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510(k) Data Aggregation
(264 days)
Ureteral Stents (AF-D series) are used for temporary internal drainage from the ureteropelvic junction to the bladder. Ureteral Stents have been used to relieve obstruction in a variety of benign, malignant, and post-traumatic conditions. The stents may be placed using endoscopic, percutaneous, or open surgical techniques. The indwelling time should not exceed 30 days.
Ureteral Stents (AF-D series) are a set of ureteral stents used for temporary internal drainage from the ureteropelvic junction to the bladder. The subject ureteral stent is a flexible, tubular double pigtail stent composed of thermoplastic polyurethane with hydrophilic coating. Depending on configurations, the device may include a ureteral stent only, or a stent with an introducer and a clamp, or a stent with an introducer, a guidewire and a clamp.
Ureteral Stents are available in 4.0 to 7.0 French (Fr) diameter, with lengths ranging from 8.0 to 28.0 centimeters (cm). The device is supplied sterile, intended for single use only, and is available for prescription use only.
Ureteral Stents are not intended as a permanent indwelling device. The subject stent is labeled for indwell time not to exceed thirty (30) days only.
The provided FDA 510(k) clearance letter and summary for the Ureteral Stents (AF-D series) do not describe a study involving an AI/Machine Learning device or software. The information focuses on the substantial equivalence of a physical medical device (Ureteral Stents) to a predicate device based on material properties, design, and physical performance characteristics.
Therefore, it is impossible to extract the requested information (acceptance criteria, details of a study proving the device meets criteria, sample sizes, expert involvement, ground truth, MRMC study, training sets) as these pertain specifically to the validation of AI/ML models, not traditional medical devices like ureteral stents.
The document covers:
- Acceptance Criteria (Implicitly): The acceptance criteria are implicitly that the device performs as safely and effectively as the predicate device across various bench tests and biocompatibility assessments.
- Study Proving Acceptance (Bench Testing): The document states: "A battery of bench testing based on the FDA guidance 'Guidance for the Content of Premarket Notification for Ureteral Stents' (1993) was conducted on the subject, predicate and reference stents using established methods and standards to demonstrate the performance substantial equivalence to the predicate device."
- Tests listed: Appearance and Dimensions, Curl Retention Test (pigtails), Break Strength & Elongation, Flow Rate, Dynamic Friction Force, Kink Stability Test, Simulated Stent Insertion and Removal Test, Chemical Performance, Guidewire: Radiopacity, bending test, compatibility with stent and introducer.
- Biocompatibility Testing: Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Material-Mediated Pyrogenicity, Subacute Systemic Toxicity, Muscle Implantation, Genotoxicity.
- Sterility and Shelf Life: SAL of 10⁻⁶ (ISO 11135:2014), packaging integrity, accelerated aging study, and simulated transportation study.
- Sample Size: The document does not specify the sample size for the physical device testing. It refers to "representative device models" for shelf life testing and "a battery of bench testing," which implies multiple units were tested but no specific number is given.
- Data Provenance: Not applicable in the context of AI/ML. The "data" here refers to physical test results from the manufactured stents.
- Experts and Ground Truth: Not applicable in the context of clinical AI/ML validation involving human readers. For physical device testing, adherence to established standards and methods serves as the "ground truth."
- MRMC, Standalone Performance, Training Set details: These are all concepts relevant to AI/ML device validation and are not discussed as this is a physical medical device.
In summary, the provided document describes the regulatory clearance of a physical medical device (Ureteral Stents) through a substantial equivalence pathway, not an AI/Machine Learning device. Therefore, the specific questions related to AI/ML validation cannot be answered from this document.
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(216 days)
The Flexima™ Ureteral Stent System and Flexima™ Ureteral Stent System Kit is intended to provide drainage from the ureteropelvic junction to the bladder and stenting of the ureter for all patients in whom it is desirable to place a drain which does not extend externally.
The Flexima™ Biliary Catheter System / Flexima™ Biliary Catheter System Kit / Flexima™ Biliary Catheter System with Radiopaque Marker / Flexima™ Biliary Catheter System with Hydrophilic Dissolving Tip / Flexima™ Biliary Catheter System with Hydrophilic Dissolving Tip and Radiopaque Marker are intended to provide external and internal percutaneous drainage of the biliary system.
The Flexima Biliary Catheters are constructed of Flexima, a Tecoflex Polyeurethane-based resin, and selected subfamilies also have a radiopaque marker (RO) made from 65%Tungsten. The radiopaque marker is located approximately 5mm proximal to the most proximal drainage hole to aid in proper placement of the catheter. Additionally, designated Flexima Biliary Catheters are available with a biocompatible, dissolving distal tip (Temp-Tip™). This dissolvable tip facilities tracking over a guidewire for percutaneous placement and dissolves within 24 hours of placement to provide a larger drainage lumen. These biliary catheters provide external and internal percutaneous drainage of the biliary system. Where long-term use is indicated, it is recommended that indwelling time not exceed 90 days.
The Flexima Ureteral Stent is also constructed of Tecoflex Polyeurethane-based resin. The pigtails on either end of the stent, are in opposite directions so that the proximal pigtail can form in the renal pelvis, while the distal pigtail forms in the bladder, to provide drainage from the ureteropelvic junction to the bladder and stenting of the ureter for all patients in whom it is desirable to place a drain which does not extend externally. The double pigtail stent prevents upward and downward movement. Also, where longterm use is indicated, this stent is recommended not to exceed 90 days of indwelling time.
The Flexima Biliary Catheters and Flexima Ureteral Stents are provided sterile, using 100% ethylene oxide (EO) gas sterilization, and are intended for hospital and single use only. These devices utilize Glidex™ Hydrophillic Coating for the reduction of surface friction during placement.
I'm sorry, but this document does not contain the information required to fulfill your request. The provided text is a 510(k) premarket notification for Flexima™ Biliary Catheter System and Flexima™ Ureteral Stent System. It focuses on demonstrating substantial equivalence to predicate devices, primarily through non-clinical performance testing related to magnetic resonance compatibility.
The document does not describe an AI/ML-based medical device. Therefore, it lacks details on:
- Acceptance criteria related to AI/ML performance (e.g., sensitivity, specificity, AUC).
- A study proving an AI/ML device meets acceptance criteria.
- Sample sizes for test sets in an AI/ML context.
- Data provenance for AI/ML training or testing.
- Number of experts and their qualifications for ground truth establishment for AI/ML.
- Adjudication methods for AI/ML test sets.
- MRMC comparative effectiveness studies for AI assistance.
- Standalone performance for an AI algorithm.
- Ground truth types or sample sizes for AI training sets, or how AI training set ground truth was established.
The document entirely pertains to the physical and material properties (e.g., radiopaque markers, dissolving tips, dimensions) and the magnetic resonance compatibility of medical catheters and stents, not an algorithm.
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(263 days)
ALL WIN Ureteral stents are intended to temporarily facilitate drainage of urine from kidney to bladder by trained physician. The recommended target population is adults and pediatrics. The indwelling time should not exceed thirty (30) days.
Not Found
The provided text is an FDA 510(k) clearance letter for various ureteral stents. It primarily details the regulatory process, product classification, and general controls applicable to these medical devices. It does not contain information on acceptance criteria or studies proving the device meets those criteria.
Therefore, I cannot provide the requested information about acceptance criteria and device performance based on the provided text. The document is a regulatory communication, not a performance study report.
To answer your request, I would need a different type of document, such as a summary of safety and effectiveness, a clinical study report, or a premarket submission detail that includes the performance data.
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(267 days)
The proposed device is intended to facilitate the passage of urine from the kidney to the bladder.
The Microvasive® Temporary Ureteral Drainage Stent is 6 Fr x 26.5 cm, with an open-ended coil at each end. The stent is an extruded polymeric tube made of a reversible cross-linked alginate polymer with an incorporated radiopacifier. The device is placed, using standard ureteral stent placement techniques that can be placed transurethrally, percutaneously or via open surgery using endoscopic and/or radiographic techniques.
Here's an analysis of the acceptance criteria and study details for the Boston Scientific/Microvasive Temporary Ureteral Drainage Stent (TUDS) based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Metric | Acceptance Criteria (Implied/Direct) | Reported Device Performance (TUDS) |
|---|---|---|---|
| Effectiveness | Primary Effectiveness Endpoint: Study Success | "adequate short term drainage defined as the presence of the stent in the ureter and the lack of surgical or other intervention to treat symptoms on the stented side during the first 48 hours following placement." (The exact quantitative hurdle for "acceptable" isn't explicitly stated but the performance against it is given as the study outcome.) | 78.2% (68/87). (17 absence of stent and 3 interventions occurred within the first 48 hours; 1 patient had both an absence of stent and intervention.) |
| Alternate Endpoint: Overall Clinical Success (90-day follow-up) | "adequate drainage with no intervention (regardless of stent presence) and no definitely device-related serious adverse events (SAEs) throughout the 90 day follow-up period." (Again, the quantitative threshold for "acceptable" isn't explicitly stated, but the performance against it is given.) | 94.3% (83/88) with the 90-day study period. | |
| Safety | Primary Safety Endpoint: Assessment of Adverse Events | "Assessment of adverse events (incidence, relationship to device, severity)" compared to published clinical studies of plastic ureteral stents. (The implicit criteria is that adverse event profiles should be comparable or improved, and there should be no unanticipated events.) | No unanticipated adverse events reported. All adverse events resolved by the end of the study without any permanent sequelae. Key findings include: - Flank pain/loin discomfort: 12.5% (11/88) - Hydronephrosis: 3.4% (3/88) - Suprapubic pain/lower abdominal pain: 8% (7/88) - Urinary frequency: 51.8% (44/85) at day 1 - Urinary urgency: 67% (59/88) at baseline - Urethral discomfort: 27.9% (24/86) at day 1- Stent migration: 19.5% (17/87) (but only 3.4% required intervention)- Additional stent specific procedures: 3.4% (3/88) through 48 hrs; 8.0% (7/88) through 90 days. |
| Device Characteristics | Successful Placement | Not an explicit acceptance criterion, but a measure of initial procedural success. | 98.9% (88/89) (1 patient required 2 stents). |
| Time to eliminate TUDS from ureter | Not an explicit acceptance criterion, but a characteristic of the device. | Mean = 13.0 (±11.3) days, Median = 8 days. | |
| Time to eliminate TUDS from body | Not an explicit acceptance criterion, but a characteristic of the device. | Mean = 21.0 (±17.8) days, Median = 15 days. | |
| Retained stent fragments at 90 days in renal pelvis | Not an explicit acceptance criterion, but a safety concern. | 3.4% (3/87). (Of these, 2 had successful ESWL, 1 declined intervention and was asymptomatic). | |
| Tolerability (Moderate to most severe pain) | Not an explicit acceptance criterion, but a measure of patient experience. | Day 1: Flank pain - 23.0% (20/87), Urethral pain - 27.9% (24/86). Day 30: Flank pain - 8.7% (7/80), Urethral pain – 2.5% (2/80). | |
| Patient Satisfaction | Not an explicit acceptance criterion, but a measure of patient experience. | 88.8% satisfied (71/80). |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: 88 patients were enrolled and had the TUDS placed. 87 were evaluable for the "Study success" endpoint, and 88 for "Overall clinical success."
- Data Provenance: The study was a prospective, single-arm, multi-center trial conducted across 6 investigative sites. The text does not specify the country of origin, but "Boston Scientific/ Microvasive, One Scientific Place, Natick, MA" suggests a US-based sponsor, and "FDA's Draft Guidance Ureteral Stents was utilized" (Section V), and the FDA 510(k) submission and approval letter, strongly imply the study was conducted to satisfy US regulatory requirements, likely within the US or under clinical trial regulations accepted by the FDA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- The study involved clinical assessments by medical professionals at various investigative sites (6 sites). These assessments included device presence, position, morphology (via KUB films), and evaluation of adverse events. Also, normal renal function was assessed by Intravenous Pyelogram (IVP) at 30 days.
- The document does not explicitly state the number or specific qualifications of individual experts (e.g., radiologists, urologists) who established the "ground truth" for each patient's condition or imaging interpretation. The data comes from direct clinical observations, imaging results (KUB, IVP) interpreted by clinical staff at the study sites, and formal capture of adverse events by the investigators.
4. Adjudication Method for the Test Set:
- The document does not describe a formal adjudication method (e.g., 2+1, 3+1, none) for the test set. Clinical outcomes, imaging results, and adverse events were presumably recorded by the treating physicians/staff at each center and then collected and analyzed by the study sponsor. There is no mention of independent expert review or a consensus panel.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done. This was a single-arm study evaluating the safety and effectiveness of the TUDS device in facilitating short-term drainage. It did not involve comparing human readers' performance with and without AI assistance.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:
- Not applicable. This device (Temporary Ureteral Drainage Stent) is a physical medical device, not an algorithm or AI system. Therefore, the concept of "standalone algorithm performance" is not relevant. The study evaluates the performance of the physical stent in patients.
7. Type of Ground Truth Used:
- The ground truth was established through a combination of clinical observation, diagnostic imaging (KUB films, Intravenous Pyelogram - IVP), and documented patient outcomes/adverse events.
- "Study success" relied on the presence of the stent in the ureter (observable via KUB) and the absence of surgical or other intervention for symptoms.
- "Overall clinical success" relied on adequate drainage (clinical judgment, potentially supported by imaging) and the absence of device-related serious adverse events documented through follow-up.
- Adverse events were based on clinical assessments and patient reporting during follow-up visits.
- Stent presence/position/morphology was assessed via radiological assessments (KUB films).
- Normal renal function was assessed by IVP.
8. Sample Size for the Training Set:
- Not applicable. As this is a study for a physical medical device and not an AI/ML algorithm, there is no "training set" in the context of machine learning. The study itself served as the primary clinical evidence for regulatory submission.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. (See point 8).
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