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The OPTEASE Filter is indicated for use in the prevention of recurrent pulmonary embolism (PE) via percutaneous placement in the vena cava in the following situations:

• Pulmonary thromboembolism when anticoagulants are contraindicated, .
• Failure of anticoagulant therapy for 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 the radiopaque contrast media to the vena cava.

The Cordis OPTEASE® Vena Cava Filter (Filter) is designed for the prevention of recurrent pulmonary embolism via placement in the inferior vena cava (IVC). The self-centering OPTEASE® Filter is laser cut from nickel titanium alloy (Nitinol) tubing. The proximal and distal baskets of the OPTEASE® Filter, consisting of struts in a six-diamond shape configuration, are designed for optimal clot capture. The constrained filter is supplied in a unidirectional storage tube that is loaded as a system into the hemostasis valve of the sheath introducer. The subject device is comprised of the filter packaged within a unidirectional storage tube, introduction kit that includes angiographic vessel dilator, catheter sheath introducer and obturator. The OPTEASE® Retrieval catheter is packaged separately.

The Cordis OPTEASE® Vena Cava Filter and OPTEASE® Retrieval Catheter are devices designed for the prevention of recurrent pulmonary embolism. The 510(k) submission K140286 describes design verification and validation testing performed to demonstrate substantial equivalence to a predicate device (K034050 and K091077).

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not specify the sample size used for each of the tests (Human Factor Assessment, Transfer filter into CSI, Filter release from storage tube, Fixation on mounting card, Fixation in storage tube, Dimensional Analysis, Visual inspection and verification of packaging and labeling).

The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. These appear to be laboratory-based engineering and performance tests conducted internally by Cordis Corporation.

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth for the test set. For tests like "Human Factor Assessment," it implies an evaluation, but the specifics of who conducted it and their expertise are not detailed. For the other performance tests, "ground truth" would likely refer to engineering specifications and performance standards.

4. Adjudication Method for the Test Set:

The document does not describe an adjudication method for the test set. Given the nature of the tests (engineering and performance benchmarks), it's likely that a pass/fail determination was made based on meeting predetermined specifications, rather than a consensus among multiple reviewers.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or reported in this 510(k) summary. This type of study is typically associated with diagnostic imaging devices or AI-assisted interpretation, where human reader performance is a key metric. This 510(k) concerns a medical device (vena cava filter) and its associated retrieval catheter, focusing on design verification and validation against established standards and a predicate device.

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

Not applicable. The device is a physical medical device (vena cava filter) and its retrieval catheter, not an algorithm or AI system. Therefore, a "standalone algorithm performance" study is not relevant to this submission.

7. The Type of Ground Truth Used:

For the performance tests, the "ground truth" implicitly refers to the engineering specifications, design requirements, and performance characteristics established for the device. These are derived from its intended function, safety considerations, and comparison to the predicate device. For the Human Factor Assessment, the ground truth would be ergonomic and safety principles related to user interaction.

8. The Sample Size for the Training Set:

Not applicable. This device is not an AI/ML algorithm that requires a "training set." The tests described are for a physical medical device.

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

Not applicable, as there is no training set for this device.

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

The AVIATOR Peripheral Dilatation Catheter has an integrated shaft system and a balloon near the distal tip. The shaft has a combination of single lumen and dual lumen tubing. One lumen is used for inflation of the balloon with contrast medium. The second lumen, located only in the distal shaft, permits the use of a .014" diameter guidewire to facilitate the advancement of the catheter to and through the stenosis to be dilated. The catheter shaft has a distal port (hole) near the distal end that accesses the guidewire lumen. The guidewire lumen begins at the distal port and ends at the distal tip. This "rapid exchange" design allows insertion and removal of the catheter without extension of the guidewire.

The balloon has radiopaque marker(s) to aid in positioning the balloon. The balloon is further designed to provide an expandable segment of known diameter and length at a specific pressure.

The design of this catheter does not incorporate a lumen for distal dye injections or distal pressure measurements.

A flushing needle accessory is also provided with the device to facilitate flushing/lubricating the catheter's inner guidewire lumen prior to use.

The AVIATOR Peripheral Dilatation Catheter is provided sterile and is intended for single use only.

The provided text describes a 510(k) premarket notification for a medical device, the Cordis AVIATOR Peripheral Dilatation Catheter. This document primarily focuses on demonstrating substantial equivalence to pre-existing predicate devices through non-clinical performance data. It does not contain information about clinical studies with "acceptance criteria" in the typical sense of measuring a device's effectiveness through patient outcomes or comparative clinical performance against a benchmark.

Here's a breakdown based on your request, highlighting the information that is present and absent:

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

Important Note: The document explicitly states, "The safety and effectiveness of the Cordis AVIATOR Peripheral Dilatation Catheter have been demonstrated via data collected from non-clinical tests and analyses..." It does not provide specific numerical acceptance criteria or detailed numerical performance results for these tests, but rather asserts that the device met the necessary standards to be "substantially equivalent" to its predicate devices.

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

This information is not provided in the document. The text refers to "non-clinical tests and analyses" but does not detail sample sizes, data provenance (e.g., country of origin), or whether the data was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and therefore not provided. The assessment was based on non-clinical engineering and material performance tests, not clinical evaluations requiring expert consensus on ground truth.

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

This information is not applicable and therefore not provided. As the testing was non-clinical, there wouldn't be an adjudication method for interpreting clinical test results.

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

An MRMC comparative effectiveness study was not done. This device is a physical medical device (catheter), not an AI diagnostic tool, so this type of study is irrelevant.

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

This information is not applicable. The device is a physical catheter, not an algorithm, so "standalone" performance in the context of an algorithm is not relevant. The device itself is designed to be used by a human operator (physician).

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

For the non-clinical tests, the "ground truth" would be established by engineering standards and specifications for medical devices (e.g., ASTM standards, internal company specifications for burst strength, compliance, etc.). There is no mention of expert consensus, pathology, or outcomes data, as these are typically associated with clinical studies.

8. The sample size for the training set

This information is not provided and not applicable in the context of this device. A "training set" typically refers to data used to train an AI algorithm, which is not what this device is. For non-clinical device testing, there might be "test sets" for various engineering experiments, but they are not referred to as training sets.

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

This information is not provided and not applicable, as there is no "training set" for this physical device.

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The Cordis PALMAZ® GENESIS™ Transhepatic Biliary Stent is intended for use in the palliation of malignant neoplasms in the biliary tree.

The Cordis PALMAZ GENESIS Transhepatic Biliary Stent is a balloon-expandable, stainless steel stent that is provided unmounted (without its recommended balloon catheter delivery device). The Cordis OPTA® PRO Balloon Catheter is recommended for the delivery of the Cordis PALMAZ GENESIS Transhepatic Biliary Stent.

The Cordis PALMAZ GENESIS Transhepatic Biliary Stent is hand crimped upon its recommended balloon catheter delivery device. The stent / balloon catheter assembly is then advanced over a guidewire through a sheath lumen, via the use of a metal introducer tube accessory, which is also provided separately, 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 removed.

The Cordis PALMAZ GENESIS Transhepatic Biliary Stent is provided sterile (via gamma irradiation) and is intended for single use only.

The provided document is a 510(k) summary for a medical device (Cordis PALMAZ® GENESIS™ Transhepatic Biliary Stent). This type of document focuses on demonstrating substantial equivalence to a previously approved device, rather than proving performance against specific acceptance criteria through a clinical trial or a standalone study.

Therefore, many of the requested points, especially those related to acceptance criteria, specific device performance numbers, and study designs (like sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance), are not typically found or required in a 510(k) submission for this type of device.

Here's an analysis based on the provided text, addressing what can be found and explicitly stating what cannot:

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

• Not Applicable / Not Provided. This document does not describe acceptance criteria in terms of quantitative performance metrics for a specific study, nor does it report specific device performance numbers against such criteria. The focus is on demonstrating "substantial equivalence" to a predicate device.

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

• Not Provided. No test set, sample size, or data provenance information (country, retrospective/prospective) is included. The demonstration of safety and effectiveness relies on "non-clinical design verification tests and analyses" and substantial equivalence to a predicate, not a clinical study on a human test set.

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 / Not Provided. There is no mention of experts establishing a ground truth for a test set, as no such clinical test set is described.

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

• Not Applicable / Not Provided. No adjudication method is described, as there is no clinical test set requiring expert review.

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 device is a transhepatic biliary stent, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study or AI-related performance metrics are irrelevant and not part of this submission.

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. Standalone performance for an algorithm is not relevant here.

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

• Not Applicable / Not Provided. No clinical ground truth is described in the context of this 510(k) summary. The "ground truth" for demonstrating device compliance would be based on engineering specifications and bench testing against the predicate device's characteristics.

8. The sample size for the training set

• Not Applicable / Not Provided. No training set is mentioned or relevant for this type of device submission.

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

• Not Applicable / Not Provided. As there is no training set, there is no ground truth establishment for it.

Summary of what the document does provide regarding device performance and equivalence:

The document states:

• "The safety and effectiveness of the Cordis PALMAZ GENESIS Transhepatic Biliary Stent have been demonstrated via data collected from non-clinical design verification tests and analyses."
• The device is "substantially equivalent to those featured with the predicate Cordis BX Transhepatic Biliary Stent and Delivery System (see 510(k) #K001258)."
• The "design, material, components, accessories, method of delivery, fundamental technology and intended use featured with the Cordis PALMAZ GENESIS Transhepatic Biliary Stent are substantially equivalent to those featured with the predecessor Cordis BX Transhepatic Biliary Stent and Delivery System."

In essence, the "acceptance criteria" for this 510(k) submission are implicitly demonstrating that the new device shares fundamental technological characteristics, intended use, and similar performance to the predicate device through non-clinical testing, rather than meeting specific quantifiable performance metrics from a new clinical study.

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The Cordis PALMAZ® CORINTHIAN™ IQ Transhepatic Biliary Stent is indicated for the palliation of malignant neoplasms in the biliary tree.

The Cordis PALMAZ CORINTHIAN IQ Transhepatic Biliary Stent is a balloonexpandable, stainless steel stent that is provided unmounted (without its recommended balloon catheter delivery device). The Cordis POWERFLEX® Plus and OPTA® LP Balloon Catheters are recommended for the delivery of the Cordis PALMAZ CORINTHIAN IQ Transhepatic Biliary Stent.

The Cordis PALMAZ CORINTHIAN IQ Transhepatic Biliary Stent is mounted upon its recommended balloon catheter delivery device via the use of accessory devices - plastic crimping tubes, which are provided with the packaged stent, and crimping tools, which are provided separately. The stent / balloon catheter assembly is then advanced over a guidewire through a sheath lumen, via the use of a metal introducer tube accessory, which is also provided separately, 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 removed.

The Cordis PALMAZ CORINTHIAN IQ Transhepatic Biliary Stent is provided sterile and is intended for single use only.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Cordis PALMAZ CORINTHIAN IQ Transhepatic Biliary Stent:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided 510(k) summary does not mention a clinical test set in the traditional sense of patient data. The safety and effectiveness were demonstrated through "non-clinical design verification tests and analyses." Therefore, there is no information on sample size, country of origin, or retrospective/prospective nature regarding patient data.

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

Given that "non-clinical design verification tests and analyses" were conducted, there is no mention of experts establishing a ground truth for a test set based on patient data. The ground truth would have been based on engineering specifications, material properties, and performance metrics established during the design verification process.

4. Adjudication Method for the Test Set

As no clinical test set with patient data is described, there is no mention of an adjudication method.

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

No MRMC comparative effectiveness study was done or mentioned. The submission focuses on substantial equivalence based on non-clinical data.

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

This device is a medical stent, not an algorithm or AI system. Therefore, the concept of a "standalone (algorithm only without human-in-the-loop performance)" study does not apply.

7. Type of Ground Truth Used

The ground truth for demonstrating safety and effectiveness was based on non-clinical design verification tests and analyses. This would involve:

• Engineering specifications and performance targets.
• Material testing results.
• Mechanical property measurements.
• Simulated deployment and expansion tests.

8. Sample Size for the Training Set

This device does not involve a "training set" in the context of an AI or algorithm. The product development would have involved iterative design and testing, but not a dataset used for machine learning training.

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

Not applicable, as there is no training set for an AI/algorithm mentioned.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study that proves the Cordis PALMAZ CORINTHIAN IQ Transhepatic Biliary Stent meets its acceptance criteria is a non-clinical design verification study. This study focused on demonstrating the safety and effectiveness of the device through a series of engineering tests and analyses rather than clinical trials with human subjects.

The core of the submission for K992755 relies on establishing substantial equivalence to previously cleared predicate devices (K990631 and K991028). This means that the "IQ" version was shown to be fundamentally the same as its predecessors in terms of:

• Design (with a minor modification to the stent design itself)
• Materials
• Components
• Accessories
• Method of delivery
• Fundamental technology
• Intended use
• Manufacturing methods
• Sterilization methods

Therefore, the "proof" that the device meets acceptance criteria is primarily through the demonstration of its comparable performance to existing, legally marketed devices via non-clinical testing, affirming that the minor design modifications do not introduce new questions of safety or effectiveness.

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