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510(k) Data Aggregation
(82 days)
The Spiral Laminar Flow™ Vascular Arteriovenous Graft is a vascular prosthesis, which is intended for use as a subcutaneous arteriovenous conduit for vascular access during hemodialysis. ONLY trained and qualified physicians and/or surgeons, under the controlled conditions of a hospital operating theatre environment are indicated for use of this device for implantation.
The TFT Spiral Laminar Flow™ Vascular Arteriovenous Graft is to be used as an arteriovenous conduit for hemodialysis access. The graft has a specially designed section which is intended to induce spiral laminar flow. This section is designed to propagate spiral flow though the graft and into the distal circulation. TFT Spiral Laminar Flow™ Vascular Arteriovenous Graft is manufactured from a straight tubular expanded polytetrafluoroethylene (ePTFE) vascular graft. The straight graft is combined with TFT's unique SLF™ external spiral flow inducer and inducer indicator, both made from ChronoFlex® C-80A; a Biodurable Medical Grade polyurethane. The inducer indicator is a palpable ring over the proximal end of the spiral flow inducer. Its purpose is to indicate to the user where the spiral inducer segment begins since it is intended that cannulation in this segment should be avoided.
The description below is based on the provided text, which details a 510(k) submission for a medical device seeking substantial equivalence, rather than a study designed to meet specific performance acceptance criteria for an AI/ML device. Therefore, many standard fields for AI/ML study descriptions (e.g., sample size for test sets, number of experts, adjudication methods) are not applicable or cannot be extracted from this type of document.
The document describes the TFT Spiral Laminar Flow™ Vascular Arteriovenous Graft and its path to 510(k) clearance by demonstrating substantial equivalence to predicate devices, rather than meeting specific performance acceptance criteria in the format typically seen for AI/ML devices.
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) submission for a vascular graft, the "acceptance criteria" are primarily based on demonstrating substantial equivalence to already cleared predicate devices through a comparison of technological characteristics, performance data (bench and animal testing), and materials. There aren't explicit numerical "acceptance criteria" presented in the document in the way one might see for an AI/ML diagnostic device with performance metrics (e.g., sensitivity, specificity).
Instead, the "acceptance criteria" are implicitly met by demonstrating that the device performs equivalently to the predicates across various physical, mechanical, and biological properties.
Criterion Category | Implicit Acceptance Criterion (Substantial Equivalence) | Reported Device Performance / Evidence |
---|---|---|
Technological Characteristics | The new device's technological characteristics, performance, and principle of operation are substantially equivalent to predicate devices. | A comparative review found substantial equivalence. The detailed comparison table (Pages 2-3) shows similar materials (ePTFE and PU, compared to ePTFE and PTFE in predicates), device classification, common name, and intended use. The key difference is the "External spiral inducer 6cm long at the distal end of tube" for the new device, compared to "helical geometry" or "straight tube" in predicates, but this design is intended to induce spiral laminar flow. |
Biocompatibility | The materials used and the device itself are biocompatible for long-term vascular implantation. | - Testing: Based on ISO 10993 parts 4, 5, 6, 10, 11, and 13, performed in compliance with GLP. Confirmed sufficient biocompatibility. |
- Prior Use: Materials (ePTFE and ChronoFlex® C-80A polyurethane) are well-characterized and approved for long-term vascular implants, with a list of 510(k) cleared devices using these materials provided in section 11 (not explicitly in provided text).
- Both materials cleared by FDA for vascular graft use. |
| Performance Testing (Fluid Dynamics) | The design (helical angle, number/height/profile of ridges) promotes intended flow characteristics (spiral laminar flow). | - Methodologies: Literature review, computational fluid dynamics (CFD), and flow rig work were used to determine optimum configuration. - Correlation: "Good correlation of CFD data, flow rig data and in vivo data confirmed the suitability of the design."
- Haemodynamic Testing (Diameter): In-house flow rig and CFD work confirmed 6mm and 8mm grafts have comparable blood flow characteristics. |
| Physical Testing | The device possesses sufficient physical and mechanical strength and properties to perform as intended under in vivo conditions. | - Testing to ISO7198: Water permeability, circumferential tensile strength, longitudinal tensile strength, probe burst strength, usable length, relaxed internal diameter, wall thickness, pressurized internal diameter, suture retention strength, kink diameter/radius, dynamic compliance. - Result: "The test results demonstrate that the TFT Spiral Laminar Flow™ Vascular Arteriovenous Graft has sufficient strength and physical properties to perform as intended under the expected in vivo loading conditions." |
| Animal Testing (Safety & Performance) | The device is safe, effective, and performs comparably to controls/predicates in an in vivo setting. | - A series of animal studies (HSAW, NPIMR, CHUM, TFT-8-007, NPIMR (SH03), G0003-09) were conducted using mini-pigs, sheep, and dogs. - These studies covered various durations (1 week to 20 weeks) and purposes, including blood flow model development, safety studies, and proof of principle/performance.
- Overall Conclusion: "Based on testing and comparison with the predicate devices, the TFT SLFTM Vascular Arteriovenous Graft indicated no adverse indications or results. It is our determination that the TFT Spiral Laminar Flow™ Vascular Arteriovenous Graft is safe, effective and performs within its design specifications and is substantially equivalent to the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance
The primary "test set" for this submission would be considered the various experimental conditions across the bench and animal studies.
- Bench Testing (Physical & Fluid Dynamics): Details on the specific sample sizes for each physical test (e.g., how many grafts were tested for tensile strength) are not provided in the summary. For CFD and flow rig work, these are experimental setups, not human patient data.
- Animal Testing: The "Number in Each Group" is provided for each animal study (see table on Pages 5-6). For example:
- HSAW (100): 8 mini-pigs
- CHUM and MHI (TFT-8-006): 10 dogs (for Safety Study/Proof of principle and Performance)
- G0003-09: 2 pigs (for Proof of principle study of 6mm ePTFE grafts)
- Data Provenance: The animal studies were conducted by various institutions (e.g., HSAW, NPIMR, CHUM, MHI, TFT). While the text doesn't explicitly state the country, the submitting company is based in Scotland, and CHUM is a common acronym for Centre hospitalier de l'Université de Montréal in Canada, suggesting international provenance for animal data. These are prospective animal studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This is a medical device (vascular graft) submission, not an AI/ML diagnostic or measurement device. Therefore, the concept of "experts used to establish ground truth" (e.g., radiologists interpreting images) is not applicable in the same way. The "ground truth" for the performance of the graft is established through objective physical measurements, detailed flow analysis, and histological/physiological assessments from animal studies, interpreted by qualified scientists and veterinarians involved in those studies. No specific number or qualifications of "experts" are cited for establishing a "ground truth" in the context of interpretation, but rather the studies themselves are the evidence.
4. Adjudication Method for the Test Set
The concept of an "adjudication method" (e.g., 2+1, 3+1 consensus) is not typically applicable to the evaluation of physical device performance or animal study outcomes in this context. The animal study outcomes would be evaluated based on predefined endpoints, measurements, and potentially histopathological analysis by veterinary pathologists.
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 question is entirely not applicable as the submission is for a physical vascular graft, not an AI/ML diagnostic or assistive device that would involve human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is entirely not applicable as the submission is for a physical vascular graft.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance is established through:
- Bench Testing: Objective physical measurements against established standards (e.g., ISO7198 for tensile strength, permeability, etc.).
- Computational Fluid Dynamics (CFD) and Flow Rig Work: Mathematical models and physical simulations of fluid flow.
- Animal Studies: In vivo observation of safety (e.g., absence of adverse reactions, patency) and performance (e.g., blood flow characteristics, histological analysis of tissue response) in comparison to control devices, using established scientific and veterinary methods.
8. The Sample Size for the Training Set
This question is not applicable. There is no "training set" in the context of an AI/ML algorithm for this physical medical device submission. The "development" and "optimization" of the graft design were based on literature review, CFD, flow rig work, and various animal studies, as well as the inherent properties of the ePTFE and polyurethane materials.
9. How the Ground Truth for the Training Set was Established
This question is not applicable as there is no "training set" in this context. The "ground truth" for guiding the device's development (analogous to how a training set might guide an AI) was established through existing scientific literature, engineering principles of fluid dynamics, material science data for ePTFE and polyurethane, and early-stage animal studies designed for model development and proof of concept.
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