Search Results
Found 5 results
510(k) Data Aggregation
(56 days)
The SUPERA VERITAS® Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System is indicated for palliative treatment of biliary strictures produced by malignant neoplasms.
The SUPERA VERITAS® Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System is a 0.014" or 0.018" guidewire compatible, multi-lumen sheath based delivery system and a SUPERA® Biliary Stent. The stent delivery catheter includes a radiopaque Stent Length Marker and Distal Sheath Marker embedded in the Outer Sheath to aid in proper stent positioning; a Thumb Slide connected internally for advancing the Stent out of the Outer Sheath while the Outer Sheath moves proximally in a de-coupled fashion; a Sheath Flush Port for flushing the central lumen of the device; a Deployment Lock that when actuated enables the final deployment stroke of the stent; a Guidewire Lumen with a radiopaque Catheter Tip located on the distal end of the Catheter Shaft; a Guidewire Flush Port used for flushing the Guidewire Lumen; a Stent Driver (ratchet) which moves the stent distally relative to the Outer Sheath; and the System Lock which eliminates the possibility of premature deployment. The working length of the delivery catheter is 80cm and 120cm. The SUPERA® Stent is housed within the SUPERA VERITAS® stent delivery catheter and is a closed end interwoven self-expanding Nitinol stent. The SUPERA stent is composed of 6 interwoven, closed loop Nitinol wires. The wire loops are closed via a proprietary welding process which utilizes small Nitinol tubes that act as a coupler to provide the mechanical means of joining the wire ends.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
Important Note: The provided document is a 510(k) summary for a medical device (SUPERA VERITAS® Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System). This type of submission focuses on demonstrating substantial equivalence to a predicate device, primarily through bench testing, and usually does not involve clinical studies with human patients or "AI" in the context of diagnostic algorithms. Therefore, many of the questions related to AI performance metrics (e.g., human reader improvement with AI assistance, MRMC studies, training set details, ground truth for training) are not applicable to this specific type of device and submission.
Acceptance Criteria and Device Performance Study (SUPERA VERITAS® Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System)
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly list quantitative "acceptance criteria" in the typical sense of performance metrics (e.g., sensitivity, specificity for a diagnostic device). Instead, the acceptance is based on demonstrating substantial equivalence to a predicate device through a series of engineering and material characterization tests. The primary acceptance criterion is that the new device performs comparably to the predicate and does not introduce new safety concerns.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Design Equivalence: No significant differences in design compared to the predicate. | "A review of the product specifications concluded that there are no differences in design..." |
| Material Equivalence: No significant differences in materials compared to the predicate. | "...no differences in...materials..." Material characterization tests (Chemical Analysis, Raw Material Mechanical Characterization, Tensile, Rotating Beam Fatigue) were performed for both vendor-passivated and in-house passivated stents. Reported to be substantially equivalent. |
| Performance Equivalence: No significant differences in performance compared to the predicate. | "...no differences in...performance..." Bench performance testing was conducted according to various ASTM and ISO standards, and FDA guidance (e.g., "Guidance for the Content of Premarket Notifications for Metal Expandable Biliary Stents"). These tests covered aspects like passivation, nickel ion release, and material properties. |
| Safety and Effectiveness Equivalence: No new safety or effectiveness concerns. | "No additional safety risks were observed during testing." The overall conclusion is that the new configurations are "substantially equivalent" to the predicate, implying equivalent safety and effectiveness based on the non-inferiority demonstrated in the engineering studies. Note: Clinical data was not required for this 510(k). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable in the context of a clinical "test set" for performance evaluation like diagnostic devices. The "test set" here would refer to the number of stents/delivery systems tested in various engineering studies. The document does not specify the exact number of units tested for each engineering study, but such tests typically involve a statistically relevant number of units to ensure reliability.
- Data Provenance: The studies were bench performance testing and engineering studies, not studies on human patients. The data is thus internally generated by the manufacturer (IDEV Technologies, Inc.) through laboratory experiments. No country of origin for patient data is relevant. The studies are by nature prospective in their design (i.e., experiments were designed and executed to test specific parameters).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. "Ground truth" in this context would refer to the characteristics being measured (e.g., material composition, mechanical properties). These are established by standardized physical/chemical testing methods, not by expert interpretation.
4. Adjudication Method for the Test Set
Not applicable. There's no interpretive "ground truth" requiring adjudication by experts. The results are quantitative measurements from engineering tests.
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. This device is a physical medical implant (stent) and its delivery system, not a diagnostic imaging device, AI software, or a device that assists human readers. Therefore, MRMC studies and AI assistance metrics are not relevant or performed.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
No. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" in this context is based on engineering and material standards and specifications. This includes:
- Chemical analysis standards (e.g., ASTM A967-05)
- Mechanical property test standards (e.g., ASTM F2516-07e2, ASTM E739-91, ASTM F2129-08, ASTM F2063-05, ASTM E1447-09, ASTM E1409-08)
- Nickel ion release testing standards.
- The established design and performance characteristics of the legally marketed predicate device (SUPERA VERITAS® Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System, K122546).
8. The Sample Size for the Training Set
Not applicable. There is no training set as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
Ask a specific question about this device
(108 days)
The SUPERA VERITAS® Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System is indicated for palliative treatment of biliary strictures produced by malignant neoplasms.
The SUPERA VERITAS® Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System is a 0.014" or 0.018" guidewire compatible, multi-lumen sheath based delivery system and a SUPERA® Biliary Stent. The stent delivery catheter includes a radiopaque Stent Length Marker and Distal Sheath Marker embedded in the Outer Sheath to aid in proper stent positioning; a Thumb Slide connected internally for advancing the Stent out of the Outer Sheath while the Outer Sheath moves proximally in a de-coupled fashion; a Sheath Flush Port for flushing the central lumen of the device; a Deployment Lock that when actuated enables the final deployment stroke of the stent; a Guidewire Lumen with a radiopaque Catheter Tip located on the distal end of the Catheter Shaft; a Guidewire Flush Port used for flushing the Guidewire Lumen, a Stent Driver (ratchet) which moves the stent distally relative to the Outer Sheath; and the System Lock which eliminates the possibility of premature deployment. The working length of the 6 Fr delivery catheter is 80cm and 120cm. The working length of the 7Fr delivery catheter is 120 cm. The SUPERA® Stent is housed within the SUPERA VERITAS® stent delivery catheter and is a closed end interwoven self-expanding Nitinol stent. The SUPERA® stent is composed of 6 interwoven, closed loop Nitinol wires. The wire loops are closed via a proprietary welding process which utilizes small Nitinol tubes that act as a coupler to provide the mechanical means of joining the wire ends.
This document describes the marketing authorization for the SUPERA VERITAS® Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System (K122546). This is a 510(k) submission, meaning the device demonstrated "substantial equivalence" to a legally marketed predicate device, rather than undergoing a de novo pathway requiring extensive clinical studies to establish safety and effectiveness from scratch. Therefore, the concept of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the traditional sense of a de novo device for performance metrics derived from clinical trials often doesn't directly apply.
Instead, for a 510(k), acceptance is based on demonstrating substantial equivalence through various means, primarily bench performance testing in this specific case, and comparison of design, materials, and intended use. The "acceptance criteria" are implicitly met by demonstrating that the modified device performs similarly or equivalently to the predicate devices across relevant engineering and performance tests.
Here's an analysis of the provided information, addressing your questions where applicable within the context of a 510(k) submission for a stent:
1. A table of acceptance criteria and the reported device performance
For this 510(k), the "acceptance criteria" are not explicitly defined as numerical thresholds in this summary. Instead, they are implied by demonstrating "substantial equivalence" to the predicate devices through bench performance testing. The reported performance is that this testing "demonstrated that the SUPERA VERITAS® Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System is substantially equivalent to its predicate devices."
The specific tests performed were:
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Performance equivalent to predicate for Deployment | Verification testing included Deployment testing, demonstrating substantial equivalence. |
| Performance equivalent to predicate for Trackability Force Characterization | Verification testing included Trackability Force Characterization, demonstrating substantial equivalence. |
| Performance equivalent to predicate for Catheter Tip Integrity | Verification testing included Catheter Tip Integrity, demonstrating substantial equivalence. |
| Sterilization effective and equivalent to predicate | Verification testing included Sterilization Validation, demonstrating substantial equivalence. |
| No major differences in design, materials, or operation principles compared to predicate. | "A review of the product specifications concluded that there are no major differences in design, materials, performance, safety and product effectiveness." |
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 for Test Set: The document does not specify the sample sizes (e.g., number of stents or delivery systems) for the Deployment, Trackability Force Characterization, Catheter Tip Integrity, and Sterilization Validation tests. These would typically be detailed in the full test reports, which are not included in this summary.
- Data Provenance: The data is from "bench performance testing," which implies laboratory testing. No country of origin is specified for the data itself, but the submitter (IDEV Technologies, Inc.) is based in Webster, Texas, USA. This testing is inherently prospective with respect to the 510(k) submission, as it was conducted to support the submission for the modified device.
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 device received 510(k) clearance based on bench testing demonstrating substantial equivalence to predicate devices, not on a clinical trial requiring expert ground truth assessment of patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this was not a clinical study involving human assessment of outcomes or images. The "adjudication" for the bench tests would have been the objective measurements obtained during the tests themselves against predefined 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
Not applicable. This is a medical device (stent and delivery system), not an AI/imaging diagnostic device, and thus MRMC studies are not relevant to its clearance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm or software-only device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this 510(k) submission is the performance of the predicate devices. The modified device's performance in bench tests (Deployment, Trackability, Catheter Tip Integrity, Sterilization) was compared against the expected performance and specifications derived from the predicate devices to establish substantial equivalence.
8. The sample size for the training set
Not applicable. This device does not use a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device submission.
Ask a specific question about this device
(438 days)
The SUPERA VERITAS® Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System is indicated for palliative treatment of biliary strictures produced by malignant neoplasms.
The SUPERA VERITAS® Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System is a 7Fr, 0.014" or 0.018" guidewire compatible, multi-lumen sheath based delivery system comprised of a Handle and a SUPERA® Biliary Stent. The stent delivery catheter includes a radiopaque Stent Length Marker Band and Distal Sheath Marker Band embedded in the Outer Sheath to aid in proper stent positioning; a Thumb Slide connected internally for advancing the Stent out of the Outer Sheath while the Outer Sheath moves proximally in a de-coupled fashion; a Sheath Flush Port for flushing the central lumen of the device: a Deployment Lock that when actuated enables the final deployment stroke of the stent; a Guidewire Lumen with a radiopaque Catheter Tip located on the distal end of the Catheter Shaft; a Guidewire Flush Port used for flushing the Guidewire Lumen; a Stent Driver which deploys the stent distally relative to the Outer Sheath; and the System. Lock which eliminates the possibility. of premature deployment. The working length of the delivery catheter is 120cm.
The SUPERA® stent housed within the 120cm SUPERA VERITAS® stent delivery catheter is a closed end interwoven self-expanding Nitinol stent. The SUPERA stent is composed of 6 interwoven, closed loop Nitinol wires. The wire loops are closed via a proprietary welding process which utilizes small Nitinol tubes that act as a coupler to provide the mechanical means of joining the wire ends.
Here's a breakdown of the acceptance criteria and the study information for the SUPERA VERITAS® Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Metric | Reported Device Performance |
|---|---|
| Bond Tensile Strength | Met product specifications |
| Torque Strength | Met product specifications |
| Thumb Slide Push Force | Met product specifications |
| Deployment | Met product specifications |
| Ratchet Slippage | Met product specifications |
| Simulated Handling | Met product specifications |
| Retraction/Removal | Met product specifications |
| Radial Force Testing | Met product specifications |
| Dimensional Characterization | Met product specifications |
| Delivery | Met product specifications |
| Proximity to Target | Met product specifications |
| Deployed Stent Length | Met product specifications |
| Stent Pullback | Met product specifications |
| Stent Integrity | Met product specifications |
| Trackability | Met product specifications |
| Radiopacity | Met product specifications |
| MRI Compatibility | Met product specifications |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "Verification Bench-top Testing" and that this testing ensured the device met product specifications. However, specific sample sizes for each test are not provided in the document. The data provenance is from bench-top testing, not clinical data, and is therefore neither retrospective nor prospective in the typical clinical sense.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not provided in the document. The testing described is physical, bench-top testing of the device's mechanical properties, not an evaluation requiring expert interpretation of diagnostic output.
4. Adjudication Method for the Test Set
This information is not applicable or not provided as the testing is bench-top performance verification, not an evaluation that typically involves adjudication of results by multiple human observers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance
No MRMC study was performed or is mentioned. This device is a medical stent, not an AI diagnostic tool. Therefore, the concept of human readers improving with or without AI assistance is not relevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No standalone algorithm performance study was done. This device is a physical medical device (stent delivery system), not a software algorithm.
7. The Type of Ground Truth Used
The ground truth for the performance testing ("Verification Bench-top Testing") was product specifications and requirements. Each test (e.g., Bond Tensile Strength, Dimensional Characterization) would have had a predefined acceptable range or threshold set by the manufacturer against which the device's performance was measured.
8. The Sample Size for the Training Set
Not applicable. This device is a physical stent and delivery system, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As the device is not an AI model, there is no training set or ground truth in that context.
Ask a specific question about this device
(118 days)
The SUPERA™ VERITAS™ Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System is indicated for palliative treatment of biliary strictures produced by malignant neoplasms.
The SUPERA VERITAS® Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System is a 0.014" or 0.018" guidewire compatible, multi-lumen sheath based delivery system and a SUPERA® Biliary Stent. The stent delivery catheter includes a radiopaque Stent Length Marker and Distal Sheath Marker embedded in the Outer Sheath to aid in proper stent positioning; a Thumb Slide connected internally for advancing the Stent out of the Outer Sheath while the Outer Sheath moves proximally in a de-coupled fashion; a Sheath Flush Port for flushing the central lumen of the device; a Deployment Lock that when actuated enables the final deployment stroke of the stent; a Guidewire Lumen with a radiopaque Catheter Tip located on the distal end of the Catheter Shaft; a Guidewire Flush Port used for flushing the Guidewire Lumen; a Stent Driver (ratchet) which moves the stent distally relative to the Outer Sheath; and the System Lock which eliminates the possibility of premature deployment. The working length of the delivery catheter is 80cm and 120cm. The SUPERA® Stent is housed within the SUPERA VERITAS® stent delivery catheter and is a closed end interwoven self-expanding Nitinol stent. The SUPERA® stent is composed of 6 interwoven, closed loop Nitinol wires. The wire loops are closed via a proprietary welding process which utilizes small Nitinol tubes that act as a coupler to provide the mechanical means of joining the wire ends. The SUPERA VERITAS® Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System is a sterile (via Ethylene Oxide sterilization) device and is intended for single use only.
The device is the SUPERA VERITAS® Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System, indicated for the palliative treatment of biliary strictures caused by malignant neoplasms.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Implied: Pass) | Reported Device Performance |
|---|---|---|
| Biocompatibility Testing | ||
| Cytotoxicity | Pass | Pass |
| Klingman Maximization (NaCl and CSO extracts) | Pass | Pass |
| Intracutaneous Injection (NaCl and CSO extracts) | Pass | Pass |
| Systemic Injection (NaCl and CSO extracts) | Pass | Pass |
| Rabbit Pyrogen | Pass | Pass |
| Hemolysis | Pass | Pass |
| Thrombogenicity Study in Dogs | Pass | Pass |
| Complement Activation Assay (C3a and SC5b-9) | Pass | Pass |
| Unactivated Partial Thromboplastin Time (UPTT) | Pass | Pass |
| Performance Bench Testing | ||
| Biliary Radial Force | Pass | Pass |
| Catheter Torque Strength | Pass | Pass |
| Deployment Testing | Pass | Pass |
| Particulate | Pass | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The provided document describes non-clinical bench and biocompatibility testing, not a clinical study involving human patient data. Therefore, there is no "test set" in the context of clinical images or patient data.
- Test Set Sample Size: Not applicable (no human patient/image test set).
- Data Provenance: Not applicable. The testing was performed on the device itself and in animal models (Thrombogenicity Study in Dogs).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. As this was non-clinical testing, there was no ground truth established by medical experts for a test set of images or clinical cases. The "ground truth" was determined by established scientific and engineering protocols and measurements.
4. Adjudication Method for the Test Set
Not applicable. There was no test set requiring expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document explicitly states: "Clinical testing was not required in order to demonstrate safety and efficacy for the device modifications described in this 510(k)." The study focused on non-clinical performance and substantial equivalence to predicate devices, not on human reader performance with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This device is a physical medical device (stent delivery system), not an AI algorithm. Therefore, no standalone algorithm performance study was conducted.
7. Type of Ground Truth Used
The "ground truth" for this non-clinical study was based on:
- Established Biocompatibility Standards: Results of biocompatibility tests were compared against predefined acceptance criteria for each specific test (e.g., cytotoxicity, pyrogenicity, hemolysis).
- Engineering Performance Specifications: Bench tests measured physical properties and performance characteristics (e.g., radial force, torque strength, deployment accuracy) against engineering specifications designed to ensure safe and effective device function, often benchmarking against predicate devices.
8. Sample Size for the Training Set
Not applicable. There was no "training set" as this was not an AI or machine learning study, nor a clinical trial that had distinct training and test patient cohorts. The non-clinical tests were performed on a sufficient number of devices/samples to yield statistically sound results for each specific test.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There was no training set. The "ground truth" for the non-clinical tests was established by adhering to recognized standards, protocols, and methods for medical device testing (e.g., 21 CFR, Part 58 Good Laboratory Practice for Non-Clinical Laboratory Studies, ISO 10555, ISO 1093, USP , AAMI TIR42).
Ask a specific question about this device
(291 days)
SUPERA VERITAS™ Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System is indicated for palliative treatment of biliary strictures produced by malignant neoplasms.
The SUPERA VERITAS™ Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System is a 7Fr, 0.014" or 0.018" guidewire compatible, multi-lumen sheath based delivery system comprised of a Handle and a SUPERA® Biliary Stent. The stent delivery catheter includes a radiopaque Stent Length Marker Band and Distal Sheath Marker Band embedded in the Outer Sheath to aid in proper stent positioning; a Thurnb Slide connected internally for advancing the Stent out of the Outer Sheath while the Outer Sheath moves proximally in a de-coupled fashion; a Sheath Flush Port for flushing the central lumen of the device; a Deployment Lock that when actuated enables the final deployment stroke of the stent; a Guidewire Lumen with a radiopaque Catheter Tip located on the distal end of the Catheter Shaft; a Guidewire Flush Port used for flushing the Guidewire Lumen; a Stent Driver which deploys the stent distally relative to the Outer Sheath; the System Lock which eliminates the possibility of premature deployment. The working length of the delivery catheter is 120cm.
The SUPERA® Stent housed within the SUPERA VERITAS" stent delivery catheter is a closed end interwoven self-expanding Nitinol stent. The SUPERA® stent is composed of 6 interwoven, closed loop Nitinol wires. The wire loops are closed via a proprietary welding process which utilizes small Nitinol tubes that act as a coupler to provide the mechanical means of joining the wire ends.
The provided text describes the 510(k) summary for the SUPERA VERITAS™ Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System. It details the device, its intended use, comparison to predicate devices, and the performance testing conducted.
Here's the information extracted and organized as requested:
1. Table of Acceptance Criteria and Reported Device Performance
The submission states that "Engineering studies were performed per the FDA's 'Guidance of Premarket notification 510(k) Submissions for Short Term and Long Term Intravascular Catheters'; the Guidance for the Content of Premarket Notifications for Metal Expandable Biliary Stents; ISO 10555 - Sterile, Single-use Intravascular Catheters; and ISO 10993 - International Standard for 'Biological Evaluation of Medical Devices.'"
While specific quantitative acceptance criteria and their corresponding reported device performance values are not explicitly listed in a detailed table within this summary, the overall acceptance criterion was demonstrating substantial equivalence to predicate devices. The reported device performance, in this context, is that the device met this criterion.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Compliance with FDA Guidances for Premarket Notification for Intravascular Catheters and Metal Expandable Biliary Stents (regarding design, materials, performance, safety, and effectiveness). | Achieved through bench and animal performance testing, demonstrating no major differences in design, materials, performance, safety, and product effectiveness compared to predicate devices. |
| Compliance with ISO 10555 (Sterile, Single-use Intravascular Catheters). | Achieved through engineering studies. |
| Compliance with ISO 10993 (Biological Evaluation of Medical Devices). | Achieved through engineering studies. |
| Substantial equivalence to predicate devices (IDEV's SureSave™ Biliary Stent System (K060557), IDEV's SUPERA® Biliary Stent System (K071646), and Bard E-Luminexx® Biliary Stent (K060557)) based on design specifications, characteristics, principle of operation, indications for use, and performance testing, with no additional safety risks observed. | Demonstrated through bench and animal performance testing, with the device also offering improvements in ease-of-use, ergonomics, and manufacturability. |
2. Sample size used for the test set and the data provenance
- Sample size for the test set: Not explicitly stated. The document mentions "bench and animal performance testing" but does not provide details on the number of units tested or animals used.
- Data provenance: Not explicitly stated, but given it's a 510(k) submission to the FDA, it is expected to be from studies conducted by the manufacturer (IDEV Technologies, Inc.) or contracted labs. The studies appear to be prospective in nature, as they were conducted to support the 510(k) submission. No country of origin for the data is specified, but the submitter is a US-based company.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This submission relies on engineering and animal testing, not human expert interpretation of data or images to establish ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This study does not involve human interpretation or adjudication of results to establish ground truth.
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 is a medical device (stent and delivery system) submission, not an AI/software-as-a-medical-device (SaMD) submission. No MRMC study was conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the performance testing was based on engineering measurements and observations from bench testing (e.g., mechanical properties, deployment characteristics, material integrity) and physiological and safety outcomes in animal models (e.g., biocompatibility, deployment success, patency).
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
Ask a specific question about this device
Page 1 of 1