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The Fogarty thru-lumen embolectomy catheter is indicated for adults requiring the removal of fresh, soft emboli and thrombi from vessels in the arteries of the peripheral vasculature. Additionally, it may also be used for temporary occlusion of blood vessels, infusion of fluids, and blood sampling in general surgical procedures.

The Fogarty Thru-Lumen Embolectomy Catheter is a double lumen catheter with a latex balloon at the distal end. One lumen is used for balloon inflation and is accessed through the gate valve at the proximal end. The thru-lumen is used for infusion of fluids, sampling of blood or guidewire passage through the distal tip. A removable stainless steel stylet(s) is provided.

It appears there might be a misunderstanding of the provided text. The document is an FDA 510(k) clearance letter for a medical device: the Fogarty Thru-Lumen Embolectomy Catheter.

This document is not about an AI/software-as-medical-device (SaMD) or a device that relies on complex algorithms requiring a study to prove its performance against acceptance criteria like sensitivity, specificity, or AUC based on a test set, ground truth, or expert readers.

Instead, this device is a physical catheter used to remove emboli and thrombi. The "acceptance criteria" and "study" proving its performance in this context relate to engineering and biocompatibility testing, not to AI model performance or interpretation of medical images.

Here's why the questions about AI/software-related study methodologies are not applicable to the provided document:

• No mention of AI, algorithms, or software: The document describes a physical medical device. There is no indication that it incorporates AI, software, or image analysis to function.
• "Study that proves the device meets the acceptance criteria" refers to bench testing: The document explicitly states under "Device Testing": "Bench testing was performed in accordance with Edwards' current design requirements. In addition, shelf-life, packaging, and sterilization validations have been performed to existing specifications. All testing met the existing predetermined acceptance criteria." This refers to mechanical, material, and sterilization performance, not diagnostic accuracy or AI performance.
• Comparison to a predicate device: The basis for clearance is "substantial equivalence" to a predicate device (Fogarty Thru-Lumen Embolectomy Catheter cleared in K892410). The comparative analysis states, "The subject device is identical to the predicate device in terms of the intended use, indications for use, and technological characteristics (including design, material, chemical composition, principle of operation)." This reinforces that it's a physical device, not an AI system that would typically undergo MRMC studies or performance validation against a ground truth dataset of patient images.

Therefore, I cannot provide the requested information (table of acceptance criteria, sample size, expert qualifications, adjudication, MRMC, standalone performance, ground truth types, training set details) because the provided FDA document pertains to a physical medical device and does not involve AI or software development with the type of validation methodology you are asking about.

To summarize, the document is about the FDA clearance of a conventional medical device, not an AI-powered one. The "acceptance criteria" and "study" refer to engineering and biological safety tests, not the performance metrics of an AI model.

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The Fogarty Fortis Arterial Embolectomy Catheters are indicated for use in adult patients for the removal of fresh, soft emboli and thrombi from vessels in the peripheral arterial system.

The Fogarty Fortis Arterial Embolectomy Catheters provide a means of clearing emboli and thrombi from vessels in the arteries of the peripheral system through inflation of the balloon and engagement with the arterial wall beyond the vascular obstruction followed by gentle withdrawal of the catheter thereby removing the obstruction from its position. The device catheter size is 4F and are available in 40 cm and 80 cm lengths. The device consists of a radiopaque catheter shaft with an integrated elastomeric latex balloon and an atraumatic tip that is inserted surgically into arterial vessels of the peripheral system. A hub at the proximal end is used for balloon inflation.

This document is a 510(k) summary for the Fogarty Fortis Arterial Embolectomy Catheter. It outlines the device description, indications for use, and a comparative analysis to a predicate device. The document states that "All testing met the existing predetermined acceptance criteria." However, it does not provide any specific acceptance criteria or detailed study results for device performance.

Therefore, I cannot extract the detailed information requested regarding acceptance criteria and the study proving the device meets them because it is not present in the provided text.

Based on the available information:

• 1. A table of acceptance criteria and the reported device performance: This information is not provided in the document. The document only states, "All testing met the existing predetermined acceptance criteria."
• 2. Sample size used for the test set and the data provenance: This information is not provided. The document mentions "Bench testing was performed in accordance with Edwards' current design requirements," but no details on sample size or data provenance are given.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided.
• 4. Adjudication method for the test set: This information is not 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 is a medical device (catheter), not an AI/software device. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and was not performed.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This is a physical medical device, not an algorithm, so this concept is not applicable.
• 7. The type of ground truth used: For a physical medical device like an embolectomy catheter, "ground truth" would typically refer to established engineering standards, biocompatibility testing guidelines (e.g., ISO 10993-1), and internal design requirements. The document states:
  • "Biocompatibility testing was performed in accordance with ISO 10993-1: 2018..."
  • "Bench testing was performed in accordance with Edwards' current design requirements."
• 8. The sample size for the training set: This is a physical medical device, not a machine learning model, so there is no "training set."
• 9. How the ground truth for the training set was established: Not applicable, as there is no training set.

The document focuses on substantiating equivalence to a predicate device through bench testing and biocompatibility assessments, stating that the new device meets "existing predetermined acceptance criteria" without detailing what those criteria are or the specific performance metrics achieved.

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Fogarty Venous Thrombectomy Catheters are indicated for use in the peripheral venous vasculature of adult patients for the removal of emboli and thrombi, and may be used for temporary vessel occlusion.

Fogarty venous thrombectomy catheters are specifically designed for the performance of venous thrombectomy in adult patients. Fogarty venous thrombectomy catheters have a long, soft tip which is intended to facilitate advancement past the venous valves while minimizing trauma. The flexibility required for the venous procedure is supplied by the spring-wound body. The spring is covered with a braiding for additional strength. The gate valve is designed for single-handed operation and to minimize the possibility of leakage. The gate valve has an arrow to indicate the "open" and "closed" positions. There are three available catheter sizes (6 French (2.0 mm), 8 French (2.7 mm), and 8/10 French (2.7/3.3 mm)). Each may be quickly identified by the color-coded body. The size and filling capacity are printed on each catheter.

This document is a 510(k) summary for the Fogarty Venous Thrombectomy Catheter. It outlines the device description, indications for use, and a comparison to a predicate device. Importantly, it focuses on demonstrating substantial equivalence to a preamendment predicate device through bench testing, biocompatibility testing, shelf-life, packaging, and sterilization validations. It does not present a study proving the device meets acceptance criteria related to AI/software performance or human-in-the-loop improvements, nor does it discuss ground truth establishment, expert consensus, or MRMC studies.

Therefore, I cannot extract the information required to answer your prompt because the provided text pertains to a traditional medical device (catheter) and does not contain information about AI, software, or the types of studies you are asking about (e.g., MRMC studies, standalone algorithm performance).

The document explicitly states: "Bench testing inclusive of design verification, packaging, sterilization, and biocompatibility testing all demonstrate that the subject devices are substantially equivalent to the predicate devices." This highlights that the device's performance is demonstrated through physical and biological testing, not through AI/software evaluation.

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The Fogarty arterial embolectomy catheter with gate valve is indicated for use in adult patients for the removal of fresh, soft emboli and thrombi from vessels in the peripheral arterial vasculature.

The Fogarty Arterial Embolectomy Catheter with Gate Valve provides a means of clearing emboli and thrombi from vessels in the arteries of the peripheral vasculature through inflation of the balloon and engagement with the arterial wall beyond the vascular obstruction followed by gentle withdrawal of the catheter thereby removing the obstruction from its position. The device catheter size is 2F and is available in 45 cm length. The catheter contains a latex balloon at the distal end and a gate valve at the proximal end for connection to a syringe for balloon inflation.

The provided document details a 510(k) premarket notification for the Fogarty Arterial Embolectomy Catheter with Gate Valve. This document is a regulatory submission to the FDA for a medical device. Based on the content, it does NOT describe an AI/ML-driven medical device or a study involving human readers or expert panels for ground truth establishment.

Instead, the device is a physical medical instrument (a catheter) for removing blood clots. The information provided focuses on the substantial equivalence of this new device to a predicate device, primarily through bench testing, biocompatibility testing, shelf-life, packaging, and sterilization validations. The document explicitly states:

• "Device Testing: Biocompatibility testing was performed in accordance with ISO 10993-1: 2018... Bench testing was performed in accordance with Edwards’ current design requirements. In addition, shelf-life, packaging, and sterilization validations have been performed to existing specifications. All testing met the existing predetermined acceptance criteria."
• "Conclusion: Based on the performance testing and the technological characteristics, the Fogarty Arterial Embolectomy Catheter with Gate Valve meets the established performance criteria and is substantially equivalent to the predicate device Fogarty Arterial Embolectomy Catheters."

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, expert involvement, and reader studies as these are not relevant to the type of device and submission described in the provided text. The document describes a traditional medical device submission, not an AI/ML diagnostic or assistive device.

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The Fogarty Corkscrew Catheter is indicated for use in adult patients with emboli/thrombi in the peripheral arterial vasculature in either native vessels or synthetic grafts.

The Fogarty Graft Thrombectomy Catheter is indicated for use in adult patients for the removal of organized thrombus and adherent non-thrombotic material from synthetic bypass grafts, specifically synthetic arteriovenous grafts used for dialysis access and synthetic grafts for ileo-femoral bypass in the peripheral arterial vasculature. General indications for arterial reconstruction of an obstructed graft include disabling claudication, ischemic pain at rest, or ischemic skin lesions or gangrene. General indications for reconstruction of a synthetic AV fistula internal bridge graft include the inability to properly dialyse the patient.

Fogarty Corkscrew Catheters:
The Fogarty Corkscrew Catheters are sterile, single use flexible catheters consisting of a polyvinylchloride outer catheter body surrounding a movable, radiopaque stainless steel spring body. A second radiopaque, spiral-shaped, stainless steel cable covered by a latex membrane is attached to the distal end of the catheter. A handle to modulate the spiral cable diameter is attached to the inner spring body at the proximal end of the catheter. The spiral cable design of the Fogarty Corkscrew catheter increases the surface area for entrapping fibrous material.

Fogarty Graft Thrombectomy Catheters:
The Fogarty Graft Thrombectomy catheters are sterile, single use catheters designed to remove organized thrombus and adherent non-thrombotic material from synthetic bypass grafts, specifically synthetic arterial vasculature fistulas for dialysis access and synthetic grafts for iliofemoral bypass. During use, the control button on the device handle is grasped and moved forward and aft to cause the spiral wires at the distal end to extend or retract. The spiral wires are extended during passage of the device through a narrowed region of a vessel. The spiral wires are then retracted to facilitate occlusive material removal.

The provided text is a 510(k) summary for the Fogarty Corkscrew Catheters and Fogarty Graft Thrombectomy Catheters. This document details the regulatory clearance process for medical devices by demonstrating substantial equivalence to existing predicate devices.

Crucially, this document does NOT describe the acceptance criteria and study proving an AI/algorithm-based device meets acceptance criteria.

The Fogarty Corkscrew and Graft Thrombectomy Catheters are physical, mechanical medical devices used for embolectomy and thrombectomy. The "Device Testing" section explicitly states: "Bench testing was performed in accordance with Edwards' design requirements. In addition, shelf-life, packaging, and sterilization validations have been performed."

Therefore, I cannot fulfill your request to describe the acceptance criteria and study for an AI device based on the provided text, as the text pertains to traditional medical devices and their mechanical/biological performance, not AI performance.

If you have a different document describing an AI medical device, please provide that.

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· Merlin Aspiration Catheter
As a part of the Merlin Aspiration System, the Merlin Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi in the peripheral arterial system.
· High Flow Tubing
As a part of the Merlin Aspiration System, the High Flow Tubing is indicated to connect the guide catheter to an aspiration pump.

The Merlin Aspiration System is comprised of two devices:

• Merlin Aspiration Catheter
• High Flow Tubing
  The Merlin Aspiration Catheter is introduced through a guide catheter or long sheath into the peripheral vasculature and guided over a guidewire to the site of primary occlusion. The Merlin Aspiration Catheter is used in conjunction with an aspiration pump, which is connected to High Flow Tubing. These devices are visible under fluoroscopy.
  Merlin Aspiration Catheter
  The Merlin Aspiration Catheter consists of single lumen, coiled construction, variable stiffness shaft with radiopaque markers on distal and proximal end of the catheter portion for angiographic visualization. The Merlin Aspiration Catheter is identical in design to the MIVI Q Distal Access Catheter (K192558).
  High Flow Tubing
  The MIVI High Flow Tubing is a sterilized and disposable (onetime use) product consisting of high-pressure PVC tubing with end fittings and an on/off switch. The MIVI High Flow Tubing connects an aspiration pump to a reperfusion catheter, providing a means for introducing vacuum during procedures. The MIVI High Flow Tubing has a flow valve that allows the physician to start and stop the flow of aspiration.

The provided text describes the MIVI Merlin Aspiration System and its premarket notification (K213771) to the FDA, demonstrating substantial equivalence to a predicate device. However, the document does not contain specific acceptance criteria, reported device performance (in quantitative metrics), human reader studies, or detailed information about the ground truth establishment in the manner typically associated with studies proving device performance against acceptance criteria for AI/ML-based devices.

The provided text focuses on the mechanical and material performance of a medical device (aspiration catheter and tubing), not an AI/ML diagnostic or therapeutic device. Therefore, the questions related to AI/ML device testing (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to the content provided.

The document instead provides information about engineering bench testing, animal testing, and biocompatibility, which are standard for physical medical devices.

Here's a summary of the information that is available, formatted to address the relevant parts of your request, and explicitly stating where information is not applicable (N/A) based on the nature of the device described:

Acceptance Criteria and Device Performance (for a physical medical device)

1. Table of Acceptance Criteria and Reported Device Performance

For this physical medical device, the "acceptance criteria" are implied by the "established criteria" that the device was tested against. The "reported device performance" is simply that the device "Met established criteria" for each test. Specific quantitative criteria and performance values are not provided in this summary.

Information for AI/ML Device Evaluation (Not Applicable for this Device)

The following points are primarily relevant for AI/ML-based medical devices, which the Merlin Aspiration System is not. Therefore, specific details for these points are Not Applicable (N/A) based on the provided text. The device is a physical aspiration system, and its evaluation focuses on mechanical performance, biocompatibility, and animal testing.

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

• N/A. This device is a physical medical device (aspiration system), not an AI/ML device that uses a "test set" of data in the common sense for diagnostic or prognostic purposes. Performance was evaluated through bench testing and animal testing.
• For animal testing: 8 animals (porcine carotid, renal, and subclavian vasculature). This is prospective testing in an animal model.

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)

• N/A. Ground truth establishment for a "test set" of data points is not relevant for the physical device performance testing described.

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

• N/A. Not relevant for the type of device 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

• N/A. This is a physical medical device, not an AI-assisted diagnostic or therapeutic tool.

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

• N/A. This is a physical medical device, not an algorithm.

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

• N/A. For the bench testing, the "ground truth" would be established engineering specifications and physical measurements. For animal testing, it would be direct observation of the device's performance in vivo concerning safety and effectiveness in removing emboli/thrombi.

8. The sample size for the training set

• N/A. This device is not an AI/ML product developed using a training set.

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

• N/A. Not applicable as there is no training set for this physical device.

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Python catheters are indicated for removal of thromboemboli from the peripheral arterial system, and for occlusion and infusion of fluids into a vessel.
The Over-the-Wire Latis Graft Cleaning Catheter is indicated for the removal of thromboemboli from vascular grafts, and for occlusion and infusion of fluids into a graft.

The Python Embolectomy Catheter & Over-the-Wire Latis Graft Cleaning Catheters are sterile, single use vascular balloon catheters intended for use in the removal of thromboemboli, occlusion of vessels, and the infusion of fluids. The devices are intended for use in arterial vessels and artificial vascular grafts respectively. The body of the catheters utilize a dual lumen design with one inflation lumen used to inflate the balloon, and one through lumen allowing for insertion over a guide wire or infusion of fluids. The outer diameter of the body is designed to accommodate use with a standard percutaneous access sheath. The Over-the-wire Latis Graft Cleaning Catheter includes a braided mesh which surrounds the balloon and is designed to increase engagement with wall of artificial vascular graft.

The provided text describes a medical device's 510(k) submission to the FDA, demonstrating substantial equivalence to predicate devices. It focuses on the physical and material characteristics of the catheters and the bench testing performed. However, it does not contain information pertinent to the typical acceptance criteria or study design for AI/ML-based medical devices, such as a test set size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details.

Therefore, I am unable to provide the requested information based on the input text.

The document discusses the following:

• Device Name: Python Catheter and Over-the-Wire Latis Graft Cleaning Catheter
• Intended Use: Removal of thromboemboli from the peripheral arterial system/vascular grafts, and for occlusion and infusion of fluids into a vessel/graft.
• Testing Performed:
  • Engineering/Bench Testing: Balloon Pull Force, Inflation & Guidewire Hub Pull Force, Catheter Body Tensile Strength, Catheter Balloon Cycling Test, Balloon Burst Pressure Test, Inflated Balloon Diameter Inspection, Guidewire & Inflation Hub Leak Test, Simulated Use Bend Test, Torsion Test, Kink Test.
  • Biocompatibility Testing: Cytotoxicity, Intracutaneous Irritation, Sensitization, Acute Systemic Toxicity, Hemolysis, Materials Mediated Pyrogenicity, Platelet and Leukocyte Counts, Partial Thromboplastin Time, Complement Activation, Thrombogenicity.
• Standards Referenced: ISO 10555-1:ed2:2017 and EN 13868.

This information relates to the physical and biological safety and performance of the catheter itself, not to the performance of an AI/ML component.

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Fogarty Arterial Embolectomy Catheter: The Fogarty Arterial Embolectomy Catheter is indicated for the removal and thrombi from vessels in the arterial system. To remove fibrous or adherent material, alternative devices such as the Fogarty Adherent Clot and Graft Thrombectomy Catheter are recommended.

Fogarty Biliary Balloon Probe: The Fogarty Biliary Balloon Probe is indicated for the removal of stones and ductal debris and exploration.

Fogarty Arterial Embolectomy Catheter: The Fogarty Arterial Embolectomy Catheter consists of a catheter body tube made out of polyvinyl chloride (PVC) or nylon (3F only) of 40, 60, or 80 cm lengths. The catheter contains a latex balloon at the distal end and a PVC hub at the proximal end for connection to a syringe for balloon inflation. They contain a soft, rounded tip, which promotes easy arterial insertion. The model with an “S” has a stylet at the proximal end to support the inflation lumen during shipping and storage. These devices are provided sterile and labeled for single use only.

Fogarty Biliary Balloon Probe: The Fogarty Biliary Balloon Probe consists of a single-lumen polyvinyl chloride (PVC) catheter body with a latex balloon at the distal end. A hub at the proximal end is used for balloon inflation. A flexible stylet is provided with Fogarty Biliary Balloon Probe. The stylet is of a designed stiffness intended to avoid perforation and yet maintain enough shape to facilitate introduction of the probe into areas of sharp angulation. These devices are provided sterile and labeled for single use only. The Fogarty Biliary Balloon Probe is not intended to be used with other devices.

This is a 510(k) summary for a medical device called the Fogarty Arterial Embolectomy Catheter and Fogarty Biliary Balloon Probe. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a new device's efficacy through extensive clinical trials with acceptance criteria directly tied to patient outcomes or AI performance metrics.

Therefore, the typical questions about acceptance criteria for AI/CADe devices, such as performance metrics (sensitivity, specificity), expert involvement in ground truth, sample sizes for test/training sets, and MRMC studies, are not applicable here.

Instead, the "acceptance criteria" in this context are related to demonstrating that the changes made to existing, legally marketed predicate devices (primarily packaging and associated manufacturing/labeling updates) do not negatively impact the device's safety and effectiveness.

Here's how to interpret the provided document in the context of your questions:

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

The document doesn't present a table of specific numerical acceptance criteria and performance for a diagnostic algorithm. Instead, the acceptance criteria are met by demonstrating that the modified device (new packaging configuration for an existing device) maintains the same performance and safety profile as the predicate device.

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

This is not applicable to this type of 510(k) submission. The "test set" here refers to the actual physical devices and packaging subjected to the engineering and biocompatibility tests. The document does not specify exact sample sizes for each test (e.g., how many catheters were tested for balloon inflation, how many packaging samples for integrity). Data provenance (country of origin, retrospective/prospective) is not relevant to these engineering and material tests.

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

Not applicable. "Ground truth" in the context of device performance in this 510(k) is established by adherence to recognized international standards (e.g., ISO 11607-1, ISO 11135, ISO 10993-7) and internal company specifications for manufacturing and quality control. There isn't an "expert" panel adjudicating test results in the same way they would for a diagnostic AI's clinical performance.

4. Adjudication method for the test set

Not applicable. Test results are evaluated against predetermined pass/fail criteria defined by the relevant standards and internal specifications, rather than through an adjudication process involving multiple human experts.

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 embolectomy catheter and biliary balloon probe, not a diagnostic AI or CADe system. Therefore, MRMC studies are not relevant.

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

Not applicable, as this is not an AI/algorithm-driven device.

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

The "ground truth" for the tests performed (packaging, sterilization, material safety, basic functional performance) is based on:

• International standards: ISO 11607-1, ISO 11135, ISO 10993-7 provide the objective criteria for what constitutes acceptable performance and safety.
• Predicate device characteristics: The modified device must perform equivalently to the existing, legally marketed predicate device, which inherently established its "ground truth" for safety and effectiveness in its original clearance.
• Engineering specifications: The manufacturer's own design and quality specifications for the device's materials, dimensions, and function.

8. The sample size for the training set

Not applicable. There is no training set for a physical medical device.

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

Not applicable, as there is no training set.

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The Bunegin-Albin Air Aspiration Set is intended to aspirate venous air emboli.

The Bunegin-Albin Air Aspiration Set is comprised of an air aspiration catheter, wire guide, entry access needle, dilator, syringe, stopcock, and scalpel. The air aspiration catheter is manufactured from radiopaque extruded polyethylene tubing and is designed with a pre-molded winged fitting. The catheter is 5.8 French in size with an endhole diameter of 0.035 inches. The wire guide is manufactured from stainless steel coils, a safety wire, and a mandril wire. The access needle is manufactured from stainless steel. The dilator is manufactured from polyethylene and has a pre-molded proximal hub. The set also includes a 12 cc syringe, a low pressure three way stopcock, and a scalpel. The Bunegin-Albin Air Aspiration Set is sterilized by ethylene oxide and intended for one-time use.

This documentation outlines the acceptance criteria and the results of various studies conducted for the Bunegin-Albin Air Aspiration Set to demonstrate its performance and substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific numerical sample sizes for each physical and chemical test (e.g., Catheter Shaft Tensile, Wire Guide Corrosion). Instead, the document refers to compliance with international standards (e.g., BS EN ISO 10555-1, BS EN ISO 11070, ISO 594-2, BS EN 13868, USP 788) which would implicitly define sample sizes for such tests.

For the Animal Testing, a specific sample size is not stated, but the testing evaluated the "acute performance" in an animal model. The provenance would be experimental ("prospective" if considered in the context of device development) rather than clinical human data. The country of origin for the animal study is not specified in the provided text.

The data for all engineering performance and biocompatibility tests is based on prospective testing conducted specifically for this device submission to demonstrate compliance with standards and design input requirements. The country of origin of this testing data is not explicitly stated, but it is for a device manufactured by Cook Incorporated, presumably in the US or one of their international facilities.

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

For the engineering performance tests (tensile strength, kink resistance, leakage, etc.) and particulate testing, "ground truth" is established by adherence to quantitative specifications defined by international standards (e.g., ≥ 15 N, no air entry, no liquid leak, USP 788 thresholds). Therefore, these do not rely on human expert consensus in the same way clinical image interpretation might. The "experts" in this context would be the technicians and engineers performing and verifying the tests against the defined standards.

For Animal Testing, the grading of "adequate" or "good" for performance parameters and ability to remove air would imply evaluation by experts, likely veterinary surgeons or researchers with expertise in animal models and medical device performance. The number and specific qualifications of these experts are not provided.

For Biocompatibility testing, "ground truth" is established by the results of standardized tests per ISO 10993-1 and FDA guidance. Experts would be toxicologists and other scientific professionals interpreting these results, but their number and specific qualifications are not detailed.

4. Adjudication Method for the Test Set

For the physical, chemical, and mechanical performance tests, the adjudication method is direct comparison of measured values against predefined numerical or qualitative acceptance criteria outlined in international standards. There is no mention of a human consensus or specific adjudication for these quantitative evaluations beyond meeting the standard.

For the Animal Testing, the "grading of 'adequate' or 'good'" suggests an assessment, but the specific adjudication method (e.g., single expert, 2+1 consensus) is not detailed.

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

No MRMC comparative effectiveness study was done. The device is a physical medical instrument (an air aspiration set), not an AI or imaging diagnostic device that would typically involve human readers interpreting cases.

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

Not applicable as this is a physical medical device. The "performance" studies are standalone in the sense that they evaluate the device's physical properties and functionality without human intervention being part of the device's performance mechanism, but rather as the operators and evaluators of the device.

7. Type of Ground Truth Used

The ground truth for the various tests is established through a combination of:

• International Standards and Specifications: For most physical, mechanical, and chemical tests (tensile strength, kink length, leakage, particulate counts, etc.), the ground truth is defined by the acceptance criteria set forth in specific ISO and BS EN standards (e.g., BS EN ISO 10555-1, BS EN ISO 11070, ISO 594-2, BS EN 13868, USP 788 thresholds).
• Empirical Observation/Expert Assessment: For animal testing, the ground truth is based on the observed "adequate" or "good" performance and the ability to remove air from target sites, likely evaluated by trained personnel.
• Biocompatibility Standards: For biocompatibility, the ground truth is compliance with the requirements of ISO 10993-1 and FDA guidance, demonstrated through specific laboratory test results.

8. Sample Size for the Training Set

Not applicable in the context of device performance testing for substantial equivalence. There is no mention of a "training set" as this device does not involve machine learning or AI algorithms requiring data for training. The studies described are for verification and validation of the manufactured product.

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

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

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The Needle's Eye Snare® Retrieval Set - 54cm is intended for use in patients requiring the percutaneous retrieval of indwelling catheters, cardiac leads, fragments of catheter tubing or wire guides and other foreign objects.

The Needle's Eye Snare® Retrieval Set- 54cm is a grasping device that forms a basketlike snare around the in-dwelling catheter, cardiac lead, fragment of catheter tubing, wire guide or other foreign object. The distal end is delivered to the vicinity of the lead through a long, flexible 12Fr. (O.D.) PTFE sheath placed coaxially within a 16Fr. (O.D.) PTFE Check-Flo® Introducer Sheath having a Check-Flo® Valve with stopcock at its proximal end. The device is comprised at the distal end of a nitinol wire needle's eye retrieval mechanism consisting of a "needle's eye" loop and "threader" with stainless steel sleeves housed within a PTFE protective cover sheath. The snare is activated through the forward advancement of the threader by fully depressing the plunger. The item is captured between the threader and needle's eye. The inner sheath is advanced forward closing the snare and securely capturing the lead or other foreign object. The Needle's Eye Snare® Retrieval Set - 54cm has nominal usable length of 54cm.

The provided text describes the Needle's Eye Snare® Retrieval Set - 54cm and its substantial equivalence to a predicate device. It includes information about the device's indications for use, comparison to the predicate, device description, and a summary of test data. However, the document does not contain the detailed acceptance criteria and study information typically associated with AI/ML device performance validation.

Based on the provided text, here's what can be extracted and what is missing:

Acceptance Criteria and Device Performance (as much as can be extracted)

Missing Information (based on typical AI/ML device validation requests):

The document is a 510(k) submission for a medical device (a snare retrieval set), not an AI/ML diagnostic or prognostic algorithm. Therefore, the typical elements of an AI/ML study (like sample size for test/training sets, data provenance, ground truth establishment, expert adjudication, MRMC studies, standalone performance, etc.) are not applicable and not present in this document.

Specifically, the following information is not available in the provided text:

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for a physical medical device. The "test data" mentioned refers to engineering performance tests (like particulate testing), not clinical or AI model validation data.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
4. 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.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
7. The sample size for the training set: Not applicable.
8. How the ground truth for the training set was established: Not applicable.

Summary of Device-Specific Information from the Text:

• Device Name: Needle's Eye Snare® Retrieval Set - 54cm
• Intended Use: For use in patients requiring the percutaneous retrieval of indwelling catheters, cardiac leads, fragments of catheter tubing or wire guides and other foreign objects.
• Predicate Device: Needle's Eye Snare®, cleared under K961992.
• Comparison to Predicate: Identical in intended use, principles of operation, basic technological characteristics, and materials of construction. Differences are the specified length (54cm vs 94cm for predicate) and the inclusion of a 12 Fr Curved Inner Sheath as an accessory in the subject device.
• Test Data Provided: Particulate Testing was performed to ensure particulates from the device are comparable to the predicate and meet USP 778 requirements. The predetermined acceptance criteria were met.

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