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The Reprocessed VersaCross Steerable Sheath is introducing various cardiovascular catheters to the heart, including the left side of the heart through the interatrial septum.

The Reprocessed SureFlex Steerable Guiding Sheath is introducing various cardiovascular catheters to the heart, including the left side of the heart through the interatrial septum.

The Reprocessed VersaCross Steerable Sheath consists of three components; a Reprocessed VersaCross Steerable Sheath, a Reprocessed VersaCross Transseptal Dilator, and a 0.035" J-tipped mechanical quidewire.

The Reprocessed VersaCross Steerable Sheath is designed for safe and easy catheterization and angiography of specific heart chambers and locations. The sheath provides superior torque control and is flexible. The Reprocessed VersaCross Transseptal Dilator provides support for the sheath, features a tapered tip and a shaft that can be reshaped manually. Radiopaque tips maximize visualization of the sheath the dilator during manipulation.

The J-tipped Guidewire, hereafter referred to as the "guidewire", comprises a stainlesssteel core with a flexible, spiral shaped PTFE coated steel coil along the full length of the device. The guidewire is coated in its entirety with a hydrophobic lubricious coating for smoother device manipulation. No pre-conditioning is required for this coating.

The Reprocessed SureFlex Steerable Guiding Sheath consists of three components: a reprocessed sheath, a reprocessed dilator and a J-tipped Mechanical Guidewire.

The Reprocessed SureFlex Steerable Sheath is designed for safe and easy catheterization and angiography of specific heart chambers and locations. The sheath provides superior torque control and is flexible. The radiopaque tip maximizes visualization of the sheath during manipulation. The dilator provides support for the sheath and has a tapered tip.

The J-tipped Guidewire, hereafter referred to as the "guidewire", comprises a stainlesssteel core with a flexible, spiral shaped PTFE coated steel coil along the full length of the device. The guidewire is coated in its entirety with a hydrophobic lubricious coating for smoother device manipulation. No pre-conditioning is required for this coating.

Note: Only the steerable sheaths and dilator are subject of this submission. The guidewires are purchased off-the shelf and packaged with the reprocessed devices.

The provided text is a 510(k) summary for the reprocessing of medical devices, specifically VersaCross Steerable Sheaths and SureFlex Steerable Guiding Sheaths. It describes the regulatory review process and confirms that the reprocessed devices are substantially equivalent to their predicate devices.

However, the document does not describe a study that proves a device meets acceptance criteria using an AI/algorithm-driven component. The entire document discusses the reprocessing of physical medical devices and their functional and safety testing to establish substantial equivalence, not the performance of an AI or software-based device.

Therefore, I cannot extract the information required to answer your prompt questions about acceptance criteria for an AI device, sample sizes for test sets, establishment of ground truth by experts, MRMC studies, or training sets, because this information is not present in the provided text.

The closest relevant information relates to functional and safety testing of the reprocessed physical medical devices, which is presented as:

Functional and Safety Testing (of physical reprocessed catheters):

Bench and laboratory testing evaluated substantial equivalence to the predicate devices. This included the following:

• Biocompatibility
• Cleaning Validation
• Sterilization Validation
• Functional Testing
  • Visual Inspection
  • Dimensional Inspection
  • Tip Deflection
  • Tip Buckling
  • Valve/Joint leak
  • Radiopacity
  • Simulated Use
  • Torque Testing
  • Tensile Testing
  • Corrosion Testing
• Packaging Validation

This list represents the acceptance criteria (or areas of testing) for the reprocessed physical device, not an AI or software device. The document does not provide specific numerical performance metrics for these tests, nor does it detail sample sizes, expert involvement, or adjudication methods for these physical device tests in the way your prompt requests for an AI study.

In summary, the provided text does not contain any information about an AI/algorithm-driven device or a study related to its performance against acceptance criteria.

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The Reprocessed Agilis NxT Introducer is indicated when introducing various cardiovascular catheters into the heart including the left side of the heart through the interatrial septum.

The reprocessed Agilis NxT steerable introducer consists of a steerable sheath, dilator, and quidewire which is designed to provide flexible catheter positioning in the cardiac anatomy. The steerable introducer is fitted with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A sideport with three-way stopcock is provided for air or blood aspiration, fluid infusion, blood sampling and pressure monitoring. The handle is equipped with a rotating collar to deflect the tip clockwise ≥ 180° and counterclockwise ≥ 90°. The steerable introducer features distal vent holes to facilitate aspiration and minimize cavitation and a radiopaque tip marker to improve fluoroscopic visualization.

The provided text is a 510(k) premarket notification for a Reprocessed Agilis NxT Steerable Introducer. This document is for a medical device that facilitates the introduction of catheters into the heart. It is not an AI/ML medical device, and therefore the provided document does not contain information on acceptance criteria for AI models, nor studies that prove an AI device meets acceptance criteria.

The information requested in the prompt (acceptance criteria for device performance, sample sizes for test/training sets, expert qualifications, ground truth establishment, MRMC studies, etc.) is typically found in submissions for AI/ML-driven medical devices, especially those related to diagnostic imaging or analysis.

Since this document pertains to a reprocessed physical medical device (a catheter introducer), the "studies" mentioned are bench and laboratory testing to prove the device's physical and mechanical performance, biocompatibility, cleaning validation, sterilization validation, and packaging validation. These are standard tests for physical medical devices, not for AI model performance.

Therefore, I cannot extract the requested information from the provided text because it describes a different type of medical device assessment.

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The Reprocessed Carto Vizigo Bi-Directional Guiding Sheath is indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.

The sheath curve can be visualized when used with compatible Carto 3 EP Navigation Systems.

The Reprocessed Carto Vizigo Bi-Directional Guiding Sheath is designed to provide accessibility and maneuverability in the cardiac anatomy. The steerable sheath is fitted with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A sideport with three-way stopcock is provided for air or blood aspiration, and fluid infusion. A handle equipped with a rotating collar to deflect the tip clockwise ≤ 180° and counterclockwise ≤ 180°. The steerable sheath features distal vent holes to facilitate aspiration and minimize cavitation and a radiopaque tip marker to allow fluoroscopic visualization.

This document describes the FDA's 510(k) clearance for the Reprocessed Carto Vizigo 8.5F Bi-Directional Guiding Sheath (K212165). This is a reprocessed medical device, and the submission focuses on demonstrating that the reprocessed device is substantially equivalent to the original predicate device.

The provided text does not contain information related to a study involving AI, machine learning, or complex algorithms. The device is a physical medical instrument (a guiding sheath used in cardiac procedures). Therefore, many of the requested criteria, such as "Sample size used for the test set and the data provenance," "Number of experts used to establish the ground truth for the test set," "Adjudication method," "Multi-reader multi-case (MRMC) comparative effectiveness study," "Stand-alone (algorithm only) performance," "Type of ground truth," "Sample size for the training set," and "How ground truth for the training set was established" are not applicable to this type of device and submission.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" for a reprocessed device like this primarily revolve around demonstrating that the reprocessed device is as safe and effective as the original, single-use device. This is typically shown through functional, material, and safety testing (e.g., sterilization, biocompatibility, mechanical integrity).

Here's an interpretation of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't provide a specific table with numerical acceptance criteria and direct performance metrics in the way one might expect for an AI algorithm (e.g., sensitivity, specificity). Instead, substantial equivalence for a reprocessed device is shown by demonstrating that the reprocessed device meets the same performance characteristics as the predicate device.

Overall Conclusion: Innovative Health concludes that the Reprocessed Carto Vizigo Bi-Directional Guiding Sheath is substantially equivalent to the predicate devices described herein, implying all functional and safety tests were met.

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

Not Applicable for this type of device. The testing performed is physical/bench testing on representative reprocessed devices, not a test set of data like in AI/ML studies. The "provenance" would be the manufactured/reprocessed devices themselves, subject to the testing protocols.

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 this context is established through validated physical, chemical, and electrical testing methods and standards, performed by qualified laboratory personnel, not by medical experts making diagnoses.

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

Not Applicable. This is a physical device re-processing submission, not an AI/ML diagnostic system requiring expert adjudication of results.

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

Not Applicable. This is not an AI-assisted device.

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

Not Applicable. This is not an algorithmic device.

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

For this device, "ground truth" is fundamentally defined by meeting established engineering specifications, safety standards (e.g., ISO, ASTM), and clinical performance criteria for physical devices. This is verified through:

• Biocompatibility testing: Conformance to standards like ISO 10993.
• Cleaning validation: Demonstrated removal of biological soil to predefined levels.
• Sterilization validation: Demonstrated sterility assurance level (SAL).
• Functional and Mechanical testing: Meeting pre-defined specifications for dimensions, leak integrity, steerability, electrical safety, etc., often benchmarked against the original predicate device's performance.

8. The sample size for the training set

Not Applicable. This is not an AI/ML device that requires a training set. The "training" in manufacturing comes from established and validated reprocessing procedures.

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

Not Applicable. As there is no training set for an AI/ML algorithm, this question is irrelevant. For a reprocessed device, established procedures and performance specifications for the predicate device guide the reprocessing "training" and validation.

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The Reprocessed Agilis NxT Steerable Introducing various cardiovascular cardiovascular catheters into the heart including the left side of the heart through the interatrial septum.

The reprocessed Agilis NxT steerable introducer consists of a steerable sheath, dilator, and guidewire which is designed to provide flexible catheter positioning in the cardiac anatomy. The steerable introducer is fitted with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A sideport with three-way stopcock is provided for air or blood aspiration, fluid infusion, blood sampling and pressure monitoring. The handle is equipped with a rotating collar to deflect the tip clockwise ≥ 180° and counterclockwise ≥ 90°. The steerable introducer features distal vent holes to facilitate aspiration and minimize cavitation and a radiopaque tip marker to improve fluoroscopic visualization.

The provided document is a 510(k) summary for a reprocessed medical device, specifically the Reprocessed Agilis NxT Steerable Introducer. The focus of the acceptance criteria and study is on demonstrating that the reprocessed device is substantially equivalent to the predicate (original) device, meaning it is as safe and effective.

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

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

The document describes several types of testing performed to demonstrate that the reprocessed device is equivalent to the original, but it does not provide a table with specific quantitative acceptance criteria or reported numerical performance data for the reprocessed device. Instead, it lists the categories of tests conducted.

The general acceptance criterion is that the reprocessed device must perform equivalently to the predicate and meet established safety and effectiveness standards for reprocessed medical devices.

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

The document does not specify the sample sizes used for any of the described tests. It also does not mention the country of origin of the data or whether the studies were retrospective or prospective. The studies described are bench and laboratory tests, not clinical studies involving patients.

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 type of information is not applicable to this submission. The studies described are physical, mechanical, and sterilization validations, which rely on established engineering and scientific testing methodologies and standards rather than expert clinical interpretation for establishing ground truth. There is no mention of human experts evaluating the "ground truth" in the context of diagnostic interpretation.

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

This detail is not applicable to the type of bench and laboratory testing described. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for diagnostic accuracy, where multiple readers evaluate cases and discrepancies are resolved.

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

There was no Multi-Reader Multi-Case (MRMC) comparative effectiveness study done. This submission is for a reprocessed physical medical device (a steerable introducer), not an AI/imaging diagnostic device. Therefore, questions about human readers or AI assistance are not relevant.

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

This question is not applicable. The device is a physical medical instrument, not an algorithm, so the concept of "standalone algorithm performance" does not apply.

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

For the types of tests performed:

• Biocompatibility, Cleaning, Sterilization: The ground truth is established through adherence to recognized standards and validated scientific methods for assessing these parameters (e.g., ISO standards for biocompatibility, validated cleaning protocols, sterilization cycle validation to achieve sterility assurance levels).
• Physical and Mechanical Testing: The ground truth is established by comparing the reprocessed device's performance against the original equipment manufacturer's specifications for the predicate device, or relevant industry standards. This includes objective measurements of dimensions, tensile strength, deflection, leak integrity, and radiopacity.
• Simulated Use: The ground truth is success in performing the intended function without failure or compromise in a simulated environment, based on pre-defined performance metrics.

8. The sample size for the training set

This question is not applicable. The device is a physical medical instrument, not a machine learning or AI model. Therefore, there is no "training set" in the context of algorithm development.

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

This question is not applicable as there is no training set for this type of device submission.

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The reprocessed steerable introducer devices are indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.

The reprocessed steerable introducer consists of a steerable sheath and plastic dilator, which is indicated for introducing various cardiovascular catheters including the left side of the heart through the interatrial septum. The device is always delivered over a guidewire. The steerable introducer device enters through the right femoral vein and is guided into the right atrium of the heart. A knob on the introducer handle dictates the amount and direction of curl at the distal tip of the sheath. The shaft of the introducer is filled with radiopaque material so the device can be seen using fluoroscopy. A guidewire pokes through the septum into the left atrium and a tapered dilator enlarges the hole. The dilator is then removed allowing the introduction of a catheter.

The device is an 8.5F asymmetrical bi-directional steerable introducer with a varying amount of curl (small, medium or large) at the distal tip and a useable length of 61 or 71 cm. The proximal end of the device sheath is fitted with a hemostasis valve to minimize blood loss during catheter insertion and/or exchange over a guidewire. A side port with three-way stopcock is provided for air or blood aspiration, fluid infusion, blood sampling, and pressure monitoring. A handle is equipped with a rotating collar to deflect the large curl 90 degrees in the counterclockwise direction and 180 degrees in the clockwise direction. The sheath is filled with radiopaque material for visualization under fluoroscopy.

The provided document is a 510(k) premarket notification letter from the FDA to Sterilmed, Inc. for a Reprocessed Steerable Introducer. This document is not a study report that includes details about acceptance criteria and device performance in the context of an AI/ML medical device.

The content focuses on demonstrating substantial equivalence of the reprocessed device to legally marketed predicate devices, rather than on the performance of a novel AI/ML algorithm. Therefore, many of the requested details about acceptance criteria, study design, expert ground truth, and AI performance metrics are not applicable to this document.

However, I can extract the information that is relevant to the device's functional and safety performance, as established for its substantial equivalence claim, even though it doesn't involve AI.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document outlines performance testing intended to show that the reprocessed device performs similarly to the new predicate device. While specific numerical acceptance criteria values are not explicitly listed in the submission summary, the intent is that the reprocessed device meets the functional and safety standards expected of the original, new device.

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

• Test Set Sample Size: The document does not specify the exact sample size for each performance test. It mentions that "the device was tested" and "functional testing has shown."
• Data Provenance: The testing was conducted by Sterilmed, Inc. as part of their premarket notification submission to the FDA. The nature of this document suggests the data is prospective for the reprocessed device, generated specifically for this submission to demonstrate substantial equivalence. The country of origin of the data is implied to be the USA (Plymouth, MN, where Sterilmed is located).

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 this submission relates to a reprocessed medical device and its physical/functional characteristics, not an AI/ML algorithm requiring expert ground truth for classification or prediction. The "ground truth" here is the performance of the new, predicate device and established engineering/biocompatibility standards.

4. Adjudication method for the test set:

• Not applicable. There is no expert adjudication process described, as the evaluation is based on objective measurements against engineering specifications and regulatory standards for device performance.

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 document is about a physical medical device (steerable introducer), not an AI/ML system. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed or described.

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

• Not applicable. This document is about a physical medical device, not an AI/ML algorithm.

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

• The "ground truth" for the reprocessed device is its ability to meet the established performance specifications and safety profiles of the original, new predicate devices (St. Jude Agilis™ NxT Steerable Introducers, K061363 and K081645), as well as relevant international standards (e.g., ISO 10993-1 for biocompatibility) and regulatory requirements. This is an engineering and materials science-based ground truth, not an expert consensus or pathology-based one.

8. The sample size for the training set:

• Not applicable. This document is about a reprocessed physical device, not an AI/ML system that utilizes a training set.

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

• Not applicable. As there is no AI/ML training set, the concept of establishing ground truth for it does not apply.

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