Search Results
Found 3 results
510(k) Data Aggregation
(28 days)
6mmx8mm and 8mmx8mm stents: The AXIOS™ Stent and Electrocautery-Enhanced Delivery System is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts ≥ 6 cm in size, that are adherent to the gastric or bowel wall and are free of solid debris. The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst resolution.
10mmx10mm and 15mmx10mm stents: The AXIOS™ Electrocautery-Enhanced-Stent and Delivery System is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts ≥ 6 cm in size and walled-off necrosis ≥ 6 cm in size that are adherent to the gastric or bowel wall. Once placed, the AXIOS™ Stent functions as an access port allowing passage of standard and therapeutic endoscopes to facilitate debridement, irrigation and cystoscopy. The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or walled-off necrosis resolution.
The AXIOS™ Stent and Electrocautery-Enhanced Delivery System is indicated for use to facilitate transguodenal endoscopic drainage of the gallbladder in patients with acute cholecystitis who are at high risk for surgery.
20mmx10mm and 15mmx15mm stents: The AXIOS™ Electrocautery-Enhanced Stent and Delivery System is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts ≥ 6 cm in size and walled-off necrosis ≥ 6 cm in size that are adherent to the gastric or bowel wall. Once placed, the AXIOS™ Stent functions as an access port allowing passage of standard and therapeutic endoscopes to facilitate debridement, irrigation and cystoscopy. The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or walled-off necrosis resolution.
AXIOS™ Stent:
The AXIOS™ Stent is a flexible, MR conditional, fully-covered, self-expanding braided nitinol stent, which comes preloaded into a delivery system. The AXIOS™ stent is designed with two flanges on each end to enable tissue plane apposition and a "saddle" in between the flanges to span the tissue implant distance.
Electrocautery-Enhanced Delivery System:
The AXIOS™ Electrocautery-Enhanced Delivery System consists of a catheter and an integrated handle with manual controls for positioning and deploying the AXIOS™ Electrocautery-Enhanced Delivery System is designed to be used in the gastrointestinal tract with commercially available echoendoscopes with a 3.7 mm diameter or larger working channel and is compatible with commercially available 0.035-inch insulated endoscopic guidewires.
The Electrocautery-Enhanced Delivery System connects with an off-the-shelf electrosurgical unit or generator that is compliant to IEC 60601-1-2 and IEC 60601-2-2.
The AXIOS™ Stent and Electrocautery-Enhanced Delivery System is provided sterile, disposable and intended for single use.
This FDA 510(k) summary (K233318) for the Boston Scientific AXIOS Stent and Electrocautery-Enhanced Delivery System does not contain information about a study proving the device meets specific acceptance criteria in the context of an AI/human-in-the-loop performance evaluation.
Instead, this document focuses on demonstrating substantial equivalence to a previously cleared predicate device (DEN230019, K22011 "AXIOS Stent and Electrocautery-Enhanced Delivery System"). The core of the evidence presented is related to bench testing for use with a different Electrosurgical Unit (ESU), specifically the ERBE VIO 3.
Therefore, I cannot provide the requested information regarding acceptance criteria and performance data for an AI-based system, sample sizes for test and training sets, expert qualifications, or adjudication methods, as these details are not present in the provided text.
Based on the text, here's what can be extracted regarding the performance testing that was performed:
Summary of Device Acceptance Criteria and Performance (as per the provided document):
The document describes performance testing conducted to demonstrate equivalent settings for the AXIOS devices when used with a specific Electrosurgical Unit (ESU). The "acceptance criteria" in this context refer to demonstrating equivalence in performance with the new ESU compared to the ESU used during the original clearance, rather than a clinical performance metric like sensitivity or specificity for a diagnostic device.
1. Table of "Acceptance Criteria" and Reported Device "Performance"
| Criteria Type | Acceptance Goal |
|---|---|
| Performance Equivalence | Achieve "equivalent performance between both ESUs" (Electrosurgical Units). This implies comparing functional outputs relevant to the device's operation. Specific quantitative values are not provided in this summary. |
| Safety & Effectiveness Impact | "updates to labeling do not affect safety, effectiveness, performance or function of the device." This is an overall claim of non-adverse impact from the change. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified. The study states "bench testing" was performed.
- Data Provenance: Not specified, but implied to be laboratory/bench data generated by Boston Scientific Corporation for this submission. The testing was based on "original clearance testing."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable. This was bench testing evaluating device function with a new ESU, not a clinical study requiring expert assessment for "ground truth" on patient outcomes or diagnoses.
4. Adjudication Method for the Test Set:
- Not applicable. This was bench testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. This document focuses on demonstrating substantial equivalence through bench testing of the device with a different ESU, not a clinical comparative effectiveness study involving human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a medical stent and delivery system, not an AI algorithm.
7. The type of ground truth used:
- Bench Test Results / Engineering Specifications. The "ground truth" for this testing was established by comparing the performance with the new ESU to the baseline performance established with the previously tested ESU (300D ESU), likely against pre-defined engineering specifications for power output, current, impedance, or other relevant electrical and mechanical properties.
8. The sample size for the training set:
- Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI/machine learning device.
In summary, the provided FDA 510(k) summary focuses on demonstrating that a change (compatibility with a new ESU) to an already cleared device does not alter its safety or effectiveness. The study described is a bench test aimed at showing equivalence in the device's technical performance with the new ESU. It does not involve AI, human readers, or clinical ground truth derived from expert consensus or pathology.
Ask a specific question about this device
(144 days)
The AXIOS Stent and Electrocautery Enhanced Delivery System is indicated for use to facilitate transgastric or transquodenal endoscopic drainage of the gallbladder in patients with acute cholecystitis who are at high risk for surgery.
The AXIOS Stent and Electrocautery-Enhanced Delivery system is designed to help facilitate the transgastric or transduodenal endoscopic drainage of the gallbladder. The AXIOS Stent remains identical to the stents cleared previously per K220112. The AXIOS Stent is a flexible, magnetic resonance conditional, fully covered, self-expanding, braided nitinol stent, which comes preloaded into the delivery system. The AXIOS stent is designed with two flanges, one on each end, to prevent migration and to enable tissue plane apposition and a "saddle" in between the flanges to span the tissue implant distance. The stent is fully covered with silicone to prevent leakage, discourage tissue in-growth within the nitinol woven braid, and facilitate removal. The AXIOS Electrocautery-Enhanced Delivery System consists of a catheter and an integrated handle with manual controls for positioning and deploying the AXIOS™ Stent. The AXIOS™ Electrocautery-Enhanced Delivery System is designed to be used in the gastrointestinal tract with commercially available echoendoscopes with a 3.7 mm diameter or larger working chamel and is compatible with commercially available 0.035-inch insulated endoscopic guidewires. The Electrocautery-Enhanced Delivery System connects with an off-the-shelf electrosurgical unit or generator that is compliant to IEC 60601-1-2 and IEC 60601-2-2.
The provided text describes the acceptance criteria and the study that proves the AXIOS Stent and Electrocautery-Enhanced Delivery System meets those criteria. The information is primarily from non-clinical/bench testing and a pivotal clinical study, supplemented by a meta-analysis of clinical literature.
Here's the breakdown of the requested information:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
The document presents two main categories of performance data: non-clinical/bench testing and clinical study results.
Table 1: Non-Clinical/Bench Testing Performance for AXIOS Stent and Delivery System
| Test | Purpose | Acceptance Criteria | Reported Device Performance (Result) |
|---|---|---|---|
| Deployed Stent Saddle Length | Verify dimensions of deployed stent | Deployed Stent Saddle Length (inside flange to inside flange) @37°C $\geq$ 8.5 mm $\leq$ 13 mm for both AXIOS 10 mm x 10 mm & AXIOS 15 mm x 10 mm | Pass |
| Deployed Stent Saddle Outer Diameter | Verify dimensions of deployed stent | AXIOS 10mm x 10 mm stent: $\geq$ 8 mm; AXIOS 15mm x 10mm stent: $\geq$ 13 mm | Pass |
| Deployed Stent Flange Width | Verify dimensions of deployed stent | AXIOS 10 mm x 10 mm: $\geq$ 3 mm; AXIOS 15 mm x 10 mm: $\geq$ 3 mm | Pass |
| Stent Pull-Out Force | Verify stent will remain in place when pull-out force is applied | AXIOS 10 mm x 10 mm: $\geq$ 2.54 N; AXIOS 15 mm x 10 mm stent: Not explicitly stated, implied same as 10mmx10mm via "Pass" result column. | Pass |
| Stent (Saddle) Radial Strength – Compression & Expansion | Verify expansion strength of the compressed stent meets product specification | In compression @ 37°C $\geq$ 0.06 N/mm of length @ 50% Ø; In expansion @ 37°C $\geq$ 0.02 N/mm of length @ 50% Ø (for both AXIOS 10mm x 10 mm and 15 mm x 10 mm) | Pass |
| Deployment (Unsheathing) Force | Verify force needed to deploy stent | AXIOS 10 mm x 10 mm: $\leq$ 40 N; AXIOS 15 mm x 10 mm stent: $\leq$ 40 N | Pass |
| Implant Anchor Function – Retention (Tensile) | Verify force needed to achieve apposition of distal flange to target structure | AXIOS 10 mm x 10 mm: $\geq$ 2 N; AXIOS 15 mm x 10 mm stent $\geq$ 2 N | Pass |
| Magnetic Resonance Testing | Verify stent will not prevent ability to use MRI | The stent should not prevent the ability of the physician to use Magnetic Resonance Imaging on the patient. | Pass |
| Fatigue Testing | Ensure stent remains intact throughout the period of use | The stent must remain intact after 940,000 translation (distal flange with respect to proximal flange) cycles. | Pass |
| Corrosion Testing | Evaluate corrosion resistance of stent | The metal stent and stent covering must show corrosion resistance when subjected to an in vitro corrosive environment equivalent to sixty days. | Pass |
| Delivery System Working Length | Verify working length of delivery device | Working Length (distal point of the handle to distal end of the catheter tip) $\leq$ 138 cm | Pass |
| Slider lock hold force testing | Evaluate performance of lock under compressional and torsional forces | Lock hold force $\geq$ 22 N | Pass |
| Nose lock hold force | Evaluate performance of lock under compressional and torsional forces | Lock hold force $\geq$ 22 N | Pass |
| Nose/slide lock cycling | Inspect function of nose/slide lock feature | Nose lock must function after 6 cycles; slide lock must function after 4 cycles. | Pass |
| Joint Strength Testing | Verify joint strength meets design requirements | Per EN ISO 10555-1, the device shall meet specific minimum force. | Pass |
| Luer to Nose Joint Strength | Verify peak tensile force of luer to nose joint | Luer to Nose Joint Strength $\geq$ 22 N | Pass |
| Outer Sheath to Handle Torque Strength | Verify ability of AXIOS catheter to withstand torque when the device is rotated 360° | The catheter system must withstand a minimum of 1 full turn. | Pass |
| Tracking Force | Verify tracking force of outer sheath through a 3.7 mm working channel | Track force $\leq$ 8.83 N | Pass |
Table 2: Clinical Study Performance (Pivotal Study and Meta-Analysis)
| Endpoint/Outcome | Acceptance Criteria (Performance Goal) | Reported Device Performance (Pivotal Study, N=30 ITT) | Reported Device Performance (Meta-Analysis, N=713 combined) |
|---|---|---|---|
| Primary Effectiveness: Days to resolution of Acute Cholecystitis (AC) | $< 3.5$ days (upper bound of 97.8% one-sided CI) | Primary Analysis (ITT, censored): Mean 5.30 $\pm$ 14.90 days. 97.8% one-sided CI [0.00, 10.78]. Failed acceptance criteria on this specific analysis using censoring. Additional Analysis (ITT, all patients observed): Mean 1.60 $\pm$ 1.50 days. 97.8% one-sided CI [0.0, 2.15]. Met acceptance criteria. Treated/Per-Protocol (N=28): Mean 1.39 $\pm$ 0.92 days. 97.8% one-sided CI [0.0, 1.74]. Met acceptance criteria. | Not applicable (this specific endpoint was not directly reported in the meta-analysis in the same way). |
| Secondary Effectiveness: Rate of re-intervention (migration/occlusion) | $< 46.2$% (upper bound of 99.7% one-sided CI) | ITT Patients (N=30): 16.7% (5/30). 99.7% one-sided CI [0.0%, 42.0%]. Met acceptance criteria. Treated/Per-Protocol Patients (N=28): 14.3% (4/28). 99.7% one-sided CI [0.0%, 40.2%]. Met acceptance criteria. | 10.3% (2.6%, 22.1%) - Broader definition of re-interventions likely. |
| Additional Endpoints: Technical success (stent placement with patency) | Not explicitly stated (implied high percentage) | ITT Patients (N=30): 93.3% (28/30). 97.9% CI [77.9%, 99.2%]. | 97.0% (95.1%, 98.5%) |
| Technical stent removal success | Not explicitly stated (implied high percentage) | Attempted (N=19): 100% (19/19). 95% CI [82.4%, 100.0%]. | Not directly reported in meta-analysis. |
| Stent patency at stent removal visit | Not explicitly stated (implied high percentage) | Assessed (N=22): 100% (22/22). 95% CI [84.6%, 100.0%]. | Not directly reported in meta-analysis. |
| Recurrence of acute cholecystitis symptoms | Not explicitly stated (implied low percentage) | ITT Patients (N=30): 10.0% (3/30). 95% CI [2.1%, 26.5%]. | 1.8% (0.4%, 4.2%) |
| Clinical Success | Not explicitly stated (implied high percentage) | Not directly defined as a primary or secondary endpoint with a specific numerical goal in the pivotal study. The "Symptom resolution" primary endpoint implies clinical success. | 92.0% (89.2%, 94.3%) |
| Procedure Related AEs | Not explicitly stated (implied low percentage) | 3.6% (4/111 of AEs at procedure), 0.0% (0/11 of related AEs). The overall rate of related AEs was 30% (9/30 subjects) with a count of 11 related AEs. | 12.0% (8.5%, 16.0%) |
| Overall AEs | Not explicitly stated (implied low percentage) | 93.3% (28/30 subjects). Total AEs: 111. SAEs: 35. One SAE was related to the device/procedure. | 22.7% (17.5%, 28.4%) |
2. Sample Sizes Used for the Test Set and Data Provenance
-
Pivotal Clinical Study (Test Set):
- Sample Size: 30 subjects (Intent-to-Treat, ITT). 28 subjects formed the Treated/Per-protocol cohort.
- Data Provenance: The study was a "Multicenter, Prospective Study" (from G170190), indicating it was a forward-looking study where data was collected specifically for this evaluation. The document does not explicitly state the country of origin, but Boston Scientific Corporation is based in Marlborough, Massachusetts, USA, suggesting a likely multi-site international or US-based study framework.
-
Meta-Analysis of Clinical Literature:
- Sample Size: 17 articles encompassing 713 patients.
- Data Provenance: Retrospective, derived from published literature from various sources. One notable included study was a "randomized multicentre controlled superiority trial (DRAC 1)" (Teoh et al., Gut, 2020) which compared the AXIOS stent to percutaneous cholecystostomy, providing prospective, comparative data within the meta-analysis.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not provide information regarding the number of experts or their specific qualifications (e.g., radiologists with X years of experience) used to establish ground truth for the clinical study data. It is a clinical trial setting, so subject outcomes, diagnoses, and adverse events would be determined by the treating physicians and study staff according to study protocols, often involving standard clinical diagnostic criteria and adjudication by a clinical events committee, though none of these details are given in the provided text.
4. Adjudication Method for the Test Set
The document does not explicitly describe a formal adjudication method (e.g., 2+1, 3+1) for the primary and secondary endpoints in the pivotal study. Clinical trials typically have predefined methods for recording and verifying endpoints and adverse events, often involving a clinical events committee (CEC), but these specific details are not provided. The determination of "symptom resolution" was based on objective clinical measures (temperature, pain score, WBC).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study typically assesses the performance of human readers with and without AI assistance on medical images. The AXIOS Stent is a medical device for drainage, not an imaging diagnostic AI device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This question is not applicable in the context of this device. The AXIOS stent is a physical medical device and delivery system, not an AI algorithm. Its performance is evaluated through bench testing and clinical outcomes, reflecting the device's function directly and its interaction with human operators (physicians) during placement and use.
7. The Type of Ground Truth Used
- For Non-Clinical/Bench Studies: The ground truth was established by physical measurements, standardized test methods (e.g., ASTM, EN ISO standards), and direct observation against predefined engineering specifications and performance criteria.
- For the Pivotal Clinical Study: The ground truth for effectiveness endpoints (e.g., symptom resolution, re-intervention) was based on clinical outcomes data from the patients enrolled in the prospective study, including physiological parameters (temperature, WBC), patient-reported pain scores, physician assessments of stent patency, and documented adverse events.
- For the Meta-Analysis: The ground truth was based on the reported outcomes from published clinical literature, which would similarly derive from clinical assessments, diagnostic findings, and patient outcomes within those individual studies.
8. The Sample Size for the Training Set
This question is not applicable. The AXIOS stent is a physical medical device, not an AI algorithm that requires a "training set" for machine learning. The term "training set" is relevant for AI/ML model development.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable, as there is no "training set" in the context of this device's development or evaluation as described.
Ask a specific question about this device
(237 days)
The AXIOS™ Stent is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts ≥ 6 cm in size, and symptomatic Walled Off Necrosis ≥ 6 cm in size, that are adherent to the gastric or bowel wall. Once placed, the AXIOS™ Stent functions as an access port allowing passage of standard and therapeutic endoscopes to facilitate debridement, irrigation and cystoscopy. The Stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or Walled-Off Necrosis resolution.
The AXIOS™ Stent is a flexible, MR conditional, fully-covered, self-expanding braided nitinol stent, which comes preloaded into a delivery system. The AXIOS™ stent is designed with two flanges on each end to prevent migration and to enable tissue plane apposition and a "saddle" in between the flanges to span the tissue implant distance.
The AXIOS™ Electrocautery-Enhanced Delivery System consists of a catheter and an integrated handle with manual controls for positioning and deploying the AXIOS™ Stent. The AXIOS™ Electrocautery-Enhanced Delivery System is designed to be used in the gastrointestinal tract with commercially available echoendoscopes with a 3.7 mm diameter or larger working channel and is compatible with commercially available 0.035-inch insulated endoscopic guidewires.
The Electrocautery-Enhanced Delivery System connects with an off-the-shelf electrosurgical unit or generator that is compliant to IEC 60601-1-2 and IEC 60601-2-2.
The AXIOS™ Stent and Electrocautery-Enhanced Delivery System is provided sterile, disposable and intended for single use.
The provided text is a 510(k) summary for a medical device (AXIOS™ Stent and Electrocautery-Enhanced Delivery System), establishing its substantial equivalence to a predicate device. It details the device's description, indications for use, and performance data from a clinical trial.
However, the request asks for information typically found in an AI/ML medical device submission, specifically concerning "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of an AI/ML algorithm's performance. The document describes a medical device (a stent and delivery system), not an AI/ML algorithm. Therefore, many of the requested fields are not applicable to the content provided (e.g., number of experts to establish ground truth, adjudication methods, MRMC studies, standalone algorithm performance, training/test set sample sizes for an algorithm, etc.).
The "Performance Data" section in the document refers to a clinical trial evaluating the safety and effectiveness of the stent, not an AI/ML algorithm's performance.
Given this discrepancy, I will extract the relevant "performance data" provided for the stent and explain why other AI/ML-specific questions are not applicable to this document.
Acceptance Criteria and Study Proving Device Meets Criteria (Based on Provided Document)
This document describes the regulatory submission for a medical device: the AXIOS™ Stent and Electrocautery-Enhanced Delivery System. It is not an AI/ML-driven device, so the typical AI/ML-specific acceptance criteria and study design (like MRMC studies, ground truth establishment by experts for an algorithm, training/test sets for an algorithm, etc.) are not applicable here.
The "acceptance criteria" in this context would implicitly refer to demonstrating safety and effectiveness for its intended use, sufficient for FDA 510(k) clearance based on substantial equivalence to predicate devices, and in support of an expanded indication. The "study that proves the device meets the acceptance criteria" is the described clinical trial.
Here's the information extracted and contextualized based on the provided document:
1. Table of "Acceptance Criteria" (Clinical Endpoints) and Reported Device Performance
Note: These are not acceptance criteria for an AI/ML algorithm's performance but rather for the clinical efficacy and safety of a medical device (stent).
| Clinical Endpoint (Analogous to Acceptance Criteria) | Reported Device Performance (N=40 subjects) |
|---|---|
| Primary Effectiveness Endpoint: | |
| Resolution of WON to ≤ 3 cm (assessed radiographically by CT scan or MRI within 60 days from AXIOS™ stent placement) | 97.5% (39/40) [86.8%, 99.9% CI] |
| Primary Safety Endpoint: | |
| AXIOS™ stent related or WON drainage procedure related serious adverse events | 7.5% (3/40) [1.6%, 20.4% CI] |
| Additional Endpoints: | |
| Technical success (AXIOS™ stent placement) | 100.0% (40/40) |
| Technical success (AXIOS™ stent removal) | 100.0% (40/40) |
| Resolution of WON by 6-month post-stent removal | 100.0% (40/40) |
| Recurrence of WON from initial resolution to 6 months post-AXIOS™ stent removal | 0.0% (0/34) |
| Visual confirmation of AXIOS™ stent lumen patency (after stent placement) | 100.0% (40/40) |
| Visual confirmation of AXIOS™ stent lumen patency (before stent removal) | 97.5% (39/40) |
| Incidence of new organ failure | 2.6% (1/39) |
2. Sample Size and Data Provenance
- Sample Size (Clinical Trial): 40 patients (with 45 AXIOS™ stents implanted, as some subjects had multiple WON).
- Data Provenance: The document states "a prospective, single arm, multi-center trial." It does not specify the country of origin but implies a formal clinical investigation under an approved Investigational Device Exemption (IDE) per GCP and 21 CFR Parts 50, 56, and 812, which are U.S. regulations. Thus, it's a prospective, clinical trial data.
3. Number of Experts and Qualifications for Ground Truth
- Not Applicable (N/A): This is a clinical trial of a medical device (stent and delivery system), not an AI/ML algorithm requiring expert ground truth for image interpretation or similar AI-specific tasks. The "ground truth" here is the clinical outcome (WON resolution, adverse events), determined by medical professionals treating the patients and clinical assessments (radiographic imaging, physical exams) as part of the trial protocol.
4. Adjudication Method for the Test Set
- N/A: As this is a clinical trial, not an AI/ML algorithm's test set requiring human reader adjudication for performance metrics. Clinical endpoints are typically evaluated by blinded assessment where possible, and adverse events are adjudicated by a clinical events committee, but the specific details of that adjudication are not provided beyond the general statement of a "prospective, single arm, multi-center trial conducted per GCP."
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No (N/A): An MRMC study is relevant for evaluating the impact of an AI/ML algorithm on human reader performance (e.g., radiologists interpreting images). This document describes a clinical trial of a physical medical device (stent), not an AI/ML algorithm.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
- N/A: This is not an AI/ML algorithm.
7. The Type of Ground Truth Used
- Clinical Outcomes and Radiographic Assessment: For the primary effectiveness endpoint, the "ground truth" was the "radiographic decrease of WON size to < 3cm evaluated by CT scan or MRI within 60 days from AXIOS™ stent placement." For safety, it was the occurrence of "AXIOS™ stent-related or WON drainage procedure-related serious adverse events." These are objective clinical and imaging-based measures.
8. The Sample Size for the Training Set
- N/A: This document does not describe the development or validation of an AI/ML algorithm, so there is no "training set" in that context. The "clinical investigation" described is for demonstrating the device's performance for regulatory clearance.
9. How the Ground Truth for the Training Set was Established
- N/A: As above, no AI/ML training set is described.
Ask a specific question about this device
Page 1 of 1