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The LimFlow V-Ceiver is intended for use in the cardiovascular system to manipulate and retrieve guidewires specified in the IFU.

The LimFlow V-Ceiver is a percutaneous snaring device with a luer on the proximal end and a snaring basket at the distal end. The basket is composed of nitinol for shape memory and visibility with radiopaque markers on either end of the basket for added visibility. The coaxial sheathing system is used to re-constrain the basket once a guide wire is captured.

I am sorry, but the provided text does not contain any information about acceptance criteria for a device's performance based on image analysis, nor does it describe a study that proves a device meets such criteria.

The document is an FDA 510(k) clearance letter for the LimFlow V-Ceiver, which is an embolectomy catheter, a physical medical device. The clearance is based on demonstrating substantial equivalence to a predicate device (LimFlow V-Ceiver K222083) through non-clinical performance tests, biocompatibility, sterilization, and packaging validation.

The "Indications for Use" explicitly state: "The LimFlow V-Ceiver is intended for use in the cardiovascular system to manipulate and retrieve guidewires specified in the IFU." This indicates it's a device for physical manipulation within the body, not an imaging or AI-based diagnostic tool.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance related to image analysis.
2. Sample size, data provenance, number of experts, adjudication methods for a test set, MRMC studies, standalone performance, or ground truth types related to an AI/imaging device.
3. Information on training sets or their ground truth establishment for an AI/imaging device.

The provided text pertains to the regulatory clearance of a physical medical device.

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The Amplatz Goose Neck Snare kit is intended for use in the cardiovascular system to retrieve and manipulate foreign bodies.

The Amplatz Goose Neck Snare kit (Snare device) contains the snare, snare catheter, snare introducer, and torque device. The snare is made of a nitinol cable and a gold-plated tungsten loop. The preformed snare loop can be introduced through catheters without risk of snare deformation because of the snare's superelastic construction. The snare catheter contains a platinum-iridium, radiopaque marker band.

The provided text describes a 510(k) premarket notification for the Amplatz™ Goose Neck Snare Kit and does not contain information about acceptance criteria or a study proving that an AI/ML device meets those criteria. The document is for a traditional medical device (a snare kit) and primarily focuses on its substantial equivalence to a predicate device, along with verification and validation testing for its physical and biocompatibility properties.

Specifically, the document lists:

• Biocompatibility tests: ISO MEM Elution, Guinea Pig Maximization Sensitization Test, Intracutaneous Irritation Test, Acute Systemic Injection Test, Materials Mediated Rabbit Pyrogen, ASTM Hemolysis Assay - Direct Contact Method, Complement Activation SC5b-9 Assay, ISO Standard Thrombogenicity in Canine, ISO Standard Thrombogenicity in Ovine.
• Design Verification tests: Snare Catheter Length, Snare Catheter OD, Snare Catheter Tip OD, Guide Catheter Compatibility.
• Packaging Validation tests: Visual Inspection (Gross Physical Damage to Package System), Visual Inspection (Label Legibility and Adhesion), Visual Inspection (Carton), IFU / eIFU Leaflet (Legibility), Visual Inspection (Device), Visual Inspection (Sterile Barrier Seal Integrity and Width), Package Integrity (Bubble Test), Peel-Open/Aseptic Presentation, Seal Strength Test.
• Shelf Life tests: Catheter Visual Inspection, Snare Catheter Tip Configuration, Snare Catheter ID and OD, Snare Catheter Length, Snare OD, Functional (general), Catheter Shaft Tensile Strength, Hub Bond Tensile Strength, Snare Catheter Tip OD, Guide Catheter Compatibility.
• Sterilization tests: Sterilization validation per ISO 11135 (overkill half cycle approach), Sterilization Residuals Testing.

These are standard engineering and safety tests for a physical medical device, not performance criteria for a software or AI/ML-driven device. The document explicitly states: "Animal testing was not required for the determination of substantial equivalence. Clinical testing was not required for the determination of substantial equivalence." This further indicates that no human clinical or AI/ML performance study, as typically described by your prompt's questions, was conducted or reported in this submission.

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Single-Loop Snare Retrieval Kit and Triple-Loop Snare Retrieval Kit are intended for the percutaneous removal of retrievable inferior vena cava (IVC) filters that are no longer medically required, via jugular approach.

The Single-Loop Snare Retrieval Kit and Triple-Loop Snare Retrieval Kit are single use devices. The disposable system consists of: [A] 9F (ID) Inner Sheath, [B] 11F (ID) Outer Sheath, [C] 8F (OD) Dilator, [D] Hemostasis Valve with Sideport, [E] High Pressure Stopcock, [F] 7F [2.4mm] (OD) x 76cm Snare Catheter with Tuohy-Borst Y-Port Adapter, 20mm x 93cm Single-Loop Snare (fully expanded) or 30mm x 93cm Triple-Loop Snare (fully expanded) with Torque Handle. The snares have radiopaque loops and are preloaded in the snare catheter. The snare catheter, inner sheath, and outer sheath have a radiopaque marker band at the distal tip for enhanced fluoroscopic visualization.

The provided text describes a 510(k) premarket notification for a medical device, specifically retrieval kits for inferior vena cava (IVC) filters. The submission focuses on a modification to an existing device.

Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission for a modification to an existing device, the "acceptance criteria" are not explicitly stated as numerical targets in a table. Instead, the acceptance criteria are implicit in meeting the performance standards of the predicate device and ensuring the modification doesn't negatively impact safety or effectiveness. The reported device performance is that all tests met their respective acceptance criteria.

The document explicitly states: "Test results demonstrate that all acceptance criteria were met; therefore, the device meets the established product specifications."

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

The document does not specify the exact sample sizes used for each individual non-clinical test. It only lists the types of tests performed. The data provenance is not explicitly mentioned in terms of country of origin, but it is implied to be from the manufacturer's internal testing. The tests are non-clinical (bench testing, biocompatibility) rather than human subject studies, so the terms "retrospective or prospective" are not applicable in this context.

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

This information is not applicable to this submission. The tests performed are non-clinical (mechanical, materials, biocompatibility) and do not involve expert interpretation or ground truth establishment in the way clinical studies with AI algorithms would. The "ground truth" for these tests is based on objective measurements against established engineering and biocompatibility standards (e.g., ISO and ASTM standards).

4. Adjudication Method for the Test Set

This is not applicable as the tests are non-clinical and do not involve human interpretation or adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This submission is for a physical medical device (retrieval kit) with a material modification, not an AI-powered diagnostic or interpretive device. The document explicitly states: "Clinical testing was not required for the determination of substantial equivalence."

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

A standalone performance study was not done. This is not an AI device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the non-clinical tests is based on:

• Engineering specifications and standards: For mechanical and dimensional tests (e.g., tensile strength, leak test, burst test, radiopacity, Luer testing, flexural modulus, radial force).
• Biocompatibility standards: For biocompatibility tests (e.g., ISO 10993 series for cytotoxicity, sensitization, irritation, pyrogenicity, systemic toxicity, hemocompatibility).
• Simulated use conditions: For tests like simulated use and design validation.

8. The Sample Size for the Training Set

This is not applicable as this is not an AI device and therefore has no "training set."

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

This is not applicable as this is not an AI device and therefore has no "training set" or associated ground truth establishment process.

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The product has been designed for retrieval of implanted Günther Tulip and Cook Celect Vena Cava Filters in patients who no longer require a filter. Retrieval of the filter can be performed only by jugular approach.

The Günther Tulip Vena Cava Filter Retrieval Set is composed of a retrieval loop system with a braided platinum wire loop, a coaxial retrieval sheath system, an entry needle, a wire guide, and a dilator. The outer sheath is provided with a radiopaque band on the distal tip to assist in positioning of the sheath. The Günther Tulip Vena Cava Filter Retrieval Set is intended to retrieve the implanted Günther Tulip and Cook Celect Vena Cava Filters in patients who no longer require a filter.

The Günther Tulip Vena Cava Filter Retrieval Set is a packaged, sterile device intended for single use.

The provided document is a 510(k) premarket notification for a medical device called the "Günther Tulip Vena Cava Filter Retrieval Set." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study for a specific performance claim (e.g., diagnostic accuracy for an AI device).

The document states that modifications were made to the predicate device, specifically a change in the dilator material and a change in the o-ring material. To demonstrate that these changes do not negatively impact safety and effectiveness, the manufacturer performed non-clinical performance tests.

Therefore, the information requested in your prompt regarding acceptance criteria, study design parameters (sample size, experts, ground truth, MRMC study, standalone performance), and training set details are not applicable (N/A) in the context of this specific 510(k) submission for a mechanical medical device. These types of details are typically required for AI/ML-based medical devices or devices making specific claims about diagnostic or predictive performance.

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

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

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 document describes non-clinical performance testing (biocompatibility, dimensional, leakage, tensile) of a mechanical device. There is no "test set" in the context of patient data, nor is there data provenance as would be relevant for clinical studies or AI/ML evaluation. These were laboratory-based physical tests.

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 - No human expert "ground truth" was established as this was non-clinical performance testing of a mechanical device.

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

N/A - Adjudication methods are not applicable to the non-clinical performance testing described.

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

N/A - This device is a mechanical Vena Cava Filter Retrieval Set, not an AI-based system. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant.

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

N/A - This is a mechanical device, not an algorithm.

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

N/A - For the non-clinical tests, the "ground truth" would be the engineering specifications and recognized standards (e.g., ISO 10993 for biocompatibility) against which the device's physical performance was measured. There is no biological or outcome-based ground truth mentioned.

8. The sample size for the training set

N/A - No "training set" is relevant for this type of mechanical device submission.

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

N/A - See point 8.

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The LimFlow V-Ceiver™ is intended for use in the cardiovascular system to manipulate and retrieve guidewires specified in the IFU.

The LimFlow V-Ceiver consists of an intravascular catheter which incorporates a nitinol basket (the "Snare") at its distal tip. The nitinol basket has an outer diameter of 6 mm. The catheter has a built-in coaxial sheathing system and incorporates radiopaque markers at the distal tip on either end of the basket for added visibility. The catheter if compatible with 4 Fr introducer sheaths and has a working length of 100 cm.

The provided text describes the LimFlow V-Ceiver, an embolectomy catheter, and its non-clinical performance tests to establish substantial equivalence with a predicate device. It does not contain information about a study involving human readers, AI assistance, or related ground truth evaluations that would typically be associated with an AI/ML device.

However, I can extract the information related to the device's acceptance criteria and the studies performed to meet these criteria, as described in the context of a medical device submission.

Here's a summary of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document outlines several performance tests conducted for the LimFlow V-Ceiver, each with a statement of meeting predetermined acceptance criteria. Specific quantitative acceptance criteria are not provided in detail, but the outcomes are stated as successful.

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

• Test Set (Non-clinical Performance Tests): The document does not specify exact sample sizes for each mechanical or biocompatibility test. It mentions that "a series of testing was conducted" and that "the below were shown to meet the acceptance criteria." The tests are typically conducted on multiple units or samples to ensure reproducibility and statistical significance, but specific numbers are not provided.
• Test Set (Pre-clinical Study): "An acute swine model" was used. The specific number of animals is not provided.
• Data Provenance: Not explicitly stated, but these are laboratory and animal model studies, not human patient data from a specific country.

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

This information is not applicable to the provided context. The studies described are non-clinical performance and pre-clinical animal studies, which do not involve expert human readers establishing ground truth in the way described for AI/ML performance evaluation studies.

4. Adjudication Method for the Test Set:

Not applicable for the non-clinical and pre-clinical studies described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This document describes the testing of a physical medical device (embolectomy catheter), not an AI/ML diagnostic or assistive tool for human readers.

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

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

7. The Type of Ground Truth Used:

For the non-clinical tests, the "ground truth" is defined by established engineering and biological standards (e.g., ISO 10555-1, ISO 10993 series) and predetermined acceptance criteria derived from these standards and clinical relevance.

For the pre-clinical swine model, the "ground truth" for performance would be the observable success of guidewire snaring and the observed thrombogenicity outcomes within the animal model, judged against pre-defined acceptable ranges.

8. The Sample Size for the Training Set:

Not applicable. There is no mention of a training set as this is not an AI/ML device.

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

Not applicable.

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The Onocor ONO Retrieval device is indicated for use in the cardiovascular system to retrieve objects using minimally invasive surgical procedures include retrieval of intravascular foreign objects such as coils, balloons, catheters, guidewires and/or filters within the cardiovascular system. This device is not intended for use in the coronary arteries or neurovasculature.

The ONO Retrieval device is constructed of 12 Fr stainless steel reinforced catheter, a series of braided nitinol loops forming a basket, a peel away sheath, inner catheter and stop-cocks. The peel away sheath is advanced to compress the nitinol basket for introduction and then removed. The ONO is compatible with up to a 7 Fr manipulation device or snare and with 12Fr to 26 Fr retrieval sheaths. The ONO has a working length of 86 cm.

The provided text is a 510(k) summary for the ONO Retrieval Device and does not contain information related to software or AI performance metrics. Therefore, it is not possible to describe acceptance criteria or a study proving device performance in the context of an AI/software device using the provided input.

The document discusses performance tests for a physical medical device (a retrieval catheter), including:

• Dimensional Testing
• Tensile Strength
• Corrosion Resistance
• Catheter Kink Testing
• Torque Strength
• Simulated Use
• Radiopacity
• Design Validation Testing and Summative Usability Testing
• Distribution Testing
• Fatigue
• Biocompatibility Testing (Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Material Mediated Pyrogenicity, Hemolysis, Thrombogenicity, Complement Activation)
• Pre-clinical study in a porcine model comparing subject and predicate devices for retrieval of foreign objects and assessment of histology and thrombogenicity.

The document states that these tests were conducted "to meet the acceptance criteria that were determined to demonstrate substantial equivalence," but it does not explicitly list the acceptance criteria values or the reported device performance for these tests. It only makes a general statement that the device was shown to meet them and is substantially equivalent to the predicate device.

To answer the requested points, the following information is not present in the provided text:

1. A table of acceptance criteria and the reported device performance: The document lists types of tests but does not provide specific criteria values or performance results.
2. Sample size used for the test set and the data provenance: For the pre-clinical study, it mentions "a porcine model" but not the number of animals or the origin of the data. For other performance tests, no sample sizes are given.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as this is a physical device and not an AI/software testing scenario for ground truth against expert interpretation.
4. Adjudication method for the test set: Not applicable.
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, as this is not an AI/software device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI/software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth in the context of AI/software performance is not relevant here. For the physical device, performance was assessed through engineering tests and an animal study.
8. The sample size for the training set: Not applicable, as this is not an AI/software device using a training set.
9. How the ground truth for the training set was established: Not applicable.

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The Aveir Retrieval Catheter is intended to be used in the peripheral vasculature and the cardiovascular system to retrieve and manipulate an Abbott Medical leadless pacemaker (LP). Retrieval and manipulation includes removing the LP from the heart or peripheral vasculature.

The Aveir™ Retrieval Catheter, model LSCR111 comprised of a valve bypass tool, a steerable/deflectable catheter, an integrated guiding catheter with a protective sleeve, and a tri-loop snare, assembled into a single catheter. The tri-loop snare, secured to a shaft, is used to grasp the docking feature on the proximal end of an Abbott Medical Leadless Pacemaker (LP), mate the LP to the Retrieval Catheter, unscrew the LP and retrieve the LP, thereby removing the LP from the patient's heart or peripheral vasculature. The Retrieval Catheter is supplied in a sterile pouch (sterilized via ethylene oxide), is intended for single-use only, and may not be re-sterilized.

This device is an accessory designed to be used with both the Aveir Leadless System and the previous Nanostim Leadless Pacemaker (LP), model number S1DLCP. The Nanostim LP device has not been manufactured or implanted since November 02, 2016. However, the Nanostim LP (model S1DLCP) is currently implanted in patients and in the event these devices need to be retrieved, the Aveir Retrieval Catheter can be used.

The Aveir Retrieval Catheter is intended to be used to retrieve an LP and to be manipulated by a single operator that allows the operator to perform these actions:

• . Advance the Retrieval Catheter from an access site in the groin (utilizing minimally invasive techniques) through the femoral vein into the heart.
• Steer and position the snare towards the docking button of the LP. .
• Snare the docking button of the LP. ●
• Dock the Retrieval Catheter to the LP.
• o Rotate the LP to unscrew the LP helix from the endocardium.
• Protect the LP helix and electrode during retrieval. ●
• Extract the LP through the access site in the groin. o

Apart from the docking mechanism, the Retrieval Catheter and its control system (handle) have the same operating principle as a conventional steerable catheter and control system, while the snare mechanism and dimensions are similar to commercially available snares systems. The Retrieval Catheter is intended to be used with the compatible Aveir Introducer.

The Retrieval Catheter effective length is 105 cm (41.3 in) and the snare loop inner diameter is 16.5mm (0.65 in). The technical details and materials used in this product can be found in the Instructions for Use.

The provided text does not describe an AI medical device. It describes a medical device, the Aveir™ Retrieval Catheter, which is a physical catheter designed to retrieve leadless pacemakers from the cardiovascular system.

Therefore, the requested information regarding acceptance criteria, study details (sample size, data provenance, expert ground truth, adjudication, MRMC, standalone performance, training set details), which are typically associated with the development and testing of AI/ML-based medical devices, cannot be extracted from this document.

The document details performance data that focuses on the physical and biological characteristics of the catheter, such as:

• Biocompatibility Testing: Cytotoxicity, sensitization, irritation, acute systemic toxicity, materials mediated pyrogenicity, hemocompatibility, particulate matter.
• Non-Clinical Testing: Physical and dimensional characteristics, tensile strength, torsional strength, deflection, simulated use, liquid leak, corrosion resistance, packaging, and shelf life.
• Animal Testing and Human Factors: Usability validation testing in a simulated use environment and a 182-day chronic GLP retrieval study in ovine subjects to demonstrate safe retrievability of pacemakers.

The document states: "Clinical evaluation is not required for the Aveir Retrieval Catheter." This further confirms that the testing paradigm described is not for an AI/ML device, which would typically involve substantial clinical validation.

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The Halo™ Single-Loop Microsnare Kit is intended for use in the retrieval and manipulation of atraumatic foreign bodies located in the coronary and peripheral cardiovascular system and the extra-cranial neurovascular anatomy.

Halo™ Single-Loop Microsnare Kit contains: (1) Microsnare, (1) Microsnare Catheter, (1) Introducer and (1) Torque Handle. The microsnare is constructed of a flexible and radiopaque loop. The pre-formed microsnare loop can be introduced through the microsnare catheter without risk of microsnare deformation because of the snare's super-elastic construction. The microsnare catheter is constructed of flexible tubing and contains a radiopaque marker band.

The Halo™ Single-Loop Microsnare Kit underwent a series of non-clinical performance tests to demonstrate substantial equivalence to its predicate devices. No clinical studies were conducted, thus, information regarding human readers or effect sizes with AI assistance is not available.

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

The document indicates that acceptance criteria were determined to demonstrate substantial equivalence, and the device was shown to meet these acceptance criteria. However, specific numerical acceptance criteria and reported performance values for each test are not provided in the given text. Instead, the document lists the types of performance tests conducted.

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

The document does not specify the sample sizes used for each non-clinical test. The data provenance is non-clinical, meaning it comes from laboratory or bench testing rather than patient data.

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

This information is not applicable as the studies were non-clinical performance and biocompatibility tests, not studies involving expert assessment of medical images or patient data.

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

This information is not applicable as the studies were non-clinical performance and biocompatibility tests.

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 MRMC study was conducted. The device is a medical instrument (microsnare kit), not an AI-powered diagnostic tool. The document focuses on demonstrating the physical and biological characteristics of the device.

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

This is not applicable since the device is a medical instrument, not an algorithm. The performance tests evaluate the physical characteristics and biocompatibility of the device itself.

7. The type of ground truth used:

For performance testing, the "ground truth" would be established engineering specifications, industry standards, and regulatory requirements against which the device's physical and mechanical properties are measured. For biocompatibility testing, the "ground truth" is established biological responses as defined by ISO standards.

8. The sample size for the training set:

This information is not applicable as this is a medical device approval based on non-clinical testing, not a machine learning model requiring a training set.

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

This information is not applicable as this is a medical device approval based on non-clinical testing, not a machine learning model requiring a training set.

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The Halo™ Single-Loop Snare Kit is intended for use in the cardiovascular system or hollow viscous to retrieve and manipulate foreign objects.

Halo™ Single-Loop Snare Kit contains: (1) Snare, (1) Snare Catheter, (1) Introducer and (1) Torque Handle. The snare is constructed of a flexible and radiopaque loop. The pre-formed snare loop can be introduced through the snare catheter without risk of snare deformation because of the snare's super-elastic construction. The snare catheter is constructed of flexible tubing and contains a radiopaque marker band.

The provided text describes a 510(k) premarket notification for the Halo™ Single-Loop Snare Kit. This documentation is for a medical device (a snare kit), not an AI device or software. Therefore, the questions related to AI device performance, such as sample size for test/training sets, experts for ground truth, MRMC studies, standalone algorithm performance, and training set ground truth establishment, are not applicable to this submission.

The document discusses non-clinical performance tests conducted to demonstrate substantial equivalence to predicate devices. These tests are focused on the physical and material properties of the snare kit.

Here's an analysis based on the provided text, focusing on what is available:

Acceptance Criteria and Reported Device Performance (Non-Clinical):

The document states that "A series of testing was conducted in accordance with protocols based on requirements outlined in guidances and industry standards and the below were shown to meet the acceptance criteria that were determined to demonstrate substantial equivalence."

While specific numerical acceptance criteria and exact performance results are not provided in a table format, the document lists the types of tests performed and indicates that the device met the acceptance criteria for each.

Regarding the AI-specific questions:

The questions provided pertain to the evaluation of an Artificial Intelligence/Machine Learning (AI/ML) powered medical device. The document describes a Halo™ Single-Loop Snare Kit, which is a physical device used for retrieving and manipulating foreign objects in the cardiovascular system or hollow viscous. This is a traditional medical device, not an AI/ML software or algorithm.

Therefore, the following questions are not applicable to this specific FDA submission:

2. Sample sized used for the test set and the data provenance: Not applicable. This is for a physical device, not an AI model.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI model is not relevant here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication of expert annotations is for AI model ground truth.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. MRMC studies are for evaluating AI's impact on human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. Ground truth for an AI model is not relevant here.
8. The sample size for the training set: Not applicable. There is no AI model to train.
9. How the ground truth for the training set was established: Not applicable. There is no AI model to train.

In summary, the provided FDA document is for a traditional physical medical device, not an AI-powered one, hence most of the detailed questions regarding AI study methodology are not relevant to this specific submission. The performance assessment relied on non-clinical (bench and material) testing to demonstrate substantial equivalence.

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The ONE Snare endovascular snare system is intended for use in the coronary and peripheral vascular system or hollow viscous to retneve and manipulate foreign objects. Retrieval and manipulation procedures include indivelling venous catheter repositioning, indwelling venous catheter fibrin sheath stripping, and central venous access veripouncture procedure assistance.

The ONE Snare Endovascular Snare System is a snare system that is designed for use in the coronary and peripheral vascular system or hollow viscous to retrieve and manipulate foreign objects. The One Snare wire consists of a Nitinol core with a ground tapered distal section, a formed nitinol cable covered with a gold-plated tungsten coil. The formed cable with coil is attached to the core wire and then covered with a PTFE polymer sleeve. The wires are packaged with an introducer, torque device and guiding catheter – this makes up the “One Snare Endovascular Snare System”.

The provided text describes the regulatory clearance for the ONE Snare™ endovascular snare system (K193507) and references its substantial equivalence to a predicate device (K122088). However, it does not contain information about a study that proves the device meets acceptance criteria in the context of an Artificial Intelligence (AI) or machine learning product.

The document details the physical characteristics and performance testing of a medical device (an endovascular snare system), focused on demonstrating its mechanical and functional equivalence to a previously cleared device. The "acceptance criteria" and "device performance" described are related to physical specifications and mechanical testing, not algorithm performance.

Therefore, many of the requested items (e.g., sample size for test/training sets, data provenance, ground truth establishment, expert adjudication, MRMC studies, standalone algorithm performance) are not applicable to the information provided.

Here's the relevant information that can be extracted, interpreted within the context of a physical medical device:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists several performance attributes that were tested. The general statement is that "All test results were comparable to the predicate devices and the subject One Snare Endovascular Snare System met the predetermined acceptance criteria." Specific, quantitative acceptance criteria are not explicitly detailed in the provided text.

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

This information is not provided as the tests are for physical device performance, not AI/ML model performance on data. The tests performed are listed as:

• Snare Size Designation
• Catheter Size Designation
• Catheter Surface Inspection
• Catheter OD Inspection
• Catheter Tip Length of Angle
• Catheter Angle
• Catheter Tip ID Inspection
• Simulated Use (design validation)

The provenance of this testing data (e.g., country of origin, retrospective/prospective) is not specified.

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

This information is not applicable as the tests relate to the physical properties and simulated performance of a medical device, not to the interpretation of medical images or data requiring expert-established ground truth.

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

This information is not applicable for the reasons stated in item 3.

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

An MRMC comparative effectiveness study is not applicable as this is not an AI/ML device for diagnostic or assistive interpretation.

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

This information is not applicable as this is a physical medical device, not an algorithm.

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

For the physical tests conducted (e.g., Catheter OD Inspection, Catheter Angle), the "ground truth" would be the engineering specifications and tolerances of the device. This is inherent to the manufacturing and design process and not explicitly detailed in terms of "expert consensus," "pathology," or "outcomes data."

8. The sample size for the training set

This information is not applicable as this is not an AI/ML device.

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

This information is not applicable as this is not an AI/ML device.

In summary, the provided document describes a 510(k) clearance for a physical medical device and its performance testing to demonstrate substantial equivalence, not an AI/ML product's validation study. Therefore, most of the requested information related to AI/ML evaluation criteria is not present.

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