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ANGIOGUARD XP and ANGIOGUARD RX Emboli Capture Guidewire devices 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 site of filter basket placement should be from 3mm to 7.5mm.

Both the subject and predicate ANGIOGUARD XP Emboli Capture Guidewire and ANGIOGUARD RX Emboli Capture Guidewire devices consists 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 (overthe-wire) or RX (rapid-exchange) deployment sheath and is captured via an OTW or RX capture sheath. The ANGIOGUARD XP Emboli Capture Guidewire and ANGIOGUARD RX Emboli Capture Guidewire 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 provided document is a 510(k) premarket notification decision letter from the FDA regarding the ANGIOGUARD XP Emboli Capture Guidewire and ANGIOGUARD RX Emboli Capture Guidewire. This document determines substantial equivalence to a predicate device, but it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of device performance related to a diagnostic or therapeutic algorithm.

Instead, it focuses on the substantial equivalence of an updated version of a medical device (the ANGIOGUARD XP/RX Emboli Capture Guidewire) to a previously cleared predicate device. The changes are limited to a material change for the Deployment and Capture Sheath components.

The "Performance Data" section (Page 4-5) lists the types of tests performed to demonstrate that the new material meets the same requirements as the previous material and that the device's performance and functionality remain substantially equivalent. However, these are not "acceptance criteria" in the sense of performance metrics for an AI algorithm or a diagnostic test with corresponding study results. They are engineering and biocompatibility tests to ensure the safety and effectiveness of the physical device after a material change.

Therefore, for the requested information:

1. A table of acceptance criteria and the reported device performance: Not available in the provided document in the context of a diagnostic or therapeutic performance study. The document focuses on showing that a material change to an existing device maintains equivalence to its predicate. The "performance data" listed are physical and biological tests, not performance metrics like sensitivity, specificity, etc., with associated target levels and results.

2. Sample size used for the test set and the data provenance: Not applicable. There is no "test set" in the context of an algorithm or diagnostic study. The tests mentioned (e.g., biocompatibility) involve laboratory samples or animal models, not human patient data in the way a diagnostic study would.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment for a diagnostic test is described.

4. Adjudication method: Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This is a physical device, not an AI or diagnostic algorithm improving human reader performance.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.

7. The type of ground truth used: Not applicable.

8. The sample size for the training set: Not applicable. There is no training set mentioned, as this is a physical device submission, not an AI algorithm submission.

9. How the ground truth for the training set was established: Not applicable.

In summary, the provided FDA letter confirms the substantial equivalence of a physical medical device following a material change. It does not describe a study involving acceptance criteria for diagnostic/therapeutic performance, nor does it involve AI or algorithmic performance evaluation.

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Cordis Angiographic Catheters with Marker Bands are designed to provide angiographic visualization and linear measurement of the vasculature when combined with the delivery of radiopaque contrast media to selected sites in the vascular system.

The SUPER TORQUE® MB Angiographic Catheter is a thin plastic tube which is inserted into an artery through a small incision in the skin. The catheter is guided to the area being examined, and contrast material is injected through the tube and images are captured using a small dose of ionizing radiation (x-rays). Each SUPER TORQUE® MB Angiographic Catheter consists of a braided Polyurethane body and a non-braided Polyurethane tip section having multiple, radiopaque marker bands.

This document is a 510(k) Premarket Notification for a medical device called the SUPER TORQUE® MB Angiographic Catheter. It is not an AI/ML device, and therefore the concepts of acceptance criteria and a study to prove the device meets those criteria (in the context of AI/ML performance metrics) do not apply in the traditional sense.

The document describes a submission seeking substantial equivalence to a legally marketed predicate device (K992347). For such devices, the "acceptance criteria" are generally that the new device is as safe and effective as the predicate device. This is typically demonstrated through a comparison of technological characteristics, and often, non-clinical (bench) testing. Clinical studies are not always required if substantial equivalence can be shown otherwise.

Here's why the requested information cannot be provided in the context of AI/ML device evaluation:

• No AI/ML Component: The SUPER TORQUE® MB Angiographic Catheter is a physical medical device (a thin plastic tube for angiography), not a software algorithm or an AI/ML system.
• No "Performance Metrics" in the AI Sense: The performance of this device is assessed by its physical characteristics, material properties, and functionality (e.g., ability to deliver contrast, radiopacity of marker bands), not by metrics like sensitivity, specificity, AUC, or reader performance improvement often used for AI.
• No "Training/Test Sets" for AI: The concept of training sets and test sets with ground truth established by experts is irrelevant for a physical catheter.

However, I can extract and present the available information in a slightly adapted format, focusing on how substantial equivalence was demonstrated, which is the closest analog to "meeting acceptance criteria" for this type of device.

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

For this physical angiographic catheter, "acceptance criteria" relate to demonstrating substantial equivalence to a predicate device. The performance is assessed through bench testing and comparison of fundamental technological characteristics.

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

Not applicable in the context of AI/ML. For a physical device, testing is typically done on manufactured samples. The document states "No new testing was required to be conducted due to addition of contraindication in the IFU." It also mentions "minor manufacturing updates were made, additional biocompatibility testing was performed, and additional sterilization facilities were qualified." This implies some level of physical testing (bench testing) on device samples, but specific sample sizes for these tests are not detailed in this submission. Data provenance would be from laboratory test reports.

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

Not applicable. This is not an AI/ML device requiring expert adjudication for ground truth.

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

Not applicable. This is not an AI/ML device requiring expert adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI/ML device. No MRMC study was performed. The document explicitly states: "No clinical data was required in support of the proposed change to the predicate device cleared under K992347."

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

Not applicable. This is not an AI/ML device, so there is no algorithm to evaluate in standalone mode.

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

Not applicable. For a physical device, "ground truth" would be engineering specifications and validated test methods for material properties, dimensions, and mechanical performance.

8. The sample size for the training set

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

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SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter is intended to dilate stenoses in iliac, femoral, ilio-femoral, poplited, infra poplited and renal arteries and for the treatment of obstructive or synthetic arteriovenous dialysis fistulae. The device is also indicated for post-dilatation of balloon-expandable and selfexpanding stents in the peripheral vasculature.

The SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter is a catheter with a distal inflatable balloon, which is the same device as its predicate, SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter (K201333), with an additional indication. The device has identical technological characteristics as the predicate, SABER™ .035 PTA Dilatation Catheter (K201333). SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation 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. The 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 crossing of tight stenoses. SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter is compatible with standard .035" guide wires and 5Fr, 6Fr and 7Fr catheter sheath introducers (CSI).

The SABER™ .035" PTA Dilatation Catheter has identical device/component constructions as the predicate, SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter (K201333). Same as the predicate, the balloon of the SABER™ .035 PTA Dilatation Catheter has radiopaque markers at the distal and proximal ends of the balloon working length to aid in balloon placement when under fluoroscopy. The SABER™ .035 PTA Dilatation Catheter has a proximal hub assembly that contains a luer locking connector with a balloon inflation port and a quide wire port. The balloon is inflated by injecting diluted contrast medium through the inflation port of the hub and the inflation lumen connected to the balloon.

The SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter is intended for single use only and is provided sterile.

This document describes the submission of the SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter (K210626) to the FDA for a 510(k) premarket notification. The submission aims to demonstrate substantial equivalence to its predicate device (K201333) with an additional indication for post-dilatation of balloon-expandable and self-expanding stents in the peripheral vasculature.

Here's an analysis based on the provided text, addressing your specific points:

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

The document does not provide a formal table of explicit acceptance criteria with numerical targets. Instead, it states that "Design Verification and Validation (DV&V) testing was performed to verify that the proposed SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter meets the pre-determined safety and performance requirements." It also mentions that testing "completed with favorable test results, meeting the applicable ISO standards and FDA's recognized consensus standards pertaining to evaluations of PTA Catheters."

The reported device performance is that all listed tests had "favorable test results" and demonstrated "conformance to the FDA's recognized standards."

Here's a summary of the performance testing categories:

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

The document does not explicitly state the numerical sample size for individual tests within the "Design Verification Performance Testing" or the "Biocompatibility Assessment." It mentions "samples" for accelerated aging and packaging validation.

For Biocompatibility Assessment, it states the testing "has been conducted at a US testing laboratory."
For Sterilization Adoption Validation and Microbiology Validation, the document points to external reports ("eCopy 002") and mentions "Confluent Medical Technologies" as the physical manufacturer and "Synergy Health" (for sterilization cycle 2.0) and "Steris AST" for sterilization.

This suggests the data provenance is primarily from US testing laboratories and manufacturing/sterilization facilities. The nature of these tests (e.g., material testing, mechanical testing) implies they are prospective tests performed on newly manufactured devices.

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 provided in the document. The tests performed are primarily engineering, chemical, and biological evaluations, not clinical studies requiring expert interpretation of patient data to establish 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. The tests described are objective measurements (e.g., burst pressure, material compatibility, sterility) and do not involve subjective interpretation or a need for adjudication among multiple experts to establish a "ground truth."

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

There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study in the document. This type of study is typically conducted for diagnostic devices (especially imaging-based AI) where human interpretation is involved. The SABER™ .035 PTA Dilatation Catheter is an interventional medical device, and its safety and efficacy are evaluated through performance testing, biocompatibility, and substantial equivalence to a predicate device, not through human reader performance with or without AI assistance.

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

This information is not applicable as the device is a physical medical device (dilatation catheter), not an AI algorithm or software. Therefore, there is no "standalone" algorithm performance to assess.

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

The concept of "ground truth" as typically applied in AI/diagnostic studies (e.g., expert consensus for image interpretation, pathology for disease diagnosis) is not directly applicable to the type of device and testing described. For this device, the "ground truth" for performance is established by objective measurements against pre-defined engineering specifications, international standards (e.g., ISO), and FDA recognized consensus standards.

For example:

• Biocompatibility: Conformance to ISO 10993-1 standards (e.g., passing cytotoxicity, sensitization tests).
• Mechanical Properties: Achieving specific values for burst pressure, tensile strength, inflation/deflation times, kink diameter, etc., as defined by design specifications and relevant standards for PTA catheters.
• Sterilization: Demonstrated sterility assurance level (SAL) according to established sterilization validation protocols.

8. The sample size for the training set

This information is not applicable as the device is a physical medical device, not an AI or machine learning model that requires a training set.

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

This information is not applicable for the same reason as point 8.

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BRITE TIP RADIANZ™ Guiding Sheath is intravascular introduction of interventional and/or diagnostic devices into the peripheral vasculature through the radial artery.

Each BRITE TIP RADIANZ™ device consists of a 6F compatible guiding sheath, a vessel dilator (0.035" guidewire compatible) and a removable hemostasis valve. The guiding sheath has a lubricious hydrophilic coating to enhance entry and withdrawal during vessel access, and a low-profile outer diameter with a smooth transition to the vessel dilator to minimize or prevent radial vasculature trauma and spasm of the radial artery. The sheath is available in two lengths, 110 cm and 135 cm. The sheath hub is an over-molded hub with a luer and is compatible with the removable hemostasis valve provided (described below) and with other hemostasis valves or common vascular accessories of the user's choice. The vessel dilator is compatible with 0.035" guidewires (not included) and is tapered such that it creates a smooth transition between the guiding sheath tip and the guidewire. The vessel dilator hub is over molded and includes a locking feature located in the distal end of the hub to facilitate locking the vessel dilator to the sheath cannula proximal hemostasis valve. The system contains a removable hemostasis valve to facilitate entry and withdrawal of intravascular devices through the guiding sheath and minimize the backflow of blood. It also has a side-port arm with attached 3-way stopcock for flushing or aspiration. The preassembled hub connector is removable, such that it can be exchanged for a hemostasis valve or other common vascular accessory of the user's preference.

The provided FDA 510(k) summary for the BRITE TIP RADIANZ™ Guiding Sheath does not contain information about acceptance criteria or a study proving that the device meets those criteria in the context of an AI/ML device. This document describes a traditional medical device (a catheter introducer) and its substantial equivalence to a predicate device based on bench testing and biocompatibility, not AI/ML performance.

Therefore, many of the requested categories related to AI/ML device evaluations (such as sample sizes for test/training sets, expert qualifications, ground truth establishment, MRMC studies, or standalone algorithm performance) are not applicable to this document.

However, I can extract information related to the device's performance testing and the general conclusion of substantial equivalence.

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

The document does not explicitly present "acceptance criteria" in a quantitative format for specific performance metrics in the way an AI/ML study would. Instead, it states that various tests were "successfully performed" or "passed" according to relevant ISO standards and internal test methods, indicating that the device met the requirements of those standards.

Acceptance Criteria & Reported Device Performance (as implied by successful testing against standards):

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The SABERX RADIANZ™ PTA Catheter is intended to dilate stenoral, ilio-femoral, popliteal, infra poplited and renal arteries. The device is also indicated for post-dilation of balloon-expandable and self-expanding stents in the peripheral vasculature.

The SABERX RADIANZ™ Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter is a single-use sterile device, sterilized by ethylene oxide. The SABERX RADIANZ™ Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter (hereafter referred to as "SABERX RADIANZ™") is a Rapid Exchange design, consisting of a single inflation lumen and a distal quidewire lumen. The quidewire lumen permits the use of a quidewire (0.018 in.) to facilitate advancement of the catheter to and through the stenosis to be dilated. It begins at the distal tip and terminates at the guidewire exit port. The guidewire exit-port (hole) is 40 cm from the distal tip. The proximal hub section of the catheter provides a clear, onepiece hub with a single-luer port for inflation of the balloon. The coaxial, concentric dual lumen distal shaft connects proximally at the quidewire exit port and distally to the balloon. The proximal shaft with a supporting stainless-steel core wire connects proximally to the hub and distally to the guidewire exit port. The balloon is designed to provide an inflatable segment of known diameter and length at recommended pressures. A balloon protector is placed over the balloon to maintain a low profile. The catheter includes a tapered tip to facilitate advancement of the catheter to and through the stenosis. A lubricious hydrophilic coating covers the distal tip. balloon, and a portion of the shaft, to facilitate balloon placement. The SABERX RADIANZ™ catheter will have multiple radiopaque marker bands that provide fluoroscopic visual reference points to facilitate balloon positioning within the vessel. The SABERX RADIANZ™ catheter is compatible with standard 0.018" guidewires and 4F, 5F, or 6F catheter sheath introducers. The usable catheter length is 190 cm and the proximal shaft has two exit markers located at 115 cm and 140 cm from the distal tip. The SABERX RADIANZ™ catheter is available in eighty-two (82) product configurations with balloon diameters of 2.00 - 8.00 mm in 0.50 mm or 1.00 mm increments. The working lengths of the treatment balloon will be offered in lengths from 20 mm to 300 mm. The associated accessories for SABERX RADIANZ™ include: - . Flushing Needle.

This appears to be an FDA 510(k) summary for a medical device called the "SABERX RADIANZ™ Percutaneous Transluminal Angioplasty Dilatation Catheter." This type of document is for demonstrating substantial equivalence to a predicate device, not for proving that a device meets specific acceptance criteria through a comparative study with a "human-in-the-loop AI system" or "standalone AI algorithm."

Therefore, most of the requested information regarding AI acceptance criteria, human reader improvement with AI assistance, sample sizes for training/test sets, expert adjudication, etc., is not applicable to this document.

However, I can extract the acceptance criteria and performance data relevant to this physical medical device and its substantial equivalence determination.

Here's a breakdown of the requested information based on the provided document, noting where the information is not applicable (N/A) to this type of device submission:

Device Name: SABERX RADIANZ™ Percutaneous Transluminal Angioplasty Dilatation Catheter

Type of Study: Substantial Equivalence Determination via Non-Clinical Performance Testing for a Physical Medical Device (Catheter)

Purpose of the Study: To demonstrate that the SABERX RADIANZ™ catheter is substantially equivalent to a legally marketed predicate device (Crosstella RX PTA Balloon Dilatation Catheter cleared under K152873) and thus safe and effective for its intended use.

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

For a physical medical device like this catheter, "acceptance criteria" and "reported performance" refer to the successful completion of specific bench tests and biocompatibility assessments, demonstrating the device's functional integrity and safety. The document states that "passing results for the above tests provide reasonable assurance that the subject device has been designed to meet its intended use."

2. Sample sizes used for the test set and the data provenance

• Sample Size for Test Set: The document does not specify the exact number of units/samples tested for each bench test or biocompatibility test. It only states that "passing results for the above tests provide reasonable assurance." For physical devices, this typically involves a statistically relevant number of samples for each specific test, but the exact N is not disclosed in this summary.
• Data Provenance: The data comes from "non-clinical design verification testing" and "biocompatibility testing" performed for the SABERX RADIANZ™ device. The specific country of origin for the testing labs is not mentioned, but the submitter is Cordis Corporation in Miami Lakes, Florida, USA. The testing is retrospective in the sense that it was completed before the 510(k) submission.

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

• N/A. This device submission does not involve human readers evaluating images or a dataset that requires "ground truth" established by medical experts in the way an AI diagnostic device would. The "ground truth" for this catheter is its adherence to engineering specifications, biocompatibility standards, and functional performance as determined by laboratory testing.

4. Adjudication method for the test set

• N/A. See explanation for #3. Adjudication is not applicable as there are no discrepant expert interpretations to resolve.

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

• N/A. This document describes a physical medical device (catheter), not an AI-assisted diagnostic system. No MRMC study was conducted, nor is it relevant.

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

• N/A. This device does not have a standalone algorithm.

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

• The "ground truth" for this device's performance is based on established engineering standards, international consensus standards (e.g., ISO, USP), and validated internal test methods that define acceptable limits for device functionality, material properties, and biological safety. For example, for "Balloon Rated Burst Pressure," the ground truth is simply whether the balloon bursts or not at a specified pressure, according to a defined test method. For biocompatibility, it's whether the biological response falls within accepted safe limits as defined by ISO standards.

8. The sample size for the training set

• N/A. This is a physical medical device, not an AI algorithm, so there is no training set in the AI sense. The device design and manufacturing processes are "trained" through iterative R&D and validation, but this doesn't correspond to an "AI training set."

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

• N/A. See explanation for #8.

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The SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter is intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter is a catheter with a distal inflatable balloon, which shares the similar technological characteristics as the predicate, Powerflex Pro PTA Catheter. The SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation 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. The 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 crossing of tight stenoses. The SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter is compatible with standard .035" guide wires and 5Fr, 6Fr and 7Fr catheter sheath introducers (CSI). The SABER™ .035" Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter has similar device/component constructions as the predicate. Powerflex Pro PTA Catheter. Same as the predicate, the balloon of the SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter has radiopaque markers at the distal and proximal ends of the balloon working length to aid in balloon placement, when under fluoroscopy. The SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter has a proximal hub assembly that contains a luer locking connector with a balloon inflation port and a guide wire port. The balloon is inflated by injecting diluted contrast medium through the inflation port of the hub and the inflation lumen connected to the balloon. The SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter is intended for single use only and is provided sterile.

The provided text describes the 510(k) submission for the SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter. A 510(k) submission is for demonstrating "substantial equivalence" to a legally marketed predicate device, not for establishing novel performance criteria or conducting studies that prove efficacy or an AI's performance against human readers. Therefore, the document does not contain the information required to answer most of the questions related to acceptance criteria, AI performance, multi-reader multi-case studies, or detailed ground truth establishment.

The document focuses on showing that the new device (SABER™) is as safe and effective as a previously cleared predicate device (Powerflex™ Pro). This is primarily achieved through:

• Comparison of technological characteristics: demonstrating similarity in design, materials, and operation.
• Biocompatibility testing: ensuring the materials are safe for human contact.
• Design Verification and Validation (DV&V) testing: confirming the device meets pre-determined engineering requirements and performance specifications (e.g., inflation/deflation, burst pressure, kink resistance).
• Sterilization and packaging validation: ensuring the device is sterile and remains so until use.

Here's what can be extracted from the provided text, and where the information is not present:

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

The document does not present a single table of acceptance criteria with corresponding performance data. Instead, it states that "Design Verification and Validation (DV&V) testing were performed to verify that the proposed SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter meets the pre-determined design verification and validation requirements." It also states that tests were completed "with favorable test results, meeting the applicable ISO standards and FDA's recognized consensus standards pertaining to evaluations of PTA Catheters" and that "favorable results... show that no new questions of safety or effectiveness are raised."

The specific performance tests conducted are listed under "Design Verification Performance Testing":

Note: The document confirms "favorable test results" for all listed tests, indicating they met their respective acceptance criteria. However, explicit numerical thresholds for these criteria are not provided.

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

• Sample Size: Not explicitly stated in terms of the number of devices tested for each performance characteristic. The document refers to "samples" being tested (e.g., "T=0 Baseline Sample Testing and T=3 Years Accelerated Aging Testing of Finished Devices").
• Data Provenance: Not specified for the performance testing if it refers to patient data. This is a device performance study, not a clinical study involving patients. Biocompatibility testing was conducted at a "US testing laboratory." The physical manufacturer of the device is Confluent Medical Technologies.
• Retrospective/Prospective: Not applicable in the context of device performance testing.

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. This submission pertains to a medical device (catheter), not an AI algorithm or diagnostic tool that requires expert human interpretation to establish ground truth for a test set. The "ground truth" here is based on engineering specifications, physical measurements, and compliance with recognized standards.

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

Not applicable. This refers to a process for resolving discrepancies in expert interpretations, which is not relevant for the type of device performance testing described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a physical catheter, not an AI or imaging software. Therefore, an MRMC study related to human reader improvement with AI assistance was not conducted.

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

Not applicable. This pertains to an AI algorithm; the device is a physical medical instrument.

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

The "ground truth" for this device's performance is established by:

• Engineering Specifications: Pre-determined design requirements and measurable performance parameters (e.g., specific dimensions, burst pressures, tensile strengths).
• Recognized Consensus Standards: Compliance with relevant ISO standards (e.g., ISO 10993-1 for biocompatibility, ISO 14971 for risk management) and FDA's recognized consensus standards for PTA Catheters.
• Physical Measurements and Laboratory Tests: Direct measurement of device characteristics (e.g., usable catheter length, balloon diameter) and tests under controlled conditions (e.g., inflation/deflation, burst, fatigue).

8. The sample size for the training set

Not applicable. There is no "training set" in the context of a 510(k) submission for a physical medical device. This term is relevant for machine learning models.

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

Not applicable. As there is no training set for a machine learning model, this question is not relevant.

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RAIN Sheath™ Transradial is indicated to facilitate placing a catheter through the skin into a radial artery.

RAIN Sheath™ Transradial is indicated to facilitate placing a catheter through the skin into a radial artery. Each RAIN Sheath™ device consists of a sheath introducer, a vessel dilator (0.021" guidewire compatible), an IV cannula needle and/or a bare access needle, and a 45 cm 0.021" guidewire (either bare or hydrophilic). The device configurations with the hydrophilic guidewire contain only the IV cannula needle whereas device configurations with the bare wire contain only the bare needle. The sheath introducer has a lubricious hydrophilic coating, a smooth shoulder transition to the dilator and low-profile outer diameters (OD). To provide an atraumatic transition between the dilator tip and the 0.021" mini guide wire, the RAIN Sheath™ dilator is tapered at the distal end and the inner diameter (ID) of the dilator has been optimized. The hub is overmolded to the dilator and includes a locking mechanism between the hub of the vessel dilator and the hub of the sheath cannula to facilitate insertion of the product while preventing the vessel dilator from backing out of the cannula. RAIN Sheath™ device is available in sixteen (16) product configurations which differ based on French size and length, and the specific wire and needle included in the system, as indicated in the table below. It is offered in French sizes of 4F, 5F, 6F and 7F, with lengths of 10 cm and 16 cm. RAIN Sheath™ device is a single-use sterile device, sterilized by ethylene oxide.

This document pertains to a 510(k) premarket notification for the RAIN Sheath™ Transradial device. As such, it does not describe a study involving device performance against predefined acceptance criteria in the manner an AI/ML clinical study would. The document focuses on demonstrating substantial equivalence to a predicate device, not on proving de novo performance criteria in a clinical setting with human subjects.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" (especially those related to AI/ML or clinical efficacy studies) are not applicable or cannot be extracted from this regulatory document.

However, I can extract information regarding the bench testing which serves as the "study" demonstrating the device's technical specifications and safety through comparison with standards and for substantial equivalence.

Here's a breakdown of what can be inferred or directly stated from the provided text, and where specific requested information is not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are implicitly defined by the referenced ISO standards and internal test methods. The "reported device performance" is the statement that the testing was "successfully performed" and yielded "passing results."

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

• Test Set Sample Size: Not explicitly stated in the document. For bench testing, sample sizes are typically determined by statistical rationale for each specific test (e.g., number of units tested for tensile strength, burst pressure, etc.).
• Data Provenance: The tests were conducted internally by Cordis Corporation or outsourced to testing facilities following international standards (ISO, USP) and FDA guidance for medical device evaluation. This does not represent patient data.

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

This is not applicable. For this type of device (catheter introducer) and submission (510(k) for substantial equivalence based on bench testing), "ground truth" established by human experts in the context of diagnostic interpretation or clinical outcomes is not a component of the evaluation. The "ground truth" is defined by the objective performance criteria set by the engineering and material standards.

4. Adjudication method for the test set

This is not applicable. Adjudication methods (like 2+1, 3+1 consensus) are used in clinical studies, often for diagnostic accuracy, where there is subjective interpretation by experts. Bench testing results are typically objective measurements against predefined limits.

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

This is not applicable. This document is for a physical medical device (catheter introducer), not an AI/ML diagnostic or assistive software. No human reader or AI assistance is involved.

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

This is not applicable. As above, this is a physical medical device, not an algorithm.

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

The "ground truth" is based on objective measurements against established engineering and material standards (e.g., ISO, USP) and internal test methods. For example, a "ground truth" for tensile strength would be the measured force at which the material breaks, compared to a predefined acceptance limit according to a standard.

8. The sample size for the training set

This is not applicable. There is no "training set" as this is not an AI/ML algorithm.

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

This is not applicable. There is no "training set."

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The RAILWAY™ Sheathless Access System is indicated for use in radial arterial procedures requiring percutaneous introduction of intravascular devices.

The RAILWAY™ Sheathless Access System (hereafter referred to as "RAILWAY System" or "RAILWAY") facilitates the direct radial access of separately sold Cordis quiding catheters. Each RAILWAY System consists of two 136 cm nylon vessel dilators (0.021" and 0.035" quidewire compatible), a 20 Gauge IV cannula needle and/or a 21 Gauge stainless steel access needle, and a 45 cm 0.021" mini-guidewire (either stainless steel or hydrophilic coated Nitinol). The system configurations containing the hydrophilic guidewire do not contain a bare needle. The RAILWAY System has been dimensionally optimized for use with Cordis quiding catheters. The compatible guiding catheters and 0.035" guidewire are not included in the system.

The RAILWAY dilators have a tapered tip and a lubricious hydrophilic coating on the distal 20 cm section to facilitate access and ease of insertion. The geometry of the RAILWAY dilator taper and outer diameter (OD) have been optimized to provide atraumatic transitions between the dilator and a quiding catheter and between the dilator and quidewire. The dilator compatible with a 0.021" quidewire is intended for use in combination with a compatible guiding catheter to initiate sheathless (i.e. without a catheter sheath introducer) radial vascular access via insertion over a guidewire into the skin, subcutaneous tissue, and artery. After access is achieved, using either RAILWAY or a traditional catheter sheath introducer, the 0.035" RAILWAY dilator can be used to support the tracking of a compatible guiding catheter over a guidewire up to but not beyond the subclavian artery.

RAILWAY is available in ten (10) product configurations which differ on the basis of guiding catheter compatibility (catheter brand and French size) and the specific wire and needle(s) included in the system, as indicated in the table below. The dilators are color coded by size to align with accepted conventions for the guiding catheters to which the dilators are compatible. The RAILWAY System is a single-use sterile device, sterilized by ethylene oxide.

The RAILWAY System is compatible with 5F, 6F and 7F guiding catheters of 90 cm and 100 cm lengths. The dilators have been optimized for fit with either the Cordis VISTA BRITE TIP® or Cordis ADROIT® guiding catheters and have not been dimensionally optimized for compatibility with other guiding catheters. The appropriate RAILWAY dilator must be chosen to match the guidewire and guiding catheter sizes selected for the procedure. The RAILWAY System is for professional use in a hospital, catheterization laboratory, or other suitable healthcare facility only.

The provided text describes the RAILWAY Sheathless Access System, a medical device for radial arterial procedures. It is a 510(k) premarket notification, indicating a claim of substantial equivalence to a predicate device, not necessarily a new clinical performance study in the way an AI/software device would have. Therefore, many of the requested categories related to AI performance, ground truth, and expert evaluation are not directly applicable or provided in this document.

However, I can extract information related to the device's technical specifications, testing, and regulatory claims:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) for a medical device (a catheter introducer), the "acceptance criteria" are not framed as a discrete performance metric (like sensitivity/specificity for AI), but rather as successful completion of various engineering, biocompatibility, and sterilization tests to demonstrate safety and effectiveness equivalent to a predicate device. The "reported device performance" is the successful completion of these tests.

• Sensitization
• Irritation
• Systemic toxicity
• Pyrogenicity
• Genotoxicity
• Hemocompatibility | RAILWAY is biocompatible for its intended use, based on testing in accordance with FDA Guidance Use of International Standard ISO 10993-1. |
  | Sterilization | - Validation per ISO 11135:2014 for Sterility Assurance Level (SAL) of 10-6
• Ethylene oxide and ethylene chlorohydrin residuals meet ISO 10993-7:2008 requirements (levels not exceeding 4 mg EO/device or 9 mg ECH/device). | Sterilization cycle validated to provide SAL of 10-6. Residuals meet requirements for limited exposure devices. |
  | Bench Testing (Dilators) | - Dimensional verification
• Visual inspection
• Dilator and guiding catheter insertion force
• Hydrophilic coating integrity
• Outer surface friction
• Flushability
• Force at break
  (Per ISO 11070:2014, FDA PTCA Guidance, USP 788) | Passing results provide reasonable assurance that the device meets its intended use and raises no different issues of safety and effectiveness vs. predicate. |
  | Bench Testing (Needles) | - IV Cannula Needle: Dimensional verification, Visual inspection, Strength of union of needle tube and needle hub, Function, Tension/pressure (Per ISO 10555-1:2013 and ISO 10555-5:2013)
• Stainless Steel Needle: Visual inspection, Strength of union of needle tube and needle hub (Per ISO 11070:2014) | Passing results provide reasonable assurance that the device meets its intended use and raises no different issues of safety and effectiveness vs. predicate. |
  | Bench Testing (Wires) | - Hydrophilic Coated Wire: Visual inspection, Hydrodurability, Particulate, Fracture, Flexing (Per ISO 11070:2014)
• Stainless Steel Wire: Visual inspection, Fracture, Flexing, Peak Tensile Force (Per ISO 11070:2014) | Passing results provide reasonable assurance that the device meets its intended use and raises no different issues of safety and effectiveness vs. predicate. |
  | Bench Testing (Packaging)| - Visual inspection
• Component position
• Peel strength
• Bubble test
• Dye leak
• Particulate
  (Per ISO 11607-1:2009/A1:2014 and ISO 11607-2:2006) | Passing results provide reasonable assurance that the device meets its intended use and raises no different issues of safety and effectiveness vs. predicate. |
  | Substantial Equivalence | - Same intended use
• Same principle of operation
• Same mechanism of action
• Same method of sterilization and sterility assurance level
• Same biocompatibility classification
• Biocompatible for intended use
• Labeled non-pyrogenic
• Similar materials
• Similar components
• Similar device dimensions
• Similar packaging configuration
• Similar compatibility with other devices used in radial access procedures | Concluded that the RAILWAY™ Sheathless Access System is appropriate for its intended use and is substantially equivalent to Glidesheath Slender®. |

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

• Sample Size for Test Set: This document does not specify a "test set" in the context of an AI algorithm based on patient data. Instead, the "testing" refers to bench testing of physical device characteristics. The sample sizes for these engineering tests are not directly provided but are implied to be sufficient for design verification and validation under the cited ISO standards.
• Data Provenance: Not applicable in the context of patient data as this is a physical medical device. The "data" comes from various laboratory and engineering tests.

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

• Not applicable. This device is not an AI/software device that requires expert-established ground truth from clinical images or data. The "ground truth" for this device's performance is objective measurements from engineering and biocompatibility tests against industry standards.

4. Adjudication Method for the Test Set

• Not applicable. (See #3)

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 not an AI device. No MRMC study was performed or required.

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

• Not applicable. This is not an AI device.

7. The Type of Ground Truth Used

• Ground truth: For this physical medical device, the "ground truth" is established by:
  • Objective measurements and physical properties: e.g., dimensions, force at break, friction, sterility assurance level.
  • Compliance with recognized international standards: e.g., ISO 10993, ISO 11135, ISO 11070, ISO 10555, ISO 11607.
  • Biocompatibility test results: demonstrating absence of cytotoxicity, irritation, etc.

8. The Sample Size for the Training Set

• Not applicable. This is not a machine learning or AI device. There is no "training set."

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

• Not applicable. (See #8)

Summary of Clinical Studies (from the document):

• Clinical Studies: "No clinical studies were deemed necessary to support substantial equivalence. Appropriate verification and validation of the device requirements were achieved based on the similarities of the subject device to the predicate and from the results bench testing." This means the FDA accepted that the extensive bench testing and comparison to the predicate device (Terumo Glidesheath Slender) were sufficient to demonstrate safety and effectiveness without requiring human trials for this 510(k) submission.

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The Cordis ELITECROSS™ Support Catheter is intended to facilitate the intraluminal placement of diagnostic/ interventional devices beyond stenotic lesions (including chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention, and to deliver saline or contrast medium. Additionally, ELITECROSS™ can be used as an accessory with the FRONTRUNNER® XP CTO Catheter.

The ELITECROSS™ Support Catheter is a single-use, 5F sheath-compatible sterile catheter designed to provide additional support to the distal portion of ancillary diagnostic/interventional devices, including the FRONTRUNNER® XP CTO Catheter, as well as to deliver saline or contrast medium. After crossing the occlusion with the ancillary device, the ELITECROSS™ may be used to facilitate placing a guide wire across the occlusion.

The ELITECROSS™ Support Catheter device is a single lumen torqueable tube containing a full-length 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 on the distal 40 cm of the catheter body. 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 ELITECROSS™ Support Catheter will be available in various configurations and several lengths. The ELITECROSS™ Support Catheter is provided sterile (by EO) and intended for single use only.

This document is a 510(k) Pre-market Notification for the ELITECROSS Support Catheter. It seeks to demonstrate substantial equivalence to a predicate device, the Cordis Micro Guide Catheter ELITE. Therefore, the information provided focuses on the substantial equivalence and performance testing compared to the predicate, rather than a standalone study proving the device meets de novo acceptance criteria for an AI/ML device.

Because this is a submission for a medical device (catheter) and not an AI/ML device, the typical acceptance criteria and study design elements you've requested for AI/ML performance (e.g., sample size for test sets, data provenance, number of experts for ground truth, MRMC studies, standalone performance) are not applicable in the context of this document.

Instead, the "acceptance criteria" for a medical device like this are generally related to its functional performance, physical dimensions, material properties, and biological safety, demonstrating that it performs as intended and is as safe and effective as a legally marketed predicate device.

Here's how to interpret the provided information in relation to your request, keeping in mind the device type:

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

Based on the document, the "acceptance criteria" are implied by the performance characteristics tested, demonstrating equivalence to the predicate and ensuring the device functions as intended. The reported performance is that the device "meets applicable performance requirements" and "continues to meet all previous performance specifications" of the predicate.

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: Not specified in the provided document. For physical device testing, sample sizes are typically determined by statistical methods or industry standards but are not usually detailed in this summary section of a 510(k).
• Data Provenance: Not specified nor is it typically relevant for this type of physical device performance testing. The tests are benchtop, laboratory evaluations.

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

• Not Applicable. This is not an AI/ML device where expert consensus on interpretations or diagnoses would be required for ground truth. Ground truth for a catheter involves objective physical and functional measurements (e.g., burst pressure, flow rate, dimensions).

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

• Not Applicable. As above, this is for AI/ML interpretative tasks, not for physical device performance validation.

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 physical medical device (catheter), not an AI/ML diagnostic or assistive tool. MRMC studies are not relevant here.

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

• Not Applicable. This is a physical medical device. There is no algorithm or "standalone" performance in the AI/ML sense.

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

• Objective Technical Measurements: The "ground truth" for this type of device testing consists of objective, quantifiable measurements of physical properties and performance characteristics (e.g., dimensions, burst pressure, flow rates, compatibility with other devices). These are typically verified against engineering specifications and industry standards.

8. The sample size for the training set

• Not Applicable. This is a physical medical device, not an AI/ML device that requires a training set.

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

• Not Applicable. No training set is involved.

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

The OUTBACK® Elite Re-Entry Catheter is a single-use device designed to facilitate placement and positioning of guidewires within the peripheral vasculature. The device consists of three primary elements: 1) Cannula, 2) Catheter shaft, and 3) Deployment handle with deployment control slide. The OUTBACK® Elite Re-Entry Catheter is supplied sterile and is available in two useable lengths.

The provided document is a 510(k) summary for the OUTBACK Elite Re-Entry Catheter. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed clinical study for a novel device. Therefore, much of the requested information regarding acceptance criteria, study design, and ground truth establishment, which are typical for studies validating AI/software-driven medical devices, is not available in this document.

However, I can extract the information provided about device performance testing:

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

The document does not explicitly present a table of acceptance criteria with corresponding performance results in a quantitative manner as would be expected for an AI study. Instead, it states that "Design verification and validation testing demonstrate that the catheter continues to meet all previous performance specifications and that none of the critical clinical performance parameters have changed." and "The OUTBACK® Elite Re-Entry Catheter continues to meet all previous performance specifications and none of the critical clinical performance parameters have changed."

The performance data listed are primarily related to physical, chemical, and biological properties of the catheter, not diagnostic accuracy or clinical outcomes as would be relevant for devices with AI components. The types of testing performed, and the general statement of conformity, are:

2. Sample size 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 as the study described is a device verification and validation study, not a clinical study involving a test set of patient data.

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/provided as the study did not involve establishing ground truth from expert interpretation of a test set.

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

This information is not applicable/provided.

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

This information is not applicable/provided. The device is a physical catheter, not an AI or software-driven diagnostic tool that would typically undergo an MRMC study.

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

This information is not applicable/provided. This device is a physical medical device, not an algorithm.

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

This information is not applicable/provided. For the physical and performance tests, the "ground truth" would be established by validated test methods and specifications, not by expert consensus or pathology on patient data.

8. The sample size for the training set

This information is not applicable/provided. This is a physical device, not an AI model, and therefore does not have a training set in the AI sense.

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

This information is not applicable/provided.

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