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Spire Biomedical Inc.'s RetrO Silver™ and XpressO Silver™ Coated Twin Lumen Chronic Hemodialysis Catheters with Separated Tips are designed for chronic hemodialysis and apheresis. They are radiopaque silicone catheters designed for percutaneous insertion or insertion via a cutdown. Catheters longer than 40cm are intended for femoral vein insertion. The silver coating on the catheter may reduce bacterial surface colonization for up to two months. This performance was supported by literature citing clinical testing.

Spire Biomedical, Inc.'s RetrO Silver™ and XpressO Silver™ are radiopaque silicone catheters that have been coated with silver using a physical vapor deposition process. The silver is applied to the distal end of the catheter from approximately 2-5mm below the cuff to the tips, and is on the exterior surfaces of the catheter only. Aside from the silver coating, the catheters have identical physical characteristics to the non-coated RetrO and XpressO catheters, both of which have 510(k) Premarket Approval. The catheter configurations (available lengths and insertion kit components) are also identical. The silver coating is applied by a vacuum-based physical vapor deposition process called ion beam assisted deposition (IBAD). IBAD combines evaporation with concurrent ion beam bombardment. The process is performed under a high vacuum environment. A silver vapor is formed via electron beam evaporation and deposited onto the catheter. Simultaneously, energetic ions bombard the catheter surface and coating as it is deposited. The coating consists of three layers: titanium, palladium, and silver. The film layers are deposited sequentially with the titanium and palladium layers being completely covered by the silver.

This document, K060288, describes the Spire Biomedical, Inc.'s RetrO Silver™ and XpressO Silver™ Coated Twin Lumen Chronic Hemodialysis Catheters with Separated Tips. The key performance claim for these devices is the silver coating's ability to reduce bacterial surface colonization for up to two months.

Here's an analysis of the acceptance criteria and the study that supports it:

1. Table of Acceptance Criteria and Reported Device Performance

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

For the reduction of bacterial surface colonization, the document refers to a published clinical study by Bambauer et al. (2001). The sample size and specific details of the test set for this study are not provided in the submission itself, but would be found in the referenced publication. The data provenance is implied to be clinical, but the country of origin is not specified in this document. It is a retrospective reference to existing literature.

For frictional resistance, silver coated catheters and uncoated catheters were compared. The document doesn't specify the exact number of catheters in the test set, but states "Tests were conducted at several different normal load conditions" and "All measurements were conducted in the dry state." This was a prospective in-vitro bench test.

For silver elution rates, "segments were cut from the shafts of silver coated catheters" and "Tests were performed in triplicate for periods ranging from 1 day to 8 weeks." This was a prospective in-vitro bench test with a sample size of at least three per time point.

For equivalent flows and mechanical properties, these were compared to predicate devices. The document does not specify the sample size but implies an in-vitro equivalence study.

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

For the reduction of bacterial surface colonization, the information is based on a referenced clinical study. The number and qualifications of experts involved in establishing the ground truth (e.g., diagnosing infections, culturing bacteria) for that study are not provided in this 510(k) submission.

For the in-vitro tests (frictional resistance, silver elution rates, flows, mechanical properties), "experts" in the traditional sense of medical diagnoses were not involved. The ground truth was established through laboratory measurement protocols and analyses by qualified technical personnel within Spire Biomedical or a contract lab.

4. Adjudication Method for the Test Set

Given the nature of the evidence provided (reference to a clinical study for bacterial colonization, and in-vitro bench testing for other characteristics), there is no mention of an adjudication method (like 2+1 or 3+1 consensus) in this submission. This type of adjudication is typically relevant for studies involving human interpretation of medical images or symptoms, which is not the primary focus of the performance data presented here.

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

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done or reported in this submission. The device is a physical medical device (catheter), and its performance data focuses on material properties, bacterial colonization rates, and mechanical equivalence, rather than human interpretation or diagnostic aid. Therefore, the concept of "how much human readers improve with AI vs without AI assistance" does not apply.

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

This question is not applicable to this device. The RetrO Silver™ and XpressO Silver™ catheters are physical medical devices, not AI algorithms. Their performance is described in a standalone manner, entirely independent of human-in-the-loop performance in the context of interpretation or decision-making.

7. Type of Ground Truth Used

• Reduction of Bacterial Surface Colonization: The ground truth for this claim is based on clinical testing from referenced literature. This would typically involve microbiological culture results or clinical infection rates.
• Frictional Resistance: The ground truth was established through direct physical measurement using a test rig platform.
• Silver Elution Rates: The ground truth was established through chemical analysis (measuring silver concentration in solution) in laboratory immersion studies.
• Equivalent Flows and Mechanical Properties: The ground truth was established through physical measurements and engineering tests to compare the coated catheters to their non-coated predicate devices.

8. Sample Size for the Training Set

This device does not involve a "training set" in the context of machine learning or AI models. Therefore, this question is not applicable. The performance data is derived from direct testing of the physical device or references to clinical studies, not from a model trained on data.

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

As there is no training set for this physical medical device, this question is not applicable.

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The MAC™Two-Lumen Central Venous Access Device with ARROWg+ard Blue® permits venous access and catheter introduction to the central circulation. It may be inserted into the jugular, subclavian, or femoral veins. The ARROWg+ard® technology is intended to help provide protection against catheter-related infections. Clinical data have not been collected that demonstrate the use of the ARROWg+ard® antimicrobial surface in decreasing catheter-related infections for this device. It is not intended to be used as a treatment for existing infections, nor is it indicated for long-term use.

The proposed device is a modification to Arrow's Two-Lumen Central Venous Access Kit with Integral Hemostasis Valve/Side Port, with the addition of ARROWg" ard Blue antimicrobial surface treatment. The proposed device was Arked to help provide protection against device-related infections. It is not intended to help provise a treatment for existing infections, nor is it indicated for long-term use.

The catheterization kit components are configured in a high-impact polystyrene (HIPS) tray, sealed with a Tyvek® lidstock, and sterilized.

Here's an analysis of the provided text, focusing on the absence of information regarding "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the context of device performance, and then answering the specific questions based on the available text:

The provided text, a 510(k) summary for a medical device called "MAC™ Two-Lumen Central Venous Access Kit with ARROWg+ard Blue®," does not contain explicit "acceptance criteria" for device performance in the way typically expected for a performance study. Nor does it describe a study specifically designed to prove that the device meets such acceptance criteria with quantitative results against those criteria.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices. The "performance tests" listed are a series of laboratory and in-vitro tests conducted to ensure the modified device (with the ARROWg+ard Blue® coating) performs similarly to its predecessors and meets general safety and effectiveness standards, rather than proving performance against predefined clinical or quantitative acceptance thresholds specific to its intended use and antimicrobial claim.

The key points from the document regarding "performance" are:

• Intended Use: "The ARROWg+ard® technology is intended to help provide protection against catheter-related infections. Clinical data have not been collected that demonstrate the use of the ARROWg+ard® antimicrobial surface in decreasing catheter-related infections for this device. It is not intended to be used as a treatment for existing infections, nor is it indicated for long-term use." This explicitly states that clinical data for the antimicrobial efficacy in vivo was not collected or submitted as part of this 510(k).
• Performance Tests: A list of 14 tests is provided (tensile, leak, elongation, flow rate, priming volume, flex, burst, in vitro efficacy zone of inhibition, in vitro safety elution profile, hemolysis, fatigue life, stability, and biocompatibility).
• Conclusions: "The results of the laboratory tests demonstrate that the device is as safe and effective as the legally marketed predicate devices."

Therefore, the answers to your questions will largely reflect the absence of a detailed performance study against explicit acceptance criteria in this submission.

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

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

Specific tests performed included:

1. Tensile
2. Leak
3. Elongation
4. Flow Rate with Catheter
5. Flow Rate without Catheter
6. Priming Volume
7. Flex
8. Burst
9. In vitro efficacy zone of inhibition
10. In vitro safety elution profile
11. Hemolysis
12. Fatigue life testing
13. Stability tests
14. Biocompatibility tests

Regarding antimicrobial claim: "Clinical data have not been collected that demonstrate the use of the ARROWg+ard® antimicrobial surface in decreasing catheter-related infections for this device." |

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 in the provided text for any of the listed performance tests.
• Data Provenance: The tests are described as "laboratory tests" and "in vitro" tests. No country of origin is specified for these tests, though the submitting company is based in Reading, Pennsylvania, USA. The data would be considered prospective for these specific tests, as they were conducted as part of the device submission.

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. The listed performance tests are primarily objective physical and chemical measurements rather than requiring expert interpretation for ground truth.

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

• Not applicable/None specified. The types of tests listed (e.g., tensile strength, leak, flow rate) typically have objective pass/fail criteria determined by measurement, rather than relying on an adjudication process involving multiple human observers.

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

• No MRMC comparative effectiveness study was done or mentioned. This type of study is relevant for diagnostic imaging devices where human interpretation is a key component, which is not the case for this central venous access device.

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

• Not applicable. This device is a physical medical device (catheter kit) and does not involve an algorithm or AI.

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

• For the performance tests mentioned (tensile, leak, flow rate, etc.), the "ground truth" would be the direct physical or chemical measurements obtained from the tests themselves, compared against engineering specifications or established standards for intravascular catheters.
• For the antimicrobial claim, the document explicitly states: "Clinical data have not been collected that demonstrate the use of the ARROWg+ard® antimicrobial surface in decreasing catheter-related infections for this device." This indicates that clinical outcomes data (which would be the ultimate ground truth for an antimicrobial claim) were not used in this submission. In vitro efficacy (zone of inhibition) and in vitro safety (elution profile) tests were performed in its place for the antimicrobial aspect.

8. The sample size for the training set

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

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

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

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