Search Results

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

The SpiralFuse Peripheral Infusion System is a simpler version of the Trellis catheter that enables the physician to infuse fluids to a treatment region and disperse the fluid through a treatment region. The SpiralFuse is a multi-lumen catheter with an infusion lumen with holes located along the treatment zone to disperse the infused fluid. The other lumen is a through-lumen that is compatible with a 0.035" guidewire. The shaped infusion lumen is deployed once catheter position is achieved. The device is introduced through a standard 6F introducer sheath and passed over a 0.035" guidewire to the treatment site. Then, physicians will infuse fluid and allow it to disperse. Device removal is the same as the predicates.

This document is a 510(k) premarket notification for the SpiralFuse Peripheral Infusion System. It is an administrative correction letter from the FDA regarding a previous substantial equivalence determination for the device. The updated letter pertains to a new product code to better categorize the device technology. The original 510(k) submission was not re-reviewed.

Here's an analysis of the provided text in relation to your request:

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

The provided document describes the SpiralFuse Peripheral Infusion System and its substantial equivalence to a predicate device (Trellis-6 Infusion System). It states: "All components, subassemblies, and/or full devices met the required specifications for the completed tests." However, the document does not provide a table of specific acceptance criteria (e.g., specific thresholds for flow rates, burst pressures, etc.) nor does it list detailed reported device performance against such criteria. It only broadly asserts that specifications were met.

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

The document mentions "Testing Summary: The SpiralFuse Peripheral Infusion System was tested in the same manner as the Trellis-6." However, it does not specify the sample size used for the test set, nor does it provide any information on the data provenance (country of origin, retrospective or prospective). The testing seems to be limited to physical device performance, not clinical data that would typically have provenance details.

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)

This information is not applicable and not provided in this document. The SpiralFuse Peripheral Infusion System is a medical device (catheter) for fluid infusion into the peripheral vasculature. The testing described is physical performance testing (e.g., mechanical, material compatibility), not a diagnostic or AI-driven system that would require expert-established ground truth for a test set.

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

This information is not applicable and not provided for the same reasons as point 3. Adjudication methods are typically used in clinical studies or for establishing ground truth for diagnostic AI, neither of which is the focus of this 510(k) summary.

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

This information is not applicable and not provided. The SpiralFuse Peripheral Infusion System is a physical medical device, not an AI-assisted diagnostic tool or an imaging system that would involve human readers or MRMC studies.

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

This information is not applicable and not provided. The device is a physical catheter, not an algorithm, and therefore does not have a "standalone" algorithmic performance in the context described.

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

This information is not applicable and not provided. As explained, the testing appears to be primarily engineering/performance based. "Ground truth" in the clinical or diagnostic sense is not relevant here. The ground truth for device performance would be the established engineering specifications and physical test results (e.g., verifying that a catheter can withstand a certain pressure without bursting, or that a lumen flows at a specified rate).

8. The sample size for the training set

This information is not applicable and not provided. The SpiralFuse Peripheral Infusion System is a physical medical device, not an AI model that requires a training set.

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

This information is not applicable and not provided for the same reasons as point 8.

Ask a specific question about this device

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.

Ask a specific question about this device

The Trellis™-8 Peripheral Infusion System is intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.

The Trellis-8 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 document is a 510(k) Premarket Notification from the FDA regarding the Trellis-8 Peripheral Infusion System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific acceptance criteria through clinical trials or performance studies in the way a pharmaceutical or novel high-risk device might.

Therefore, the document does not contain the detailed information typically found in a study report designed to rigorously quantify device performance against pre-defined acceptance criteria, especially not for AI/ML-driven diagnostics.

Based on the information provided in the 510(k) Summary (page 4), here's what can be extracted and why other requested information is not available:

1. Table of acceptance criteria and reported device performance:

The document states: "The Trellis-8 Peripheral Infusion System was tested in the same manner as the Trellis Reserve. All components, subassemblies, and/or full devices met the required specifications for the completed tests."

• Acceptance Criteria (Implicit): That "all components, subassemblies, and/or full devices met the required specifications" as established for the predicate device, Trellis Reserve Infusion System (K032261), and as designed under Bacchus Vascular's Quality System, which complies with 21 CFR. Specific numerical or qualitative acceptance criteria (e.g., burst pressure, flow rate deviation limits, etc.) are not detailed in this summary.
• Reported Device Performance: The summary states that the device "met the required specifications for the completed tests." No specific performance metrics or values are reported.

Summary of available information for Table of Acceptance Criteria and Reported Device Performance:

Regarding the other requested information:

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

• This information is not provided. The 510(k) summary mentions "Testing Summary" but does not detail sample sizes, test types (e.g., in-vitro, in-vivo, clinical), or data provenance. Since this is a device for fluid infusion, testing would likely involve bench testing (e.g., material compatibility, structural integrity, flow rates) rather than human clinical data for this type of submission.

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

• This information is not applicable/provided. For a device like the Trellis-8 Peripheral Infusion System, "ground truth" in the diagnostic or AI sense (e.g., confirmed diagnosis by experts) is not relevant. Performance is typically measured against physical and engineering specifications.

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

• This information is not applicable/provided. Adjudication methods are relevant for studies involving human interpretation or clinical outcomes, which are not detailed in this 510(k) summary.

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:

• This information is not applicable/provided. MRMC studies are specific to diagnostic tools, especially those involving AI/ML interpretation. The Trellis-8 Peripheral Infusion System is an infusion system, not a diagnostic imaging device.

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

• This information is not applicable/provided. This device does not feature an AI algorithm.

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

• The "ground truth" (or basis for evaluation) for this device would be established engineering specifications derived from relevant standards, risk analysis, and performance of the predicate device. It would not involve expert consensus, pathology, or outcomes data in the sense of diagnostic accuracy.

8. The sample size for the training set:

• This information is not applicable/provided. This device does not involve AI or machine learning, so there is no "training set."

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

• This information is not applicable/provided. As above, there is no AI or associated training set.

In summary, the provided document is a 510(k) clearance letter for a medical device (Trellis-8 Peripheral Infusion System), indicating its substantial equivalence to a predicate device. It does not include detailed study results, acceptance criteria, or ground truth methodologies that would be typical for an AI/ML-enabled diagnostic device or a study designed to rigorously quantify performance against explicit criteria in a clinical setting. The "study" mentioned is a general statement that the device was tested to meet "required specifications" similar to its predicate.

Ask a specific question about this device

The Solera Plus Thrombectomy Catheter permits mechanical thrombectomy of synthetic dialysis grafts.

The Solera Plus is a single-use, over-the-wire disposable catheter, with an integral Motor Drive Unit (MDU). The Solera Plus has a central hollow drive shaft connected to an expanding clot maceration and removal system. The clot removal system is comprised of a Nitinol macerator and a Nitinol outer protective basket. The macerator is attached to the drive shaft and rotates within the stationary protective basket. The protective basket expands to the lumen diameter and acts to protect the graft wall from the rotating macerator. Mechanical aspiration is achieved by rotation of the drive shaft and by an applied vacuum (locking syringe). The rotation of this drive shaft in conjunction with the vacuum causes material to be pumped out of the treatment area after maceration. Aspiration is controlled (i.e., on/off) by a button on the motor drive unit, which may be activated by the physician to allow flow out of the Solera Plus. The default position is 'off' to and is designed to minimize blood loss during the procedure.

This document is a 510(k) summary for the Solera™ Plus Thrombectomy Catheter. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study proving device performance against those criteria in a clinical setting.

Therefore, the information requested in your prompt regarding acceptance criteria and performance study details (e.g., sample size, ground truth, MRMC studies) is not present in the provided text.

Based on the provided text, here's what can be extracted and what cannot:

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

• Not Available: The document states that "All components, subassemblies, and/or full Maginan The required specifications for the completed tests," and that mechanical tests were done in the same manner as the predicate device. However, it does not explicitly list specific acceptance criteria (e.g., specific thresholds for thrombus removal percentage, flow rates, or device integrity parameters) nor does it provide a table of reported device performance against such clinical or bench-testing criteria.

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

• Not Available: The document mentions "Testing Summary" but does not specify any sample sizes for tests, nor does it refer to clinical test sets or data provenance in the context of performance proof. The testing appears to be primarily bench or in-vitro, comparing it to predicate devices.

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 Available: This type of information is relevant for studies involving human interpretation or clinical outcomes. The provided document relates to a medical device's technical specifications and substantial equivalence, not a study evaluating diagnostic or treatment efficacy with expert adjudication.

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

• Not Applicable/Not Available: As with point 3, this is not relevant to the type of information presented in this 510(k) summary.

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/Not Available: MRMC studies are typically for diagnostic AI systems or those involving human interpretation. This document describes a mechanical thrombectomy catheter, not an AI or diagnostic tool.

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

• Not Applicable/Not Available: This refers to AI algorithm performance. The device is a mechanical catheter.

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

• Not Available: The document vaguely refers to "required specifications" for mechanical tests, implying engineered benchmarks rather than clinical "ground truth" as typically defined in diagnostic studies.

8. The sample size for the training set

• Not Applicable/Not Available: This refers to AI model training data. The device is a mechanical catheter.

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

• Not Applicable/Not Available: This refers to AI model training data. The device is a mechanical catheter.

In summary, the provided 510(k) summary is for a mechanical thrombectomy catheter and focuses on establishing substantial equivalence to previously cleared devices through material suitability and a testing summary that asserts compliance with specifications, rather than a clinical performance study with detailed acceptance criteria and human expert evaluation.

Ask a specific question about this device

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 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.

This FDA document is a 510(k) premarket notification for the "Trellis Reserve Infusion System." It outlines the device's technical specifications and asserts its substantial equivalence to a previously marketed predicate device.

However, this document does not contain the detailed information necessary to answer the questions about acceptance criteria and a study proving the device meets those criteria.

Here's why and what information is missing:

• Acceptance Criteria and Reported Device Performance: This document states that the device "met the required specifications for the completed tests" (page 5), but it does not list specific quantitative acceptance criteria for performance metrics (e.g., infusion rate, balloon inflation pressure, dispersion efficiency, safety parameters) nor does it provide the numerical results or reported device performance against those criteria.
• Study Details (Sample size, data provenance, ground truth, experts, adjudication, MRMC, standalone): The document mentions "Testing Summary" and that the device "was tested in the same manner as the original Trellis Reserve Infusion System (K023514)" (page 5). However, it does not provide any specifics about the studies conducted, such as:
  • The sample size used for any test sets.
  • The provenance of the data (country, retrospective/prospective).
  • The number or qualifications of experts.
  • Any adjudication methods.
  • Whether comparative effectiveness studies (MRMC) or standalone algorithm performance studies were done.
  • The type of ground truth used.
  • The sample size or ground truth establishment for a training set (if applicable to this type of device, which is a physical medical device, not an AI/software device).

Therefore, based on the provided text, I cannot complete the table or answer the specific questions about the study design and results.

The document is a regulatory submission focused on establishing substantial equivalence, primarily by demonstrating that the device's design, materials, and intended use are similar to a predicate device, and that it has passed internal verification testing. It does not go into the level of detail regarding clinical trial design, ground truth establishment, or performance metrics typically found for AI/software as a medical device (SaMD) clearances or more extensive clinical studies.

Ask a specific question about this device

The Solera Magnum Thrombectomy Catheter permits mechanical thrombectomy of synthetic dialysis grafts.

The Solera Magnum is a single-use, over-the-wire disposable catheter, with an integral Motor Drive Unit (MDU). The Solera Magnum has a central hollow drive shaft connected to an expanding clot maceration and removal system. The clot removal system is comprised of a Nitinol macerator and a Nitinol outer protective basket. The macerator is attached to the drive shaft and rotates within the stationary protective basket. The protective basket expands to the lumen diameter and acts to protect the graft wall from the rotating macerator. Mechanical aspiration is achieved by rotation of the drive shaft and by an applied vacuum (locking syringe). The rotation of this drive shaft in conjunction with the vacuum causes material to be pumped out of the treatment area after maceration. Aspiration is controlled (i.e., on/off) by a button on the motor drive unit, which may be activated by the physician to allow flow out of the Solera Magnum. The default position is 'off' to and is designed to minimize blood loss during the procedure.

The provided text does not contain the information required to complete the requested output regarding acceptance criteria and a study proving a device meets them.

The document is a 510(k) summary for the Solera Magnum Thrombectomy Catheter, focusing on demonstrating substantial equivalence to a predicate device (Solera Thrombectomy Catheter). It lists the intended use, device description, materials, and a general statement about testing.

Here's why the information is missing:

• No specific acceptance criteria are listed. The document states, "All components, subassemblies, and/or full devices met the required specifications for the completed tests," but it does not specify what those specifications or acceptance criteria were.
• No detailed study is described. The document mentions "The Solera Magnum Thrombectomy Catheter was tested in the same manner as the Solera Thrombectomy Catheter (K003570)," and that all components "met the required specifications for the completed tests." However, it does not provide any details about this testing, such as:
  • The type of study (e.g., in-vitro, ex-vivo, clinical trial).
  • Specific performance metrics measured.
  • Sample sizes for anything.
  • Data provenance.
  • Ground truth establishment.
  • Expert involvement.
  • Comparative effectiveness.
  • AI-related information (this device is a catheter, not an AI/software device).

Therefore, I cannot populate the table or answer the specific questions based on the provided text. The document's purpose is to show substantial equivalence through general statements about testing, not to provide detailed study results for specific performance metrics against pre-defined acceptance criteria.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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

The Trellis 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 text is related to a 510(k) premarket notification for the Trellis Infusion System. It describes the device, its intended use, and the testing conducted to demonstrate substantial equivalence to predicate devices. However, it does not contain specific acceptance criteria or detailed results of a study that prove the device meets precise acceptance criteria in the format required for a typical AI/ML device submission.

The document pre-dates many of the modern requirements for AI/ML device submissions, which typically involve detailed performance metrics like sensitivity, specificity, AUC, and their associated confidence intervals against established ground truth.

Given the information available, I can extract and infer some aspects, but I cannot fulfill all parts of your request as the document doesn't provide the level of detail seen in a modern AI/ML device submission.

Here's an attempt to structure the information based on your request, highlighting what is present and what is missing:

Device Name: Trellis Infusion System

Acceptance Criteria and Device Performance (Based on provided text):

The document lists various tests conducted to ensure the Trellis met "all specifications" and reports a general conclusion of safety and effectiveness without numerical performance metrics or explicit acceptance thresholds.

Study Details:

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

   • Test Set Sample Size: Not explicitly stated for each test. For the pre-clinical in vivo testing, it mentions "animal arteries" but doesn't quantify the number of animals or vessels.
   • Data Provenance: Not specified (e.g., country of origin). The in vivo testing was "pre-clinical," implying animal studies rather than human clinical data. The description of testing does not specify retrospective or prospective.

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

   • This information is not provided. The testing described primarily involves engineering performance tests and anatomical/histological assessments in animal models, not human expert interpretation in the way AI/ML ground truth is established.

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

   • Not applicable as the tests described are primarily objective engineering and in vivo animal studies, not human interpretation-based assessments requiring adjudication.

4. 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 a traditional medical device submission for an infusion system, not an AI/ML device. Therefore, no MRMC study or AI assistance evaluation was conducted.

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

   • No. This device is a physical catheter system, not an algorithm.

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

   • For the engineering tests, the ground truth would be the defined specifications for each test (e.g., a specific tensile strength value).
   • For the in vivo testing, the "ground truth" was established by direct observation during the procedure (e.g., visualization under fluoroscopy) and subsequent "histological examination of treated vessels" by presumably qualified pathologists/veterinary pathologists, though their details are not provided.

7. The sample size for the training set:

   • Not applicable. This is not an AI/ML device, so there is no "training set."

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

   • Not applicable.

Ask a specific question about this device

Ask a specific question about this device