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The Aspirex™ Thrombectomy System is indicated for the removal of acute emboli and thrombi from vessels of the peripheral venous system.

The 6F and 8F Aspirex™ Thrombectomy Systems are indicated for the removal of acute emboli and thrombi from hemodialysis access grafts and native arteriovenous fistulas.

The Aspirex™ Thrombectomy System-composed of the Aspirex™ Thrombectomy Catheter Set and the Drive System-is designed for efficient thrombus removal with strong, continuous, and controlled aspiration. The Drive System is composed of the control unit, a motor, and a footswitch. The Drive System is small and portable, and designed for simple, quick set up and ease of use.

The Aspirex™ Thrombectomy Catheter Set is composed of multiple components, including the Aspirex™ Thrombectomy Catheter, the Aspirex™ Guidewire, collecting bag, and sterile drape. The Aspirex™ Thrombectomy Catheter consists of a braided shaft, to add strength and torque, through which runs a helix. The catheter shaft connects to a metallic head constructed with a side window(s) at the distal end. The head has a smooth, rounded, atraumatic shape so unintentional contact with the vessel wall will not cause damage to the vessel. Contact with the vessel wall is not necessary for the catheter to exert its effect. An ergonomic handle, connected to the catheter shaft at the proximal end, connects to the motorized Drive System via a magnetic clutch. The entire catheter tracks over the Aspirex™ Guidewire previously navigated across the thrombus/embolus.

The provided text is a 510(k) summary for the Aspirex™ Thrombectomy System. This document focuses on demonstrating substantial equivalence to a predicate device, not on proving a device meets specific acceptance criteria through a study with predefined performance metrics like those typically found in an AI/ML context.

Therefore, many of the requested items (e.g., acceptance criteria table, sample sizes, expert ground truth establishment, MRMC studies, standalone performance, training set details) are not applicable or not provided in this type of FDA submission for a medical device that processes human biological material.

However, I can extract information related to the device, its intended use, and the performance data that was reviewed (rather than generated by a specific study to meet acceptance criteria).

Here's what can be extracted and what cannot:

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

• Not Applicable/Not Provided: This document does not present a table of specific acceptance criteria (e.g., target specificity, sensitivity, or image quality metrics) or reported device performance against those criteria in the way an AI/ML device would. Instead, it discusses the device's functional specifications and clinical outcomes in terms of existing literature and clinical study reports.

Here's information related to the device specifications that might be considered "performance" in a mechanical sense, but not quantitative "acceptance criteria" for an AI/ML model:

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

• Not Provided: The document states that a "review of clinical data from scientific literature and clinical study reports" was performed. It does not specify a "test set" sample size, as it's a review of existing data, not a new, controlled study to validate a new claim against a test set.
• Data Provenance: The data provenance is "scientific literature and clinical study reports." The country of origin and whether it was retrospective or prospective is not specified.

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

• Not Applicable/Not Provided: This is not a study involving expert readers establishing ground truth for a diagnostic AI/ML device. The "performance data" is derived from a review of clinical outcomes reported in existing literature and studies, which reflects real-world clinical results, not expert "ground truth" for a device's diagnostic performance.

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

• Not Applicable/Not Provided: No adjudication method is mentioned as this is not a study comparing human performance or diagnostic accuracy.

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

• Not Applicable/Not Provided: This is a physical medical device (thrombectomy system), not an AI/ML diagnostic aid. Therefore, an MRMC study and effects on human reader performance are irrelevant.

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

• Not Applicable/None: This is a physical medical device (thrombectomy system) that is used by humans, not an algorithm.

7. The type of ground truth used:

• Clinical Outcomes/Patency Rates: The "performance data" relied on reviewing "primary patency rates" in hemodialysis access grafts and native arteriovenous fistulas. This is long-term clinical outcome data, not a diagnostic "ground truth" established by experts or pathology for a specific event.

8. The sample size for the training set:

• Not Applicable/Not Provided: This is not an AI/ML device, so there is no "training set." The device's design and manufacturing are identical to the predicate.

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

• Not Applicable/Not Provided: No training set exists for this type of device.

Summary of Device Performance (from the document):

The performance data reviewed for the Aspirex™ Thrombectomy System focused on:

• Type of data: Clinical data from scientific literature and clinical study reports.
• Focus: Device performance and clinical outcomes of percutaneous mechanical thrombectomy with the Aspirex™ Thrombectomy System for the removal of occlusions from hemodialysis access grafts and native arteriovenous fistulas.
• Key Metric Analyzed: Primary patency rates.
• Conclusion: Vascular access patency rates after treatment with the Aspirex™ device are similar to those observed with treatment with other mechanical thrombectomy devices or surgery. Sub-group analyses confirmed these results. The review concluded that the use of the Aspirex™ Thrombectomy System in these expanded indications "does not raise new questions of safety and effectiveness" and "provides satisfactory clinical outcomes in terms of patency rates and the functioning of hemodialysis vascular access."

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The Highlander™ 014 PTA Balloon Dilatation Catheted for use in percutaneous transluminal angioplasty (PTA) of the peripheral vasculature, including femoral, popliteal and renal arteries. This device is also indicated for post-dilatation of balloon expanding stents in the peripheral vasculature. This catheter is not for use in coronary arteries.

The Highlander™ 014 PTA Balloon Dilatation Catheter is a small vessel balloon catheter consisting of an over the wire catheter with a balloon fixed at the distal tip. The proprietary non-compliant, low-profile balloon is designed to provide consistent balloon diameters and lengths even at high pressures. For all balloon lengths, radiopaque markers delineate the working length of the balloon and aid in balloon placement. For balloon lengths of 100mm and greater, two radiopague markers are positioned on the distal portion of the balloon and one radiopaque marker is positioned on the proximal portion of the balloon to differentiate between the distal and proximal ends of the balloon. The catheters include an atraumatic tip to facilitate advancement of the catheter to and through the stenosis. A silicone-based, hydrophobic coating is present on the distal segment of the shaft and balloon. Highlander™ 014 is compatible with 0.014" guidewires. The proximal portion of the catheters include a female luer lock hub connected to the inflation lumen, and a female luer lock hub connected to the guidewire lumen.

Packaged with every product is a profile reducing sheath that is positioned over the balloon for protection before use. A stylet is placed into the tip of the catheter to aid in rewrap/refolding of the balloon. These products are not made with natural rubber latex.

The GeoAlign™ Marking System is a non-radiopaque ruler on the catheter shaft measured from the distal tip. The GeoAlign™ markings are designated on the catheter shaft by 1cm increment bands with an accuracy within ±1mm. The distance from the distal catheter tip is labeled in 10cm increments. Thicker bands denote the midway point (5cm) between the labeled distances. The GeoAlign™ Marking System is designed to be used as a tool to externally measure the intravascular advancement and/or retraction of the catheter. This can provide an intravascular reference regarding the location of the distal tip of the catheter or an approximate intravascular length measurement between two points. The GeoAlign™ Marking System may also facilitate geographic alignment of an adjunctive therapy that includes the same GeoAlign™ Marking System.

The provided text is a 510(k) summary for the Highlander™ 014 PTA Balloon Dilatation Catheter. This document details the device's characteristics, indications for use, and a comparison to a predicate device to demonstrate substantial equivalence. It is important to note that this document does not contain information about studies related to AI/ML device performance, ground truth establishment, or expert reviews as it is for a physical medical device (balloon catheter).

Therefore, this response will focus on the acceptance criteria and performance data for the physical device as described in the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

The document lists various in vitro tests performed to demonstrate substantial equivalence. It does not provide specific numerical acceptance criteria or detailed quantitative performance results for each test. Instead, it states a general conclusion for each category: "The results from these tests demonstrate that the technological characteristics and performance criteria of the Highlander™ 014 PTA Balloon Dilatation Catheter are substantially equivalent to the predicate device, and that it can perform in a manner equivalent to devices currently on the market for the same intended use." and "met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs."

However, based on the categories of tests listed, a general representation of acceptance criteria and reported performance is as follows:

2. Sample Size for the Test Set and Data Provenance

The document does not specify the sample sizes used for each in vitro test. The tests are "in vitro" (performed in a lab setting, not on human or animal subjects). Therefore, there is no data provenance in terms of country of origin or retrospective/prospective nature as would be relevant for clinical studies.

3. Number of Experts and Qualifications

This information is not applicable. The evaluations described are in vitro engineering and materials tests, not clinical studies requiring expert interpretation of diagnostic images or patient outcomes.

4. Adjudication Method

This information is not applicable as there is no mention of a ground truth needing adjudication by human experts in the context of this device's testing.

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

No. This type of study is typically performed for AI-driven diagnostic imaging devices to assess the impact of AI assistance on human reader performance. The Highlander™ 014 PTA Balloon Dilatation Catheter is a physical medical device, not an AI/ML diagnostic tool.

6. Standalone Performance Study

Yes, the in vitro tests conducted on the Highlander™ 014 PTA Balloon Dilatation Catheter can be considered a standalone performance study. These tests evaluated the device's physical and mechanical properties and biocompatibility independent of human use in a clinical setting. The conclusion states that "The subject device, the Highlander™ 014 PTA Balloon Dilatation Catheter, met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs." This indicates a standalone assessment of its performance against established benchmarks.

7. Type of Ground Truth Used

The "ground truth" for the in vitro tests would be defined by the technical specifications, industry standards, relevant FDA guidance documents, and internal risk assessment procedures. For example, for physical dimensions, the ground truth is the specified design dimension; for burst pressure, it's the minimum acceptable pressure according to device-specific or industry standards. For biocompatibility tests, the ground truth is the pass/fail criteria established by recognized international standards (e.g., ISO 10993 series).

8. Sample Size for the Training Set

This information is not applicable. The described tests are for a physical medical device and do not involve AI/ML algorithms that require training data.

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

This information is not applicable for the reasons stated in point 8.

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The WavelinQ™ Generator is used to deliver RF energy via an assortment of surgical devices to cut and coagulate different kinds of tissue.

The WavelinQ™ Generator is a high frequency isolated generator that utilizes electrical current to deliver radiofrequency (RF) energy to the catheter electrode for formation of a vascular fistula. The generator offers a receptacle for a monopolar handpiece. The WavelinQ™ Generator is intended to be used with the currently marketed and cleared device WavelinQ™ EndoAVF System (K192239). The generator has one setting (AV1) equivalent to the mode (Cut T, 60W, 0.7s) of the predicate device, ESU-1 Electrosurgical Generator, that is used during the WavelinQ™ EndoAVF System procedure. This mode is set to deliver energy at 60 Watts for 0.7 seconds. The generator has a return electrode contact, for use with a split ground pad, and quality monitoring system (NEM) to reduce the risk of patient burns at the return electrode site. The pad-sensing feature allows the user to use only a split return electrode, also referred to as a split ground pad.

The device consists of a generator and power cord and is packaged with a User's Guide in a cardboard shipping box with protective foam inserts. The main device components are a front panel containing the power button, LED numeric display, alarm and return electrode indicator lights, and connector ports for accessories, a back panel consisting of volume controls, a power cord outlet and fuse, and internal components (printed circuit boards, speakers, cabling).

The provided text is a 510(k) Summary for a medical device (WavelinQ™ Generator) and does not contain information about an AI/ML-based device. Therefore, it is not possible to describe acceptance criteria, a study proving device performance, or details regarding AI/ML ground truth, expert opinions, or MRMC studies, as none of that information is applicable to this document.

The document discusses the substantial equivalence of the WavelinQ™ Generator to a predicate device based on its intended use, indications for use, technological characteristics, and performance testing for electrical safety, mechanical aspects, reliability, and functionality. The tests performed are standard for electro-surgical devices and do not involve AI/ML components or human interpretation of outputs that would require multi-reader studies or complex ground truth establishment for AI model evaluation.

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The Aspirex™ Thrombectomy System is indicated for the removal of acute emboli and thrombi from vessels of the peripheral venous system.

The Aspirex™ Thrombectomy System-composed of the Aspirex™ Thrombectomy Catheter Set and the Drive System-is designed for efficient thrombus removal with strong, continuous, and controlled aspiration The Drive System is composed of the control unit, a motor, and a footswitch. The Drive System is small and portable, and designed for simple, quick set up and ease of use.

The Aspirex™ Thrombectomy Catheter Set is composed of multiple components, including the Aspirex™ Thrombectomy Catheter, the Aspirex™ Guidewire, collecting bag, and sterile drape. The Aspirex™ Thrombectomy Catheter consists of a braided shaft, to add strength and torque, through which runs a helix. The catheter shaft connects to a metallic head constructed with a side window(s) at the distal end. The head has a smooth, rounded, atraumatic shape so unintentional contact with the vessel wall will not cause to the vessel. Contact with the vessel wall is not necessary for the catheter to exert its effect. An ergonomic handle, connected to the catheter shaft at the proximal end, connects to the motorized Drive System via a magnetic clutch. The entire catheter tracks over the Aspirex™ Guidewire previously navigated across the thrombus/embolus.

The Aspirex™ Guidewire has a LubriSkin PTFE-coated nitinol core wire with a gold-plated tungsten tip coated with DSM ComfortCoat® hydrophilic coating. The guidewire is used to initially cross through the area to be treated.

The provided text describes a medical device, the Aspirex™ Thrombectomy System, and its performance data to demonstrate substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study related to an AI/algorithm-based device's performance, human reader assistance, or ground truth establishment for such a device.

The study described is a GLP animal study comparing the Aspirex™ catheter (test article) to the Indigo Aspiration Catheter (control article) in healthy veins. This study assesses the physical and biological performance of the catheters, not an AI algorithm.

Therefore, I cannot provide the requested information regarding AI device acceptance criteria and performance based on the input text. The text does not discuss:

1. A table of acceptance criteria and the reported device performance for an AI/algorithm.
2. Sample size for a test set (related to AI data) or data provenance.
3. Number of experts or their qualifications for establishing ground truth for AI data.
4. Adjudication method for an AI test set.
5. Multi-reader multi-case (MRMC) comparative effectiveness study for AI assistance.
6. Standalone performance of an AI algorithm.
7. Type of ground truth used for AI (e.g., expert consensus, pathology, outcomes data).
8. Sample size for a training set for an AI algorithm.
9. How ground truth for a training set for an AI algorithm was established.

The document focuses on the mechanical and biological performance of a physical medical device (thrombectomy system) through in vitro and animal studies, and its substantial equivalence to a predicate device, as required for FDA 510(k) clearance.

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The Rotarex™ Atherectomy System is intended for use as an atherectomy device and to break up and remove thrombus from native peripheral arteries or peripheral arteries fitted with stents, stent grafts or native or artificial bypasses.

The Rotarex™ Atherectomy System is made up of a single use Rotarex™ Atherectomy Catheter Set and the Drive System, consisting of the control unit, motor and foot switch. The Rotarex™ Atherectomy Catheter Set is composed of multiple components, including the Rotarex™ Atherectomy Catheter, guidewire, collecting bag, and sterile drape. Rotarex™ Atherectomy Catheters are over-the-wire, single use, percutaneous devices for the removal of atheromatic plaque and thrombi in native arteries fitted with stents, stent grafts or native or artificial bypasses. The catheters are latex and phthalate free, and consist of a flexible outer covering, a rotating head, and a rotating helix which runs the length of the catheter. A lumen for the passage of the supplied guidewire runs the entire length of the helix and through the head of the catheter. The catheter head is made up of two overlying metal cylinders, with two side openings. The outer cylinder is connected to the rotating helix, and the inner cylinder to the catheter shaft. The helix and the catheter head rotate at approximately 40,000-60,000 rpm depending on the model, by means of a gear box in the catheter housing and a motor contained within the catheter handle driven by the Drive System. The rotating outer cylinder is fitted with abrading facets at its foremost tip. The Rotarex™ Atherectomy System Guidewires are 0.018" and are included with each Rotarex™ Atherectomy Catheter Set. These guidewires consist of a Nitinol core and a PTFE coating with a 9.5cm hydrophilic distal coating and a 4 cm angled flex tip. All components within the Rotarex™ Atherectomy Catheter Sets are supplied sterile for single use only. The method of sterilization is ethylene oxide.

This document is a 510(k) Summary for the Rotarex™ Atherectomy System. It describes the device, its intended use, comparison to predicate devices, and performance data used to demonstrate substantial equivalence.

Here's the breakdown of the requested information based on the provided text:

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

The document does not provide a specific table of quantitative acceptance criteria with corresponding performance metrics. Instead, it states overall conclusions:

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 mentions "in vitro tests" and "Clinical Literature Review."

• In vitro tests:
  • Sample size: Not specified.
  • Data provenance: Not specified, but generally in vitro tests are laboratory-controlled and do not have country of origin in the same way clinical data does. The tests were performed "using FDA Guidance Documents on non-clinical testing of medical devices and internal Risk Assessment procedures."
• Clinical Literature Review:
  • Sample size: Not specified, as it's a review of existing literature, not a new study with a defined sample size. It refers to "a significant body of medical literature."
  • Data provenance: Not specified in terms of country of origin or retrospective/prospective nature. Clinical literature usually encompasses both retrospective analyses and prospective studies from various global locations.

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 document describes a literature review and in vitro testing, neither of which typically involves experts establishing ground truth for a test set in the way an AI algorithm test might.

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

This information is not provided in the document. The document describes laboratory testing and a literature review, not a study that would involve expert adjudication of a test set.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or described. This document focuses on demonstrating substantial equivalence of a physical medical device (atherectomy system), not a diagnostic AI tool. The "clinical literature" review examined the safety and efficacy of the device itself compared to other treatments, not the improvement of human readers with AI assistance.

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

This question is not applicable as the Rotarex™ Atherectomy System is a physical interventional medical device, not an AI algorithm. Therefore, no standalone algorithm performance was assessed.

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

• For in vitro tests: The "ground truth" would be established by the physical and chemical properties of the materials tested, the design specifications, and the quantifiable outcomes of the specific tests (e.g., heat generation measurements, absence of emboli in collected fluid).
• For Clinical Literature Review: The "ground truth" comes from the aggregated findings of published clinical studies, which typically rely on clinical outcomes data (e.g., patency rates, complication rates, re-intervention rates) and potentially expert diagnoses within those studies.

8. The sample size for the training set

This information is not applicable. The Rotarex™ Atherectomy System is a physical medical device, not an AI algorithm that requires a training set.

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

This information is not applicable, as it's not an AI algorithm with a training set.

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The BD Recanalization System (console and footswitch) and Crosser iQ™ Ultrasonic CTO Device are indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions.

Crosser iQ™ Ultrasonic CTO Device: The Crosser iQ™ Ultrasonic CTO Device is intended for use only with the BD Recanalization System (console and footswitch).

BD Recanalization System: The BD Recanalization System (console and footswitch) is intended for use only with the Crosser iQTM Ultrasonic CTO Crossing Device.

The BD Recanalization System (Console and Footswitch) includes a non-sterile, reusable console with an integrated roller pump and user interface, as well as a footswitch. The footswitch can be used as an alternative to the hand-controlled activation of the Crosser iQ™ Ultrasonic CTO Device. The console delivers ultrasonic energy to the Crosser iQ™ Ultrasonic CTO Device. The console is comprised of a molded outer housing and internal structural components to support and protect the electro-mechanical components, including the internal generator. The user interface includes an LCD screen to display images for guiding system preparation and use. The back of the console includes an AC power control switch and clamp assembly to allow the user to secure the console to an IV pole before the procedure and remove after, if desired. The roller pump delivers sterile saline for irrigation from a saline bag through the Crosser iQ™ Ultrasonic CTO Device saline tubing to the tip of the crossing catheter. The saline bag is not included with the BD Recanalization System. In addition to initial package labeling is present on both the front and back of the console to aid the user in identifying console interface features.

The Crosser iQ™ Ultrasonic CTO Device is a single use crossing catheter, consisting of a catheter assembly, handle, power cord, and saline tubing with spike set. The Crosser iQ™ Ultrasonic CTO Device is connected to the console via the power cord, through which AC power is converted into high frequency ultrasonic mechanical vibrations to the tip by a transducer within the Crosser iQ™ CTO Device handle. The Crosser iQ™ Ultrasonic CTO Device includes the GeoAlign™ Marking System along the working length of the catheter assembly, with a hydrophilic coating over the distal portion of the working length. The GeoAlign™ Marking System is a non-radiopaque ruler on the catheter shaft measured from the distal tip. The GeoAlign™ markings are designated on the catheter shaft by 1 cm increment bands with an accuracy within ± 1 mm. The distance from the distal catheter tip is labeled in 10 cm increments. Thicker bands denote the midway point (5 cm) between the labeled distances. The GeoAlign™ Marking System is designed to be used as a tool to externally measure the intravascular advancement and/or retraction of the catheter. This can provide an intravascular reference reqarding the location of the distal tip of the catheter or an approximate intravascular length measurement between two points. The GeoAlign™ Marking System may also facilitate geographic alignment of an adjunctive therapy that includes the same GeoAlign™ Marking System. The GeoAlign™ Marking System provides an approximation that may not be an exact representation of the actual distance traveled intravascularly and should be confirmed under fluoroscopy. The GeoAlign™ Marking System includes non-radiopaque white markings and are designed to be utilized outside the sheath.

The provided text describes the Crosser iQ™ CTO Recanalization System and its performance data to demonstrate substantial equivalence to a predicate device. It includes information on a summative usability study and an animal study.

Here's the extracted information based on your request:

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

The document does not provide a specific table of discrete acceptance criteria with numerical performance metrics for the summative usability study or the animal study. Instead, it states high-level conclusions:

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

• Summative Usability Study:

  • Sample Size: 15 physicians and 15 technologists (total 30 participants).
  • Data Provenance: Not explicitly stated, but implies a simulated environment given the description of "simulated CTO procedure."

• Animal Study:

  • Sample Size: 9 animals (non-diseased porcine, with each animal receiving six individual/non-overlapping treatments).
  • Data Provenance: Not explicitly stated, but implies laboratory setting for a GLP animal study.

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

• Summative Usability Study: The "participants" (15 physicians and 15 technologists) were the users being evaluated, not establishing ground truth. The study assessed their use of the device. Qualifications are implicitly "physicians" and "technologists."
• Animal Study: The document mentions "necropsy for gross examination" and "histological analysis" by unspecified personnel, but does not detail "experts" establishing ground truth in the way one might for diagnostic AI. The "ground truth" here is the biological/physiological response observed and assessed by the study's protocol and investigators.

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

Not explicitly mentioned for either study.

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, nor any evaluation of human readers improving with AI assistance. This device is a physical medical device (catheter system), not an AI-powered diagnostic tool.

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

This question is not applicable. The device is a physical medical device, not an algorithm. Its performance is inherent in its physical and mechanical operation, guided by human operators.

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

• Summative Usability Study: The "ground truth" was likely defined by the success or failure of participants to complete tasks as outlined in the Instructions for Use (IFU) and the evaluation of safety outcomes, likely assessed by observers/evaluators of the study.
• Animal Study: The "ground truth" was established through direct observation during the study, gross examination at necropsy, and histological analysis of tissues.

8. The sample size for the training set

This question is not applicable. The device is a physical medical device. There is no "training set" in the context of machine learning or AI algorithms.

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

This question is not applicable. There is no training set for this type of device.

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The GlidePath™ Retro Long-Term Hemodialysis Catheters are indicated for use in attaining short-term or long-term vascular access for hemodialysis, hemoperfusion or apheresis therapy. Access is attained via the internal jugular vein, subclavian vein, or femoral vein. Catheters longer than 40 cm are intended for femoral vein insertion.

The GlidePath™ Retro Long-Term Hemodialysis Catheter features a dual-lumen polyurethane catheter shaft with optimized double-D cross-sectional design providing separate arterial and venous lumens, an external bifurcation hub with SwiftClick connector assembled by physician upon placement, and arterial and venous extension legs that connect to an external dialysis machine or blood cleansing device. The arterial (red) luer connector secures to the blood intake on the dialysis machine and the venous (blue) luer connector secures to the blood return line on the dialysis machine. Each extension leg has an atraumatic occlusion clamp which closes access to the lumen. The symmetrical catheter tip contains holes that aid in the distribution of blood flow or aid in over-the-guidewire placement. The dialysis catheter is offered in various lengths.

This document describes the GlidePath™ Retro Long-Term Hemodialysis Catheter. It addresses the performance data and comparison to predicate devices, but does not describe a study involving an AI medical device or clinical performance data that would typically include acceptance criteria and reporting on sensitivity, specificity, or other performance metrics for an AI algorithm.

Therefore, I cannot provide the information requested in your prompt regarding AI device acceptance criteria and study details because the provided text is for a traditional medical device (a catheter) and does not contain information about an AI-powered device or its performance study.

The document focuses on demonstrating substantial equivalence of the catheter to a predicate device through non-clinical testing of various physical and functional characteristics.

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The Groshong® NXT PICC provides short (less than 30 days) or long (greater than 30 days) term peripheral access to the central venous system for intravenous therapy or blood sampling.

Groshong™ NXT Peripherally Inserted Central Catheters are made from specially formulated and processed medical grade materials in a tray with accessories for reliable long- (greater than 30 days) or short- (less than 30 days) term vascular access.

Groshong™ Valve Function

The Groshong™ catheter incorporates the patented, 3-position, pressure-sensitive Groshong™ valve. The valve is located near the rounded, closed, radiopaque catheter tip and allows fluid infusion and blood aspiration. When not in use, the valve restricts blood backflow and air embolism by remaining closed.

The Groshong™ valve is designed to remain closed between -7- and 80-mm Hg. Since the normal central venous pressure range in the superior vena cava is 0 to 5 mm Hg, the valve remains closed at normal central venous pressure. Pressure in the superior vena cava must exceed 80 mm Hg to open the valve inward. Also, negative pressure (vacuum) will cause the valve to open inward, allowing blood aspiration.

Positive pressure into the catheter (gravity, pump, syringe) will open the valve outward, allowing fluid infusion. The need for the anticoagulant effect of heparin is eliminated because the closed valve prevents blood from entering the catheter and clotting. If the catheter is aspirated, pulling the valve inward, it must be flushed with normal saline to clear blood from the lumen and allow the valve to return to its normal, closed position.

The provided text is a 510(k) summary for the Groshong™ NXT PICC Catheter. It outlines the device's characteristics, its similarities to a predicate device, and the testing performed to demonstrate substantial equivalence. However, it does not contain detailed acceptance criteria, specific reported device performance values, or information about a study proving the device meets these criteria in the format requested.

The document focuses on demonstrating substantial equivalence to a predicate device (also named Groshong™ NXT PICC Catheter, K034020), rather than establishing and meeting novel acceptance criteria for the new device and then detailing a study specifically proving the new device's performance against them. The premise is that because the new device is largely similar to the predicate and differences have been evaluated not to raise new safety/effectiveness concerns, its performance is considered substantially equivalent.

Therefore, many of the requested items cannot be extracted from this document, as it's designed for a different purpose (510(k) clearance based on substantial equivalence) than a detailed clinical or performance study report.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

• Cannot be provided directly from the text. The document lists performance tests and reference standards (e.g., ISO 10555-1, ASTM F640), but it does not specify quantitative acceptance criteria or the reported performance values for the "subject device" against these criteria. It only states that the tests were "conducted per guidance documents, industry standards, and in-house protocols to establish the performance of the device, thereby leading to a conclusion of substantial equivalence."

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

• Cannot be provided. The document mentions "Verification and validation tests" and "Performance tests for Subject Device," but does not specify sample sizes for these tests, the country of origin of the data, or whether the data was retrospective or prospective. These would typically be detailed in a separate test report, not the 510(k) summary.

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

• Not applicable / Cannot be provided. This type of information is relevant for studies involving expert review, such as image analysis for AI devices. The Groshong™ NXT PICC Catheter is an intravascular catheter, and the performance tests mentioned (e.g., biocompatibility, sterility, radiopacity) do not typically involve human expert interpretation in the way an AI diagnostic device would.

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

• Not applicable / Cannot be provided. Similar to point 3, adjudication methods are typically used in studies involving human interpretation or outcome assessment, not for the technical performance testing of a catheter.

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 medical catheter, not an AI-assisted diagnostic tool.

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

• Not applicable. This device is a medical catheter, not an algorithm.

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

• Limited information. For the physical and material tests, the "ground truth" would be the established scientific principles and specifications defined by the referenced ISO and ASTM standards. For example, for biocompatibility, the ground truth is adherence to ISO 10993-1. For radiopacity, it's meeting the criteria of ASTM F640. There isn't "expert consensus" or "pathology" in the sense of a diagnostic outcome for this type of device performance testing.

8. The sample size for the training set

• Not applicable. This is a physical medical device, not a machine learning model that requires a training set.

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

• Not applicable. As above, no training set is involved.

Summary of what is available from the text:

The document describes the Groshong™ NXT PICC Catheter and states that its technological characteristics are substantially equivalent to a predicate device (K034020) with the same name. The key differences evaluated were:

• A change to the inner lumen geometry (from round to rectangular).
• A material and formulation change to the catheter silicone and catheter silicone colorant.

These differences were evaluated through risk assessment and performance tests. The document asserts these changes "do not raise new or different questions of safety or effectiveness."

Performance Tests Conducted (Verification / Validation Method and Reference Standards):

• Performance:
  • ISO 10555-1:2013/Amd 1:2017: Intravascular Catheters - Sterile and Single-Use Intravascular Catheters - Part 1: General Requirements
  • ISO 10555-3:2013: Intravascular catheters - Sterile and single-use catheters - Part 3: Central venous catheters
  • ASMT F640-12: Standard Test Methods for Determining Radiopacity for Medical Use
  • ASTM F2119-07: Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants
  • ASTM F2182: Standard Test Method for Measurement of Radio Frequency Induced Heating on or Near Passive Implants During Magnetic Resonance Imaging
  • ASTM F2052-15: Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
  • ASTM F2213-17: Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
• Biocompatibility Evaluations:
  • ISO 10993-1:2018: Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process
  • USP<788>: Particulate Matters in Injections (method 1 Light Obscuration Particle Count Test)
• Sterilization:
  • ANSI AAMI ISO 11135:2014C: Sterilization of Health Care Products - Ethylene Oxide - Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices.

In conclusion, while the document confirms tests were done according to established standards to support substantial equivalence, it does not provide the detailed study information or quantitative acceptance criteria and results as typically found in a clinical study report for an AI device.

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The Recon™ Support Catheters are single lumen catheters intended to create a pathway for other devices in the peripheral vasculature.

The Recon™ Support Catheters are single lumen catheters with a standard luer fitting hub and separate detachable hemostatic valve to guide and provide support for the Crosser™ Ultrasonic CTO Device. The product hub identifies the BD logo and sheath profile (6F) on one side and on the opposite side, the product hub identifies the working length of catheter in centimeters (110 cm) and S for Straight and A for Angled, and T for Tapered. The Recon™ Support Catheters are available in angled and straight, tapered and non-tapered configurations in 110 cm working lengths. The Recon™ Support Catheter has a single radiopaque marker 1mm from the distal tip. The GeoAlign™ Marking System is a non-radiopague ruler on the catheter shaft referenced from the distal tip. The GeoAlign™ markings are designated on the catheter shaft by 1 cm increment bands with an accuracy within ±1 mm. The distance from the distal catheter tip is labeled in 10 cm increments. Thicker bands denote the midway point (5 cm) between the labeled distances. The GeoAlign™ Marking System is designed to be used as a tool to externally measure the intravascular advancement and/or retraction of the catheter. This can provide an intravascular reference reqarding the location of the catheter or an approximate intravascular length measurement between two points. The GeoAlign™ Marking System may also facilitate geographic alignment of an adjunctive therapy that includes the same GeoAlign™ Marking System. The GeoAlign™ Marking System provides an approximation that may not be an exact representation of the actual distance traveled intravascularly and should be confirmed under fluoroscopy. The GeoAlign™ Marking System includes non-radiopaque white markings and is designed to be utilized outside the sheath.

This document is a 510(k) summary for the Recon™ Support Catheter. It outlines the safety and effectiveness testing performed to demonstrate substantial equivalence to predicate devices (Sidekick™ & Usher™ Support Catheters).

Here's a breakdown of the requested information based on the provided text:

Important Note: The provided document is a 510(k) summary for a medical device (a support catheter), not an AI/ML powered device. Therefore, many of the questions related to AI/ML specific concepts (like multi-reader multi-case studies, expert consensus for ground truth on images, training sets, etc.) are not applicable to this type of traditional medical device submission. The performance testing is primarily in vitro (bench testing) and biocompatibility to ensure the physical and biological characteristics of the catheter are safe and effective.

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the Recon™ Support Catheter met all the predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs. It further concludes that the device is "as safe, as effective, and performs as well as or better than the Sidekick™ and Usher™ Support Catheters."

While a specific table with numerical acceptance criteria and precise performance metrics for each test is not provided in this summary, the document lists the types of tests performed. For a traditional medical device, meeting the acceptance criteria means the device functioned within predetermined specifications, demonstrating equivalence to the predicate.

Below is a table of the types of tests performed to demonstrate that the device meets acceptance criteria. The "Reported Device Performance" column reflects the overall conclusion stated in the document regarding these tests.

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

• Sample Size for Test Set: The document does not specify the exact sample sizes used for each in vitro test. For this type of device, sample sizes are typically specified by the relevant ASTM/ISO standards or internal validation protocols for physical and mechanical tests.
• Data Provenance: The tests are in vitro (bench testing) and therefore do not involve patient data or geographical provenance in the way clinical studies for AI/ML devices would. These tests were conducted by the manufacturer, Bard Peripheral Vascular. The document implies these are prospective tests conducted specifically for this 510(k) submission.

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

• Not Applicable (N/A): This is a traditional medical device (catheter), not an AI/ML device that requires human expert review of images or data to establish 'ground truth' for algorithm performance. The ground truth for this device is established by physical measurement, chemical analysis, and adherence to engineering specifications and international standards (e.g., ISO for biocompatibility).

4. Adjudication Method for the Test Set

• N/A: As this is in vitro bench testing, there is no need for adjudication by multiple human readers. The results are typically quantitative measurements against predetermined specifications.

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

• N/A: This type of study is specifically relevant to devices that assist human readers in interpreting medical images or data (e.g., AI for radiology). This device is a catheter, which is a physical tool used in a medical procedure, not an image analysis or diagnostic software.

6. Standalone (Algorithm Only) Performance

• N/A: This question pertains to AI/ML algorithms. This device is a physical catheter, not an algorithm.

7. Type of Ground Truth Used

• Ground Truth for Catheter: For the physical and mechanical tests, the ground truth is based on engineering specifications, established industry standards (e.g., ASTM, ISO), and performance of predicate devices. For biocompatibility, the ground truth is established by adherence to ISO 10993-1:2018 and the negative results from the battery of biological tests.

8. Sample Size for the Training Set

• N/A: This concept of a "training set" applies to machine learning models. The device under review is a physical medical device and does not involve machine learning.

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

• N/A: As there is no training set for a machine learning model, this question is not applicable.

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The GlidePath™ 7.5F Long-Term Hemodialysis Catheter is indicated for use in attaining short-term or long-term vascular access in pediatric, adolescent, and adult patients for hemodialysis, hemoperfusion or apheresis as determined by the prescribing physician. Access is attained via the internal jugular vein, subclavian vein, or femoral vein.

The GlidePath™ 7.5F Long-Term Hemodialysis Catheter features a dual-lumen shaft with optimized double-D cross-sectional designs providing separate arterial and venous lumens, a molded bifurcation and, extending from the bifurcation, arterial and venous extension legs that connect to an external dialysis machine or blood cleansing device. The arterial (red) luer connector secures to the blood intake on the dialysis machine and the venous (blue) luer connector secures to the blood return line on the dialysis machine. Each extension leg has an atraumatic occlusion clamp which closes access to the lumen. Long-term dialysis catheters are packaged in a tray with legally marketed accessories intended for use during catheter placement. The symmetrical catheter tip contains holes that aid in the distribution of blood flow or aid in over-the-guidewire placement. The symmetrical catheter tip contains holes that aid in the distribution of blood flow or aid in over-the-guidewire placement. The dialysis catheter is offered in various lengths. This line extension of GlidePath™ has been designed with smaller patients in mind and for physicians that may prefer a smaller diameter catheter, so product offerings include smaller lumen diameter and shorter lengths, 8 cm to 19 cm, tip to cuff measurement. Additionally, GlidePath™ 7.5F Long-Term Hemodialysis Catheters have been designed to reach adequate flow rate requirements for pediatric patients or smaller adult patients for whom a physician desires a smaller catheter size.

The provided text describes a 510(k) premarket notification for the GlidePath™ 7.5F Long-Term Hemodialysis Catheter. The document focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a human-in-the-loop study for a device that meets acceptance criteria for an AI/ML based device.

Therefore, based solely on the provided text, I cannot provide the information requested in your prompt regarding acceptance criteria and a study proving an AI/ML device meets those criteria. The document describes a medical device (a catheter) and its non-clinical performance testing.

Here's what I can extract and address from your prompt based on the provided text, and what I cannot address:

Information NOT Found in the Provided Text (relevant to AI/ML device studies):

• A table of acceptance criteria and the reported device performance for an AI/ML device. The document lists performance tests for a physical catheter, not acceptance criteria for an AI/ML algorithm.
• Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective). This is specific to data used for AI/ML model validation, which is not discussed.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts. Not applicable to a physical catheter.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set. Not applicable.
• 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. No mention of human readers or AI assistance.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done. No mention of an algorithm.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc). Not applicable to a physical catheter.
• The sample size for the training set. Not applicable.
• How the ground truth for the training set was established. Not applicable.

What CAN be stated from the provided text (related to the physical catheter):

The document states:
"The subject device, the GlidePath™ 7.5F Long-Term Hemodialysis Catheter, meets all predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs."

This indicates that prior to the 510(k) submission, the manufacturer established and met certain acceptance criteria for the physical device's performance. However, the document does not detail these specific criteria in a table or provide the raw results against them. It only lists the types of in-vitro tests performed to demonstrate substantial equivalence.

List of In-Vitro Performance Tests Performed for the GlidePath™ 7.5F Long-Term Hemodialysis Catheter (as a proxy for components of the "study"):

The following in-vitro tests were performed based on FDA Guidance Documents and internal Risk Assessment procedures:

• Catheter Tip (Damage After Flexure)
• Tip Tensile
• Tunneler (Shaft to Tunneler Tensile)
• Catheter Tip Stiffness
• Surface Inspection
• Catheter Insertion Over Split Sheath Introducer
• Assembly Leak Resistance
• Flow Rates
• Catheter Collapse
• Catheter Tensile (Shaft to Bifurcation)
• Catheter Tensile (Extension Leg to Bifurcation)
• Catheter Tensile (Extension Leg to Connector)
• Cuff Securement
• Burst
• Recirculation
• Mechanical Hemolysis
• Catheter Shaft Stiffness
• Catheter Radiopacity
• Thumb Clamps
• Extension Legs (Knitting, Flow)

Conclusion regarding your query:

The provided FDA 510(k) clearance letter and summary concern a physical medical device (a catheter), not an AI/ML-based device. Therefore, the specific details requested about an AI/ML device's acceptance criteria, test set characteristics (sample size, provenance, expert ground truth, adjudication), MRMC studies, standalone performance, and training set information are not present in this document. The document confirms that the physical catheter met its predetermined acceptance criteria for design verification and validation through in-vitro testing.

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