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The Trellis™-6 Peripheral Infusion System is intended for controlled and selective infusion of physician specified fluids, including thrombolytics, into the peripheral vasculature.

The Trellis-6 Peripheral Infusion System 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. The device also has a central through-lumen that is compatible with a 0.035" guidewire. The Dispersion Wire provides oscillation when activated. The Dispersion Wire is connected to an integral Oscillation Drive Unit that oscillates the Dispersion Wire 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.

The provided documentation is a 510(k) premarket notification for the Trellis-6 Peripheral Infusion System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific performance acceptance criteria through a standalone study. The document explicitly states: "The Trellis-6 Peripheral Infusion System was tested in the same manner as the Trellis-8. All components, subassemblies, and/or full devices met the required specifications for the completed tests."

Therefore, the acceptance criteria and study proving the device meets them would have been established for the predicate device, the Trellis-8 Infusion System (K050147), and the K071664 submission leverages that prior work by demonstrating the Trellis-6 system is equivalent.

Based on the provided text for K071664, I can infer the following about what would have been implicitly accepted based on the predicate device, but the document does not contain the detailed study results for the Trellis-6 itself.

1. Table of acceptance criteria and reported device performance:

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

• The document for K071664 does not specify the sample size for any test set or the data provenance. It only states that the Trellis-6 was "tested in the same manner as the Trellis-8" and "All components, subassemblies, and/or full devices met the required specifications for the completed tests." The details of these tests would be in the K050147 submission for the Trellis-8.

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

• This type of information is not applicable or provided in a 510(k) submission focused on substantial equivalence for a device like the Trellis-6 Peripheral Infusion System, which is a mechanical delivery system rather than an diagnostic AI/imaging tool requiring expert interpretations for ground truth.

4. Adjudication method for the test set:

• Not applicable or provided for the same reasons as above.

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. The Trellis-6 is an infusion system, not an AI or imaging device that would involve human readers or comparative effectiveness studies of AI assistance.

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

• Not applicable. The Trellis-6 is a physical medical device, not an algorithm.

7. The type of ground truth used:

• For mechanical devices like this, "ground truth" typically refers to engineering specifications, physical measurements, and performance benchmarks (e.g., flow rates, balloon integrity, material strength, oscillation frequency). The document implies these were assessed against "required specifications," but does not detail them.

8. The sample size for the training set:

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

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

• Not applicable. This device is not an AI/ML algorithm.

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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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