and Silver Impregnated Sleeve (Palindrome™ Sapphire™) has a radiopaque polyurethane shaft with two large inner lumens designed in a "double D" configuration. The distal end of the catheter extends to a symmetrical tip. The proximal end of the catheter shaft contains a polyurethane hub assembly and silicone extension sets. The catheter contains a heparin coating on its surface, from the tip of the catheter to the cuff on the external surface, and throughout the entire length on the internal surface (tip to luer adapters), for the purpose of reduction of platelet adhesion. The proposed catheter also contains a silver impregnated sleeve permanently bound to the outer surface of the device from the hub to the cuff for the purpose of reducing microbial colonization on the external surface of the catheter in the subcutaneous tunnel tract.

The provided document describes a Special 510(k) submission for a device modification: the Kendall 14.5 Fr Chronic Hemodialysis Catheter with Heparin Coating and Silver Impregnated Sleeve (Palindrome™ Sapphire™). The modification involves adding a silver impregnated sleeve to an existing device (Kendall's 14.5 Fr Chronic Hemodialysis Catheter with Heparin Coating - Palindrome™ Emerald™).

Here's an analysis of the acceptance criteria and the supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

Test Set (for Heparin Coating Performance):

• In-vitro circulating blood loop test: Sample size not explicitly stated for individual catheters, but "uncoated control" implies multiple comparisons. Data provenance is a bench test using fresh heparinized bovine blood.
• Coating durability test: Sample size not explicitly stated, but "the catheter was subjected to 720 hours of simulated dialysis". Data provenance is an in-vitro simulation.
• In-vivo ovine model: Six sheep. Each sheep had both a coated and non-coated catheter. Data provenance is prospective animal testing (ovine model).

Test Set (for Silver Impregnated Sleeve Performance):

• Biocompatibility testing: Not specified, but typically involves a battery of tests with multiple samples. Data provenance not specified (likely lab-based).
• Total silver amount in sleeve determination: Not specified. Data provenance not specified (likely lab-based).
• Silver elution: Not specified, but likely multiple samples over time. Data provenance not specified (likely lab-based).
• In-vitro studies (microbial colonization): Sample size not specified for each microbial challenge, but tests were "after repeated challenges". Data provenance is in-vitro laboratory testing with clinical isolates.
• In-vivo studies (microbial colonization): Not specified (e.g., number of rabbits or catheters). Data provenance is prospective animal testing (rabbit infection model) with a clinical isolate.

3. Number of Experts and Qualifications for Ground Truth:

Not applicable. The reported studies are primarily bench and animal testing, not human user studies requiring expert adjudication or ground truth establishment in the clinical sense.

4. Adjudication Method for the Test Set:

Not applicable for these types of studies. The end results are quantitative measurements (e.g., platelet counts, thrombus weight, microbial log reduction, heparin activity).

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

No, an MRMC comparative effectiveness study was not done. The studies are focused on the device's functional performance in bench and animal models, not on human reader performance, with or without AI assistance, or direct human clinical outcomes.

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

Not applicable. This device is a medical catheter, not an AI algorithm. The performance evaluation is for the physical device and its coatings.

7. Type of Ground Truth Used:

• For Heparin Coating:
  • In-vitro platelet adhesion: Quantitative measurement of radiolabeled platelet counts on catheter surfaces.
  • In-vivo thrombus formation: Gravimetric analysis of extracted thrombus from catheter surfaces.
  • Heparin activity: Chemical assay to measure heparin levels.
• For Silver Impregnated Sleeve:
  • Microbial colonization: Quantitative measurement of microbial load (e.g., colony-forming units, reported as log10 reduction).
  • Biocompatibility: Standardized toxicological endpoints (e.g., cytotoxicity, sensitization, irritation).
  • Silver elution/content: Analytical chemistry techniques.

8. Sample Size for the Training Set:

Not applicable. This is a medical device and its coatings undergoing performance testing, not a machine learning model.

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

Not applicable, as there is no training set for a machine learning model.

Ask a specific question about this device

The Kendall 14.5 Fr Chronic Hemodialysis Catheter with Silver Impregnated Sleeve (Palindrome™ Ruby™) is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by cutdown. Catheters greater than 40 cm implant length are indicated for femoral insertion. The performance of the silver impregnated sleeve in reducing colonization on the catheter surface for up to 30 days was supported by bench and animal testing.

The Kendall 14.5 Fr Chronic Hemodialysis Catheter with Silver Impregnated Sleeve (Palindrome™ Ruby™) has a radiopaque polyurethane shaft with two large inner lumens designed in a "double D" configuration. The distal end of the catheter extends to a symmetrical tip. The proximal end of the catheter shaft contains a polyurethane hub assembly and silicone extension sets. The catheter contains a silver impregnated sleeve permanently bound to the outer surface of the device from the hub to the cuff for the purpose of reducing microbial colonization on the external surface of the catheter in the subcutaneous tunnel tract.

Here's a breakdown of the acceptance criteria and the study information for the Kendall 14.5 Fr Chronic Hemodialysis Catheter with Silver Impregnated Sleeve (Palindrome™ Ruby™):

1. Table of Acceptance Criteria and Reported Device Performance

The device is claiming substantial equivalence to a predicate device (Kendall Palindrome™ 14.5 Fr Chronic Hemodialysis Catheter with Slotted Symmetrical Tip, K043272). The primary modification is the addition of a silver-impregnated sleeve. Therefore, the acceptance criteria and performance are focused on demonstrating that this modification is safe and effective, and that the new device remains substantially equivalent.

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

• Sample Size:
  • In-vitro studies: Not explicitly stated how many samples were used for each microorganism or how many repeated challenges were performed.
  • In-vivo studies: Not explicitly stated how many rabbits were used in the infection model.
• Data Provenance: The studies were prospective bench and animal testing conducted specifically for this device submission. The clinical isolates used for in-vitro and in-vivo testing indicate a connection to real-world pathogen strains, but the testing itself was performed in a controlled laboratory/animal environment. There is no mention of human clinical data from any country in this summary.

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

Falls outside the scope of this document. This submission details bench and animal testing. There are no human "readers" or "experts" establishing ground truth in the context of diagnostic interpretation, as this is a medical device for placement within the body, not a diagnostic imaging or AI product. The ground truth for the microbial studies would be objective laboratory measurements (e.g., colony-forming unit counts).

4. Adjudication Method for the Test Set

Not applicable. As this is not a study involving human interpretation of data where adjudication would be necessary.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI-assisted diagnostic or interpretation device that would involve human readers or MRMC studies.

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

Not applicable. This is not an algorithm, but a physical medical device with a modified component. The "standalone" performance here refers to the device's inherent physical and antimicrobial properties, which were tested in a controlled environment without human intervention during the measurement phase.

7. The Type of Ground Truth Used

• Biocompatibility, Silver Amount, Silver Elution: Objective laboratory measurements against established standards and limits.
• Microbial Colonization Reduction (In-vitro & In-vivo): Quantitative microbiological methods (e.g., colony-forming unit counts) that directly measure the reduction in microbial load. This is an objective, empirical ground truth.

8. The Sample Size for the Training Set

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

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

Not applicable. There is no training set for this device.

Ask a specific question about this device

The device is intended for gastric decompression and delivery of fluids, including irrigation, nutritional supplements, and medication.

The GiEntriport with Universal Single Lumen Adaptor is a multiport Device Description. The GiEnthport with Offirstal Surges or to a single lumen feeding tube.

The provided text contains information about a 510(k) Premarket Notification for the GiEntriport Single Lumen Adaptor. However, it does not describe a study involving acceptance criteria, reported device performance, sample sizes for test/training sets, expert involvement, or comparative effectiveness studies of AI. The document focuses on regulatory approval based on substantial equivalence to predicate devices, rather than a performance study with detailed metrics.

Therefore, many of the requested sections cannot be filled from the provided text.

Here's a breakdown of what can and cannot be extracted:

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

• Cannot be provided. The document states that "Engineering evaluation, and testing were conducted to demonstrate that the design of the proposed device was equivalent to the predicate devices, and/or met the requirements for gastric decompression and delivery of fluids as such devices, as defined in EN1615:2000." This indicates that some testing was done to meet standards (EN1615:2000) and demonstrate equivalence, but the specific acceptance criteria and detailed reported performance metrics are not provided in this 510(k) summary.

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

• Cannot be provided. The document mentions "Engineering evaluation, and testing" but does not detail sample sizes, types of tests performed, or data provenance.

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

• Not applicable. This device is a medical tube/adaptor, not a diagnostic imaging AI system. The concept of "ground truth" established by experts for a test set, as typically applied to AI/Machine Learning in diagnostics, does not apply here. The "ground truth" for this device would relate to its physical performance and safety characteristics.

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

• Not applicable. See point 3.

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

• Not applicable. This is a physical medical device, not an AI system. No MRMC studies or AI assistance are mentioned or relevant to this type of device.

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

• Not applicable. This is a physical medical device.

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

• Cannot be directly answered in the AI/ML context. For this device, the "truth" would be its adherence to established engineering standards (EN1615:2000) for safety and performance, and functional equivalence to predicate devices for its intended use (gastric decompression, fluid/nutritional delivery).

8. The sample size for the training set

• Not applicable. There is no mention of a "training set" as this is not an AI/ML device.

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

• Not applicable. See point 8.

Ask a specific question about this device

The 14.5 Fr Chronic Hemodialysis Catheter with Insertion Stylets is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted percutaneously or by cut down.

The 14.5 Fr Chronic Hemodialysis Catheter has a radiopaque polyurethane shaft with two large inner lumens designed in a "double D" configuration. The tip of the Maxid catheter is staggered, while the Palindrome is symmetrical. The proximal end of the catheter shaft contains a polyurethane hub assembly and silicone extension sets. The insertion stylets are polyethylene, and extend the full length of the catheter and protrude from the tip. The purpose of the insertion stylet is to provide the clinician with an additional option for catheter placement.

The provided text describes a 510(k) Premarket Notification for a 14.5 Fr Chronic Hemodialysis Catheter with insertion stylets. However, it does not contain the specific acceptance criteria or a detailed study section with quantitative performance data that would allow for the direct completion of all requested fields.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices (Maxid™ and Palindrome™ 14.5 Fr Chronic Hemodialysis Catheters) based on "intended use, materials, physical characteristics, and performance characteristics." The key modification is the addition of insertion stylets.

Here's an attempt to answer the questions based on the available information, with explicit notes where information is not available in the provided text:

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

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

• Sample size for test set: Not specified. The document refers to "verification / validation" but does not detail the nature or sample size of these tests.
• Data provenance: Not specified.

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

• Not applicable/Not specified. This is a medical device submission focused on physical and performance characteristics, not an AI or diagnostic imaging study that typically relies on expert-established ground truth.

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

• Not applicable/Not specified. This is a medical device submission focused on physical and performance characteristics.

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 an AI-assisted diagnostic imaging device.

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

• Not applicable. This is not an AI algorithm.

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

• The "ground truth" or basis for acceptance in this context is the comparison to the existing predicate devices (Maxid™ and Palindrome™ 14.5 Fr Chronic Hemodialysis Catheters) in terms of their established performance and materials. The document states "Performance data for the insertion stylets...is compared to the design requirements of the predicate devices."

8. The sample size for the training set

• Not applicable. This is a medical device, not a machine learning model.

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

• Not applicable. This is a medical device, not a machine learning model.

Summary of the Study (Based on Provided Text):

The study referenced is a "verification / validation" process comparing the performance data of the new 14.5 Fr Chronic Hemodialysis Catheter with insertion stylets against the design requirements of the existing predicate devices (Maxid™ and Palindrome™ 14.5 Fr Chronic Hemodialysis Catheters). The intent was to demonstrate substantial equivalence in terms of intended use, materials, physical characteristics, and performance. The document explicitly states that the results "demonstrate that the new catheter/insertion stylet configuration is substantially equivalent to the legally marketed device." No specific quantitative data, sample sizes for testing, or details of the "verification / validation" methodologies are provided in this summary.

Ask a specific question about this device

The 14.5 Fr Chronic Hemodialysis Catheter with Slotted Symmetrical Tip (Palindrome™) is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted percutaneously or by cut down. Catheters greater than 40 cm implant length are indicated for femoral placement.

The 14.5 Fr Chronic Hemodialysis Catheter (Palindrome™) has a radiopaque polyurethane shaft with two large inner lumens designed in a "double D" configuration. The distal end of the catheter extends to a symmetrical tip configuration. The proximal end of the catheter shaft contains a polyurethane hub assembly and silicone extension sets.

The provided text is a 510(k) Premarket Notification for a medical device (Palindrome 14.5Fr Chronic Hemodialysis Catheter with slotted symmetrical tip). It asserts substantial equivalence to a predicate device and includes details about its description, intended use, and regulatory classification.

However, the document does not contain any information regarding specific acceptance criteria, a study proving the device meets those criteria, or details regarding performance metrics, sample sizes for testing/training, expert involvement, or comparative effectiveness studies. The "Performance Data" section simply states that verification/validation results demonstrate substantial equivalence to the predicate device based on comparison, but offers no specific data or methodology.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer the specific questions about study details regarding AI or human reader improvement, as this information is not present in the provided text.

The document primarily focuses on regulatory approval and substantial equivalence with a predicate device, rather than a detailed performance study against specific acceptance criteria.

Ask a specific question about this device

The catheter is designed for cases in which venous catheterization or long term I.V. administration is necessary. Placement is routinely achieved from a peripheral venous site, but the catheter may be placed via subclavian cutdown as well. The catheter may be used to administer fluids for hydration and parenteral nutrition, as well other commonly used intravenous medications.

The proposed PICC catheter is designed for cases in which venous catheterization or long term I.V. administration is necessary in the neonate or pediatric patient. Placement is routinely achieved from a peripheral venous site. The catheter may be used to administer fluids simultaneously for hydration and parenteral nutrition, as well as other commonly used intravenous medications.

The Argyle 1.9 Fr Neonatal/Pediatric Peripherally Inserted Central Catheter PICC) is a dual lumen polyurethane tube that bifurcates into two 5.0 Fr polyurethane tubes (pigtails), the proximal ends of the tubes ending in insert molded hubs. One pigtail is longer than the other. The primary longer lumen will be clear. The shorter secondary lumen will be tinted a lavender color to distinguish it from the primary lumen.

The provided text is a 510(k) premarket notification summary for a medical device, the Kendall/Argyle 1.9 Fr. Neonatal/Pediatric Peripherally Inserted Central Catheter (PICC). This document primarily focuses on demonstrating substantial equivalence to predicate devices and does not describe acceptance criteria, a study proving the device meets those criteria, or details regarding AI/algorithm performance.

Therefore, I cannot provide the requested information about acceptance criteria or a study proving the device meets those criteria based on the given text.

The text does briefly mention "Nonclinical testing," specifically "Biocompatibility testing... following ISO-10993 Biological Evaluation of Medical Devices." This testing found that "the materials used in the Kendall Argyle PICC catheter are biocompatible." However, this is a general statement about biocompatibility and not a detailed study report with specific acceptance criteria or performance metrics as requested in your prompt.

The document does not contain information on:

• A table of acceptance criteria and reported device performance.
• Sample sizes, data provenance, number of experts for ground truth, or adjudication methods for any test set.
• Multi-reader multi-case (MRMC) comparative effectiveness studies or human reader improvement with AI.
• Standalone (algorithm-only) performance, as this is not an AI/algorithmic device.
• The type of ground truth used.
• Sample size for training set or how ground truth for a training set was established.

This type of 510(k) submission generally relies on demonstrating that the new device has the same intended use and similar technological characteristics to legally marketed predicate devices, and that any differences do not raise new questions of safety or effectiveness. The core of the submission is often non-analytical and comparative, rather than a detailed performance study against specific acceptance criteria for a novel technology.

Ask a specific question about this device

Used to assist verification of tube location during oral or nasal placement of a gastric tube in adults.

The Kendall CO2nfirm NOW™ CO2Detector is a disposable device that is used during the oral or nasal placement of a gastric tube to preliminarily determine if the tube is properly placed by detection of CO2

Based on the provided 510(k) summary for the Kendall C02nfirm NOW™ C02 Detector, here's an analysis of the acceptance criteria and supporting study information:

The Kendall C02nfirm NOW™ C02 Detector is a disposable device used to assist in the verification of gastric tube placement by detecting CO2.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly list quantitative acceptance criteria or specific performance metrics for the Kendall C02nfirm NOW™ CO2 Detector. Instead, it relies on demonstrating equivalence to predicate devices and meeting industry standards.

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

The 510(k) summary does not provide details on a specific "test set" in terms of subject or patient data. The non-clinical testing described focuses on demonstrating design equivalence to predicate devices and adherence to industry standards for device construction and function. It does not mention a clinical study involving human subjects or patient data. Therefore, there's no information on sample size, country of origin, or whether it was retrospective or prospective for a clinical test set.

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

Since no clinical test set with human subjects or patient data is described, there is no mention of experts being used to establish ground truth in this context. The evaluation appears to be purely technical and comparative against existing devices and standards.

4. Adjudication Method for the Test Set

Given the absence of a clinical test set and expert review for ground truth, no adjudication method is described.

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

No MRMC comparative effectiveness study is mentioned. The submission focuses on substantial equivalence to predicate devices, not on comparing human reader performance with and without AI assistance. The device is a diagnostic tool, not an AI-powered image analysis system.

6. Standalone Performance Study

The summary describes "Nonclinical Testing" conducted to demonstrate design equivalence and adherence to industry standards. This can be considered a form of standalone testing in the sense that the device itself was tested for its physical and functional characteristics. However, it's not a standalone clinical performance study in the way it's typically understood for diagnostic algorithms (e.g., performance metrics like sensitivity, specificity on a clinical dataset). The testing described is more about the intrinsic properties of the device (colorimetric detection, materials, construction) rather than its diagnostic accuracy in a clinical setting.

7. Type of Ground Truth Used

For the nonclinical testing, the "ground truth" implicitly used would be:

• Predicate Device Performance: The established functionality and performance of the Easy Cap® CO2 detector and Pedi-Cap® CO2 detector.
• Industry Standards: The requirements and specifications outlined in EN1615:2000 and ISO 594, Parts 1&2.
  The summary does not mention pathology, outcomes data, or expert consensus in a clinical context as ground truth.

8. Sample Size for the Training Set

No training set is mentioned. This device is a passive, colorimetric CO2 detector, not a machine learning or AI-driven system that requires a "training set" in the computational sense.

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

As there is no training set for an AI/ML model, this question is not applicable. The device's function is based on a well-understood chemical principle, not on learned patterns from a dataset.

Ask a specific question about this device

The 14.5 Fr x 55cm Chronic Hemodialysis Catheter with Symmetrical Tip (Palindrome™) is intended for hemodialysis, apheresis, and infusion, same indications as the predicate device. The 55cm length is specifically intended for femoral placement.

The 14.5 Fr Chronic Hemodialysis Catheter (Palindrome™) has a radiopaque polyurethane shaft with two large inner lumens designed in a "double D" configuration. The distal end of the catheter tapers to a symmetrical tip configuration. The proximal end of the catheter bifurcates into two color-coded and silicone extension sets.

The provided text describes a 510(k) Premarket Notification for a medical device, the Palindrome™ 14.5 Fr Chronic Hemodialysis Catheter, Femoral Length, and its substantial equivalence to an existing predicate device. However, it does not contain information about acceptance criteria, a study proving the device meets those criteria, or details regarding sample sizes, expert ground truth establishment, or comparative effectiveness studies.

The document primarily focuses on establishing substantial equivalence based on intended use, materials, physical characteristics, and performance characteristics to the existing 14.5 Fr Palindrome™ Hemodialysis Catheter, with the modification being a longer shaft length and an indication for femoral placement.

Therefore, I cannot provide the requested table and study details.

Here's what I can extract from the provided text relevant to your questions (even if it's to state the absence of information):

1. Table of Acceptance Criteria and Reported Device Performance:

• No acceptance criteria or specific performance metrics are reported in the provided text. The document states "Performance data for the femoral length 14.5 Fr Chronic Hemodialysis Catheter with Symmetrical Tip (Results of verification / validation activities) supports the conclusion that the new length device is substantially equivalent to the legally marketed device." This implies performance testing was done, but the results and criteria themselves are not detailed.

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

• Not explicitly mentioned. No sample size for a test set is provided.
• Data Provenance: Not mentioned (e.g., country of origin, retrospective/prospective). The document focuses on the regulatory submission rather than a clinical study report.

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

• Not applicable/Not mentioned. This information would typically be relevant for studies involving human interpretation (e.g., imaging studies), which is not the focus of this device's submission.

4. Adjudication Method for the Test Set:

• Not applicable/Not mentioned.

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

• No. This type of study is not mentioned as part of the submission or review for this device. The focus is on demonstrating substantial equivalence to a predicate, not improving human reader performance with AI.

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 or AI system.

7. The Type of Ground Truth Used:

• Not applicable/Not mentioned in the context of a "ground truth" for a study. For this type of device, "ground truth" would relate to the physical and functional characteristics of the catheter meeting specifications, which is assumed to be covered by "verification/validation activities" but not detailed.

8. The Sample Size for the Training Set:

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

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

• Not applicable. This device is a physical medical catheter, not an AI model.

In summary, the provided document is a regulatory submission for a medical device, focusing on substantial equivalence to a predicate device rather than detailing specific performance studies with acceptance criteria, sample sizes, or expert evaluations in the way one would describe for an AI/algorithm-based device.

Ask a specific question about this device

The 10 Fr Tandem-Cath Chronic Hemodialysis Catheter is intended for hemodialysis, The 1011 Tandem Outh Online Homeans on each either percutaneously or by cutdown.

The Kendall TANDEM-CATH 10 Fr. Catheter System consists of two 10 Fr. Single lumen catheters. Each catheter is 50 cm long, however, the implant length measured from the cuff to the distal tip differs in arterial and venous catheters. The arterial catheter has an implant length 3 cm shorter than its paired venous catheter. The catheter lumens are distinguished by color-coded printing on the catheter shaft (redarterial / blue-venous). The catheters are offered with and without side holes. One configuration has 6 side holes oriented in a spiral pattern at the tip of both the arterial and venous catheters. The second configuration has no side holes on ether the arterial or venous catheter. The TANDEM-CATH is available in three different implant lengths. These variations are 19 cm / 22 cm (arterial / venous), 23 cm / 26 cm, and 28 cm / 31 cm. The Kendall TANDEM-CATH 10 Fr. Catheter System is supplied in kits that include other accessory devices to be used during the catheter implant process.

A Kendall TANDEM-CATH 10 Fr. Catheter repair kit to replace damaged extensions and / or extension adapters is currently marketed, however as there are no changes made to the repair kit, it is not intended to be within the scope of this special 510k.

The provided text describes a Special 510(k) Summary for a modified medical device, the Kendall Tandem-Cath 10Fr Catheter System, seeking substantial equivalence to a previously cleared device. Due to the nature of a 510(k) submission, especially a "Special 510(k)", the focus is on demonstrating that the modified device's performance is equivalent to an existing, legally marketed predicate device rather than establishing entirely new performance criteria or conducting a comprehensive study to prove novel "acceptance criteria" as one might find for a de novo device or a Class III device requiring PMA.

Therefore, the requested information elements related to a "study proving the device meets acceptance criteria" in the context of AI/software performance metrics (like sample size for test/training sets, ground truth establishment, expert adjudication, MRMC studies, standalone performance) are not applicable to this specific submission. This document pertains to physical device modifications and their performance characteristics against a predicate device.

Here's how the available information relates to your request:

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

The document states: "Performance data for the modified 10Fr Tandem-Cath is compared to that of the predicate device identified in this 510(k) summary. Results of verification / validation demonstrate that the modified device is substantially equivalent to the legally marketed device."

This implies that the "acceptance criteria" are the performance characteristics of the predicate device. The "reported device performance" is that the modified device meets or is substantially equivalent to these predicate device characteristics. However, specific numerical acceptance criteria or performance metrics are not explicitly detailed in this summary. The assessment is qualitative, focusing on substantial equivalence.

Table (reconstructed based on the document's intent):

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. This document describes a physical medical device modification (catheter), not an AI/software product requiring a "test set" of data in the sense of AI model evaluation. The "performance data" refers to engineering verification and validation tests, not clinical data sets for AI.

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 establishment by experts is relevant for AI models, not a physical device modification as described.

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

• Not applicable. No adjudication method for a "test set" is mentioned as it's not relevant to this type of submission.

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

• Not applicable. This submission is about a physical catheter, not an AI system. MRMC studies are for evaluating diagnostic AI.

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

• Not applicable. This is not an AI algorithm.

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

• Not applicable. The "ground truth" in this context would be the established performance and safety profile of the predicate device, against which the modified device's performance (e.g., tensile strength, flow rates, biocompatibility, etc. – although not detailed in this summary) would be compared through engineering tests.

8. The sample size for the training set:

• Not applicable. No AI training set is involved.

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

• Not applicable. No AI training set is involved.

In summary: The provided document is a regulatory submission for a physical medical device (catheter) modification, demonstrating substantial equivalence to a predicate device. The information requested, particularly points 2-9, is pertinent to AI/software device evaluation, which is not the subject of this 510(k) summary. The "study" mentioned is the internal "verification / validation" that ensured the modified device performed equivalently to the predicate, but specific details of these engineering tests (like exact benchmarks or test protocols) are not included in this high-level summary.

Ask a specific question about this device