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The NaviGo 12F Steerable Intracardiac Catheter Introducer Kit is intended to introduce various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.

The NaviGo 12F Steerable Intracardiac Catheter Introducer Kit consists of a 1) Steerable Sheath, 2) Dilator and 3) Guidewire, and is indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum. When the left side of the heart is accessed, the device is used with a compatible Transseptal Needle to puncture the interatrial septum for transseptal catheterization procedures. The NaviGo 12F Steerable Intracardiac Catheter Introducer Kit is a sterile, single use device, with asymmetrical bi-directional steerable introducer with usable length of 65cm. The Steerable Sheath is fitted with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A side port 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 Steerable Sheath tip clockwise ≥ 180° and counterclockwise ≥ 90°. The steerable introducer features distal vent holes to facilitate aspiration and a radiopaque tip marker to improve fluoroscopic visualization.

The provided text describes the NaviGo 12F Steerable Intracardiac Catheter Introducer Kit and its substantial equivalence to a predicate device. Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and the Reported Device Performance

The document describes various performance tests conducted, but it does not explicitly list quantitative acceptance criteria for each test in a table format with corresponding reported performance values. Instead, it generally states that the device "met the acceptance criteria" or "demonstrated robust biocompatibility."

However, based on the descriptions, we can infer some general criteria and outcomes:

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

• Sterilization Testing: Not explicitly stated, but bioburden testing, LAL testing, and EO/ECH residual testing were performed on "the subject device."
• Shelf-Life Testing: Not explicitly stated, but accelerated aging studies and various package integrity tests were performed on "the subject device."
• Biocompatibility Testing: Not explicitly stated, but various in-vitro and in-vivo tests were conducted. The "In-Vivo Thrombogenicity Evaluation [GLP Animal Study]" refers to the animal study below. Materials were from the device itself.
• Benchtop Studies: Not explicitly stated, but various devices would have been tested for each category.
• Pre-Clinical (GLP Animal Study):
  • Sample Size: Six (6) healthy canines.
  • Data Provenance: Prospective animal study conducted in a GLP (Good Laboratory Practice) environment. The location/country of the GLP lab is not specified but it's an animal model, not human data.

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

• Pre-Clinical (GLP Animal Study):
  • Number of Experts: Two (2)
  • Qualifications: "Board Certified Electrophysiologists specializing in ablation of pulmonary veins in the management of atrial fibrillation."

4. Adjudication Method for the Test Set

• For the Pre-Clinical (GLP Animal Study), the two electrophysiologists "performed the procedures and rated the overall performance and usability of the subject device." The document does not specify a formal adjudication method (e.g., 2+1, 3+1). It states "predominant rating of Acceptable and Above Average," suggesting a consensus or combined assessment was reached, but the process is not detailed.
• For other tests (benchtop, sterilization, biocompatibility), the ground truth is based on standard test methods and established scientific criteria, not expert adjudication in the same sense.

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

No, an MRMC comparative effectiveness study was not done. This device is a physical medical device (catheter introducer kit), not an AI/software device that would typically involve human readers interpreting images with or without AI assistance. The study described is a pre-clinical animal study to assess safety, performance, and usability of the physical device.

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

No, a standalone algorithm performance study was not done. This is not an AI/software device.

7. The Type of Ground Truth Used

• Sterilization: Regulatory standards (ISO, ANSI/AAMI, EN ISO) for sterilization efficacy, bioburden levels, endotoxin levels, and residual limits.
• Shelf-Life: Regulatory standards (ASTM F1980-21, ASTM F2096-11(2019), ASTM F88/F88M-21) and product V&V testing.
• Biocompatibility: Regulatory standards (ISO 10993-1:2018, ISO 10993-4, -5, -7, -10, -11, -23) and FDA guidance for biological evaluation endpoints.
• Benchtop Studies: Design input acceptance criteria based on engineering specifications and industry standards relevant to catheter function (e.g., buckle force, deflection, kink resistance, leakage, bond strength).
• Pre-Clinical (GLP Animal Study): Direct observation, clinical assessment, and expert rating by Board Certified Electrophysiologists in a canine model for safety, performance, and usability. This includes observations for adverse events, device maneuverability, and overall handling, as well as thrombogenicity assessment.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device. The "training set" concept is typically relevant to AI/machine learning models.

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

Not applicable, as there is no mention of a training set for an AI/ML model.

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The CIRCA Scientific CardioCurve™ Steerable Sheath is indicated when introducing various cardiovascular devices to the epicardial or endocardial surfaces of the heart, including the left side of the interatrial septum.

The CardioCurve™ Steerable Sheath from CIRCA Scientific is an 8.5 Fr sterile, single-use catheter introducer used for the introduction, withdrawal, and exchange of guidewires and catheters while minimizing blood loss. It is available in lengths of 40cm, 61cm, 71cm, or 82cm. The introducer is packaged with a custom dilator and a 180 cm, 0.032", super stiff, marketed cleared guidewire (K935170). A side port with a 3-way stopcock allows air or blood aspiration, fluid infusion, blood sampling, and pressure monitoring. A handle equipped with two linked rotating dials is used to deflect the tip clockwise and counterclockwise 180°. The steerable sheath features distal vent holes to facilitate aspiration and minimize cavitation, a radiopaque tip marker to improve fluoroscopic visualization, and a lubricious coating on the outer surface.

The CardioCurve™ Steerable Sheath shaft is made from Pebax and Nylon. The shaft includes a radiopaque tip marker for visibility under fluoroscopy and is braided, except for the distal tip, for kink resistance; the handle is made of ABS. The dilator is made of HDPE that is barium loaded for visibility under fluoroscopy.

The CardioCurve™ dilator can be used with a curved transseptal Abbott BRK™ type needle with stylet if indicated on the package label.

This Special 510(k) is submitted to support the changes made to the predicate device: the Tuohy Borst adapter in the CardioCurve Steerable Sheath is replaced with a cap; as a result of this change, the dilator shaft usable length is shortened, and the Instruction for Use (IFU) is updated.

This document describes the premarket notification for the CardioCurve™ Steerable Sheath (K240004), which is a modification of a previously cleared device (K210185). The key changes are the replacement of a Tuohy Borst adapter with a cap and a resulting shortening of the dilator shaft usable length, along with an updated Instruction for Use (IFU).

Based on the provided text, the device in question is a physical medical device (a catheter introducer), not an AI/software-based device. Therefore, the questions related to AI/algorithm performance (e.g., ground truth, training set, MRMC study, standalone performance, experts for ground truth) are not applicable to this submission. The validation for this medical device focuses on physical performance testing to demonstrate that the design changes do not raise new questions of safety or effectiveness.

Here's the information that can be extracted relevant to the physical device's acceptance criteria and study, followed by an explanation of why AI-specific questions are not applicable:

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

The document references a "Summary of Performance Testing" which includes a list of tests. It states: "The methods and acceptance criteria were the same or equivalent to the predicate device and are relevant to the changes under review. The testing identified in the list below was based on well-established test methods and requirements."

Since specific numerical acceptance criteria and reported performance values are not explicitly provided in the text for each test, the table reflects the types of tests conducted and infers that the device met the criteria, as it received clearance.

Study Details (for a physical medical device):

1. Sample sizes used for the test set and data provenance:
   The document states "Verification testing has been conducted to support that the subject device meets the design specifications and is substantially equivalent to the predicate device." It also mentions "Design verification tests were performed to demonstrate that the subject device...met predetermined performance specifications."
   However, the exact sample sizes for each test (e.g., number of units tested for fatigue, leak, etc.) and the data provenance (e.g., specific country of origin for test materials or retrospective/prospective nature of the physical tests) are not specified in the provided text. These tests would typically be performed in a lab setting rather than on patient data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   Not Applicable. This is a physical medical device. "Ground truth" in the context of physical medical devices typically refers to engineering specifications, material properties, and established test methods, not expert consensus on medical images or clinical outcomes. The testing is based on "well-established test methods and requirements," implying engineering and quality control expertise, but not necessarily a panel of medical experts for "ground truth" establishment in the way it's understood for AI.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   Not Applicable. Adjudication methods like "2+1" or "3+1" are used in studies involving human interpretation (e.g., radiology reads) to resolve discrepancies. This device undergoes physical performance testing against engineering specifications, not human interpretation against a medical standard.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
   Not Applicable. An MRMC study is relevant to AI-assisted diagnostic devices. This is a physical catheter introducer, not a diagnostic AI tool.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
   Not Applicable. This refers to AI algorithm performance.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   As explained in point 2, "ground truth" for this physical device refers to engineering specifications, design requirements, and established testing standards. The document mentions an FMEA (Failure Modes and Effects Analysis) and that testing "met critical design specifications as well as performance attributes for its intended use."

7. The sample size for the training set:
   Not Applicable. There is no "training set" as this is not an AI/machine learning device.

8. How the ground truth for the training set was established:
   Not Applicable.

Summary of Device, Study, and Why AI-specific Questions are Not Applicable:

The CardioCurve™ Steerable Sheath is a Class II medical device, specifically a catheter introducer. The submission is a Special 510(k) to support changes to a previously cleared predicate device. The changes are physical design modifications (replacement of a Tuohy Borst adapter with a cap and resulting dilator length adjustment).

The "study" described is a series of design verification tests conducted to ensure that these physical changes do not negatively impact the device's safety and effectiveness. This is a standard process for physical medical device modifications.

The questions regarding "ground truth," "training set," "experts," "adjudication," and "MRMC studies" are typically applied to diagnostic AI/machine learning devices where the output is an interpretation of data (e.g., medical images), and human performance or algorithmic performance needs to be evaluated against a clinical standard. Since the CardioCurve™ Steerable Sheath is a physical, interventional device, these AI-centric questions do not apply to its regulatory clearance process as described in this document. The "acceptance criteria" relate to engineering and performance specifications, and the "study" involves physical bench testing.

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This Product is designed to direct a catheter to the desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures.

The CROSSLEAD Peripheral Guide Wire (hereafter "CROSSLEAD") is a steerable guide wire with a maximum diameter of 0.035 inches (0.89mm) and available in 200cm and 300cm length. The guide wire is constructed from a Ni-Ti alloy core wire with a stainless steel coil. The coil is soldered to the core wire with Ag-Sn solder. The coil has radiopacity to achieve visibility and can be made to bend easily with the vessel curve. A hydrophilic coating is applied to the distal portion of the guide wire. A hydrophobic coating is applied to proximal portion The basic structure, construction, and coating of the CROSSLEAD are unchanged from that previously described in the predicate Radifocus Glidewire Advantage (K063372) and reference ASAHI Silverway (K183062) and ASAHI Regalia XS 1.0 (K083146)

The provided text describes the regulatory submission for a medical device called "CROSSLEAD Peripheral Guide Wire". This document does not contain information about an AI/ML powered device, and therefore the acceptance criteria and study details related to AI/ML device performance are not present.

The document discusses the substantial equivalence of the CROSSLEAD device to previously cleared predicate devices through non-clinical testing and biocompatibility assessments.

Here's a breakdown of the information that is provided, as it relates to the non-AI device:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that the CROSSLEAD met "all acceptance criteria" but does not provide specific quantitative acceptance criteria or the numerical performance results for each test. Instead, it offers a list of tests performed.

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

• Sample Size: Not specified for the non-clinical or biocompatibility tests.
• Data Provenance: Not specified. The tests were performed in a lab setting ("bench testing") and are likely internal to the manufacturer or conducted by contract research organizations.

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

This concept is not applicable to the non-clinical and biocompatibility testing described. These tests involve laboratory measurements against established standards, not expert interpretation of data.

4. Adjudication Method for the Test Set:

Not applicable, as this refers to expert review in clinical or diagnostic assessments.

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

No. This type of study is not relevant for the evaluation of a physical guide wire.

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

No. This device is not an algorithm.

7. The Type of Ground Truth Used:

For the non-clinical tests, the "ground truth" would be the established engineering specifications and performance benchmarks derived from relevant FDA guidance documents (e.g., "Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling, 15JUN2018"). For biocompatibility, the ground truth is defined by the ISO 10993 standards and the expected biological responses.

8. The Sample Size for the Training Set:

Not applicable. This device is not an AI/ML model, so there is no "training set."

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

Not applicable.

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The Steerable Introducer is intended for percutaneous catheter introduction into the vasculature and into the chambers of the heart. The sheath deflection facilitates catheter positioning.

The Steerable Introducer consists of a single use, bi-directional steerable sheath connected to a handle with steering controls, a hemostasis valve with side port and 3-way stopcock, a tapered dilator and compatible guidewire. The device is provided sterile in a sealed Tyvek pouch and carton with IFU.

The sheath distal tip and dilator shaft are radiopaque for visualization under fluoroscopy. The dilator is designed to accommodate a guidewire and includes a proximal hub with a female luer tapered fitting for flushing.

This document is a 510(k) premarket notification for a medical device (Steerable Introducer 12F), seeking a determination of substantial equivalence to a predicate device. It details the device's technical characteristics, intended use, and performance data from various tests. However, it does not describe an AI/ML-based device or its acceptance criteria and study in the context of AI/ML performance.

The information provided in the document refers to a physical medical device (a steerable catheter introducer) and its non-AI related performance testing (e.g., dimensional, material, mechanical, biocompatibility, sterilization).

Therefore, I cannot extract the information required by your prompt, as it specifically asks for details related to an AI/ML device's acceptance criteria and the study proving it meets those criteria.

The provided text does not contain any information about:

1. AI/ML Acceptance Criteria or Device Performance: There is no mention of metrics like sensitivity, specificity, AUC, or any other performance indicators typically used for AI/ML models.
2. Test Set Sample Size or Data Provenance: This document is about a physical medical device, not a software algorithm tested on data.
3. Experts for Ground Truth/Adjudication: This concept is not applicable here.
4. MRMC Comparative Effectiveness Study: Not relevant for a physical device.
5. Standalone AI Algorithm Performance: There is no AI algorithm.
6. Type of Ground Truth: Not applicable.
7. Training Set Sample Size or Ground Truth Establishment: Not applicable.

The document focuses on:

• Device Description: Physical attributes and components.
• Intended Use & Indications for Use: What the device is meant to do (introduce catheters into the heart).
• Technological Characteristics: How it operates (bi-directional steering, radiopacity).
• Performance Data: Bench testing (e.g., deflection, kink resistance, hemostasis), biocompatibility testing (ISO 10993-1), and sterilization methods, all aimed at demonstrating the device's safety and effectiveness as a physical product.
• Substantial Equivalence Claim: Comparing the new device's features and performance to a legally marketed predicate device (FlexCath Advance K123591) to show it's "as safe and effective."

In conclusion, based on the provided text, I cannot answer your request as it pertains to AI/ML device performance and testing. The document describes a traditional physical medical device.

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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 RXI Guider ™ Catheter Introducer is indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.

The Guider Catheter Introducer set contains a fixed-curve introducer, integrated vessel dilator/transseptal needle (component branded as Lancer™), guidewire, and ECG adapter cable. The set is designed to facilitate vascular access to the heart and then provide catheter positioning within the cardiac anatomy. The Guider Catheter Introducer is an elongated shaft with central lumen capable of accepting the Lancer dilator/needle as well as various catheters. The Guider handle is also fitted with a hemostasis valve to minimize blood loss during catheter introduction, and/or exchange, as well as a sideport with 3way stopcock to allow blood aspiration, fluid infusion, and pressuremonitoring. The introducer shaft features distal side holes to facilitate aspiration and prevent cavitation plus an embedded platinum radiopaque tip marker to facilitate fluoroscopic visualization. The Lancer integrated dilator/needle combines a dilator and transseptal needle into a single component. The needle is used to puncture the interatrial septum to gain access to the left atrium. The Lancer consists of an elongated shaft with a tapered tip and central lumen to track over a guidewire in a similar fashion to conventional dilators. The lumen of the Lancer is fitted with a hollow stainless steel transseptal needle and both the shaft and needle are connected to the same proximal handle. The needle lumen will accept guidewire sizes up to 0.032 inches in diameter. Inside the Lancer handle, the needle is affixed to a spring-tensioned actuator that prevents needle extension until the operator purposely advances the needle via a slider button located on the outer surface of the handle. The proximal handle is fitted with a Luer connector to gain access to the central lumen of the needle. The handle is also fitted with an electrical connector to monitor an ECG from the needle while in the heart, utilizing the ECC adapter cable. The guidewire included in the set is manufactured by Lake Region Medical (K935170) and is supplied in a polypropylene retainer coil with a J-straightener and Luer fitting. The ECG adapter cable included is manufactured by Bioconnect (RF Industries, Inc.), is one (1) meter long, and has male/female DIN 0.080 inch touch- proof connectors on the ends.

The provided text describes the "Guider Catheter Introducer" and its testing for substantial equivalence to a predicate device. However, it does not describe an AI/ML powered medical device. Therefore, many of the requested categories related to AI performance, ground truth, and expert evaluation are not applicable or cannot be extracted from this document.

The document primarily focuses on non-clinical testing (biocompatibility, sterilization, packaging, shelf life, and performance testing) and an animal study to demonstrate the device meets safety and performance requirements and is substantially equivalent to a predicate.

Here's the information that can be extracted, with notes where the requested categories are not applicable.

Acceptance Criteria and Device Performance (Summary from various sections)

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

As provided above. The document generally states "Pass" or "All protocol requirements/specifications were met" rather than specific numerical acceptance criteria for many tests, except for biocompatibility where "Non-Hemolytic", "Non-Reactive", etc., serve as the criteria.

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

• Test Set Sample Size: Not explicitly stated numerically for most non-clinical tests. For the animal study, it mentions "2 canines" for in vivo thrombogenicity and "A single animal study" for the overall device performance comparison, but doesn't quantify the number of devices or trials within that study.
• Data Provenance:
  • Biocompatibility and animal study: American Preclinical Services, Inc., Minneapolis, MN, USA.
  • Sterilization: Steris Isomedix, Minneapolis, MN, USA.
  • Environmental Conditioning, Distribution Simulation, Accelerated Aging, Peel Strength, Bubble Leak Testing: Distribution Dynamic Labs, Inc. (DDL) in Eden Prairie, MN, USA.
  • Particulate testing: Nelson Labs, Salt Lake City, UT, USA.
  • Electrical testing: Medical Equipment Compliance Associates, LLC. (MECA), Franklin, WI, USA.
  • All other testing: Internally at CRI-Devices in Maple Grove, MN, USA.
  • The studies are prospective, conducted specifically for this 510(k) submission.

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):

• Not applicable for this type of device. This device is a catheter introducer, which is a physical medical instrument, not an AI/ML software device or diagnostic tool that requires expert-established ground truth on patient data. The "ground truth" here is the performance of the device against engineering specifications and regulatory standards, assessed by testing laboratories and the FDA.

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

• Not applicable. This refers to methods for resolving discrepancies in expert opinions for ground truth establishment in AI/ML studies. This document concerns physical device testing against predefined specifications.

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 an AI/ML-specific study type. The document describes an animal study comparing the device to a predicate device, not human reader performance with AI. The animal study showed the device "performed for the selected parameters substantially equivalent to the commercially available St. Jude Medical Swartz™ Braided Transseptal Guiding Introducer (K052644)."

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

• Not applicable. This relates to AI/ML algorithm performance. The device is a physical medical instrument.

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

• Not applicable in the AI/ML context. For physical device testing, the "ground truth" is established through adherence to recognized national and international standards (e.g., ISO, ASTM, AAMI) and internal performance specifications. For the animal study, the ground truth was the performance of the legally marketed predicate device under specific physiological parameters.

8. The sample size for the training set:

• Not applicable. There is no AI/ML component, thus no training set.

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

• Not applicable. No training set exists.

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The Flextra™ Steerable Introducer is introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.

The Flextra Steerable Introducer set contains a steerable introducer, integrated vessel dilator/transseptal needle (component branded as Lancer"), guidewire, and ECG adapter cable. The set is designed to facilitate vascular access to the heart and then provide variable catheter positioning within the cardiac anatomy. The Flextra introducer is an elongated shaft with central lumen capable of accepting the Lancer dilator/needle as well as various cardiac catheters. The shaft has a proximal handle with a rotating actuator that allows the user to change the degree of curvature on the distal tip of the shaft (referred to as steerable tip, deflectable tip, or dynamic tip). Rotating the actuator can deflect the tip, in a planar fashion, +/- 180°. The handle is also fitted with a hemostasis valve to minimize blood loss during catheter introduction, and/or exchange, as well as a sideport with 3way stopcock to allow blood aspiration, fluid infusion, and pressure monitoring. The introducer shaft features distal side holes to facilitate aspiration and prevent cavitation plus an embedded platinum radiopaque tip marker to facilitate fluoroscopic visualization. The Lancer integrated dilator/needle combines the dilator and transseptal needle into a single component. The needle is used to puncture the interatrial septum to gain access to the left atrium. The Lancer consists of an elongated shaft with a tapered tip and central lumen to track over a guidewire in a similar fashion to conventional dilators. The lumen of the Lancer is fitted with a hollow stainless steel transseptal needle and both the shaft and needle are connected to the same proximal handle. The needle lumen will accept guidewire sizes up to 0.032 inches in diameter. Inside the Lancer handle, the needle is affixed to a spring-tensioned actuator that prevents needle extension until the operator purposely advances the needle via a slider button located on the outer surface of the handle. The proximal handle is fitted with a Luer connector to gain access to the central lumen of the needle. The handle is also fitted with an electrical connector to monitor an ECG from the needle while in the heart, utilizing the ECG adapter cable. The guidewire included in the kit is manufactured by Lake Region Medical (K935170) and is supplied in a polypropylene retainer coil with a J-straightener and Luer fitting. The ECG adapter cable included is manufactured by Bioconnect (RF Industries, Inc.), is one (1) meter long, and has male/female DIN 0.080 inch touchproof connectors on the ends.

The provided document describes the predicate device and the new device being submitted for 510(k) clearance, the Flextra Steerable Introducer. It focuses on demonstrating substantial equivalence to the predicate device through various non-clinical tests.

Since this document describes a medical device undergoing premarket notification (510(k)) for substantial equivalence, the "acceptance criteria" are generally established regulatory standards and the "study that proves the device meets the acceptance criteria" refers to the comprehensive non-clinical testing performed to show the device functions as intended and is safe, effective, and performs as well as or better than the predicate device.

Here's a breakdown of the requested information based on the provided text, recognizing that it pertains to a device, not an AI algorithm:

1. Table of Acceptance Criteria and Reported Device Performance

For a medical device, "acceptance criteria" are typically defined by recognized standards and performance specifications derived from these standards or from the predicate device's performance. The "reported device performance" are the results of tests against these criteria.

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

• Biocompatibility: Various numbers per test, e.g., "2 canines" for thrombogenicity.
• Sterilization, Packaging, Shelf Life, Performance Testing: The document refers to "samples" or "test devices" but does not specify the exact number of units used for each test. For accelerated aging, it mentions "test devices."
• Animal Study: "A single animal study was performed that combined the evaluation of another device... to limit the number of animals required." The thrombogenicity test also used "2 canines."
• Data Provenance: The tests were conducted by various vendors and labs primarily in the USA (Minneapolis, MN; Salt Lake City, UT; Franklin, WI; Eden Prairie, MN). The studies are prospective evaluations of the manufactured device.

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

Not applicable to this type of device submission. The "ground truth" for device performance is established by objective measurements against engineering specifications and validated test methods (e.g., ASTM, ISO standards), or by comparison to a predicate device in an animal model. There is no mention of human experts establishing ground truth in the context of diagnostic performance or image interpretation.

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

Not applicable. Adjudication methods like 2+1 (two readers, one adjudicator if disagreement) are typically used in clinical studies or diagnostic performance evaluations for subjective assessments. This document describes objective engineering tests and an animal study.

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

Not applicable. This device is a steerable introducer catheter, not an AI algorithm for diagnostic interpretation. Therefore, no MRMC study or AI-assisted human reader improvement assessment was performed.

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

Not applicable. The device is a physical medical instrument, not an AI algorithm.

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

The "ground truth" for this device's performance is established by:

• Compliance with recognized international and national standards (e.g., ISO, ASTM IEC) for physical, mechanical, chemical, and biological properties.
• Direct measurement and verification against pre-defined engineering specifications.
• Comparison to a legally marketed predicate device (SJM Agilis™ NxT Steerable Introducer, K061363) in an animal model for functional and performance aspects, demonstrating substantial equivalence.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI algorithm that requires a training set.

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

Not applicable. See point 8.

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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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TFX Medical Guidewires are intended to fit inside a percutaneous catheter for the purpose of directing it through a blood vessel or other natural channel excluding use in coronary arteries and in the neurovasculature.

TFX Medical will supply a standard range of guidewires as sterile, packed finished products, and will also supply in bulk to other manufacturer to their specific size requirements (for example: for inclusion in a kit).

The kev features of the TFX Medical Guidewire are:

• O Core Wire
• O Ribbon Wire (where fitted)
• O Spring Wire
• O Welds
• Coating (p.t.f.e. coating or uncoated stainless steel)
• Tips (available straight and "J" forms, one or two tips)

Guidewires will be manufactured of grade 302/304 stainless steel and be available:

• . with and without a ribbon wire
• ♥ in fixed and moveable core designs
• . uncoated and p.t.f.e. coated
• with straight and "J" formed end(s)
• with and without a length marking

I am sorry, but the provided text does not contain the detailed information required to fulfill your request. The document is a 510(k) summary for a medical guidewire and mentions "Test data in the premarket notification demonstrates TFX Medical Guidewires meeting the requirements of the appropriate parts of British Standard BS 7174: 1990: Part 4." However, it does not provide the specific acceptance criteria, reported device performance in a table, details about the study (sample size, data provenance, ground truth, experts, adjudication, MRMC, or standalone performance), or information about the training set.

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