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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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Existing indications cleared in K021933:

The TempFix External Fixation System is indicated for external fixation of open or closed long bone fractures and correction of bony or soft tissue defects or deformities.

When used without adjunctive support, the TempFix External Fixation System is intended to be nonweight bearing.

DePuy also sceks the following additional indications:

The TempFix External Fixation System is MR safe when specific safety guidelines are followed relative to the use of 1.5-Tesla MR systems, only.

The TempFix External Fixation System consists of components that can be assembled to provide multiple degrees of freedom for positioning implantable threaded fixation pins on either side of a fracture or deformity. The unique frame materials provide radiolucent viewing of the fracture and are lightweight for patient comfort. The components are preassembled in kits with three basic frame configurations: a knee frame, a half pin ankle frame, a 400 mm bar, and a transfixing pin ankle frame. Each kit is provided in sterile and non-sterile versions.

The provided text from the 510(k) submission (K043113) for the TempFix™ External Fixation System, MR Safe, does not contain a detailed study report with specific acceptance criteria, reported device performance metrics, or information about sample sizes, ground truth establishment, or expert involvement for a clinical study.

Instead, this submission primarily focuses on establishing "MR safety" for the device based on material conformance to standards and comparison to previously cleared devices. The document does not describe a clinical performance study with the types of metrics requested (e.g., sensitivity, specificity, accuracy) that would apply to an AI/algorithm-based device.

Therefore, I cannot populate the requested table and answer many of the questions as the information is not present in the provided text.

Here is an attempt to address what can be extracted:

Device Acceptance Criteria and Performance (Based on MR Safety Claim)

The "acceptance criteria" here would relate to the device's ability to be considered "MR Safe" according to relevant standards and FDA guidance, rather than clinical performance metrics like diagnostic accuracy.

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information (Not available in the provided text):

• Specific quantitative metrics for MR safety (e.g., temperature rise limits, artifact size limits, force/torque limits) and actual measured values. The document only states "conformance of the material to the standards," but doesn't list the standards or the test results.

2. Sample size used for the test set and the data provenance

Not applicable. This was not a data-driven clinical performance study evaluating an algorithm or AI. The assessment was based on material characterization and potentially bench testing for MR safety.

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

Not applicable. Ground truth in the context of clinical performance (e.g., disease presence) was not established for this submission. The "ground truth" for MR safety would be derived from physical measurements and adherence to engineering standards.

4. Adjudication method for the test set

Not applicable. There was no test set requiring expert adjudication in the context of a clinical performance study for an algorithm.

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 for an external fixation device, not an AI or imaging diagnostic tool.

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, not an algorithm.

7. The type of ground truth used

For the MR safety claim, the "ground truth" would be established by:

• Physical properties and composition of the device materials.
• Results from standardized bench tests (e.g., for magnetic force, torque, heating, artifact) according to relevant industry standards (though these specific tests and their results are not detailed in the provided text).

8. The sample size for the training set

Not applicable. There was no training set for an algorithm.

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

Not applicable. No training set was used.

Summary based on given document:

The 510(k) submission K043113 primarily seeks to add an "MR Safe" claim to the existing TempFix™ External Fixation System. This claim is based on the conformance of the device's materials to established (but unspecified in the provided text) MR safety standards, and comparison to predicate devices that have already been cleared for MR safety. It is not a submission for a software, AI, or diagnostic device, and therefore the criteria for clinical performance studies as typically understood for such devices are not relevant here and thus, not present in the document.

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