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To replace: Cracked or broken female Luer-lock connector or repair damaged extension where there is a minimum of 4.5 cm of viable extension tubing on the following catheters: Equistream Long-Term Dual Lumen Catheter.

The Dialysis Catheter Repair kit is used to perform a repair of an Equistream Long-Term Dual Lumen Catheter, replacing cracked or broken luer-lock connectors, clamps and/or damaged extension legs when a minimum of 4.5 cm of viable extension tubing exists. The repair kit components are made from Delrin.

Here's a breakdown of the acceptance criteria and study information based on the provided document:

This device is a Catheter Repair Kit with Replacement Connector (K101261). It is essentially a repair kit for specific hemodialysis catheters, designed to replace damaged Luer-lock connectors or extensions.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a specific table with quantitative acceptance criteria (e.g., specific tensile strength values, leak rates, etc.) and corresponding reported device performance. Instead, it states that the device "met all predetermined acceptance criteria derived from the above mentioned references." The references listed are:

• Guidance on Premarket Notification [510(k)] Submission for Short-Term & Long-Term Intravascular Catheters; March 16, 1995
• ISO 10555-1:1995/Amd 1:1999, Amd 2:2004; Sterile, single-use intravascular catheters, Part 1. General requirements
• AAMI/ANSI/ISO 10993-1:2003; Biological Evaluation of Medical Devices Part 1: Evaluation and Testing
• ISO 594-2: 1998: Conical Fittings with 6% (Luer) Taper for Syringes, Needles and Certain Other Medical Equipment—Part 2: Lock Fittings
• AAMI/ANSI/ISO 11135-1:2007, Sterilization of Health Care Products - Ethylene Oxide –Part 1: Requirement for the development, Validation and Routine Control of a Sterilization Process for Medical Devices.

The general performance statement is: "Design validation was conducted on the subject Catheter Repair Kit with Replacement Connector configuration and yielded acceptable results."

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

The document does not specify exact sample sizes for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It generically states: "Tests were performed on sterilized, finished devices."

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

This type of information is not applicable to this device. This is a physical medical device (a catheter repair kit), and its performance is evaluated through non-clinical bench testing against established engineering and medical device standards, not through expert review of diagnostic images or clinical data for ground truth.

4. Adjudication Method for the Test Set

Not applicable. As the device performance is evaluated using non-clinical, objective testing (e.g., mechanical strength, leak tests, biocompatibility), there is no "adjudication method" in the sense of human interpretation or consensus.

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

No, a MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic or screening devices where human interpretation is involved. This device is a repair kit for a catheter, and its effectiveness is determined through physical and material property testing, not human reader performance.

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 an algorithm or AI system. Therefore, the concept of "standalone performance" in the context of AI is irrelevant here. Its performance is inherent in its design and manufacturing.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by engineering and medical device standards (e.g., ISO and AAMI standards) and in-house protocols that specify acceptable measurable parameters for catheter components regarding mechanical integrity, fluidic performance (e.g., Luer-lock fit), biocompatibility, and sterilization efficacy.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device. The concept of a "training set" is relevant for machine learning algorithms, not for the physical testing of a medical device like a catheter repair kit.

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

Not applicable. As a physical medical device, there is no "training set" or corresponding ground truth established in the context of data for an algorithm. The "ground truth" for its design and manufacturing is adherence to established regulatory and engineering standards.

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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.

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To replace: Cracked or broken female luer lock connectors or repair damaged extension where there is a minimum of 4.5 cm of viable extension tubing on the following catheters: Soft-Cell* Long-Term Dual Lumen Catheter, Opti-Flow* Long-Term Dual Lumen Catheter, Slim-Cath* Short-Term Dual Lumen Catheter, Vaccess* Short-Term Single Lumen Catheter, HemoStar* Long-Term Dual Lumen Catheter, Flexxicon* Short-Term Dual Lumen Catheter, Niagara* Short-Term Dual Lumen Catheter, Flexxicon* II Short-Term Dual Lumen Catheter, HemoGlide* Long-Term Dual Lumen Catheter, and HemoSplit* Long-Term Hemodialysis Catheter.

The Catheter Repair Kit with Replacement Connector is exactly the same as the predicate device.

Here's an analysis of the provided text regarding the Catheter Repair Kit with Replacement Connector:

The provided document is a 510(k) summary for a medical device called the "Catheter Repair Kit with Replacement Connector." This type of submission aims to demonstrate that a new device is substantially equivalent to a previously cleared device (predicate device), rather than proving stand-alone safety and effectiveness through extensive clinical trials. Therefore, the information typically found in studies designed to "prove the device meets acceptance criteria" in the way one might expect for novel, high-risk devices or AI algorithms is not present here.

Instead, the "study" demonstrating that the device meets acceptance criteria primarily consists of non-clinical performance testing to show equivalence to the predicate device, especially in light of a minor material formulation change.

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

1. Table of Acceptance Criteria and Reported Device Performance:

   The document does not explicitly present a table of "acceptance criteria" and "reported device performance" in the typical format of sensitivities, specificities, or other statistical measures for a decision-making algorithm. Instead, the acceptance criteria implicitly relate to the device functioning in a manner equivalent to the predicate device after a material change. The "performance" is demonstrated through non-clinical testing.

   Acceptance Criterion (Implicit)	Reported Device Performance (Summary)
   Safety and Effectiveness not adversely affected by minor material change.	FMEA conducted, no new safety/effectiveness questions raised. Performance data demonstrate equivalence.
   Maintain intended use and functional characteristics of predicate device.	Testing based on FDA guidance and standards to evaluate performance. Performance data demonstrate equivalence.
   Compatibility with listed catheters for repair (cracked/broken luer lock, damaged extension).	Assumed to be met through equivalence to predicate device and non-clinical testing.

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

   • Sample Size for Test Set: Not specified. The document refers to "testing" and "performance data" without detailing the number of units or test iterations.
   • Data Provenance: Not applicable in the context of human data. The testing would be laboratory-based (in-vitro) on device components.

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 study described is for a physical medical device (catheter repair kit) and not an AI/diagnostic algorithm where expert ground truth is typically established. The "ground truth" would be the engineering specifications and intended function of the device.

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

   • Not applicable as this is not a study involving human readers or diagnostic interpretation. The "adjudication" of test results would be based on engineering and quality control standards.

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 device.

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

   • No. This is not an AI device.

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

   • For this type of device, the "ground truth" for performance testing (e.g., tensile strength, leak resistance, biocompatibility) would be defined by engineering specifications, recognized industry standards (e.g., ISO), and FDA guidance documents. The device must meet these predetermined physical and functional criteria.

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. As above, there is no training set for this type of device.

Summary of the "Study" from the document:

The "study" referenced in the 510(k) process for the Catheter Repair Kit with Replacement Connector is a non-clinical performance testing program. This program was undertaken because of a minor material formulation change in the new device compared to its predicate.

• Objective: To determine if the material change affects the safety or effectiveness of the device and to demonstrate substantial equivalence to the predicate device (K030442).
• Methodology:
  • A Failure Modes and Effects Analysis (FMEA) was conducted in accordance with ISO 14971:2000 to identify potential risks.
  • Performance testing was conducted based on FDA guidance documents and standards.
• Results/Conclusion:
  • The FMEA did not raise any new types of safety or effectiveness questions.
  • The performance data generated from the testing demonstrated equivalence to the predicate device.

This approach is standard for 510(k) submissions where changes to an existing device are minor and do not introduce new scientific or technological challenges. The "acceptance criteria" are intrinsically linked to demonstrating that the new device performs identically (or equivalently) to the already cleared predicate device, ensuring no new risks or diminished effectiveness due to the material change.

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To replace damaged female luer connectors, clamps, or repair extensions where there is a minimum of 2.5 cm viable extension tubing. Repairs Spire BioMedical Xpresso®, Decathlon™, & Alta LR™ catheters.

The Spire BioMedical repair kit is used to replace damaged female luer connectors, clamps, or repair extensions where there is a minimum of 2.5 cm viable extension tubing. This repair kit is to be used on the Spire BioMedical Xpresso®, Decathlon™, and Alta LR™ catheters.

The provided K062435 document describes a 510(k) premarket notification for a "Repair Kit for XpressO®, Decathion™, and Alta LR™ Catheters." This device is a repair kit for existing medical catheters, and the submission focuses on demonstrating substantial equivalence to a predicate device, the Pourchez Retro Repair Kit (K022644).

Given the nature of this submission (a repair kit for existing catheters, demonstrating equivalence to an existing repair kit), the "study" conducted is a series of bench tests rather than a clinical trial involving human or animal subjects that falls under a typical AI/ML performance study. The focus is on physical and material characteristics.

Therefore, many of the requested categories (such as sample size for test/training sets, ground truth establishment for AI, expert involvement, MRMC studies, standalone AI performance) are not applicable to this type of device and submission. The "acceptance criteria" and "device performance" in this context refer to the physical and mechanical properties tested during bench validation.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "A series of physical tests were conducted to demonstrate substantial equivalence to the Pourchez Retro Repair Kit (K022644). Refer to Section 18 'Bench Testing' for physical test data."

However, Section 18 "Bench Testing" is not included in the provided excerpts. Therefore, the specific acceptance criteria and the quantitative reported performance values are not available here. We can infer that the general acceptance criterion would be that the repair kit's performance in these physical tests is equivalent to or not worse than the predicate device.

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

• Sample Size: Not specified in the provided document. For physical bench testing, sample sizes vary depending on the specific test and statistical requirements.
• Data Provenance: The tests were conducted "in-house" by Spire Biomedical, Inc. (manufacturer), likely at their facility in Bedford, MA, USA. This is a retrospective evaluation based on laboratory testing of the device prototypes.

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

• Not Applicable. For physical bench testing of a medical device repair kit, "ground truth" is typically established by engineering specifications, material standards, and benchmark performance of predicate devices, not by expert consensus on clinical data. The tests are objective measurements of physical properties.

4. Adjudication Method for the Test Set

• Not Applicable. Adjudication methods (like 2+1 or 3+1) are relevant for subjective assessments, such as image interpretation or clinical outcomes, typically involving multiple human readers. Bench testing involves objective measurements against established technical specifications.

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

• Not Applicable. This device is not an AI/ML-driven diagnostic or assistive tool for human readers. It's a physical medical device repair kit.

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

• Not Applicable. This device does not involve an algorithm or AI.

7. The Type of Ground Truth Used

• For physical tests: Engineering specifications, material standards, and benchmark performance data of the predicate device (Pourchez Retro Repair Kit K022644).
• For biocompatibility: Adherence to recognized biocompatibility standards (e.g., ISO 10993 series) for medical devices.

8. The Sample Size for the Training Set

• Not Applicable. This is not an AI/ML device, so there is no "training set." The repair kit itself is the "device," designed and manufactured according to specifications.

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

• Not Applicable. As there is no training set for an AI/ML model, this question does not apply.

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To replace: Cracked or broken female luer lock connectors or repair damaged extension leg where there is a minimum of 4.5 cm of viable extension tubing on the following catheters: Soft-Cell® Long-Term Dual Lumen Catheter, Opti-Flow® Long-Term Dual Lumen Catheter, Slim-Cath™ Short-Term Dual Lumen Catheter, Vaccess® Short-Term Single Lumen Catheter, Flexxicon® Short-Term Dual Lumen Catheter, Niagara™ Short-Term Dual Lumen Catheter, Flexxicon® II Short-Term Dual Lumen Catheter, HemoGlide™ Long-Term Dual Lumen Catheter, and HemoSplit™ Long-Term Hemodialysis Catheter.

The Catheter Repair Kit with Replacement Connector is exactly the same as the predicate device.

Here's an analysis of the provided text regarding the HemoSplit Repair Kit, focusing on the acceptance criteria and study information:

HemoSplit Repair Kit: Acceptance Criteria and Study Information

Note: The provided documentation (K030442) is a 510(k) summary for a medical device. This type of submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed clinical study results with specific performance metrics and acceptance criteria in the way a PMA (Pre-Market Approval) or a more extensive clinical trial report would. Therefore, much of the requested information, particularly regarding specific performance metrics, sample sizes for test sets, expert involvement, and advanced study methodologies like MRMC or standalone performance, is not present in this document. The "study" here is largely based on demonstrating equivalence rather than new performance.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of this 510(k) submission, the "acceptance criteria" are interpreted as the requirements for demonstrating substantial equivalence, and the "reported device performance" is framed in terms of meeting those equivalence criteria.

Conclusion from the 510(k): Based on these criteria, the Catheter Repair Kit with Replacement Connector (HemoSplit Repair Kit) was deemed substantially equivalent to the predicate device (Catheter Repair Kit with Replacement Connector, K022561).

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

• Sample Size for Test Set: Not applicable / Not mentioned. This 510(k) submission does not describe a separate "test set" in the context of performance evaluation with specific data points. The focus is on comparing the design and stated intended use to a predicate device.
• Data Provenance: Not applicable / Not mentioned. No specific data is presented that would have a country of origin or be classified as retrospective/prospective.

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

• Number of Experts: Not applicable / Not mentioned. As there is no specific "test set" described for performance evaluation, there's no mention of experts establishing ground truth for such a set.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable / Not mentioned. Without a test set and expert review, an adjudication method is not relevant to this submission.

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

• MRMC Study: No. This type of study is not described or referenced in the 510(k) summary. The device is a physical repair kit, not an AI or imaging diagnostic tool where MRMC studies are common.
• Effect Size of Human Readers Improve with AI vs. Without AI: Not applicable. (See above.)

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

• Standalone Study: Not applicable. This device is a physical product (a repair kit), not an algorithm or software. Therefore, the concept of "standalone performance" in the context of AI/software does not apply.

7. Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" in this 510(k) submission is the established performance and safety profile of the predicate device (Catheter Repair Kit with Replacement Connector, K022561). The new device demonstrates "substantial equivalence" to this known entity.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable / Not mentioned. This submission does not involve machine learning or AI, so there is no concept of a "training set" for an algorithm.

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

• How Ground Truth for Training Set Was Established: Not applicable / Not mentioned. (See above.)

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Pourchez RetrO™ Repair Kit is designed to replace worn or damaged extension connector adapters on Spire Biomedical, Inc.'s Pourchez RetrO catheters.

Pourchez RetrO™ Repair Kit is designed to replace worn or damaged extension connector adapters on Spire Biomedical, Inc.'s Pourchez RetrO Twin Lumen Silicone Hemodialysis Catheters with Separated Tips.

Here's an analysis of the provided text regarding the Pourchez RetrO Repair Kit, focusing on acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample size used for the tensile tests. It only states "A series of tensile tests were performed."
The data provenance (country of origin, retrospective/prospective) is not mentioned.

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

Not applicable. The study involves tensile strength testing against an ISO standard, not expert review of medical images or conditions.

4. Adjudication Method for the Test Set

Not applicable, as it is a physical device performance test against a standard, not a subjective assessment requiring adjudication.

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

No. This type of study is not applicable to
a physical device performance test.

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

Not applicable. This is not an AI/algorithm-based device.

7. The Type of Ground Truth Used

The ground truth used is the minimum tensile strength required by ISO 10555-1. This is a recognized international standard for sterile intravascular catheters.

8. The Sample Size for the Training Set

Not applicable. There is no mention of a training set as this is not an AI/machine learning device.

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

Not applicable, as there is no training set for this type of device.

Summary of the Study and Device Performance:

The Spire Biomedical, Inc. Pourchez RetrO Repair Kit was evaluated through a series of tensile tests. The acceptance criteria for the device's performance was its ability to meet or exceed the minimum tensile strength specified by the ISO 10555-1 standard for hemodialysis catheters. The study concluded that the repair kit's extension adapters successfully "exceed the minimum tensile strength required by ISO 10555-1," demonstrating its substantial equivalence or conformity to established standards. The exact number of units tested (sample size) for these tensile tests is not detailed in the provided K510 summary.

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THE MEDCOMP REPAIR KIT IS INDICATED FOR USE IN REPLACING DAMAGED FEMALE LUER CONNECTORS, CLAMPS, OR REPAIRING EXTENSIONS WHERE THERE IS A MINIMUM OF 4.5cm VIABLE EXTENSION TUBING.

REPAIRS MEDCOMP CATHETERS: 10F Ash Split Cath® XL, 10F Ash Split Cath® II, 14F Ash Split Cath®, 14F Ash Split Cath® XL, 14F Ash Split Cath® II, 16F Ash Split Cath® II

The Medcomp Repair Kit is two-piece replacement luer adaptor and cap used to repair damaged female luer connectors on Medcomp Hemodialysis Catheters. The Medcomp Repair Kit also consists of replacement arterial and venous clamps.

Acceptance Criteria and Device Performance Study for Medcomp Repair Kit (K022570)

The Medcomp Repair Kit is a two-piece replacement luer adaptor and cap intended for repairing damaged female luer connectors on Medcomp Hemodialysis Catheters. It also includes replacement arterial and venous clamps. The device is designed to repair extensions where there is a minimum of 4.5cm viable extension tubing on specific Medcomp Catheter models.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

No specific test set sample size is explicitly stated in the provided document. The performance data relied on in-vitro testing only. Therefore, there is no information regarding the country of origin or whether the data was retrospective or prospective, as these aspects are typically relevant for clinical studies.

3. Number of Experts and Qualifications for Ground Truth Establishment

Not applicable. The study involved in-vitro testing, not clinical evaluation requiring expert consensus for ground truth establishment.

4. Adjudication Method for Test Set

Not applicable. As the study was an in-vitro performance evaluation, there was no human adjudication process involved.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. The submission explicitly states that "Clinical studies were not deemed necessary."

6. Standalone (Algorithm Only) Performance Study

Not applicable. The Medcomp Repair Kit is a physical medical device, not an algorithm or AI-driven system. Therefore, a standalone (algorithm only) performance study is not relevant.

7. Type of Ground Truth Used

The ground truth for this device's performance was established through in-vitro testing against the performance characteristics of a legally marketed predicate device (K011015 Bard Catheter Repair Kit). This implies that the 'ground truth' was defined by the established performance benchmarks and regulatory compliance of the predicate device.

8. Sample Size for the Training Set

Not applicable. There was no "training set" as this device is not an AI/ML algorithm requiring training data. The assessment was based on comparing the repair kit's physical and functional performance to a predicate device.

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

Not applicable. As there was no training set, there was no ground truth established for one. The evaluation focused on demonstrating that the performance of the Medcomp Repair Kit was substantially equivalent to the predicate device through in-vitro testing.

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To replace: Cracked or broken female luer lock connectors or repair damaged extension leg where there is a minimum of 4.5 cm of viable extension tubing on the following Vas-Cath catheters: Soft-Cell® Long-Term Dual Lumen Catheter, Opti-Flow® Long-Term Dual Lumen Catheter, Slim-Cath™ Short-Term Dual Lumen Catheter, Vaccess® Short-Term Single Lumen Catheter, Flexxicon® Short-Term Dual Lumen Catheter, Niagara™ Short-Term Dual Lumen Catheter, Flexxicon® II Short-Term Dual Lumen Catheter, HemoGlide™ Long-Term Dual Lumen Catheter.

The Catheter Repair Kit with Replacement Connector is exactly the same as the predicate device.

The provided document is a 510(k) summary for a Catheter Repair Kit with Replacement Connector. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the safety and effectiveness of a novel device through clinical performance studies with acceptance criteria.

Therefore, this document does not contain information regarding:

• Acceptance criteria and reported device performance in the context of a clinical study.
• Sample sizes for test sets or training sets.
• Data provenance (country of origin, retrospective/prospective).
• Number/qualifications of experts for ground truth establishment.
• Adjudication methods.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or effect sizes.
• Standalone algorithm performance.
• Type of ground truth used (pathology, outcomes data, expert consensus).
• How ground truth for a training set was established.

Instead, the document focuses on demonstrating substantial equivalence based on technological characteristics and intended use.

Here's a breakdown of what the document does state in relation to the prompt:

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

• Not Applicable. This document does not describe performance in terms of clinical acceptance criteria for a device. It asserts that the new device has "exactly the same" technological characteristics as the predicate device (K011015) and that the intended use is "identical" or "the same." The only difference noted is the addition of one catheter trade name (HemoGlide™) to the list of repairable catheters and a minor labeling consistency change (temporary to short-term).
• The "performance" implied is that it will perform identically to the predicate device because it is technologically the same.

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

• Not Applicable. No test set or clinical data is presented or referenced for device performance. The 510(k) relies on comparison to a predicate.

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. No "ground truth" establishment by experts for a test set is described.

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

• Not Applicable. No test set or adjudication is mentioned.

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 (Artificial Intelligence) device, and no MRMC study or AI assistance is discussed.

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

• Not Applicable. This is a physical medical device (catheter repair kit), not an algorithm or software. "Standalone performance" in this context would typically refer to bench testing, which is assumed to be part of the product development but not detailed as a comparative study in this 510(k) summary.

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

• Not Applicable. The concept of "ground truth" in the context of clinical data for performance assessment is not relevant to this 510(k) submission. The basis for approval is substantial equivalence to a predicate device.

8. The sample size for the training set:

• Not Applicable. There is no mention of a training set as this is not an AI/machine learning device.

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

• Not Applicable. No training set or ground truth establishment for a training set is discussed.

In summary: The provided document is a 510(k) premarket notification that demonstrates substantial equivalence of a physical medical device (Catheter Repair Kit) to a predicate device, rather than presenting a clinical study with acceptance criteria, ground truth, or statistical performance metrics.

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The Diatek Connector Assembly Replacement Kit is to be used for replacing the original connector assembly on a Diatek Cannon-Cath Dialysis Catheter if the connector assembly becomes damaged or dysfunctional. This prevents the patient from requiring additional surgery for catheter removal and replacement.

The Connector Assembly Replacement Kit is intended for use in any patient who has a previously implanted Diatek Cannon-Cath implanted.

The Diatek Connector Assembly Replacement Kit consists of a Cannon-Cath connector assembly and components needed to remove the previously implanted connector assembly and attach the new connector assembly to the previously implanted dialysis catheter.

The provided 510(k) summary for the Diatek Connector Assembly Replacement Kit (K020430) is not a study of device performance in the typical sense of measuring efficacy or safety in a clinical trial. Instead, it describes a component replacement kit for an existing, already cleared device (Diatek Cannon-Cath Dialysis Catheter).

The "study" cited here is not a clinical study but rather a statement of equivalence based on the components being identical to those already tested and found acceptable for the predicate device. Therefore, many of the requested categories related to clinical study design and performance metrics are not applicable in this context.

Here's an analysis based on the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a component replacement kit, the acceptance criteria are primarily focused on maintaining the safety and effectiveness profile of the original device. The "performance" is the fact that the components are the same as those already proven acceptable.

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

• Sample Size for Test Set: This information is not provided in the summary. The summary refers to previous testing performed on the predicate device's components.
• Data Provenance: The original testing on the predicate device's components was conducted by "both internal and outside laboratories." The country of origin and whether it was retrospective or prospective data are not specified.

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

• Not Applicable. This type of information is pertinent to studies involving diagnostic accuracy or interpretation, often with imaging or clinical data. Since this is a hardware component replacement kit, "ground truth" established by experts in this manner is not relevant to the testing described. The "ground truth" would be the successful function and safety of the original components as determined by engineering and biocompatibility testing.

4. Adjudication Method for the Test Set

• Not Applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies where expert consensus is needed to resolve discrepancies in diagnosis or assessment. This is not reported for the engineering and material testing referenced.

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

• No. An MRMC study is typically for evaluating diagnostic imaging systems or decision support tools where human readers are interpreting cases. This device is a mechanical component, so an MRMC study is not relevant.

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

• Not Applicable. This refers to the performance of an AI algorithm without human involvement. This device is not an AI algorithm. The performance of the components themselves (e.g., strength, biocompatibility, fluid dynamics) was likely evaluated in a standalone manner without human intervention during the specific tests, but this isn't in the context of an AI algorithm.

7. The Type of Ground Truth Used

• For the original predicate device components, the "ground truth" would have been established through bench testing results, material specifications, biocompatibility studies, and potentially animal or clinical performance data validating the functional integrity and safety of the components. The exact types are not specified beyond "a range of criteria."

8. The Sample Size for the Training Set

• Not Applicable. A "training set" refers to data used to train machine learning models. This device is a mechanical component, not an AI system.

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

• Not Applicable. As above, there is no training set for a mechanical device.

Summary of the "Study" Proving Acceptance Criteria:

The "study" cited for the Diatek Connector Assembly Replacement Kit is a bridging argument based on identity to a predicate device's components, rather than new, independent testing or a clinical trial for the kit itself. The critical information provided is:

• The components in the replacement kit are identical to those in the predicate Diatek Cannon-Cath product.
• These identical components were previously tested (via 510(k) 010399) by internal and external laboratories against "a range of criteria" and found acceptable.

This approach is common for component-level changes or replacement kits that do not introduce new technology or alter the fundamental operating principles of an already cleared device. The focus is on demonstrating that the replacement kit maintains the same safety and effectiveness profile as the original, proven components.

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