Search Results
Found 7 results
510(k) Data Aggregation
(28 days)
AXIOS Stent and Electrocautery-Enhanced Delivery System (6mmx8mm); AXIOS Stent and Electrocautery-Enhanced
Delivery System (8mmx8mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (10mmx10mm); AXIOS
Stent and Electrocautery-Enhanced Delivery System (15mmx10mm); AXIOS Stent and Electrocautery-Enhanced
Delivery System (20mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mmx15mm)
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.
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AXIOS Stent and Electrocautery-Enhanced Delivery System (10mm x 10mm Stent); AXIOS Stent and Electrocautery-Enhanced
Delivery System (15mm x 10mm Stent)
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) | $ |
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(237 days)
AXIOS Stent and Electrocautery-Enhanced Delivery System
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
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(178 days)
AXIOS Stent and Electrocautery Enhanced Delivery System
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 davs and should be removed upon confirmation of pseudocyst resolution.
The AXIOS Stent is a flexible, MR conditional, fully-covered self-expanding braided nitinol stent, which comes preloaded into the 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 deploving 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.
This FDA 510(k) summary describes a medical device, the AXIOS Stent and Electrocautery-Enhanced Delivery System, and its performance. However, it does not involve an AI/ML algorithm, and therefore the acceptance criteria and study information related to AI/ML performance metrics (such as effect size for human readers with AI assistance, type of ground truth, training set size, etc.) are not applicable here.
The document focuses on demonstrating substantial equivalence to a predicate device (K181905) through engineering performance data (bench testing) rather than clinical study data involving AI/ML.
Here's a breakdown of the available information based on your request, with an emphasis on what is not present due to the nature of this device submission:
1. A table of acceptance criteria and the reported device performance
The document provides a table summarizing the types of bench tests performed and their results. The "acceptance criteria" are implied by the "Pass" result for each test, indicating that the device met the pre-defined product specifications for these engineering parameters. Specific numerical acceptance criteria values are not provided, only the pass/fail outcome.
| Test Item | Reported Result (Pass/Fail) |
|---|---|
| AXIOS Stent | |
| Deployed Stent Saddle Length | Pass |
| Deployed Stent Saddle Outer Diameter | Pass |
| Deployed Stent Flange Width | Pass |
| Stent Pull-out Force | Pass |
| Stent (Saddle) Radial Strength - in compression & expansion | Pass |
| Deployment Force | Pass |
| Implant Anchor Function- Retention (tensile) | Pass |
| Magnetic Resonance Testing | Pass |
| Fatigue Testing | Pass |
| AXIOS 9 Fr. Electrocautery-Enhanced Delivery System | |
| Delivery System Working Length | Pass |
| Catheter Extension | Pass |
| Nose Lock Hold Force | Pass |
| Slider Lock Hold Force | Pass |
| Nose Lock Cycling | Pass |
| Slider Lock Cycling | Pass |
| Distal Pusher Catheter to Distal Nose Joint Strength | Pass |
| Pusher Catheter to Hypotube Joint Strength | Pass |
| Outer Sheath to Hypotube Joint Strength | Pass |
| Pusher Hypotube to Handle Joint Strength | Pass |
| Outer Sheath Hypotube to Handle Joint Strength | Pass |
| Distal Pusher to Proximal Pusher Catheter Joint Strength | Pass |
| Outer Sheath to Handle Torque Strength | Pass |
| Luer to Nose Joint Strength | Pass |
| Tracking Force | Pass |
2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: Not specified for the bench tests. For medical devices, bench testing typically involves a sufficient number of samples to ensure statistical confidence in the results, but the exact N is not disclosed in this summary.
- Data Provenance: Not applicable as this relates to engineering bench testing of physical device components, not clinical data sets.
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 is not an AI/ML diagnostic tool requiring expert interpretation for ground truth establishment. The "ground truth" for the performance tests are engineering specifications verified through physical measurement and functional testing.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This is not a clinical study involving human interpretation or adjudication of cases.
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 not an AI/ML powered device, and no MRMC study was conducted or mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. There is no algorithm to test in a standalone configuration.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for these tests are the pre-defined product specifications and engineering requirements for the device's physical and functional characteristics. This is established through engineering design, material science, and manufacturing standards.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no training set.
9. How the ground truth for the training set was established
Not applicable. As there is no AI/ML component, there is no training set or associated ground truth establishment process.
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(26 days)
AXIOS Stent and Electrocautery Enhanced Delivery System
The AXIOS Stent and Electrocautery Enhanced Delivery System is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts ≥6cm in size, and symptomatic Walled Off Necrosis ≥6cm in size, with ≥70% fluid content, 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 the 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 Sten. 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 contains information about the AXIOS Stent and Electrocautery-Enhanced Delivery System, specifically an FDA 510(k) summary for a new version of the device (K192043). However, it does not describe a clinical study that proves the device meets specific acceptance criteria based on human or expert evaluation. Instead, it describes bench testing against predefined product specifications to demonstrate substantial equivalence to a predicate device.
Therefore, many of the requested items (sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, training set details) are not applicable or cannot be answered from the provided document as it does not detail a clinical performance study with human readers or AI.
Here's a breakdown of what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes "pre-defined product specifications" for bench tests as the acceptance criteria. The device is reported to have met these criteria.
| Acceptance Criteria (Pre-defined Product Specifications) | Reported Device Performance (Results) |
|---|---|
| Deployed Stent Saddle Length | Pass |
| Deployed Stent Saddle Outer Diameter | Pass |
| Deployed Stent Flange Width | Pass |
| Stent Pull-out Force (tensile) | Pass |
| Stent (Saddle) Radial Strength - in compression & expansion | Pass |
| Deployment Force | Pass |
| Implant Anchor Function- Retention (tensile) | Pass |
| Magnetic Resonance Testing | Pass |
Regarding the other requested information:
- 2. Sample size used for the test set and the data provenance: This information is not provided in the document. The tests performed were bench tests on the device itself, not clinical tests on a patient population.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for the bench tests would be the established product specifications for physical properties, not expert-derived medical diagnoses.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are typically used for clinical studies involving interpretation of medical images or patient outcomes, not for bench testing of device 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 MRMC study was mentioned. The device is a medical stent and delivery system, not an AI diagnostic tool that assists human readers.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a physical medical device, not a standalone AI algorithm.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the bench tests, the ground truth was the pre-defined product specifications for mechanical and physical properties of the device (e.g., specific dimensions, force resistance, MR compatibility).
- 8. The sample size for the training set: Not applicable. This document describes a physical medical device, not an AI model that requires a training set.
- 9. How the ground truth for the training set was established: Not applicable, as there is no training set for an AI model.
Summary from the document:
The provided text focuses on the technical characteristics and bench testing of a medical device (AXIOS Stent and Electrocautery-Enhanced Delivery System) to demonstrate substantial equivalence to a previously cleared predicate device. The "acceptance criteria" here refer to predefined product specifications for the physical device, and the "study" is a series of bench tests. No clinical studies involving human readers, AI, or patient outcomes for the purpose of establishing device performance against clinical acceptance criteria are described in this document.
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(252 days)
AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced Delivery System
The AXIOS Stent and Delivery System & AXIOS Stent and Electrocautery Enhanced Delivery System are indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts ≥6cm in size, and symptomatic Walled Off Necrosis ≥6cm in size, with ≥70% fluid content, 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 the 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.
Non-Cautery Enhanced Delivery System: The stent is preloaded within the AXIOS delivery catheter. The Delivery System consists of a catheter and an integrated handle with manual controls for positioning and deploying the AXIOS stent. The Delivery System is designed to be used in the gastrointestinal tract in conjunction 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.
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 Sten. 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 describes a 510(k) submission for the AXIOS Stent and Delivery System. The focus of this submission is to reinstate a passivation/etching manufacturing step that had previously been removed. Because the change involves reinstating a prior manufacturing step and the device is being claimed as substantially equivalent to previously cleared versions, the performance data presented is primarily bench testing to confirm that the reinstation of this step does not negatively impact the device's performance or safety.
Here's the breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" values in a quantitative format for each test. Instead, it states that the device "successfully passed all pre-defined product specifications and is equivalent to the predicate passivated AXIOS stent for the tests performed." This implies that the acceptance criteria for each test were met, resulting in a "Pass" outcome.
| Test | Reported Device Performance (Pass/Fail) | Acceptance Criteria (Implied) |
|---|---|---|
| Deployed Stent Saddle Length | Pass | Met pre-defined product specifications; equivalent to predicate device |
| Deployed Stent Saddle Outer Diameter | Pass | Met pre-defined product specifications; equivalent to predicate device |
| Deployed Stent Flange Width | Pass | Met pre-defined product specifications; equivalent to predicate device |
| Corrosion Testing via ASTM Standard F2129 | Pass | Met pre-defined product specifications; equivalent to predicate device |
| Stent Fatigue | Pass | Met pre-defined product specifications; equivalent to predicate device |
| Stent Radial Strength – in expansion & in compression | Pass | Met pre-defined product specifications; equivalent to predicate device |
| Stent Deployment Force | Pass | Met pre-defined product specifications; equivalent to predicate device |
| Biocompatibility Testing (Cytotoxicity test on finished stent) | Pass | Confirmed manufacturing change did not impact toxicity; equivalent to predicate device |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes for each bench test conducted (e.g., number of stents tested for fatigue, corrosion, etc.). It only lists the types of tests performed.
The data provenance is from bench testing performed to verify design and validation requirements after reinstating a manufacturing step. The document does not specify if these tests were conducted internally by Boston Scientific or by an external laboratory. It does not refer to patient data (retrospective or prospective), as this submission is focused on a manufacturing change for an already cleared device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This submission concerns bench testing of a physical device for manufacturing changes, not diagnostic or interpretive tasks requiring expert ground truth establishment.
4. Adjudication method for the test set
Not applicable. This submission concerns bench testing of a physical device, not a diagnostic study requiring adjudication.
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 submission is for a medical device (stent and delivery system), not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This submission is for a medical device (stent and delivery system), not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the bench testing, the "ground truth" would be the pre-defined product specifications and performance characteristics of the predicate device. The tests were designed to verify that the modified device met these engineering and material standards. For example, for "Deployed Stent Saddle Length," the ground truth would be the specified design length within allowable tolerances.
8. The sample size for the training set
Not applicable. This submission focuses on bench testing a physical device after a manufacturing change, not on training a machine learning algorithm.
9. How the ground truth for the training set was established
Not applicable. There is no training set for a machine learning algorithm in this submission.
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(89 days)
AXIOS Stent and Electrocautery Enhanced Delivery System
The AXIOS Stent is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts ≥6cm in size, and symptomatic Walled Off Necrosis ≥6cm in size, with ≥70% fluid content, 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 the 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 Sten. 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 describes a medical device, the AXIOS Stent and Electrocautery Enhanced Delivery System, and its acceptance criteria as evaluated through bench testing, animal testing, and a clinical literature review.
Here's the information extracted and organized:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Test) | Reported Device Performance (Result) |
|---|---|
| Deployed Stent Saddle Length | Pass |
| Deployed Stent Saddle Outer Diameter | Pass |
| Deployed Stent Flange Width | Pass |
| Stent Pull-out Force (tensile) | Pass |
| Stent (Saddle) Radial Strength - in expansion | Pass |
| Stent (Saddle) Radial Strength - in compression | Pass |
| Tracking Force | Pass |
| Stent Fatigue | Pass |
| Stent Deployment Force | Pass |
| Implant Anchor Function - Retention (tensile) | Pass |
| MR Testing | Pass |
| Safety and performance in animal models | Performed as intended, no new safety/performance issues |
| Clinical success of larger diameter stents (literature review) | Similar to existing predicate devices; no increased risk for stent migration despite increased flange diameter |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Bench Testing: The sample sizes for each specific bench test are not provided in the document.
- Animal Testing: The sample size for animal testing is not specified. The provenance (country/retrospective/prospective) is also not specified, though it implies a prospective study as it states "The proposed device performed as intended."
- Clinical Literature Review: The sample size is not explicitly stated as it's a review of existing literature, not a new clinical study. The provenance and details of the studies reviewed (e.g., country of origin, retrospective/prospective nature of those individual studies) are not provided.
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 provided in the document. The bench tests rely on objective physical measurements, and the animal testing and clinical literature review do not mention expert involvement for establishing ground truth in the way a diagnostic imaging study might.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and therefore not provided in the document. The tests described (bench, animal, literature review) do not typically involve adjudication of results in the expert consensus sense.
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
There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study, nor is there any AI component described for this device. The device is a physical stent and delivery system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical medical implant and delivery system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Bench Testing: Ground truth is established by engineering specifications and physical measurement standards.
- Animal Testing: Ground truth is established by direct observation of device performance, and potentially histological examination or other animal physiology assessments to verify safety and function.
- Clinical Literature Review: Ground truth is derived from the reported outcomes and findings of the clinical studies included in the review, presumably based on clinical endpoints like stent migration, drainage efficacy, etc.
8. The sample size for the training set
Not applicable. This document describes the performance data for a medical device (stent), not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for a medical stent device.
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