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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 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 EN Snare® Endovascular Snare System is intended for use in the coronary and peripheral vascular system or hollow viscous to retrieve and manipulate foreign objects. Retrieval and manipulation procedures include, indwelling venous catheter repositioning, indwelling venous catheter fibrin sheath stripping, and central venous access veupuncture procedure assistance.

The EN Snare Endovascular Snare System consists of four individual components: snare: catheter: insertion tool and torque device. Systems are available in various sizes and lengths. The snare is comprised of 3 interlaced stranded cables of platinum and super-elastic nitinol that form 3 loops and are mechanically secured with a crimp collar to a nitinol shaft wire. The superelastic nitinol construction enables the loops of the snare to be introduced through a catheter without the risk of deformation. The catheter is manufactured with a Pebax outer layer and a PTFE inner layer with an embedded iridium/platinum markerband at the distal end, a Pebax hub and a polycarbonate luer. A snare insertion tool is also included for optional back-end loading of the snare into a preplaced catheter. The snare insertion tool is manufactured from polypropylene. The snare is inserted into an intravascular catheter and manipulated by use of an external torque device. The snare is offered in sizes ranging from 2mm to 45mm, with catheter sizes of 3.2F, 6F, and 7F.

The provided document is a 510(k) Premarket Notification from the FDA for a medical device called the "EN Snare Endovascular Snare System." It focuses on demonstrating substantial equivalence to a predicate device through various performance and safety tests.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that a "battery of testing was conducted in accordance with protocols based on requirements outlined in guidance's and industry standards and these were shown to meet the acceptance criteria that were determined to demonstrate substantial equivalence." However, it does not explicitly list specific numerical acceptance criteria for each test. Instead, it lists the types of tests performed and concludes that the device "met the acceptance criteria applicable to the safety and effectiveness of the device."

Therefore, a table cannot be constructed with specific numerical acceptance criteria. The performance is reported as meeting these (unspecified in detail) criteria.

Note: For medical devices, acceptance criteria are typically well-defined in the test protocols, but these are often considered proprietary and not included in publicly available 510(k) summaries beyond broad statements of compliance.

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

The document does not explicitly state the sample sizes used for each specific test (e.g., number of devices tested for kink resistance). It reports a "battery of testing" was conducted.

Moreso, this is a premarket notification for a medical device (EN Snare Endovascular Snare System), and the studies described are engineering and bench testing rather than clinical trials with human subject data. Therefore, concepts like "country of origin of the data" (for human subjects) or "retrospective or prospective" do not directly apply in the typical sense. The data provenance would be from laboratory and bench testing environments, likely performed at the manufacturer's (Merit Medical Systems, Inc.) facilities or certified testing labs.

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

This question is not applicable to the type of studies described. The "ground truth" for these engineering and biocompatibility tests is established by objective measurements against predefined engineering specifications, international standards (e.g., ISO, ASTM), and regulatory guidance documents, not by expert human consensus (like in diagnostic AI studies). The "experts" involved would be engineers, material scientists, and microbiologists who design and execute the tests and interpret the results against those standards.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where human readers are making subjective diagnoses or assessments which then need to be reconciled. For device performance testing, the results are objective measurements from instruments or standardized observations which either meet or fail the specified acceptance criteria.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of diagnostic algorithms, often in comparison to human readers, and involves multiple human readers assessing medical cases.

The document describes pre-market testing for a physical medical device (an endovascular snare system), focusing on its mechanical, material, and biological safety characteristics, not its diagnostic or interpretative capabilities.

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

This is not applicable. The device described, the "EN Snare Endovascular Snare System," is a physical medical instrument used for retrieving foreign objects and manipulating catheters. It is not an algorithm, software, or AI system requiring standalone performance evaluation in that context.

7. The Type of Ground Truth Used

The "ground truth" for the tests performed on the EN Snare Endovascular Snare System is constituted by:

• Engineering Specifications: Explicit design requirements and performance parameters set by the manufacturer.
• International Standards: Compliance with relevant ISO (e.g., ISO 10555-1, ISO 594-1/2, ISO 11135, ISO 10993-1, ISO 2233) and ASTM (e.g., ASTM F1980-07) standards.
• FDA Guidance: Adherence to FDA guidance documents (e.g., Coronary and Cerebrovascular Guide Wire Guidance, FDA Modified ISO 10993 Test Profile FDA Memo G95-1).

The tests confirm that the device physically functions as intended, is safe in terms of materials and interactions with the body, and meets required structural integrity, rather than confirming a medical diagnosis.

8. The Sample Size for the Training Set

This question is not applicable. The studies described are physical performance, material, and biocompatibility tests for a medical device. There is no "training set" in the context of machine learning or AI algorithms. The device's design and manufacturing processes are informed by engineering principles, material science, and regulatory requirements, not by training data in the AI sense.

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

This question is not applicable, as there is no "training set" for physical device testing in the context of AI. The "ground truth" for the device's design and manufacturing relies on established scientific and engineering principles, verified material properties, and adherence to quality control standards, rather than a labeled dataset.

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The ONE Snare Endovascular Microspare System is intended for use in adult and pediations for the retrieval and manipulation of atraumatic foreign bodies located in the coronary and peripheral cardiovascular system and the extracranial anatomy.

ONE Snare Endovascular Microsnare System contains: (1) Snare, (1) Snare Catheter, (1) Insertion Tool and (1) Torque Device. The snare is constructed of nitinol cable and a gold plated tungsten loop. The pre-formed snare loop can be introduced through catheters without risk of snare deformation because of the snare's super-elastic construction. The snare catheter is constructed of polyether block amide (Pebax®) and contains a platinum/iridium radiopaque marker band.

The provided text describes the 510(k) premarket notification for the ONE Snare Endovascular Microsnare System. However, it does not explicitly define acceptance criteria or specific study results in the format requested. The document primarily lists performance attributes that were tested to demonstrate substantial equivalence to predicate devices, rather than providing quantitative acceptance criteria and corresponding detailed device performance data.

Based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table with specific numerical or quantitative acceptance criteria and corresponding performance metrics for the ONE Snare Endovascular Microsnare System. Instead, it lists a comprehensive set of tests performed and states that these tests were "successfully completed" or "designed to demonstrate that the device meets critical design specifications as well as clinical performance attributes for its intended use."

The identified performance attributes tested include (but are not limited to):

The document implies that the device "meets critical design specifications as well as clinical performance attributes for its intended use" by successfully completing these tests, but the specific numerical "acceptance criteria" and "reported device performance" are not detailed.

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

The document does not specify the sample size used for any of the tests conducted. It also does not provide information on data provenance (e.g., country of origin, retrospective or prospective) as the studies appear to be bench and laboratory-based performance tests rather than clinical studies with patient data.

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

This information is not applicable as the studies described are in vitro or bench tests, not clinical studies requiring expert interpretation of medical images or patient outcomes for ground truth establishment.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as #3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No MRMC comparative effectiveness study is mentioned in the provided text. The studies focus on the device's physical and functional performance and biocompatibility.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable as the device is a physical medical instrument (an endovascular microsnare system), not an algorithm or AI software. There is no "algorithm only" performance to evaluate.

7. The Type of Ground Truth Used

For the performance tests described (e.g., tensile strength, corrosion resistance, biocompatibility), the "ground truth" would be objective measurements and established standards (e.g., ISO, ASTM, FDA guidance documents). The tests were designed to demonstrate adherence to critical engineering specifications and regulatory requirements.

8. The Sample Size for the Training Set

This is not applicable as the device is a physical medical device, not an AI model requiring a training set.

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

This is not applicable for the same reasons as #8.

Summary of Study Type:

The studies described are a series of bench testing, laboratory testing, and biocompatibility assessments to demonstrate the physical, chemical, and functional performance of the ONE Snare Endovascular Microsnare System. The purpose of these tests was to establish substantial equivalence to predicate devices under the 510(k) pathway, not to evaluate clinical efficacy or diagnostic accuracy using patient data or expert adjudicated ground truth. The acceptance of the device is based on its ability to perform robustly under various conditions and meet recognized standards (e.g., ISO, ASTM) and design specifications.

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