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The VersaCross Connect Transseptal Dilator is indicated for use in procedures where access to the left atrium via the transseptal technique is desired.

The subject VersaCross Connect™ Transseptal Dilator (VXA-AG) is a single-use device that is supplied sterile to the user.

The subject VersaCross Connect™ Transseptal Dilator (VXA-AG) represents modifications to the legally marketed VersaCross Connect™ Transseptal Dilator (K241720).

The VersaCross Connect™ Transseptal Dilator (VXA-AG) is designed for safe and easy catheterization and angiography of specific heart chambers and locations. The dilator provides torque control and is flexible. The dilator features a tapered tip and a shaft that can be reshaped manually. The echogenic shaft and tip and radiopaque tip maximize visualization of the dilator during manipulation in procedures.

The dilator can be used with separately cleared compatible access sheaths such as Agilis™ NxT Steerable Introducer (K061363 or K081645). The dilator provides support and helps guide separately cleared compatible transseptal wires to the atrial septum for puncture. The dilator subsequently dilates the atrial septal defect to enable larger diameter devices to cross the septum. The subject device can be used by electrophysiologists, interventional cardiologists, and other users trained in catheter techniques for any procedure that requires left atrial access via transseptal puncture. Procedures using the devices are performed in fully equipped catheter labs with imaging equipment, including fluoroscopy and echocardiography under sterile technique.

The provided FDA 510(k) Clearance Letter for the VersaCross Connect™ Transseptal Dilator does not contain information related to an AI/ML-driven medical device. The clearance is for a physical medical device (a vessel dilator) which has undergone design modifications.

Therefore, the requested information regarding acceptance criteria and studies proving the device meets those criteria, specifically concerning AI/ML performance, human reader improvement with AI assistance, standalone algorithm performance, and ground truth establishment for training and test sets, is not applicable to this document.

The document details the following for the physical device:

• Device: VersaCross Connect™ Transseptal Dilator
• Purpose: Used for procedures requiring access to the left atrium via the transseptal technique.
• Modifications: Design changes (hub color, dilator shaft dimensions, snap fit hub geometry, hub length) and non-patient contacting material changes from its predicate device (K241720).
• Verification and Validation Activities: These focused on the physical and material properties of the dilator, ensuring it meets performance, safety, and biocompatibility standards. Examples include:
  • Torque Transmission, Dilator Protrusion Length, Shaft Outer Diameter, Flexural Rigidity, etc.
  • Biocompatibility, Sterilization, Pyrogen testing, Packaging integrity.
  • Benchtop validation to confirm performance during normal intended use.
• Substantial Equivalence: The submission demonstrates that the modified device is substantially equivalent to its predicate, sharing the same intended use, indications for use, fundamental scientific technology, operating principles, and mechanism of action. The changes do not raise new questions of safety or effectiveness.

In summary, there is no AI/ML component described or evaluated in this 510(k) clearance document, and thus, no information is available to address the specific questions about AI/ML acceptance criteria and performance studies.

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The Merit Micro Ace™ Gold Advanced Micro Access System is intended for percutaneous placement of a 0.035" (0.89mm) or 0.038" (0.97mm) guidewire into the vascular system.

The Merit Micro Ace™ Gold Advanced Micro Access System (hereafter referred to as Micro Ace™ Gold) provides access to the vascular system and facilitates the placement of a 0.035" (0.89mm) or 0.038" (0.97mm) guide wires. The system is available in 4 French and 5 French sizes – and includes the coaxial introducer-dilator pair, a 21 gauge needle and a 0.018” (0.46mm) guide wire.

The introducer-dilator assembly that is included in each kit is 10 cm effective length. The system will be offered with optional guidewires: Some catalog codes will include a nitinol wire with platinum guidewire tips; Some catalog codes will be offered with a stainless steel wire with platinum guidewire tips.

The provided text is a 510(k) summary for the Merit Micro Ace™ Gold Advanced Micro Access System. It describes the device, its intended use, comparison to a predicate device, and the safety and performance testing conducted.

However, this document does not describe a study proving a device meets acceptance criteria related to an AI/Software as a Medical Device (SaMD) product. Instead, it pertains to a physical medical device (vessel dilator for percutaneous catheterization) and describes the verification and validation tests for its physical characteristics and biocompatibility.

Therefore, many of the requested items, such as "effect size of how much human readers improve with AI vs without AI assistance," "standalone (i.e. algorithm only without human-in-the-loop performance)," "number of experts used to establish ground truth," and "sample size for training set," are not applicable to this type of device and review.

The document focuses on demonstrating substantial equivalence to a predicate device through physical and material property testing, rather than performance of an AI algorithm based on data analysis.

Given this, I will answer the applicable questions based on the provided text, and explicitly state when a question is not applicable.

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

The document lists "Design Verification Studies" and "Design Validation Studies" as evidence that the device meets "pre-established performance criteria" and addresses "unacceptable risks." The acceptance criteria are implicitly the successful completion of these tests as per relevant international standards.

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

The document broadly states: "All tested samples met pre-established performance criteria and were deemed acceptable." It does not provide a quantitative table of specific acceptance criteria values and the measured performance results for each test. Instead, it lists the types of tests performed.

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

• Sample Size: The document states that "The tests were performed on both 4F and 5F Micro Ace™ Gold products." It also mentions "All samples were manufactured in accordance with existing and validated processes, and when sterile, are representative of product that Merit Medical intends to commercialize." It does not specify the exact number of samples per test for the test set.
• Data Provenance: The data provenance is from internal testing conducted by Merit Medical Systems, Inc. The document does not specify country of origin for the data (beyond the company's location in South Jordan, Utah, USA), nor does it classify the study as retrospective or prospective in the context of clinical data, as this is a device verification/validation study.

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

• Not Applicable in the context of AI/SaMD ground truth establishment.
• For the "Clinician feedback following assessment of design changes" in the Design Validation Studies, the specific number and qualifications of clinicians are not provided. This feedback typically informs the practical usability and design, rather than establishing a 'ground truth' for an AI algorithm.

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

• Not Applicable. This concept is relevant for reconciling discrepancies in expert annotations for AI ground truth, which is not what this document describes.

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. This type of study is for evaluating the impact of AI on human reader performance, and is not applicable to a physical vessel dilator device.

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

• No. This applies to AI/SaMD performance, which is not the subject of this submission.

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

• Not Applicable in the sense of 'ground truth' for AI performance. The "ground truth" for this device's performance is defined by its compliance with engineering specifications, industry standards (ISO 10555-1, EN ISO 11070 2014/A1:2018, ISO 10993-1, ISO 14971), and successful completion of pre-established physical, mechanical, and biocompatibility criteria.

8. The sample size for the training set:

• Not Applicable. This document describes a physical medical device, not an AI algorithm requiring a training set.

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

• Not Applicable. As above, this document does not describe an AI algorithm or its training set.

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The VersaCross Connect™ Transseptal Dilator is indicated for use in procedures where access to the left atrium via the transseptal technique is desired.

The subject VersaCross Connect™ Transseptal Dilator is a single-use device that is supplied sterile to the user. The subject VersaCross Connect™ Transseptal Dilator represents modifications made to the dilator component of the legally marketed VersaCross Connect™ Transseptal Dilator (K220414) (comprising of a dilator and J-tipped guidewire). A guidewire is not supplied with the subject device. However, the end user can use a separately cleared compatible 0.035″ quidewire. The VersaCross Connect™ Transseptal Dilator is designed for safe and easy catheterization and angiography of specific heart chambers and locations. The dilator provides torque control and is flexible. The dilator features a tapered tip and a shaft that can be reshaped manually. The echogenic shaft and tip and radiopaque tip maximize visualization of the dilator during manipulation in procedures. The dilator can be used with separately cleared compatible access sheaths such as CARTO VIZIGO™ Bi-Directional Guiding Sheath (K231412). The dilator provides support and helps guide separately cleared compatible transseptal wires to the atrial septum for puncture. The dilator subsequently dilates the atrial septal defect to enable larger diameter devices to cross the septum.

The provided document is an FDA 510(k) clearance letter for the VersaCross Connect™ Transseptal Dilator. It primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing.

Crucially, this document does not describe a study involving "acceptance criteria" for an AI/ML powered device, nor does it detail a study proving such a device meets these criteria.

The device in question, the VersaCross Connect™ Transseptal Dilator, is a mechanical medical device (a vessel dilator), not an AI/ML-powered one. The testing described is typical for a mechanical device and includes:

• Mechanical Testing: Torque Transmission, Torque Withstand, Flexural Rigidity, Shapeability, Curve Retention, Hub-Shaft Tensile, Tip to Tip Cap Cantilever and Tensile, Clamshell Tensile, Clamshell Cantilever.
• General Physical Testing: Luer Tests, Air and Liquid Leakage Tests, Corrosion Test.
• System Verification Testing: Compatibility Test, Snap Force Test.
• Biocompatibility Verification: Evaluated through adopted biological data of the predicate device (K220414).
• Sterilization Verification: Ethylene Oxide sterilization to a SAL of 10-6.
• Pyrogen Testing: Limulus Amoebocyte Lysate (LAL) testing.
• Packaging Verification: Ship testing and sterile barrier integrity.
• Benchtop Validation: To validate performance during normal intended use.

Therefore, I cannot extract the information required to populate the requested table and answer the questions about AI/ML device acceptance criteria and study details from the provided text.

The document states: "The proposed VersaCross Connect™ Transseptal Dilator met all test requirements as specified by applicable standards and test protocols. The verification and validation activities for safety and effectiveness, along with the testing completed for the design changes demonstrated the subject device meets its intended use and is as safe, as effective, and performs in a manner that is substantially equivalent to the predicate device." This is the general statement of compliance, but it does not provide specific acceptance criteria values or performance metrics in a tabulated format that would be relevant for an AI/ML device.

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The VersaCross Connect™ Transseptal Dilator is indicated for use in procedures where access to the left atrium via the transseptal technique is desired.

The subject VersaCross Connect™ Transseptal Dilator is a single-use device that is supplied sterile to the user. The device is comprised of a single dilator.

The subject VersaCross Connect™ Transseptal Dilator represents modifications made to the dilator component of the legally marketed VersaCross Connect™ Transseptal Dilator (K220414) (comprising of a dilator and J-tipped guidewire). A quidewire is not supplied with the subject device. However, the end user can use a separately cleared compatible 0.035″ quidewire.

The VersaCross Connect™ Transseptal Dilator is designed for safe and easy catheterization and angiography of specific heart chambers and locations. The dilator provides torque control and is flexible. The dilator features a tapered tip and a shaft that can be reshaped manually. The echogenic shaft and tip and radiopaque tip maximize visualization of the dilator during manipulation in procedures.

The dilator can be used with separately cleared compatible access sheaths such as FARADRIVE™ Steerable sheaths. The dilator may also be used as a standalone device to facilitate access to the left atrium following transseptal puncture. The dilator provides support and helps quide separately cleared compatible transseptal wires to the atrial septum for puncture. The dilator subsequently dilates the atrial septal defect to enable larger diameter devices to cross the septum.

This document describes the premarket notification (K233647) for the VersaCross Connect™ Transseptal Dilator. It is an updated version of a previously cleared device (K220414), with modifications primarily in dimensions and design for compatibility and the absence of a supplied guidewire. The FDA's review confirms substantial equivalence to the predicate device due to identical indications for use, fundamental scientific technology, and operating principles, supported by a comprehensive suite of non-clinical performance tests.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and 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)

The document does not specify exact sample sizes for each mechanical, physical, or system verification test conducted. It generally refers to "test requirements" being met. The data provenance is not explicitly stated in terms of country of origin, but the tests were conducted by Baylis Medical Company Inc., which is based in Canada. These tests are non-clinical (benchtop) and are typically performed in a laboratory setting. They would be considered prospective in the sense that they were designed and executed to evaluate the new device.

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 device is a medical dilator, not an AI or diagnostic imaging device that requires expert interpretation for "ground truth" in the traditional sense of clinical data. The "ground truth" for this device's performance is established through adherence to recognized international standards (e.g., ISO, ANSI/AAMI) and the manufacturer's internal engineering requirements. Therefore, the "experts" involved would be a team of engineers, regulatory affairs specialists, quality assurance personnel, and potentially design validation specialists from Baylis Medical Company Inc. with expertise in medical device design, testing, and regulatory compliance. The document does not specify the number or specific qualifications of these individuals, as it's typically understood to be part of standard manufacturing and quality system practices.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving human interpretation (e.g., reading medical images) to resolve discrepancies among experts. For a physical medical device undergoing non-clinical benchtop testing, the results are objectively measured against predefined scientific and engineering standards, not subject to subjective adjudication among 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 is a physical medical device (dilator), not an AI algorithm for diagnostic interpretation or a device designed to assist human readers. Therefore, an MRMC comparative effectiveness study, which is relevant for AI-powered diagnostic tools, was not performed.

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

Not applicable. This is a physical medical device, not an algorithm. Benchtop tests are inherently "standalone" in the sense that the device's physical properties and performance are measured objectively without human-in-the-loop clinical scenarios.

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

The "ground truth" for the performance tests conducted on the VersaCross Connect™ Transseptal Dilator is based on:

• International Standards: e.g., ISO 11070:2014/Amd.1:2018 (Vessel Dilators), ISO 80369-7:2021 (Luer connectors), ISO 10993-1:2020 (Biocompatibility), ISO 11135:2014/A1:2019 (Sterilization), ISO 10993-7:2008/A1:2022 (EO residuals), ANSI/AAMI ST72:2019 (Pyrogen testing), ISO 11607-1:2020 (Packaging).
• Manufacturer's Internal Requirements: Baylis Medical Company Inc. requirements, often derived from risk assessments and design specifications.
• Predicate Device Data: For biocompatibility, data from the predicate device (K220414) was adopted, indicating that prior established safety profiles serve as a ground truth baseline.

8. The sample size for the training set

Not applicable. This is a physical medical device undergoing non-clinical testing, not an AI model that requires a training set.

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

Not applicable, as there is no training set for a physical medical device.

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The Micro Ace™ Advanced Micro Access System is intended for percutaneous placement of a 0.035" (0.89mm) or 0.038" (0.97mm) guidewire into the vascular system.

The Merit Micro Ace™ Advanced Micro Access System (hereafter referred to as Micro Ace™) provides access to the vascular system and facilitates the placement of a 0.035" (0.89mm) or 0.038" (0.97mm) guide wire. The system is available in 4 French and 5 French sizes – and includes the coaxial introducer-dilator pair, a 21 gauge needle and a 0.018" (0.46mm) guide wire.

The introducer-dilator assembly that is included in each kit is 10 cm effective length. The system will be offered with optional guidewires:
• Some catalog codes will include a nitinol wire with platinum guide wire tips;
• Some catalog codes will be offered with a stainless steel wire with platinum guidewire tips.

The provided text is a 510(k) Premarket Notification from the FDA for a medical device called the "Micro Ace™ Advanced Micro Access System." This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific acceptance criteria based on human-in-the-loop or standalone AI performance.

Therefore, the following information cannot be extracted from the provided text:

• No AI/Machine Learning Component: The prompt's questions (e.g., about AI assistance, standalone algorithm performance, training/test set ground truth, expert adjudication) are relevant to a medical device that incorporates AI or machine learning. The Micro Ace™ Advanced Micro Access System is a physical medical device (a vessel dilator for percutaneous catheterization) and does not appear to have any software or AI component described in this document. The term "algorithm" is not mentioned in the context of device performance.
• No "Acceptance Criteria" for AI/Software Performance: The document outlines the performance testing conducted to ensure the device functions as intended and is safe, but these are typical engineering and biocompatibility tests for a physical device, not performance metrics for an AI algorithm.
• No Human Reader Study: Since there's no AI component, there's no multi-reader multi-case (MRMC) comparative effectiveness study with human readers assisting with AI.
• No Training or Test Sets for AI: The concepts of training and test sets and ground truth establishment (expert consensus, pathology, outcome data) are specific to AI/ML model development and evaluation. These do not apply to the physical device described.

Instead, the document details the following for a physical medical device:

1. Acceptance Criteria and Reported Device Performance (Summary):

The document states that "All tested samples met pre-established performance criteria and were deemed acceptable." Specific numeric acceptance criteria are not provided in the text, nor are the detailed reported performance metrics for each test. The document lists the types of tests performed:

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

The document mentions that both 4F and 5F Micro Ace™ products were tested, and testing included sterile devices (following ethylene oxide processing) and aged devices. The exact numerical sample size for each test is not specified.
The data provenance is from Merit Medical Systems, Inc., the manufacturer. It is internal device testing, not patient data from a specific country or retrospective/prospective study in a clinical setting.

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

This question is not applicable as the studies relate to physical device performance testing (e.g., mechanical properties, biocompatibility), not the establishment of ground truth for diagnostic imaging or similar applications requiring expert consensus. "Clinician feedback" was part of design validation, but the number and qualifications of these clinicians are not detailed.

4. Adjudication Method for the Test Set:

Not applicable. This refers to consensus building among experts for tasks like image labeling, which isn't relevant to the described device testing.

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

No. This type of study is for evaluating diagnostic performance (often with AI assistance). The Micro Ace™ is a physical medical access system, not a diagnostic device.

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

No. This refers to AI algorithm performance.

7. The Type of Ground Truth Used:

Not applicable in the context of diagnostic AI. The "ground truth" for this device's performance is determined by meeting pre-specified engineering and biocompatibility test standards (e.g., a specific tensile strength value, absence of cytotoxic effects).

8. The Sample Size for the Training Set:

Not applicable. There is no AI model or "training set" for this physical device.

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

Not applicable.

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The TightRail Guardian motorized dilator sheath is intended for use in patients requiring the percutaneous dilation of tissue to facilitate removal of cardiac leads.

The TightRail Guardian motorized dilator sheath is a sterile, single use, prescription only device used for cardiac leads. The device is comprised of:

1. Drive Assembly
2. Dilation Extension Selection (DES) Assembly
3. Motor Drive Handle
4. Outer Sheath Accessory
5. Fish Tape Accessory
   The motorized dilator sheath is advanced or retracted along the target lead to be removed. Pulling the trigger on the handle of the TightRail Guardian device results in activation of the motor and subsequent rotation of the inner shaft and cam blade. Triager activation results in bidirectional rotation mechanism. Actuation of the distal dilation mechanism causes dilation of tissue and fibrous attachments surrounding the lead tarqeted for removal, thereby facilitating removal of said lead. The device has two modes of operation, providing dilation with the blades shielded or extended. The diameter sizes range from 9 French (F) to 13 F. The nominal effective length of the TightRail Guardian is 47.5 cm. The outer sheath accessory may be used for additional support by creating a conduit for the device's shaft assembly. The outer sheath may also be used to maintain venous access for quidewire placement, prior to implantation of a new lead. The fish tape accessory may be used to feed a target lead and locking stylet through the inner lumen of the device.

This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device for regulatory clearance. As such, it does not contain the detailed information typically found in a clinical study report or a validation study for an AI-powered medical device.

Specifically, this document describes a mechanical device (a motorized dilator sheath) and its validation through engineering and performance testing, not an AI algorithm. Therefore, most of the requested information regarding AI device acceptance criteria, human reader studies, ground truth establishment, and training/test set details is not applicable to this submission.

The document states: "Preclinical and clinical data was not required to demonstrate substantial equivalence. The design characteristics of the subject device are similar to the predicate. The design verification and validation test results demonstrated that the subject device is as safe and clinically effective as the predicate device." This confirms that the approval was based on demonstrating equivalence in mechanical and performance characteristics to a previously cleared device, not on the performance of a novel AI algorithm.

However, I can extract the relevant "acceptance criteria" and "study" information that is present in the document, which pertains to the engineering and performance testing of this mechanical device.

Acceptance Criteria and Study for the TightRail Guardian Motorized Dilator Sheath (Mechanical Device)

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide specific quantitative acceptance criteria or precise reported performance values in a table format. Instead, it lists the types of design verification and validation testing performed to ensure the device met its specifications and performed comparably to its predicate. The implicit acceptance criterion for all these tests is that the device demonstrated performance equivalent to or better than the predicate, and met all engineering specifications for safety and effectiveness.

Since this is not an AI/software device, the following points are not applicable (N/A) based on the provided document:

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 (No test set of patient data/images for an AI algorithm). Testing was engineering-based on physical devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (No ground truth established by experts for images/data for AI).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A.
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 (No AI, no human reader study).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A (No algorithm).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): N/A (No ground truth as defined for diagnostic AI). The "ground truth" for this mechanical device is proper functioning according to engineering specifications and safety standards.
8. The sample size for the training set: N/A (No training set for an AI algorithm).
9. How the ground truth for the training set was established: N/A (No training set for an AI algorithm).

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The TightRail Guardian Motorized Dilator Sheath is intended for use in patients requiring the percutaneous dilation of tissue to facilitate removal of cardiac leads.

The TightRail Guardian Motorized Dilator Sheath is a sterile, single use, prescription only device used for cardiac leads. The device is comprised of:

1. Drive Assembly
2. Dilation Extension Selection (DES) Assembly
3. Motor Drive Handle
4. Outer Sheath Accessory
5. Fish Tape Accessory
   The motorized dilator sheath is advanced or retracted along the target lead to be removed. Pulling the trigger on the handle of the TightRail Guardian device results in activation of the motor and subsequent rotation of the inner shaft and cam blade. Triager activation results in bidirectional rotation mechanism. Actuation of the distal dilation mechanism causes dilation of tissue and fibrous attachments surrounding the lead tarqeted for removal, thereby facilitating removal of said lead. The device has two modes of operation, providing dilation with the blades shielded or extended. The diameter sizes range from 9 French (F) to 13 F. The nominal effective length of the TightRail Guardian is 47.5 cm. The outer sheath accessory may be used for additional support by creating a conduit for the device's shaft assembly. The outer sheath may also be used to maintain venous access for guidewire placement, prior to implantation of a new lead. The fish tape accessory may be used to feed a target lead and locking stylet through the inner lumen of the device.

The provided text describes the regulatory clearance for the TightRail Guardian Motorized Dilator Sheath and does not contain information about a study proving the device meets acceptance criteria in the context of an AI/ML powered device evaluation.

The document is a 510(k) summary for a medical device (a motorized dilator sheath), outlining its intended use, design, and comparison to predicate devices for regulatory clearance. It focuses on demonstrating substantial equivalence to existing devices, not on evaluating the performance of an AI/ML model.

Therefore, I cannot provide the requested information regarding:

• A table of acceptance criteria and reported device performance (as it relates to AI/ML metrics).
• Sample size and data provenance for an AI/ML test set.
• Number of experts and qualifications for establishing ground truth in an AI/ML context.
• Adjudication method for an AI/ML test set.
• MRMC comparative effectiveness study results for AI vs. without AI assistance.
• Standalone algorithm-only performance.
• Type of ground truth used for an AI/ML model.
• Sample size for the training set of an AI/ML model.
• How ground truth for the training set was established for an AI/ML model.

The document lists various Design Verification and Validation Testing performed, such as Simulated Use Testing, Human Factors Evaluation, and Biocompatibility testing. These are typical engineering and safety tests for a physical medical device, not performance metrics for an AI/ML algorithm.

The statement "Preclinical and clinical data was not required to demonstrate substantial equivalence" further indicates that this is a traditional medical device clearance, not one involving extensive clinical trials or AI/ML performance evaluation studies against specific acceptance criteria for diagnostic/prognostic accuracy.

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The Xtractor™ device is intended for use in patients requiring the percutaneous dilation of tissue to facilitate removal of cardiac leads, indwelling catheters, and foreign objects.

The Xtractor™ device is a single use sterilized device designed to be advanced through the veins over a cardiac pacemaker/defibrillator lead. The device is a motor driven mechanical tool that is introduced over the lead and follows its path, using a flexible and steerable shaft connected to a control handle. The proximal section of the shaft maintains pushability while the distal section is very flexible, to facilitate easy passage through vein curves and junctions. The device' distal tip is designed to facilitate dilation of fibrous binding tissue and passage through calcified binding sites along the implanted lead (for example by use of combined rotational and impact movements). The device' control handle, which is connected to the shaft, contains a steering mechanism for assisting the device maneuverability, and a motorized power transmission mechanism to activate the device tip. The Xtractor™ device is visible under fluoroscopy during the procedure.

The provided document does not contain information about the acceptance criteria and study that proves the device meets them as typically presented for AI/ML-driven medical devices.

The document is a 510(k) premarket notification for the Xtractor™ device, which is a mechanical device for lead extraction, not an AI/ML diagnostic or prognostic tool. Therefore, it does not include details such as:

• A table of acceptance criteria and reported device performance related to diagnostic accuracy (e.g., sensitivity, specificity, AUC).
• Sample sizes for test sets used for diagnostic accuracy, data provenance, or the number/qualifications of experts for ground truth.
• Adjudication methods for ground truth.
• Results from multi-reader, multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• Type of ground truth (pathology, outcomes data, etc.) for diagnostic accuracy.
• Training set sample size or ground truth establishment for a machine learning model.

Instead, the performance data section focuses on standard medical device testing for a physical device, including:

• Biocompatibility: Tests like cytotoxicity, irritation, sensitization, systemic toxicity, complement activation, hemolysis, and pyrogenicity per ISO 10993-1.
• Sterilization, Packaging, and Shelf Life Testing: Validation per ISO 11135-1, transportation simulation, and environmental tests.
• Performance Testing (Mechanical/Physical):
  • Bending Test
  • Corrosion Resistance (ASTM A967/A967M)
  • Device Radiopacity
  • Dimensional Verification
  • Tensile Strength
  • Extended Use
  • Torque Test
  • Simulated Use (in an anatomical model simulator at T0 and Tx shelf life)
  • Hydrophilic Coating Testing (particles, visual, pinch test)
  • Xtractor™ vs. Predicate comparison test
• Software Validation: Conducted as per FDA guidance for contained software, with a moderate level of concern.
• Electrical Safety and EMC: Per IEC 60601-1 and IEC 60601-1-2.

The document states that "All tests passed and met the predefined acceptance criteria," but it does not explicitly list these criteria in a table alongside reported performance for each test. The predefined acceptance criteria would be specific thresholds or results required for each of the performance tests listed above (e.g., "no signs of defects, wear or deformations" for extended use, or specific values for tensile strength, etc.). An "Xtractor™ vs. Predicate comparison test" is mentioned, indicating a direct comparison was likely part of the performance evaluation.

In summary, the provided text details the type of non-clinical performance studies conducted for a mechanical medical device to demonstrate safety and effectiveness for 510(k) clearance, rather than the kind of AI/ML evaluation typically requested in the prompt.

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Intended to be used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular applications in the arterial system.

Endovascular Dilator and Sets are manufactured from vinyl radiopaque dilator tubing and consist of either one or two dilators that are used percutaneously to dilate puncture sites or catheter tracts, thereby facilitating the placement of other therapeutic or diagnostic devices into an artery for vascular clinical applications that require percutaneous access. The serial dilator components are designed with long, gradual tapers and include hydrophilic coating, and are available in various inner and outer diameter and length combinations.

The provided text is a 510(k) Premarket Notification from the FDA for a medical device called "Endovascular Dilator and Sets." This type of document is a regulatory submission for medical devices, not a study report or clinical trial. Therefore, it does not contain the detailed information about acceptance criteria, study methodologies, or performance results that would be found in a clinical study publication.

Specifically, the document states:
"There are no device, material, or design changes to any of the devices included in the Endovascular Dilator and Sets. Since there is no design change to the device subject of this submission, the testing that was provided for the predicate device in submission K183036 remains to support this submission. No additional testing or design control activities or risk assessment are required to support substantial equivalence."

This indicates that the FDA clearance for this device (K210734) is based on its substantial equivalence to a previously cleared predicate device (K183036), meaning no new performance studies were conducted for this specific submission to demonstrate the device meets acceptance criteria. The original testing for the predicate device (K183036) would contain such information.

Therefore, I cannot provide the requested information from this document because it is not a study report. The document asserts that no new testing was performed specific to this submission (K210734) as the device itself hasn't changed.

To address your request, one would need access to the 510(k) submission for the predicate device, K183036, as that is where the original performance data and testing details would be described.

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The ExpanSure™ Large Access Transseptal Dilator is indicated for use in procedures where access to the left atrium via the transseptal technique is desired.

The subject ExpanSure™ Large Access Transseptal Dilator represents a modification to the dilator component of the legally marketed ExpanSure™ Transseptal Dilation System (K182064). The modification was for the addition of a metallic marker coil to the dilator distal tip for increased visibility under imaging during procedures.

The subject device is comprised of a dilator (ExpanSure Dilator) and J-tip guidewire, which are single-use and supplied sterile to the user. The ExpanSure Dilator is designed for safe and easy catheterization and angiography of specific heart chambers and locations. The dilator consists of an inner and outer polyethylene layer containing radio-pacifier for visibility under imaging during procedures. The inner and outer shaft layers are separated by a braid material for torqueability. The dilator distal tip includes a metallic marker coil to facilitate visualization under imaging during procedures. The outer surface of the dilator is coated with a silicone lubricant. The ExpanSure Dilator is compatible with 0.032″ and 0.035″ transseptal devices/quidewires and 12.5 Fr introducer sheaths. The J-tip quidewire is comprised of stainless steel.

This document describes the ExpanSure™ Large Access Transseptal Dilator (K201288), a medical device. However, it does not describe a software-based medical device or AI system. Therefore, the provided text does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria in the context of AI/software performance.

Instead, this document is a 510(k) Premarket Notification summary for a traditional medical device (a vessel dilator). The "acceptance criteria" and "study" described herein refer to non-clinical performance testing (mechanical, physical, pyrogen, biocompatibility, packaging, and sterilization verification) to demonstrate substantial equivalence to a predicate device, not performance against clinical metrics for an AI algorithm.

Therefore, I cannot provide the requested information in the format of AI/software performance as the input document does not pertain to such a device.

Here's why the provided input doesn't fit the request about AI/software performance:

• Device Type: The device is a "vessel dilator for percutaneous catheterization," a physical, sterile, single-use medical instrument, not a software system.
• Performance Testing: The "Performance Testing" section lists mechanical tests, general physical tests, pyrogen testing, benchtop validation (for intended use), biocompatibility, packaging verification, and sterilization verification. These are standard tests for physical medical devices, not for evaluating AI model performance.
• Substantial Equivalence: The entire submission focuses on demonstrating "substantial equivalence" to a predicate physical device (K182064) based on shared intended use, technology, and similar materials, with modifications (a metallic marker coil) validated through the non-clinical tests listed.
• Absence of AI/Software Specifics: There is no mention of algorithms, data sets (training, validation, test), ground truth, expert readers, or performance metrics like sensitivity, specificity, or AUC, which would be expected for an AI/software device.

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