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The Option(TM) ELITE Vena Cava Filter 100cm System is intended for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the following conditions:

• Pulmonary thromboembolism when anticoagulant therapy is contraindicated;

• Failure of anticoagulant therapy in thromboembolic diseases;

• Emergency treatment following massive pulmonary embolism when anticipated benefits of conventional therapy are reduced:

• Chronic, recurrent pulmonary embolism when anticoagulation therapy has failed or is contraindicated

The filter may be retrieved according to the instructions supplied in section entitled "Optional Procedure for Filter Retrieval" in patients who no longer require a filter can be performed only by jugular approach

The Option™ ELITE Vena Cava Filter is designed for the prevention of recurrent pulmonary embolism via percutaneous delivery in the inferior vena cava (IVC).

The Option ELITE Vena Cava Filter 100cm System is designed for IVC filter insertion, delivery, deployment and placement via the popliteal and antecubital approach.

The self-centering Option™ ELITE Filter is laser cut from nickel -titanium alloy (Nitinol) tubing. The Option™ ELITE Filter consists of shape memory Nitinol struts emanating from a central location and is designed for optimal clot capture. Retention anchors (retention hooks) are located at the caudal portion of the filter. These anchors are intended for filter fixation to the vessel wall. The Option™ ELITE Filter is intended to be used in caval diameters up to 30mm. A retrieval hook is centrally located at the cranial extremity.

The constrained Option™ ELITE Filter is flexible and expands to the internal diameter of the IVC upon deployment. The Option™ ELITE Filter imparts an outward radial force on the luminal surface of the vena cava to ensure proper positioning and stability. The Option™ ELITE Filter is designed to prevent pulmonary embolism while maintaining caval patency through central filtration.

The introduction kit is comprised of a filter housed in a filter cartridge, Catheter Sheath Introducer (5F ID), Angiographic Vessel Dilator with an open end, and a Pusher with deployment marker. The Angiographic Vessel Dilator has side holes and 2 radiopaque markers, separated by 32mm (between the marker bands), that provide linear measurement of the inferior vena cava and assists in angiographic visualization when radiopaque contrast is delivered. The pusher advances the filter through the Catheter Sheath Introducer up to the deployment marker, and is then used to fix the filter in place during uncovering. The distal end of the Catheter Sheath Introducer can be controlled by rotating the entire device to position the Catheter Sheath Introducer in the center of the vena cava. The Filter Cartridge houses the Option™ ELITE Filter. The body of the Cartridge has text and colored arrows printed on it that identify assembly orientation; femoral is printed in green and jugular is printed in blue. The femoral orientation is used for the popliteal approach and the jugular orientation is used for the antecubital approach. The arrow of the desired access site will point into the Catheter Sheath Introducer hub. The Angiographic Vessel Dilator is designed to provide angiorraphic visualization and linear measurement of the vasculature when used in conjunction with the delivery of radiopaque contrast media to the vena cava.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Option™ ELITE Vena Cava Filter 100cm System:

The document is a 510(k) premarket notification for a medical device. This type of submission aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, rather than providing extensive clinical efficacy studies typically required for a PMA (Premarket Approval). Therefore, the "studies" described are primarily non-clinical and focus on demonstrating equivalence in performance and safety.

Since this is a 510(k) submission based on substantial equivalence, the "acceptance criteria" are implied to be that the device performs as safely and effectively as the predicate device, particularly for the modifications made (increased length for new access approaches). There isn't an explicit table of acceptance criteria for diagnostic performance metric.

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

Study Description:

The study was a non-clinical performance testing effort, focused on demonstrating the safety and performance of the device's modifications, specifically the increased length to allow for new access approaches (antecubital and popliteal).

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

• Sample Size: The document does not specify a numerical sample size for the simulated use testing. It states "A simulated use model... was used for testing." It's likely that a sufficient number of tests were performed to demonstrate consistency, but this detail is not provided.
• Data Provenance: The data is generated from non-clinical bench testing and simulated use testing conducted by the manufacturer, Rex Medical, L.P. The origin is the manufacturer's testing facilities (implied, likely USA given the submission to the FDA).
• Retrospective or Prospective: This is a prospective non-clinical study, as the tests were designed and conducted specifically to support this 510(k) submission.

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 for this type of non-clinical, bench-testing study. Ground truth in this context relates to the physical and mechanical performance of the device, which is evaluated against engineering specifications and industry standards, not against expert medical diagnoses.

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

Not applicable. This was not a human-reader study requiring adjudication of interpretations. The "adjudication" was implicitly done by engineers/scientists evaluating the physical performance and measurements against pre-defined acceptance criteria.

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 physical medical implant (vena cava filter), not an AI/software-as-a-medical-device (SaMD) that assists human readers in interpreting medical images.

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

Not applicable. This is not an algorithm or SaMD.

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

The "ground truth" for this non-clinical study was based on:

• Engineering specifications and design requirements: The device had to perform within specified ranges for deployment forces, tilt angles, and other mechanical parameters.
• Risk assessment: The potential failure modes identified in the risk assessment guided the testing.
• Relevant ISO standards: ISO 10555-1 (Sterile, single-use intravascular catheters) and ISO 10993-1 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process) provided the framework for testing methodology and performance expectations for certain aspects, particularly biocompatibility and catheter characteristics.
• Predicate device performance: The ultimate "ground truth" for substantial equivalence is that the modified device performs comparably to the predicate.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI model requiring a training set.

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

Not applicable.

Summary of Study:

The study was a series of non-clinical bench and simulated use tests conducted by Rex Medical. The primary objective was to demonstrate that modifications to the Option™ ELITE Vena Cava Filter System (specifically the increased length for new access approaches) did not negatively impact its safety and efficacy, maintaining substantial equivalence to its predicate device (K133243). The tests evaluated aspects like deployment forces, filter tilt, integrity of the system, and adherence to relevant ISO standards, ensuring the modified device continued to perform as intended and was safe for its stated indications for use. No clinical trials or human-reader studies were conducted or required for this 510(k) submission.

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The Option (TM) ELITE Vena Cava Filter System is intended for the prevention of recurrent pulmonary embolion (PE) via placement in the vena cava in the following conditions:

• · Pulmonary thromboembolism when anticoagulant therapy is contraindicated;
• · Failure of anticoagulant therapy in thromboembolic diseases;
• · Emergency treatment following massive pulmonary embolism when anticipated beaeffits of conventional therapy are realised;
• · Chronic, recurrent pulmonary embolism when anticoagulation therapy has failed or is contraindicated

The filter may be retrieved according to the instructions supplied in section entitled "Optional " in patients who no longer require a filter. Retrieval of the fitter can be performed only by jugular approach.

The Option™ ELITE Vena Cava Filter is designed for the prevention of recurrent pulmonary embolism via percutaneous delivery in the inferior vena cava (IVC).

The self-centering Option™ ELITE Filter is laser cut from nickel - itanium alloy (Nitinol) tubing. The Option™ ELITE Filter consists of shape memory Nitinol struts emanating from a central location and is designed for optimal clot capture. Retention anchors (retention hooks) are located at the proximal or caudal portion of the filter. These anchors are intended for filter fixation to the vessel wall. The Option™ ELITE Filter is intended to be used in caval diameters up to 30mm. A retrieval hook is centrally located at the cranial extremity.

The constrained Option™ ELITE Filter is flexible and expands to the internal diameter of the IVC upon deployment. The Option™ ELITE Filter imparts an outward radial force on the luminal surface of the vena cava to ensure proper positioning and stability. The Option™ ELITE Filter is designed to prevent pulmonary embolism while maintaining caval patency through central filtration.

The introduction kit is comprised of a filter housed in a filter cartridge, Catheter Sheath Introducer (5F ID), Angiographic Vessel Dilator with an open end, and a Pusher with deployment marker. The Angiographic Vessel Dilator has side holes and 2 radiopaque markers, separated by 32mm (between the marker bands), that provide linear measurement of the inferior vena cava and assists in angiographic visualization when radiopaque contrast is delivered. The pusher advances the filter through the Catheter Sheath Introducer up to the deployment marker, and is then used to fi x the filter in place during uncovering. The location of the distal end of the Catheter Sheath Introducer can be controlled by rotating the entire device to position the Catheter Sheath Introducer in the vena cava. The Filter Cartridge houses the Option™ ELITE Filter. The body of the Cartridge has text and colored arrows printed on it that identify assembly orientation, femoral is printed in green and jugular is printed in blue. The arrow of the desired access site will point into the Catheter Sheath Introducer hub. The Angiographic Vessel Dilator is designed to provide angiographic visualization and linear measurement of the vasculature when used in conjunction with the delivery of radiopaque contrast media to the vena cava.

The provided text describes a 510(k) submission for the REX MEDICAL Option™ ELITE Vena Cava Filter System. This document focuses on the substantial equivalence of the modified device to a predicate device, rather than the development and validation of an AI/ML-driven medical device.

Therefore, the information required to describe the acceptance criteria and study proving an AI/ML device meets those criteria (e.g., sample sizes for training/test sets, expert qualifications, ground truth establishment, MRMC studies, standalone performance) is not available in the provided text.

The document discusses:

• Device Description: The physical characteristics and mechanism of the vena cava filter.
• Intended Use: The clinical conditions for which the filter is designed.
• Technological Characteristics: How the device is similar to its predicate.
• Modifications: Specific changes made to the Option™ ELITE compared to its predecessor (e.g., number and type of retention hooks, sheath material/design, alternate implantation procedure).
• Non-Clinical Performance Testing: A brief mention that testing was derived from risk assessment and aimed to evaluate safety and effectiveness of design modifications, with acceptance criteria derived from Rex Medical and related ISO standards. However, it does not specify what those acceptance criteria were in detail, nor does it present the results in a table format that would demonstrate meeting those criteria. It also doesn't detail the study that proves this, beyond saying "performance testing."
• Conclusion: A statement of substantial equivalence based on performance testing and similarities.

In summary, this document is a regulatory submission for a physical medical device, not an AI/ML diagnostic or therapeutic device. As such, the requested information regarding AI/ML device acceptance criteria and validation studies (like those featuring human readers, ground truth consensus panels, training datasets, etc.) is not applicable and is not present in the provided text.

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The Rex Medical Cleaner™ Rotational Thrombectomy System is designed for mechanical declotting of synthetic dialysis access grafts.

The Rex Medical Cleaner™ Rotational Thrombectomy System is percutaneous mechanical thrombectomy device which provides an effective means to restore patency to occluded synthetic dialysis access grafts. The device is used in exactly the same manner as the predicate devices.

Based on the provided text, the Cleaner™ Rotational Thrombectomy System is a medical device, and the submission is a Special 510(k) for device modification. This means the device is already cleared, and the submission addresses changes rather than proving initial effectiveness. Therefore, the information typically requested for AI/software-as-a-medical-device (SaMD) studies (like sample size, ground truth, expert adjudication, etc.) is largely "Not Applicable" or not explicitly detailed in this type of submission.

Here's the breakdown of the information as it relates to the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document mentions that "Test methodology and acceptance criteria were derived from within Rex Medical and from related ISO standards for evaluation of this device" for the non-clinical tests. However, the specific acceptance criteria and the detailed results of these tests (e.g., in a table format) are not provided in this summary.

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

• Test Set Sample Size: Not applicable/Not provided. The document states "Discussion of Clinical Tests Performed: Not Applicable." This indicates that no clinical studies were performed for this specific 510(k) submission, as it relates to a modification of an already cleared device. The non-clinical tests were likely bench or in-vitro tests, and the "sample size" in that context would refer to the number of devices or components tested, which is not specified.
• Data Provenance: Not applicable/Not provided, as no clinical data is presented for this modification.

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

• Number of Experts: Not applicable. Since no clinical studies were performed, there was no need for experts to establish ground truth in the context of clinical performance evaluation.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. As no clinical studies were performed, no adjudication method for a test set 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

• MRMC Study: No. This device is a mechanical thrombectomy system, not an AI or imaging diagnostic device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this product.
• Effect Size: Not applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Standalone Performance: No. This device is a mechanical thrombectomy system, not an algorithm.

7. The Type of Ground Truth Used

• Type of Ground Truth: Not applicable for a clinical study. For the non-clinical tests, the "ground truth" would be engineering specifications, physical measurements, and performance benchmarks defined by Rex Medical and ISO standards. The specific details of these are not provided.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This document describes a physical medical device, not an AI or machine learning algorithm that requires a training set.

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

• Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.

Summary of Device Performance (from the document):

The document states: "The verification testing contained in our submission demonstrates that there are no differences in their technological characteristics due to the device modification, thereby not raising any new issues of safety or effectiveness." This implies that the device, with its modifications, performs identically to the predicate device in terms of safety and effectiveness. The specific details of how this was demonstrated (e.g., quantitative performance data) are not included in this 510(k) summary.

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The Short Introducer Sheath is used to facilitate placing a catheter through the skin into a graft. The dilator is an accessory device which is used by placing it into the sheath to create an occlusion and further provide support to the wall of the indwelling system.

The Rex Medical Short Introducer Sheath, offered in both 6F and 7F sizes, is a vascular access device consisting of a central lumen, angled side arm extension. and a hemostasis valve. The device is used under identical indications for use as the predicate device, as well other substantially equivalent 510(K) cleared devices.

The provided document is a 510(k) summary for a medical device called the "Short Introducer Sheath." This type of document is for premarket notification and focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel clinical effectiveness.

Therefore, the document does not contain the kind of detailed information typically found in a clinical study report that rigorously tests acceptance criteria for a new AI or diagnostic device. Specifically, it states "Discussion of Clinical Tests Performed: Not Applicable."

As such, I cannot provide the requested information in the format of a table describing acceptance criteria and device performance based on a study, nor details on sample sizes, ground truth establishment, or multi-reader studies, because these elements are not present in the provided text.

The document discusses non-clinical tests performed to demonstrate substantial equivalence, focusing on material changes from an original device.

Here's a breakdown of what can be extracted or inferred from the document regarding its non-clinical testing and regulatory submission:

• Acceptance Criteria and Reported Device Performance: This information is not explicitly detailed in quantifiable terms in the 510(k) summary. It states that "Test methodology and acceptance criteria were derived from ISO 11070, Sterile Single-Use Intravascular Catheter Introducers." The reported performance is that "The bench testing contained in our submission demonstrates that there are no differences in their technological characteristics, thereby not raising any new issues of safety or effectiveness." This implies the device met the ISO 11070 criteria, but the specific numerical performance metrics are not given.
• Sample Size Used for the Test Set and Data Provenance: Not applicable, as this was non-clinical (bench) testing. The "test set" would refer to the physical units produced for bench testing. The document does not specify the number of units tested, only that testing was "derived from the risk assessment."
• Number of Experts Used to Establish Ground Truth and Qualifications: Not applicable, as this was non-clinical (bench) testing.
• Adjudication Method for the Test Set: Not applicable, as this was non-clinical (bench) testing.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No, explicitly stated "Not Applicable" for clinical tests.
• Standalone (algorithm only without human-in-the-loop performance) study: Not applicable, as this is a physical medical device, not an algorithm, and no clinical studies were performed.
• Type of Ground Truth Used: For the non-clinical testing, the "ground truth" would be established by the specifications defined in ISO 11070 for sterile single-use intravascular catheter introducers.
• Sample Size for the Training Set: Not applicable, as this is a physical medical device, not an algorithm.
• How the Ground Truth for the Training Set Was Established: Not applicable.

In summary: The provided document is a 510(k) summary for a physical medical device, not a diagnostic or AI device. It focuses on demonstrating substantial equivalence to an existing device through non-clinical (bench) testing and explicitly states that clinical tests were "Not Applicable." Therefore, the detailed information requested about acceptance criteria, study design, and ground truth for clinical performance is not available in this text.

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