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The Trellis ™ Reserve Infusion System is intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.

The Trellis Reserve Infusion Catheter enables the physician to isolate a treatment region, infuse a physician-specified fluid, and disperse the fluid by means of oscillation of a Dispersion Wire. The Isolation/Infusion component is a multi-lumen catheter with two compliant balloons at the distal end and infusion holes located between these balloons. When inflated, the compliant balloons isolate a treatment zone to maintain concentration of the infused fluid. The device also has a central through-lumen that is compatible with a 0.035" guidewire. The Dispersion Wire component is a sheathed, shape-set Nitinol cable that provides oscillation when activated. The Dispersion Wire is connected to an integral Oscillation Drive Unit which oscillates the Dispersion Wire up to 25 Hertz within the isolated region to further disperse the infused fluid. If desired by the physician, post procedure aspiration of the isolated area between the occluding balloons may be accomplished through the catheter by using the guidewire lumen.

This document is a 510(k) summary for the Trellis Reserve Infusion System. It describes the device, its intended use, and claims substantial equivalence to previously cleared devices. However, it does not contain information about acceptance criteria or a specific study proving the device meets those criteria in the way requested.

The document states: "The Trellis Reserve Infusion System was tested in the same manner as the Trellis and Trellis Plus Infusion Systems (K013635 & K021958). All components, subassemblies, and/or full devices met the required specifications for the completed tests." This is a general statement that internal testing was conducted and met "required specifications," but it doesn't provide the details needed to answer your questions.

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

Here's what can be extracted based on the instruction to "describe the acceptance criteria and the study that proves the device meets the acceptance criteria" using 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 used for the test set: Not specified. The document only states "All components, subassemblies, and/or full devices."
• Data provenance: Not specified. This would typically be internal testing by the manufacturer (Bacchus Vascular, Inc.), likely in the USA where the company is based.

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 type of information is usually relevant for studies involving human interpretation or clinical endpoints, not for performance testing of a medical device's physical and functional specifications. The "ground truth" for device specifications is typically defined by engineering standards and design requirements.

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

• Not applicable for performance testing of engineering 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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done, as this document pertains to a medical device for infusing fluids, not an AI software.

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

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

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

• The "ground truth" for this device's performance testing would be defined by the engineering specifications and design requirements set by Bacchus Vascular, Inc. and presumably validated against industry standards or regulatory guidance for similar devices.

8. The sample size for the training set

• Not applicable, as this is a physical medical device, not a machine learning model requiring a training set.

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

• Not applicable, as this is a physical medical device, not a machine learning model.

In summary: The provided FDA 510(k) summary is a regulatory filing for a medical device (Trellis Reserve Infusion System). It confirms that the device was tested and met required specifications, drawing equivalence to previously cleared predicate devices. However, it does not provide detailed information about the specific "acceptance criteria" (e.g., specific quantitative performance metrics) or the methodology of the "study that proves the device meets the acceptance criteria" in the format of a clinical trial or AI performance study. The testing mentioned refers to standard engineering and performance verification for medical devices.

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The Trellis™ Plus Infusion System is intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.

The Trellis Plus Infusion Catheter enables the physician to isolate a treatment region, infuse a physician-specified fluid, and disperse the fluid by means of oscillation of a Dispersion Wire. The Isolation/Infusion component is a multi-lumen catheter with two compliant balloons at the distal end and infusion holes located between these balloons. When inflated, the compliant balloons isolate a treatment zone to maintain concentration of the infused fluid. The device also has a central through-lumen that is compatible with a 0.035" guidewire. The Dispersion Wire component is a sheathed, shape-set Nitinol cable that provides oscillation when activated. The Dispersion Wire is connected to an integral Oscillation Drive Unit which oscillates the Dispersion Wire up to 25 Hertz within the isolated region to further disperse the infused fluid.

The provided documents describe a 510(k) premarket notification for the Trellis Plus Infusion System, a medical device for infusing fluids into the peripheral vasculature. The submission focuses on demonstrating substantial equivalence to a predicate device (the Trellis Infusion System, K013635). As such, it does not include a study or acceptance criteria in the typical sense of a novel device performance study. Instead, the "acceptance criteria" are implied by the demonstration of equivalence to the predicate device, meaning the new device performs at least as well as the predicate for its intended use, and the "study" is the battery of tests performed to demonstrate this equivalence.

Here's an analysis based on the provided text, addressing the requested points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

The documents do not present a formal table of specific acceptance criteria (e.g., specific quantitative performance metrics like accuracy, sensitivity, specificity, or error rates) for the Trellis Plus Infusion System, nor does it report detailed quantitative device performance data against such metrics. Instead, the "acceptance criteria" are implicitly met by demonstrating that the device functions as intended and is substantially equivalent to its predicate.

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

• Sample Size: The document does not specify a numerical sample size for any "test set" in terms of patient data. The "Testing Summary" indicates that "All components, subassemblies, and/or full devices met the required specifications," implying in-vitro or bench testing rather than in-vivo human studies for this 510(k).
• Data Provenance: Not applicable as no human patient data is described. The testing described appears to be laboratory-based (bench testing).
• Retrospective/Prospective: Not applicable.

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

Not applicable. The ground truth for this type of 510(k) submission, particularly for a mechanical device demonstrating substantial equivalence, is generally based on engineering specifications, regulatory standards, and performance of the predicate device, not on expert consensus from clinical image interpretation or diagnosis.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of adjudication for a test set, as the evaluation type is focused on engineering and functional testing rather than clinical interpretation.

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

No. The document makes no mention of an MRMC comparative effectiveness study. This type of study is typically performed for AI or diagnostic imaging devices where human interpretation is a key component, which is not the case for an infusion system.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No. This concept is not relevant to the Trellis Plus Infusion System, which is a physical medical device (catheter system) with mechanical functions, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for the substantial equivalence claim is effectively:

• Engineering specifications and regulatory requirements: The device's components and overall system performance meeting predefined technical requirements.
• Performance of the predicate device: The Trellis Plus Infusion System is considered substantially equivalent if its performance characteristics (function, materials, manufacturing) are similar to the legally marketed Trellis Infusion System (K013635).

8. The Sample Size for the Training Set

Not applicable. The Trellis Plus Infusion System is a mechanical device, not an AI or machine learning model that requires a training set.

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

Not applicable. No training set is used for this type of device.

In summary, for the Trellis Plus Infusion System, the "acceptance criteria" and "study" are framed within the context of a 510(k) submission demonstrating substantial equivalence to a predicate device. This involves rigorous engineering and functional testing against established specifications, rather than clinical trials with patient-specific ground truth data or AI model performance metrics.

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