Search Results

The Micro Guide Catheter ELITE accessory is to be used with the Frontrumer® CTO Catheter. The Frontrumer® CTO Catheter is intended to facilitate the intraluminal placement of conventional guide wires beyond stenotic lesions (including chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention.

The Micro Guide Catheter ELITE is a 6F sheath compatible catheter designed to navigate and place guidewires in the peripheral vasculature and to provide additional support for the Frontrunner® CTO Catheter. The Frontrunner® CTO Catheter is indicated to facilitate the intraluminal placement of conventional guidewires beyond the stenotic lesions (including chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention. The Micro Guide Catheter ELITE is a single lumen torqueable tube containing a PTFE inner liner that is surrounded by a stainless steel braid, which is further encompassed by a polymer jacket, and features a final external hydrophilic coating. The proximal end utilizes a molded hub with a luer fitting for flushing, with winged tabs designed to facilitate maneuvering and torqueing in the vasculature, while the distal tip contains a radiopaque marker band for visibility under fluoroscopy. The Micro Guide Catheter ELITE is available in various configurations and several lengths. The Micro Guide Catheter ELITE is provided sterile (by EO) and is intended for single use only.

The provided document is a 510(k) summary for the Micro Guide Catheter ELITE. It outlines the device description, intended use, and comparison to a predicate device, along with performance data. However, it does not explicitly present acceptance criteria in a table format with reported device performance for specific clinical or diagnostic metrics as one would expect for an AI/ML powered device.

Instead, the document details various types of performance tests conducted to demonstrate substantial equivalence to a predicate device. For the purpose of answering your request, I will interpret "acceptance criteria" as the successful completion and meeting of specifications for each listed performance test, and "reported device performance" as the documented successful outcome of these tests.

It's important to note that this device is a physical medical device (catheter), not an AI/ML-powered diagnostic tool. Therefore, many of your specific questions regarding AI/ML study design (ground truth, expert consensus, MRMC studies, training sets, etc.) are not applicable in this context.

Here's an attempt to structure the information based on your request, with a focus on how the provided document does address performance and testing, and explicitly stating where information requested for AI/ML devices is not present or not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size:
  • Animal Study: Two animals were used. Within each animal, four devices were evaluated (2 test articles, 2 control articles). This gives a total of 4 uses of the test device (Micro Guide Catheter ELITE) across two animals.
  • Other Testing (Biocompatibility, Dimensional, Functional, Packaging/Sterilization): The document does not specify the exact number of units or samples used for each of these in vitro/bench tests. It mentions "finished and sterilized catheters" for biocompatibility.
• Data Provenance:
  • Animal Study: Prospective, conducted in a porcine model. The country of origin is not specified but it was a GLP (Good Laboratory Practice) study.
  • Biocompatibility & Other Tests: Likely lab-based (in vitro/bench) testing of manufactured devices. Provenance (country of origin) not specified. These were not human data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not applicable. This is a physical medical device, not an AI/ML diagnostic device requiring expert interpretation for ground truth establishment. The "ground truth" for its performance is determined by physical measurements, chemical analyses, and biological responses in animal models.

4. Adjudication Method for the Test Set

• Not applicable. There was no expert adjudication in the context of diagnostic interpretation. For the animal study, evaluation was done by the study investigators.

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

• No. This type of study is relevant for diagnostic devices, especially those using AI, to assess reader performance. It does not apply to a physical catheter.

6. Standalone (Algorithm Only) Performance Study

• No. This applies to AI/ML algorithms, not physical medical devices.

7. Type of Ground Truth Used

• Physical/Chemical Measurements and Biological Observations:
  • For biocompatibility: Adherence to ISO standards and observed biological responses (cytotoxicity, hemolysis, etc.).
  • For dimensional/functional: Engineering specifications and measurements.
  • For packaging/sterilization: Measured levels of contaminants or residuals against safety limits.
  • For animal study: Direct observation of device performance (radiopacity, rotation, advancement, retraction) and gross pathological evaluation of tissues for damage.

8. Sample Size for the Training Set

• Not applicable. This device does not involve an AI/ML algorithm that requires a training set. The device design and testing are based on engineering principles and preclinical evaluations.

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

• Not applicable. As there is no AI/ML training set, there is no ground truth related to it.

Ask a specific question about this device

The S.M.A.R.T. ® RE-FLEX™ Biliary Self Expanding Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.

Not Found

This document is an FDA 510(k) clearance letter for a medical device called "The S.M.A.R.T. RE-FLEX™ Biliary Self Expanding Stent System". It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain the detailed information necessary to describe acceptance criteria or a study proving the device meets those criteria, as typically found in clinical trial reports or detailed premarket submission documents.

The provided text is an FDA clearance letter, which is a regulatory decision document. It states that the device is substantially equivalent and can be marketed, but does not explain the data leading to that conclusion in the format requested.

Therefore, I cannot populate the table or answer most of the questions based on the input provided. The document primarily focuses on regulatory approval, labeling requirements, and general controls, not on the specifics of performance testing or clinical study results.

Here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

• Cannot be provided. This document does not specify acceptance criteria (e.g., specific clinical endpoints, success rates, patency rates) or detailed performance results in a quantitative manner.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Cannot be provided. This information is not present in the FDA clearance letter.

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/Cannot be provided. This type of detail is relevant for studies involving human interpretation (e.g., medical imaging AI), not typically for a self-expanding stent device in this context where "ground truth" would be related to clinical outcomes or device functionality established through different types of studies (e.g., mechanical testing, animal studies, human clinical trials). The document mentions no such experts or ground truth establishment.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Not applicable/Cannot be provided. Similar to point 3, this is for studies involving human interpretation.

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/Cannot be provided. This type of study relates to AI-assisted diagnostic or interpretative devices. The S.M.A.R.T. RE-FLEX™ Biliary Self Expanding Stent System is a physical interventional device, not an AI diagnostic tool.

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

• Not applicable. This pertains to AI algorithms.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Cannot be provided. The document does not describe the types of data (e.g., clinical trial results, pathology) that would have established the ground truth for the performance claims in the actual submission to the FDA.

8. The sample size for the training set

• Not applicable/Cannot be provided. This applies to machine learning models, not to a physical medical device like a stent.

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

• Not applicable/Cannot be provided. This applies to machine learning models.

In summary: The provided FDA 510(k) clearance letter serves as proof of regulatory approval based on substantial equivalence, but it is not the study report itself. The detailed clinical or performance study data (including acceptance criteria, sample sizes, and specific results) that informed this FDA decision would be found in the actual 510(k) submission and associated technical reports, which are not included in this extract.

Ask a specific question about this device

Ask a specific question about this device

The Powerflex™ Pro Percutaneous Transluminal Angioplasty (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 device is also indicated for post-dilatation of balloon-expandable and self-expanding stents in the peripheral vasculature.

The Powerflex™ Pro Percutaneous Transluminal Angioplasty (PTA) catheter with a distal inflatable balloon. The Powerflex™ Pro PTA Catheter is designed for use with a 0.035" guide wire and a catheter sheath introducer and is available in a variety of diameters and lengths. Two radiopaque marker bands indicate the dilating section of the balloon and aid in balloon placement. The catheter tip is tapered to ease entry into peripheral arteries and to facilitate the crossing of tight stenoses.

The provided text describes the Cordis Powerflex™ Pro Percutaneous Transluminal Angioplasty Catheter. It outlines the device description, indications for use, and a summary of performance testing to establish substantial equivalence to predicate devices.

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly list "acceptance criteria" with specific quantitative thresholds. Instead, it states that the conducted in-vitro performance tests provide "reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use." The performance is demonstrated by the completion of these tests aligning with engineering standards and existing predicate devices.

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

• Sample Size: The document does not specify the exact sample sizes used for each of the in-vitro performance tests. It merely lists the tests that were completed.
• Data Provenance: The studies were "non-clinical design verification and validation tests and analyses," meaning they were laboratory/bench tests. The origin of the data is therefore laboratory-based, and not patient-specific (i.e., not a clinical study involving human subjects). It also mentions "post-market surveillance data analyses of the predicate devices," which would be retrospective data from existing devices.

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

Not applicable. This device's safety and effectiveness were demonstrated through non-clinical, bench testing and comparison to predicate devices, not through a diagnostic accuracy study requiring expert consensus on a test set to establish "ground truth."

4. Adjudication Method for the Test Set

Not applicable, as there was no test set requiring human adjudication in the context of diagnostic accuracy. The testing was laboratory-based.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a medical device (catheter), not an AI diagnostic software.

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

Not applicable. This is a medical device (catheter), not an AI algorithm. The performance described is "standalone" in the sense that the device itself was tested in a lab setting, but not in the context of an AI algorithm's performance.

7. The Type of Ground Truth Used

For the in-vitro performance tests, the "ground truth" would be established by:

• Engineering specifications and design requirements.
• Industry standards (e.g., ISO for biocompatibility).
• Performance characteristics of the legally marketed predicate devices.
• Accepted scientific and engineering principles for material properties and mechanical function.

8. The Sample Size for the Training Set

Not applicable. This is a medical device (catheter), not an AI algorithm requiring a training set.

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

Not applicable. This is a medical device (catheter), not an AI algorithm requiring a training set.

Ask a specific question about this device

The ANGIOGUARD™ XP Emboli Capture Guidewire is indicated for use as a guidewire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing carotid artery angioplasty and stenting procedures in carotid arteries. The diameter of the artery at the site of filter basket placement should be from 3mm to 7.5 mm.

The ANGIOGUARD™ RX Emboli Capture Guidewire is indicated for use as a guidewire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing carotid artery angioplasty and stenting procedures in carotid arteries. The diameter of the artery at the site of filter basket placement should be from 3mm to 7.5 mm.

Both subject and predicate ANGIOGUARD XP and RX devices consist of a guidewire with integrated emboli filter basket at the distal end. The devices function as an interventional guidewire and distal protection device during delivery and placement of stents and interventional devices in carotid procedures. The guidewire is delivered via an OTW (over-the-wire) or RX (rapid-exchange) deployment sheath and is captured via an OTW or RX capture sheath. ANGIOGUARD devices have a fitter basket at the distal end that is deployed prior to the stenting procedure. When deployed, the filter basket opens in an umbrella-like fashion, allowing passive hemo-filtration with subsequent emboli capture. At the end of the procedure, the filter is collapsed and retrieved.

The Cordis Corporation ANGIOGUARD XP & RX Emboli Capture Guidewires are embolic protection guidewires used during carotid artery angioplasty and stenting procedures. The device's primary function is to contain and remove embolic material (thrombus/debris). This 510(k) notification is for a special 510(k) due to a change in the adhesive material used to adhere radiopaque markers to the filter basket struts.

Here's an analysis of the acceptance criteria and study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document describes "Design verification activities" rather than a clinical human trial needing a test set with specific sample sizes. The testing involved:

• Deployment and Capture Testing: This would likely involve in vitro or bench testing. No specific sample size is provided.
• Visual Inspections: No specific sample size is provided.
• Bioburden Testing: No specific sample size is provided.
• Endotoxin Testing: No specific sample size is provided.
• EtO Residual Testing: No specific sample size is provided.
• Biocompatibility Testing: Conducted per ISO 10993-1. This is a series of tests, and the "sample size" would relate to the number of test articles and controls used in each specific biological evaluation (e.g., cytotoxicity, sensitization, irritation). No specific detailed numbers are given in this summary.

The data provenance is not explicitly stated as retrospective or prospective in the context of human data. Given the "Special 510(k)" for a material change, the focus is on bench testing and laboratory evaluations to confirm the new adhesive does not alter the device's fundamental performance or safety.

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

Not applicable. This submission is for a material change to an already cleared device, relying on design verification activities (bench testing, lab tests) rather than a clinical test set requiring expert ground truth establishment for a diagnostic or imaging device.

4. Adjudication Method for the Test Set:

Not applicable. Since the evaluation consists of design verification activities (bench and lab testing), there is no "adjudication method" in the sense of expert review for clinical data.

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 an embolic protection guidewire, a physical medical device, not an AI software. Therefore, an MRMC study related to AI assistance is irrelevant.

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

Not applicable. This is a physical medical device, not an algorithm or AI software.

7. The Type of Ground Truth Used:

For the design verification activities:

• Technical Specifications/Device Inputs: The "ground truth" for the tests described (Deployment and Capture Testing, Visual Inspections, Bioburden, Endotoxin, EtO residual testing, biocompatibility testing) is adherence to predefined engineering specifications, performance standards, and regulatory standards (e.g., ISO 10993-1). The summary states "Results demonstrated that design outputs continue to meet device inputs."

8. The Sample Size for the Training Set:

Not applicable. This is a change to a physical medical device, not a machine learning model requiring a training set.

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 OPTEASE Vena Cava Filter is indicated for the prevention of recurrent pulmonary embolism (PE) via percutaneous placement in the inferior vena cava in the following situations: Pulmonary thromboembolism when anticoagulants are contraindicated, Failure of anticoagulant therapy in thromboembolic disease, Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced, Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated. The OPTEASE Filter may be retrieved according to the instructions supplied in the Section labeled: Optional Procedure for Filter Retrieval. The Angiographic Vessel Dilator is designed to provide angiographic visualization and linear measurement of the vasculature when combined with the delivery of radiopaque contrast media to the vena cava. The Cordis OPTEASE Retrieval Catheter is has been designed for retrieval of an implanted OPTEASE Filter in patients who no longer require a filter. Retrieval of the filter can be performed only by femoral approach.

The subject device is a system that consists of a flexible, self-expanding vena cava filter to be deployed in the infra-renal inferior vena cava via a 6F sheathed introduction kit. The filter is designed to trap large, life threatening emboli and therefore prevent recurrent pulmonary embolism, while maintaining caval patency. The OptEase Permanent Vena Cava Filter is packaged with a filter introduction kit that includes the Angiographic Vessel Dilator, a directional filter storage tube, catheter sheath introducer and obturator for safe and accurate deployment of the filter.

This is a 510(k) premarket notification for a medical device called the OPTEASE® Vena Cava Filter and OPTEASE® Retrieval Catheter. It is a request for substantial equivalence to previously cleared devices. Therefore, the device does not provide specific acceptance criteria or an explicit study proving performance against those criteria in the same way a new, de novo device or a PMA submission might.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices based on intended use, application, and user application. The regulatory review process for a 510(k) primarily assesses whether the new device is as safe and effective as a legally marketed predicate device.

Based on the provided text, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission seeking substantial equivalence to predicate devices, there are no explicit "acceptance criteria" in the form of specific performance metrics with target values that a study was designed to meet for the subject device. The "reported device performance" is essentially the claim of substantial equivalence to the predicate devices.

Regarding the "Study that proves the device meets the acceptance criteria":

The document does not describe a new clinical or performance study for the subject device to prove specific performance metrics. Instead, the "proof" is based on demonstrating that the modified device (the current OPTEASE Vena Cava Filter and Retrieval Catheter) is fundamentally unchanged from its predicate, except for labeling:

"The change to the predicate devices, OPTEASE Vena Cava Filter and OPTEASE Retrieval Catheter, only affects the labeling."

This statement is critical. It implies that no new significant performance data was required because the physical device and its mechanism of action were not altered. The "study" here is essentially a comparison to predicate devices and a declaration of labeling changes only, rather than a full-scale performance study.

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. The submission states only labeling was changed, implying no new clinical or performance test data was generated for a "test set" to establish equivalence. The equivalence is based on the previously cleared predicate device's performance.

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

Not applicable. No new test set requiring expert ground truth establishment is described in the provided text, as the change was only to labeling.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No new test set requiring adjudication is 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 vena cava filter and retrieval catheter, not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study is not relevant.

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

Not applicable. This device is a physical medical implant and retrieval system, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable. As noted earlier, the submission states that only the labeling was changed, implying no new performance data was generated for the subject device beyond what existed for the predicate devices. The "ground truth" for the predicate devices' performance would have been established through clinical trials, bench testing, and potentially post-market surveillance associated with their initial clearances.

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.

Ask a specific question about this device

The Outback LTD Re-Entry Catheter is intended to facilitate placement and positioning of guidewires and catheters within the peripheral vasculature. The Outback LTD Re-Entry Catheter is not intended for use in the coronary or cerebral vasculature.

The Outback LTD Re-Entry Catheter is a sterile (via Ethylene Oxide sterilization) device and is intended for single use only.

Here's an analysis of the provided text regarding the Outback LTD Re-Entry Catheter, focusing on acceptance criteria and study details:

Overall Assessment:

The provided document (K083814) is a 510(k) summary for a medical device – a re-entry catheter. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and results. As such, much of the requested information (like specific acceptance criteria values, sample sizes for test/training, expert details, MRMC studies, standalone performance, and ground truth types) is not present in the provided text. The submission relies solely on non-clinical in-vitro bench testing for its substantial equivalence claim, not clinical studies.

Description of Acceptance Criteria and Study to Prove Device Meets Them

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, specific quantitative acceptance criteria or detailed performance data are not explicitly stated. The submission's "Summary of Substantial Equivalence" indicates:

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

• Sample Size for Test Set: Not specified. The document only mentions "non-clinical in-vitro bench testing" data was collected. No specific number of tests/samples is provided.
• Data Provenance: The data is from non-clinical in-vitro bench testing. The country of origin is not explicitly stated, but the manufacturer (Cordis Corporation) is a Johnson & Johnson Company, likely based in the US (given the regulatory submission to FDA). The data is not clinical (i.e., not from human subjects) and would be considered experimental/bench data, not retrospective or prospective in the clinical sense.

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

• Not Applicable / Not Specified. For non-clinical bench testing focused on device functionality and substantial equivalence, "ground truth" as established by medical experts (like radiologists for image analysis) is generally not relevant. The "ground truth" would be the measured physical properties or performance of the device against engineering specifications. The document does not mention any expert involvement in establishing ground truth for the bench tests.

4. Adjudication Method for the Test Set

• Not Applicable / Not Specified. Since the testing is described as non-clinical in-vitro bench testing, an adjudication method (like 2+1, 3+1, etc., typically used for reconciling expert opinions in clinical ground truth establishment) is not described or implied.

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

• No. An MRMC study is a type of clinical comparative effectiveness study involving human readers' performance with and without AI assistance. The provided document explicitly states that substantial equivalence was demonstrated via "non-clinical in-vitro bench testing," indicating no clinical human-reader studies were conducted.

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

• Not Applicable. This device is a physical medical catheter, not an algorithm or AI software. Therefore, the concept of "standalone performance" for an algorithm is not relevant. The substantial equivalence was based on the physical device's performance in bench tests.

7. The Type of Ground Truth Used

• Not explicitly stated in terms of "ground truth" for clinical data. For the non-clinical in-vitro bench testing, the "ground truth" would be implicitly defined by the engineering specifications and performance characteristics expected of such a catheter, and the performance observed in the predicate device (K043534). This would typically involve physical measurements, material properties, and functional tests (e.g., re-entry success rates in a simulated vessel model, guidewire trackability, etc.). The document does not detail these specific "ground truths."

8. The Sample Size for the Training Set

• Not Applicable / Not Specified. As this is a physical medical device and not an AI/ML algorithm, there is no "training set."

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

• Not Applicable. Again, no training set for an algorithm exists for this device.

Ask a specific question about this device

The Micro Guide Catheter XP accessory is to be used with the Frontrunner® XP CTO Catheter. The Frontrunner XP CTO Catheter is intended to facilitate the intraluminal placement of conventional guide wires beyond the stenotic lesions (including chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention.

The Micro Guide Catheter XP is a single lumen, braided guide catheter with a PTFE liner. The Micro Guide Catheter has a 4.5 French profile, an inner diameter of 0.042" and overall lengths of 82 cm and 132 cm.

The Micro Guide Catheter XP is provided sterile (via Ethylene Oxide sterilization) and is intended for single use only.

The provided text is related to a 510(k) submission for a medical device called the "Micro Guide Catheter XP." This document focuses on demonstrating substantial equivalence to predicate devices through non-clinical in-vitro bench testing and biocompatibility testing. It does not involve a study to establish performance against specific acceptance criteria in the context of an AI/algorithm-driven device for diagnostic or prognostic purposes, which is what your questions are geared towards.

Therefore, I cannot extract the information you requested about acceptance criteria, sample sizes for test/training sets, expert involvement, adjudication methods, or MRMC studies, as these aspects are not present in the provided 510(k) summary for this type of medical device.

The document states:

• Summary of Testing and Conclusion: "The Micro Guide Catheter XP is substantially equivalent to the predicate devices. The substantial equivalence to the predicate devices has been demonstrated via data collected from non-clinical in-vitro bench testing."
• Biocompatibility testing: "Biocompatibility testing was conducted per ISO 10993-1 (2003)(E): 'Biological Evaluation of Medical Devices. Part 1: Evaluation and Testing'."

These types of tests are physical or chemical evaluations of the device itself, rather than studies assessing diagnostic or prognostic performance with human input or an algorithm.

Ask a specific question about this device

The S.M.A.R.T. ® Nitinol Stent Transhepatic Biliary System is intended for use in the palliation of malignant neoplasms in the biliary tree.
The S.M.A.R.T. " Nitinol Stent Transhepatic Biliary System is intended for palliation of malignant strictures in the biliary tree.

6 French stent delivery system profile; . Stent material - Nickel Titanium alloy and tantalum . micromarkers; Expanded stent diameters: 6, 7 and 8 mm; . Stent lengths: 120 and 150 mm; . Stent delivery system usable length: 120 cm; and . Guidewire lumen 0.035" ● The S.M.A.R.T. ® Nitinol Stent Transhepatic Biliary System is provided sterile (via Ethylene Oxide sterilization) and is intended for single use only.

The provided text describes a 510(k) premarket notification for a medical device, the S.M.A.R.T. Nitinol Stent Transhepatic Biliary System. This documentation is for demonstrating substantial equivalence to predicate devices, not for proving specific performance criteria through a study with acceptance criteria in the manner one might find for a novel device or software. Therefore, the information typically requested in your prompt (e.g., acceptance criteria table, sample sizes for test/training sets, ground truth establishment, expert qualifications, MRMC studies) is not present in the provided text, as it doesn't describe such a study.

The primary "proof" in this context is the demonstration of substantial equivalence to existing legally marketed predicate devices, supported by non-clinical in-vitro bench testing and animal testing.

Here's an analysis based on the information available in the provided text:

1. A table of acceptance criteria and the reported device performance:

This information is not provided in the given text. The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel performance acceptance criteria for a new device type.

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

• Sample Size for Test Set: Not applicable/Not provided. The text does not describe a clinical "test set" for performance evaluation in the way a diagnostic AI device would. It mentions "non-clinical in-vitro bench testing and animal testing (stent placement in a biliary duct)" but does not specify sample sizes for these tests.
• Data Provenance: The testing mentioned (in-vitro bench testing and animal testing) would typically be conducted by the manufacturer (Cordis Corporation). The text does not specify country of origin for the data or whether it was retrospective or prospective.

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

Not applicable/Not provided. Since there's no mention of a clinical test set requiring ground truth established by human experts, this information is absent. Animal testing (stent placement in a biliary duct) would likely be evaluated by veterinary or medical professionals, but their number and specific qualifications are not detailed.

4. Adjudication method for the test set:

Not applicable/Not provided. No clinical test set requiring adjudication is 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/Not provided. This is a medical device (stent), not an AI/software device designed to assist human readers. Therefore, an MRMC study related to AI assistance is irrelevant and not mentioned.

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

Not applicable/Not provided. This is a physical medical device (stent), not an algorithm or software. "Standalone performance" in this context refers to the device's functional integrity as a physical implant, which is assessed through bench and animal testing.

7. The type of ground truth used:

• For the non-clinical in-vitro bench testing, the "ground truth" would be engineering specifications and measurements (e.g., stent diameter, length, expansion force, material properties) compared against design requirements.
• For the animal testing (stent placement in a biliary duct), the "ground truth" would likely involve direct observation, imaging, and potentially histopathological analysis of the animal tissue to assess stent patency, migration, and tissue reaction.
• No explicit mention of "expert consensus," "pathology," or "outcomes data" in the typical AI/diagnostic study sense.

8. The sample size for the training set:

Not applicable/Not provided. The device is a physical stent, not a machine learning algorithm. There is no concept of a "training set" in this submission.

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

Not applicable/Not provided. As there is no training set, this information is not relevant.

Summary of Device and Approval Process based on Provided Text:

• Device Name: S.M.A.R.T.® Nitinol Stent Transhepatic Biliary System
• Intended Use: Palliation of malignant neoplasms (strictures) in the biliary tree.
• Regulatory Pathway: 510(k) Premarket Notification.
• Mechanism of Proof: Substantial Equivalence to predicate devices (Cordis S.M.A.R.T.® CONTROL™ Nitinol Stent Transhepatic Biliary System, Cordis S.M.A.R.T.® Nitinol Stent Transhepatic Biliary System, Cordis PRECISE™ Nitinol Stent Transhepatic Biliary System, ev3 Protégé EverFlex Self-Expanding Nitinol Stent).
• Supporting Data for Substantial Equivalence: Non-clinical in-vitro bench testing and animal testing (stent placement in a biliary duct).
• FDA Conditions: The FDA required specific labeling limitations: "The safety and effectiveness of this device for use in the vascular system have not been established" and the biliary use indication must be prominently displayed.

The provided document is a regulatory approval document for a physical medical device (stent) via the 510(k) pathway, which focuses on demonstrating substantial equivalence, not on studies proving acceptance criteria for a diagnostic/AI device. Therefore, most of your requested information is not relevant or present in this context.

Ask a specific question about this device

The ANGIOGUARD™ XP Emboli Capture Guidewire and the ANGIOGUARD™ RX Emboli Capture Guidewire are indicated for use as a guidewire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing carotid artery angioplasty and stenting procedures in carotid arteries. The diameter of the artery at the site of filter basket placement should be from 3mm to 7.5 mm.

ANGIOGUARD XP and ANGIOGUARD RX devices consist of a guidewire with an integrated emboli filter at the distal end. The devices function as an interventional guidewire and distal protection device during delivery and placement of the stents and interventional devices during carotid procedures. The devices are delivered via a deployment sheath and captured via a capture sheath. The ANGIOGUARD devices have a filter basket at the distal end that is deployed prior to the stenting procedure. When deployed, the filter basket opens in an umbrella-like fashion, allowing passive hemo-filtration with subsequent emboli capture. At the end of the procedure, the filter is collapsed and retrieved. The device is available with filter basket diameters of 4, 5, 6, 7 and 8mm. The ANGIOGUARD devices are intended to capture emboli during carotid stenting procedures.

The provided text describes the ANGIOGUARD™ XP Emboli Capture Guidewire System and the ANGIOGUARD™ RX Emboli Capture Guidewire System. However, it does not include a table of acceptance criteria or a direct study proving the device meets specific numerical criteria. Instead, it demonstrates substantial equivalence to predicate devices and presents clinical trial outcomes for safety and effectiveness.

Here’s the information based on the provided text, addressing the requested points:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in a table format for the device's performance in preventing emboli capture or reducing adverse events. Instead, it highlights the device's performance through a non-inferiority study against a surgical alternative.

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

• Test Set (Clinical Study):
  • Randomized Arm: 334 subjects (167 in the stent group and 167 in the CEA group).
  • Non-randomized Stent Arm: 406 subjects.
  • Non-randomized Surgical Arm: 7 subjects.
  • Overall Total: 747 patients.
• Data Provenance: The clinical evaluation was a multi-center, randomized study (SAPPHIRE) conducted at 29 investigative sites in the United States. This indicates a prospective, multi-center US study.

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

The document does not specify the number of experts or their qualifications used to establish ground truth for the clinical endpoints (death, stroke, MI). Clinical endpoints like death and MI are typically determined by clinical event committees or adjudicated by qualified medical professionals, but specifics are missing here.

4. Adjudication Method for the Test Set

The document does not explicitly state the adjudication method (e.g., 2+1, 3+1, none) for the clinical endpoints. However, in major clinical trials like SAPPHIRE, it is standard practice to have an independent Clinical Events Committee (CEC) adjudicate events to ensure consistency and minimize bias.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted as this device is a physical medical device (guidewire with an embolic filter) and not an imaging or diagnostic AI-powered tool that would typically involve human readers interpreting cases. The study compared the device (in conjunction with stenting) against surgical intervention (Carotid Endarterectomy).

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

Yes, in a sense, a "standalone" performance was assessed for the device itself through:

• In-vitro testing: dimensional, tensile/torque testing, and functional testing.
• Biocompatibility, sterilization qualification, residual analysis, packaging testing, product shelf-life testing.
• Functional testing in animal models (porcine models): used to evaluate device performance and demonstrate satisfactory characteristics.
• Emboli capture and vessel damage studies utilizing an earlier version of the ANGIOGUARD device, showing satisfactory results with no significant luminal disruption or hemolysis.

These tests evaluate the device's physical and functional properties independent of human decision-making in real-time, focusing on its design and material integrity in performing its intended function.

7. Type of Ground Truth Used

The ground truth used in the clinical study was based on clinical outcomes data (death, stroke, MI) and ipsilateral stroke at specific time points, as adjudicated by medical professionals based on established definitions.

8. Sample Size for the Training Set

The document does not mention a training set in the context of an algorithm or AI model, as this is a physical medical device. The "training data" for the device's design and preclinical evaluation would implicitly be the various in-vitro tests and animal models used during its development. If we interpret "training set" as the data that informed the device's development or initial design, then the preclinical data (in-vitro, animal studies) served this purpose. No specific "sample size" is applicable in the AI/ML sense.

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

Given that this is a physical medical device and not an AI/ML algorithm, the concept of "ground truth for the training set" as it relates to expert annotation or consensus is not directly applicable.

• The "truth" for the in-vitro tests was based on engineering specifications and physical measurements.
• For animal models, the "truth" was established through direct observation, physiological measurements, and histological analysis (e.g., for luminal disruption or hemolysis) in the porcine arteries after device deployment and retrieval. Pathological assessment would likely be the ground truth method in such cases. The document states these demonstrated "satisfactory device performance characteristics."

Ask a specific question about this device