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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.

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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.

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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.

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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."

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