Search Results

The Cordis AVIATOR PLUS PTA Balloon Dilatation catheter is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature, including iliac. femoral, ilio-femoral, popliteal, infra popliteal, renal, and carotid arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilatation of balloon-expandable and self-expanding stents in the peripheral vasculature.

The Cordis AVIATOR PLUS PTA Balloon Dilatation Catheter is a catheter with a distal balloon and utilizes a rapid exchange design and accepts a 0.014" guide wire. The catheter tip is tapered to facilitate crossing of tight lesions. The proximal hub is used as a balloon inflation port. Two radiopaque marker bands within the balloon indicate the dilating section of the balloon and aid in balloon placement.

The provided text describes a Special 510(k) submission for a device modification, the Cordis AVIATOR PLUS PTA Balloon Dilatation Catheter. This type of submission relies on the concept of "substantial equivalence" to a predicate device, rather than explicit acceptance criteria with numerical performance targets from a clinical study.

Therefore, many of the requested data points (like sample size for test sets, number of experts, MRMC studies, standalone performance, training set details) are not applicable to this type of regulatory submission because clinical performance studies with specific acceptance criteria are generally not required for device modifications that can demonstrate substantial equivalence through non-clinical design verification and validation testing.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable in the traditional sense. The 510(k) summary states: "The safety and effectiveness of the subject Cordis AVIATOR PLUS PTA Balloon Catheter has been demonstrated via data collected from non-clinical design verification and design validation tests and analyses."

This indicates that the device met internal design specifications and engineering performance criteria (e.g., burst pressure, durability, trackability, crossing profile, guidewire compatibility) through bench testing and potentially animal studies, which are not detailed in this public summary. These non-clinical tests would have their own acceptance criteria, but they are not the type of clinical performance criteria usually associated with AI/diagnostic devices.

The "reported device performance" is essentially that it passed these non-clinical tests and is "substantially equivalent" to its predicate device.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. No clinical "test set" in the context of human data or diagnostic imaging was used for this 510(k) submission. The evaluation was based on non-clinical design verification and validation tests.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. Ground truth in the context of clinical endpoints or diagnostic accuracy is not relevant for this non-clinical submission. Engineering and quality control experts would have assessed the device against its specifications.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set requiring adjudication was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is not relevant for a balloon dilatation catheter's 510(k) submission, especially one based on device modification and non-clinical data. This type of study would be for AI-powered diagnostic devices comparing human performance with and without AI assistance.

6. If a Standalone Performance Study Was Done

Not applicable. Standalone (algorithm-only) performance is relevant for AI algorithms. This is a physical medical device (balloon catheter), and its performance is evaluated through non-clinical engineering tests.

7. The Type of Ground Truth Used

For the purpose of this 510(k) submission, the "ground truth" was established by engineering design specifications and performance standards. The device performs as intended according to its design and manufacturing criteria, which are sufficient to demonstrate substantial equivalence to the predicate device.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of machine learning or AI for this physical device submission.

9. How the Ground Truth for the Training Set Was Established

Not applicable. No training set was used.

Ask a specific question about this device

The Cordis AMIIA PTA Balloon Dilatation catheter is intended for Percutaneous Transluminal Angioplasty in the peripheral vasculature, including iliac, femoral, ilio-femoral, popliteal, infra popliteal, renal, and carotid arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilatation of balloonexpandable and self-expanding stents in the peripheral vasculature.

The Cordis AMIIA PTA Balloon Dilatation Catheter is a catheter with a distal DURALYN™ inflatable balloon. The catheter utilizes a Rapid Exchange design, consisting of a single inflation lumen and a distal guide wire lumen. The guide wire lumen begins at the distal tip and terminates at the guide wire exit port. The guide wire exit port (hole) is approximately 25 cm from the distal tip. The maximum guide wire diameter that may be used is printed on the package label. The catheter tip is tapered to facilitate crossing of tight lesions. The proximal hub is used as a balloon inflation port. The balloon is inflated by injecting diluted contrast medium through this hub. Two radiopaque marker bands within the balloon indicate the dilating section of the balloon and aid in balloon placement. The nominal balloon diameter and length are printed on the identification band near the hub. The working pressure range for the balloon is between the nominal pressure and the rated burst pressure. All balloons distend to sizes above the nominal size at pressures greater than the nominal pressure. Consult the compliance table incorporated with the product, for diameters of the balloon at given pressures. The design of this catheter does not incorporate a lumen for distal dye injection. The balloon catheter with a usable shaft length of 142 cm has two proximal shaft markers (90 cm and 100 cm from the distal tip). Both indicate the relative position of the catheter tip to the distal end of the guiding catheter. An additional marker is located at the distal port exit notch and aids in locating the guide wire exit.

The provided text describes the Cordis AMIIA PTA Balloon Dilatation Catheter and its substantial equivalence to predicate devices, focusing on its intended use and safety. It does not contain information about specific acceptance criteria, device performance metrics, or a formal study with a test set, ground truth, or statistical analysis (like MRMC studies) as requested in the prompt. The document explicitly states that "No biocompatibility test was required, as the original device has not changed and there was no change in the vascular application of the device" and that safety and effectiveness were demonstrated via "non-clinical design verification tests and analyses." This suggests that the approval was based on engineering and design verification rather than a clinical performance study with human subjects.

Therefore, many of the requested details cannot be extracted from the provided text.

Here is an attempt to answer the questions based only on the provided information, noting where information is absent:

1. A table of acceptance criteria and the reported device performance
   The document does not explicitly list quantitative acceptance criteria or reported device performance metrics from a formal study. It broadly states that safety and effectiveness were demonstrated through "non-clinical design verification tests and analyses."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
   Not applicable (N/A). The document indicates that safety and effectiveness were demonstrated via "non-clinical design verification tests and analyses" rather than a clinical test set. No sample size for a test set or data provenance is mentioned.

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 (N/A). There is no mention of experts or ground truth establishment for a test set. The approval is based on substantial equivalence and non-clinical design verification.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
   Not applicable (N/A). No test set requiring adjudication is mentioned.

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 (N/A). The device is a physical medical catheter, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
   Not applicable (N/A). The device is a physical medical catheter, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
   Not applicable (N/A). The document refers to "non-clinical design verification tests and analyses" for safety and effectiveness, implying engineering and performance specifications rather than clinical ground truth like pathology or outcomes data. The basis for approval is substantial equivalence to predicate devices.

8. The sample size for the training set
   Not applicable (N/A). No training set is mentioned as this is a physical medical device.

9. How the ground truth for the training set was established
   Not applicable (N/A). No training set or associated ground truth establishment is mentioned.

Ask a specific question about this device

The InScope Precision Balloon Dilator - Wire Guided - with pre-loaded 0.035" guide wire - Is a sterile, single use, disposable dilator used in the alimentary tract (esophagus, pylorus and colon). In the sterile product packaging also a stopcock is provided to maintain pressure or vacuum by an inflation device. The balloon specific pressure / diameter relationship is represented on the labeling of each product.

The InScope Precision Balloon Dilator is intended for use in adult and adolescent populations to endoscopically dilate strictures of the alimentary tract (i.e. esophagus, pylorus and colon).

The subject InScope Precision Balloon Dilator - Wire Guided described in this submission is virtually identical to its predicate device(s), which already have received 510(k) concurrence.

Compared to the previously cleared predicate device - InScope Precision Balloon Dilator - Fixed Wire, the subject InScope Precision Balloon Dilator - Wire Guided in this submission now resembles the Boston Scientific's CRE Wireguided Balloon Dilator, which already received FDA 510(k) concurrence.

The provided text is related to a 510(k) premarket notification for the "InScope™ Precision Balloon Dilator - Wire Guided." This document describes the device, its intended use, and its substantial equivalence to previously cleared predicate devices.

However, the document does not contain information regarding specific acceptance criteria, a study proving the device meets these criteria, or any details about a standalone algorithm, human-in-the-loop performance, expert consensus, training set, or ground truth establishment.

Instead, the document focuses on:

• Substantial Equivalence: The primary assertion is that the InScope™ Precision Balloon Dilator - Wire Guided is "virtually identical" and "substantially equivalent" to its predicate device(s) that have already received 510(k) concurrence.
• Performance Data: It states that performance has been "demonstrated via non-clinical bench type tests and analyses." However, it does not provide the results, acceptance criteria for these tests, or any details about a clinical study involving human patients or expert evaluations.
• FDA Clearance: The letter from the FDA confirms that based on the substantial equivalence argument, the device can be marketed.

Therefore, an answer based on your request and the provided text is not possible, as the necessary information for a detailed description of acceptance criteria, a supporting study, and related metrics (sample sizes, expert details, adjudication methods, MRMC studies, standalone performance, ground truth) is absent.

The document is a regulatory submission for a medical device that establishes substantial equivalence to a predicate device, and thus, detailed performance metrics and studies are often not required in the same way they would be for a novel device or a device making new performance claims.

Ask a specific question about this device

The InScope™ Precision Balloon Dilator is intended for use in adult and adolescent populations to endoscopically dilate strictures of the esophagus.

The InScope Precision Balloon Dilator is a sterile, single use, disposable esophageal dilator. The InScope Precision Balloon Dilator contains three marking bands on the balloon to facilitate more precise centering the balloon within the stricture. The middle band is located at the center of the balloon at 5 cm distance from the shaft marker. The proximal and distal bands are set 2.5 cm from the centre band. The InScope Precision Balloon Dilator is provided with a stopcock to maintain pressure or vacuum. The InScope Precision Balloon Dilator is capable of 3 distinct and progressive larger diameters as a function of the applied inflation pressure. The specific pressure / diameter relationship is represented on the labeling of each product. The subject InScope Precision Balloon Dilator described in this submission is virtually identical to its predicate device (Boston Scientific's CRE Balloon dilatation catheter), which already has received FDA 510(k) concurrence.

This document is a 510(k) Pre-market Notification for the InScope Precision Balloon Dilator, seeking substantial equivalence to a predicate device. As such, it does not contain acceptance criteria in the traditional sense of a performance study with numerical targets for sensitivity, specificity, etc. Instead, it demonstrates substantial equivalence through comparisons of technological characteristics and non-clinical bench testing.

Here's an analysis based on the provided text, addressing the points you requested where applicable:

1. Table of Acceptance Criteria and Reported Device Performance

As noted above, no explicit acceptance criteria with quantitative targets are provided in the document. The "performance" is assessed through comparison to a predicate device and non-clinical bench tests.

2. Sample Size for the Test Set and Data Provenance

• Sample Size: This document refers to "non-clinical bench type tests and analyses." It does not specify a sample size for these tests.
• Data Provenance: The document does not specify country of origin for the data, nor whether it was retrospective or prospective. Given it's non-clinical bench testing, these distinctions (retrospective/prospective) are less applicable than for clinical data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Number of Experts: Not applicable or not specified. Bench testing typically relies on predefined physical or engineering standards, not expert clinical interpretation of test results in the same way clinical ground truth is established.
• Qualifications of Experts: Not applicable or not specified.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. For non-clinical bench testing, results are typically determined by measurement against established standards, not through adjudication of expert opinions.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not done. This submission is for a device, an esophageal dilator, not an AI/imaging diagnostic tool that would typically involve a multi-reader study. The evaluation focuses on the safety and effectiveness of the device itself, primarily through bench testing and comparison to a predicate device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Not applicable. This device is an esophageal dilator, not an algorithm.

7. The Type of Ground Truth Used

• Ground Truth: For non-clinical bench tests, "ground truth" refers to established engineering specifications, physical measurements, and materials science standards. The document states "materials used in the subject device are found to be biocompatible," implying adherence to biocompatibility standards. The functional aspects like "3 distinct and progressive larger diameters as a function of the applied inflation pressure" would be verified against engineering specifications and measured outcomes.

8. The Sample Size for the Training Set

• Not applicable. This document describes a medical device (dilator), not an AI model requiring a training set.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. As above, no training set for an AI model is involved.

Ask a specific question about this device

The Cordis Palmaz BLUE .018 Transhepatic Biliary Stent System is indicated for the palliation of malignant neoplasms in the biliary tree.

The PALMAZ BLUE Transhepatic Biliary Stent is a balloon expandable Cobalt Chromium Biliary stent. The stent is provided premounted on a balloon catheter, i.e., the Cordis SLALOM 0.18" Delivery System. The stent and delivery system are advanced over a guidewire through a sheath lumen, via the use of a stainless steel introducer tube accessory, (which is provided together with the Palmaz BLUE .018 Transhepatic Biliary Stent System) to an obstruction site in the biliary tree where the balloon is then inflated to expand the stent. After full expansion of the stent, the balloon is then deflated and subsequently the delivery system is removed. The Cordis PALMAZ BLUE .018 Transhepatic Biliary Stent System is provided sterile (via Ethylene Oxide sterilization) and is intended for single use only.

The provided 510(k) summary (K040413) for the Cordis Palmaz® BLUE™ .018 Transhepatic Biliary Stent System details its safety and effectiveness through substantial equivalence to predicate devices, rather than through presenting acceptance criteria and a study demonstrating the device meets those criteria.

Therefore, the requested information elements related to specific acceptance criteria, device performance, sample sizes for test/training sets, ground truth establishment, expert reviews, and comparative effectiveness studies are not contained within the provided document.

The document focuses on demonstrating that the new device is substantially equivalent to legally marketed predicate devices.

Here's a breakdown of what is available regarding safety and effectiveness, based on the provided text, and what is not:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not available. The document does not specify quantitative acceptance criteria or report specific device performance metrics in numerical form. It relies on demonstrating substantial equivalence to predicate devices.

2. Sample size used for the test set and the data provenance:

• Not available. The document states that safety and effectiveness were demonstrated via "non-clinical in-vitro and animal testing (stent placement in biliary duct)". It does not provide sample sizes for these tests, nor does it specify the data provenance (e.g., country of origin, retrospective/prospective) beyond stating it was non-clinical.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not available. Ground truth establishment by experts for a test set is not described, as the evaluation was non-clinical.

4. Adjudication method for the test set:

• Not available. Adjudication methods are not applicable to the non-clinical testing described.

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 device is a transhepatic biliary stent system, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies and AI effect sizes are irrelevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. See point 5.

7. The type of ground truth used:

• Implied non-clinical data: The document refers to "non-clinical in-vitro and animal testing (stent placement in biliary duct)". The "ground truth" here would likely be derived from measurements, observations, and histological findings from these non-clinical tests demonstrating stent function, patency, and biocompatibility in the animal model. It is not an expert consensus, pathology, or outcomes data from human patients.

8. The sample size for the training set:

• Not applicable. As this is not an AI/machine learning device, there is no concept of a "training set."

9. How the ground truth for the training set was established:

• Not applicable. See point 8.

Summary of Studies (from the document):

The document explicitly states:

• "The safety and effectiveness of the device and the substantial equivalence to the predicate devices have been demonstrated via data collected from non-clinical in-vitro and animal testing (stent placement in biliary duct) which was prescribed in the FDA's – Guidance for the content of premarket notifications for metal expandable biliary stents. February 5, 1998."
• "The Cobalt Chromium based stent material has been tested according to the ISO10993 part 1 and were concluded biocompatible."

The 510(k) submission relies on demonstrating substantial equivalence to already cleared predicate devices, citing similarities in:

• Intended use
• Components
• Dimensions (size range)
• Accessories
• Method of delivery
• Fundamental technology (operating principle)
• Packaging configuration and materials
• Manufacturing and sterilization processes
• Stent material (Cobalt Chromium-alloy, comparing to components in knee implants)

This approach is common for medical devices where a new device is similar enough to an existing one that extensive new clinical trials are not required for market clearance.

Ask a specific question about this device

The POWERFLEX EXTREME PTA catheter is intended for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae and to dilate stenoses in iliac, femoral, popliteal, infra popliteal and renal arteries.

The POWERFLEX P3 PTA catheter is intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The OPTA PRO PTA catheter is intended to dilate stenoses in ilio-femoral, ilio-femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The modified PTA catheters described in this submission are virtually identical to its original cleared devices, which received 510(k) concurrence.

The Cordis over-the-wire (OTW) PTA balloon catheters have a dual lumen design with a distal inflatable balloon. Two radiopaque marker bands indicate the dilatation section of the balloon and aid in balloon placement. The radiopaque marker bands indicate the nominal length of the balloon. The balloon inflation lumen is used to inflate and deflate the balloon. The guide wire lumen is used to track the catheter over a pre-positioned guide wire or to inject contrast medium and/or saline.

Compared to the previously cleared predicate devices, the devices in this submission are identical, except for the following feature: Polyamide hub instead of polycarbonate hub Injection molded hub instead of UV-glued hub Slight design configuration change for user preference.

The provided text is a 510(k) Premarket Notification for Cordis PTA Balloon Catheters, and it does not include information about a study proving the device meets specific acceptance criteria in the way a clinical trial or AI/ML performance study would.

Instead, this document focuses on demonstrating substantial equivalence to previously cleared predicate devices based on non-clinical design verification tests and analyses. This approach is typical for 510(k) submissions where the new device is very similar to an already approved one.

Therefore, many of the requested points related to acceptance criteria, ground truth, expert adjudication, MRMC studies, standalone performance, and training/test set details are not applicable or discoverable in this type of submission.

Here's a breakdown of what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

There is no explicit table of acceptance criteria and reported device performance in the context of a clinical performance study with defined metrics (e.g., sensitivity, specificity, accuracy).

Instead, the "performance" demonstrated is that the modified devices are "virtually identical" to their original cleared devices, with changes limited to non-clinical aspects like hub material and design configuration for user preference. The regulatory "acceptance criteria" here are implicitly that these minor design changes do not negatively impact the safety and effectiveness, and the device continues to meet the safety and performance of its predicate.

• Acceptance Criteria (Implicit): The modified devices demonstrate biocompatibility, and their non-clinical performance (e.g., inflation/deflation, tracking over a guidewire, radiopacity) is equivalent to the predicate devices, and the changes do not introduce new safety concerns.
• Reported Device Performance: "Safety and The safety and effectiveness of the affected PTA Balloon Catheters have been Performance demonstrated via data collected from non-clinical design verification tests and Data analyses. All materials used in these modified devices have been tested according to ISO 10993-Part 1 and were found biocompatible."

2. Sample size used for the test set and the data provenance:

• Test Set Size: Not applicable. This submission relies on non-clinical design verification tests, not a clinical test set with patient data.
• Data Provenance: Not applicable, as there are no patient data. The "data" are from non-clinical laboratory tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Number of Experts: Not applicable. Ground truth as typically understood for clinical performance studies (e.g., diagnosis, lesion identification) is not established here.
• Qualifications of Experts: Not applicable.

4. Adjudication method for the test set:

• Not applicable. There is no clinical test set 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:

• MRMC Study: No. This is a medical device (balloon catheter), not an AI/ML diagnostic or assistive device that would involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

• Ground Truth: For biocompatibility, the "ground truth" is adherence to ISO 10993-Part 1 standards. For functional performance, the "ground truth" is equivalence in non-clinical bench testing to the predicate device. This is a technical (engineering/materials) ground truth, not a clinical ground truth.

8. The sample size for the training set:

• Not applicable. There is no AI/ML component, so no training set.

9. How the ground truth for the training set was established:

• Not applicable.

Ask a specific question about this device

The Cordis PALMAZ® GENESIS™ Transhepatic Biliary Stent on SLALOM™ .018" Delivery System is intended for use in the palliation of malignant neoplasms in the biliary tree.

The PALMAZ GENESIS Transhepatic Biliary Stent on SLALOM .018" Delivery System is a balloon-expandable, stainless steel stent that is provided premounted upon the Cordis SLALOM balloon catheter (ref. K003159). The stent is provided in four nominal, unexpanded stent lengths: 12, 15, 18 & 24 mm. The stent is designed for expansion to diameters from 3 to 6 mm, depending on the diameter of the associated balloon upon which it is mounted. The PALMAZ GENESIS Transhepatic Biliary stent on SLALOM .018" Delivery System is provided sterile and is intended for single use only.

The provided text describes a 510(k) premarket notification for a medical device (Cordis PALMAZ® GENESIS™ Transhepatic Biliary Stent on SLALOM™ .018" Delivery System), not a study that establishes acceptance criteria and proves the device meets those criteria.

The 510(k) process is used to demonstrate that a device is substantially equivalent to a predicate device, meaning it is at least as safe and effective. It does not typically involve the establishment of new acceptance criteria through clinical studies in the same way an investigational device exemption (IDE) or premarket approval (PMA) application would for novel devices.

Here's a breakdown based on the provided text, highlighting what is not present:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: Not applicable/Not provided. The document refers to "non-clinical design verification tests and analyses," which are typically bench testing and engineering verification, not human clinical trials with 'sample size' in the traditional sense of patient numbers.
• Data Provenance: Not applicable/Not provided. Since it's described as "non-clinical design verification," there is no country of origin for patient data or retrospective/prospective classification.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

• Not applicable/Not provided. This information pertains to studies where human experts evaluate cases to establish a "ground truth" (e.g., diagnosing disease from images). The provided text describes engineering verification tests, not expert-adjudicated clinical data.

4. Adjudication Method for the Test Set:

• Not applicable/Not provided. Pertains to expert review, which is not described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No. The document does not mention any MRMC study, human reader performance, or AI assistance. The device in question is a physical medical device (stent), not a diagnostic AI algorithm.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

• No. This question is also not applicable as the device is a physical stent, not an algorithm.

7. Type of Ground Truth Used:

• Not explicitly stated in terms of "ground truth" for a clinical outcome. The "effectiveness" is demonstrated through "non-clinical design verification tests and analyses." This would imply that the "ground truth" for these tests would be compliance with engineering specifications, material properties, mechanical performance, etc., as determined by validated test methods.

8. Sample Size for the Training Set:

• Not applicable/Not provided. There is no mention of a "training set" as this is not an AI/algorithm-based device.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable/Not provided. (Refer to point 8).

In summary:

This 510(k) submission focuses on demonstrating substantial equivalence to predicate devices through non-clinical design verification tests and analyses for a physical medical device (biliary stent). It explicitly states that "Performance standards have not been established for this device by the FDA under section 514 of the Food, Drug and Cosmetic Act." Therefore, the document does not contain the information about acceptance criteria, clinical study designs, sample sizes for patient data, expert ground truth establishment, or AI-related metrics that your prompt requests.

Ask a specific question about this device