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

The proposed device includes Steerable Intracardiac Catheter Introducer Kit as well as its accessory, Transseptal Needle. The Steerable Intracardiac Catheter Introducer Kit is intended for introducing various cardiovascular catheters into heart, including both right and left side. When left side of heart is accessed, Transseptal Needle is intended for puncture the interatrial septum during a transseptal catheterization procedure.

The Steerable Intracardiac Catheter Introducer Kit includes three components, which are (1) steerable sheath introducer, (2) dilator and (3) guidewire. The steerable sheath introduced into a body vessel, along with the dilator, over the guidewire, it is available in variable specification and curve configuration: Dilator is assembled with the sheath introduced into a body vessel over the guidewire. It is used to provide support to sheath and ensure smooth advancement; the guidewire is percutaneous placed into the body vessel to function as a guide for the introduction into the chambers of the heart.

The handle of Steerable Intracardiac Catheter Introducer is equipped with the rotation collar, turn the collar in clockwise, the tip can be stered from 0 to 180 degree(s), while turn the collar in counterclockwise, the tip can be steered from 0 to 90 degree(s) on the other side.

The transseptal needle includes two components, which are (1) stylet. The needle is used to puncture the interatrial septum during a transseptal catheterization procedure; the stylet is used to keep the needle lumen intact during handling and facilitate the needle advancement within the dilator.

The kit and the transseptal needle are provided sterilized. They are subject to Ethylene Oxide sterilization prior to release. The Sterility Assurance Level (SAL) is 10-6.

The shelf life of the proposed device is three (3) years.

This document is a 510(k) premarket notification for a medical device called the "Steerable Intracardiac Catheter Introducer Kit and Transseptal Needle". It seeks to demonstrate substantial equivalence to a predicate device, not to prove the device meets specific acceptance criteria through a clinical study with an AI component. Therefore, much of the requested information regarding AI study details cannot be extracted from this document.

However, I can provide information based on the non-clinical tests performed to demonstrate substantial equivalence.

1. Acceptance Criteria and Reported Device Performance

The document states that non-clinical tests were conducted to verify that the proposed device met all design specifications and was substantially equivalent to the predicate device. The acceptance criteria for these non-clinical tests are implicitly defined by compliance with the listed international and ASTM standards. The "reported device performance" is the conclusion that the device complied with these standards.

2. Sample Size and Data Provenance

This document describes non-clinical bench testing and biocompatibility testing, not a clinical study involving patient data. Therefore, the concepts of "test set" sample size and "data provenance" (country of origin, retrospective/prospective) are not applicable in this context. The samples used would be units of the manufactured device for the specific tests.

3. Number of Experts and their Qualifications for Ground Truth

Not applicable. This is a submission for a physical medical device, not an AI/software device that requires expert-established ground truth for image or data interpretation. The "ground truth" for the non-clinical tests is derived from the objective measurements and defined parameters within the standardized test methods.

4. Adjudication Method

Not applicable. This is a submission for a physical medical device. Adjudication methods like 2+1 or 3+1 are typically used in clinical trials or studies involving human readers/interpreters to resolve discrepancies in assessment.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The document explicitly states: "No clinical study is included in this submission." Also, the device is a physical medical instrument (catheter introducer), not an AI system. Therefore, a study comparing human readers with and without AI assistance is not relevant to this submission.

6. Standalone (Algorithm Only) Performance Study

No. This device is a physical medical instrument and does not involve an algorithm with standalone performance.

7. Type of Ground Truth Used

For the non-clinical tests, the "ground truth" is defined by the objective pass/fail criteria and measurable parameters established within the referenced international and ASTM standards (e.g., specific sterility assurance levels, cytotoxicity assays, seal strength measurements, etc.).

8. Sample Size for the Training Set

Not applicable. This document does not describe the development or evaluation of an AI algorithm; there is no "training set."

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

Not applicable, as there is no AI algorithm or training set discussed in this document.

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Intracardiac Catheter Introducer Kit is intended for introducing various cardiovascular catheters into heart. Transseptal Needle is intended for puncture the interatrial septum during a transseptal catheterization procedure.

The proposed device includes Intracardiac Catheter Introducer Kit as well as its accessory, Transseptal Needle. Intracardiac Catheter Introducer Kit is intended for introducing various cardiovascular catheters into heart, including both right side. When left side of heart is accessed, Transseptal Needle is intended for puncture the interatrial septum during a transseptal catheterization procedure.

The Intracardiac Catheter Introducer Kit includes three components, which are (1) sheath introducer, (2) dilator and (3) guidewire. The sheath introduced into a body vessel, along with the dilator, over the guidewire, it is available in variable specification and curve configuration; Dilator is assembled with the sheath introducer and introduced into a body vessel over the guidewire. It is used to provide support to sheath and ensure smooth advancement; the guidewire is percutaneous placed into the body vessel to function as a guide for the introduction into the chambers of the heart.

The transseptal needle includes two components, which are (1) needle and (2) stylet. The needle is used to puncture the the interatrial septum during a transseptal catheterization procedure; the stylet is used to keep the needle luman intact during handling and facilitate the needle advancement within the dilator.

This document describes a medical device, the Intracardiac Catheter Introducer Kit and Transseptal Needle, and its substantial equivalence determination by the FDA. It does not contain information about a study proving the device meets specific acceptance criteria in the context of an AI/ML or Diagnostic device.

The acceptance criteria and study described here are for a traditional medical device (catheter introducer and needle) aiming to demonstrate equivalence to a predicate device, rather than proving a diagnostic performance metric.

Therefore, many of the requested fields are not applicable to the information provided in this document.

Here's the closest possible interpretation of the requested information based on the provided text, primarily focusing on "non-clinical tests" as the "study" substitute:

1. Table of acceptance criteria and the reported device performance:

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

The document does not specify the sample sizes for the individual non-clinical tests. The tests were conducted to verify design specifications and substantial equivalence, implying they were performed on samples of the manufactured device. The manufacturer is Synaptic Medical Limited, located in Beijing, PR China, which can be considered the country of origin for the device and likely where these tests were performed. These appear to be prospective tests on newly manufactured devices.

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. The tests are engineering and biological evaluations against established standards, not expert-derived ground truth on patient data.

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

Not applicable. This is for expert review of data, not for engineering or biological testing.

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 traditional medical device, not an AI/ML-driven diagnostic or assistance tool.

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

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

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

The "ground truth" here is compliance with established international and ASTM standards (e.g., ISO 11070, ISO 10993, ASTM F88, ASTM F1140), and verification of specific performance characteristics (e.g., anti-kink, torque strength). These are objective measurements against defined criteria.

8. The sample size for the training set:

Not applicable. There is no AI/ML model for which a training set would be used.

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

Not applicable. There is no AI/ML model.

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The Catheter Introducer Sheath is indicated for use in patients requiring access of the venous system or to facilitate catheter insertion (e.g. pulmonary artery or infusion catheter). It is intended to be used for ≤ 72 hours.

Edwards Lifesciences' Catheter Introducer Sheath is an 11 Fr. sterile, non-pyrogenic, single-use introducer made of flexible and non-flexible polymeric materials. It consists of a single lumen shaft and a hemostasis valve with a side-arm extension tube with a female luer and clamp.

The provided text describes a 510(k) premarket notification for a Catheter Introducer Sheath and does not contain information about studies proving the device meets specific acceptance criteria in the manner of a clinical trial or AI/ML performance evaluation. The document focuses on demonstrating substantial equivalence to a predicate device through functional and safety testing.

Here's an analysis based on the provided text, addressing your questions where possible:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for each test performed, nor does it provide specific numerical results of device performance. Instead, it concludes: "The functional data indicate that the Catheter Introducer Sheath performs in a substantially equivalent manner when compared to the predicate device." and "All data met acceptance criteria." This implies that for each test listed below, there were pre-defined acceptance criteria, and the device successfully met them.

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

The document does not specify the sample sizes used for any of the functional or safety tests. It also does not mention any test sets in the context of clinical data, or the provenance (country of origin, retrospective/prospective) of any data beyond the physical device testing. The "tests" described are laboratory-based, not patient-based clinical trials.

3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts

This information is not applicable to the provided document. The "ground truth" here is established by engineering and material standards, and the results of laboratory tests are presumably interpreted by qualified engineers and scientists involved in the testing and regulatory submission, not by medical experts establishing diagnostic ground truth.

4. Adjudication Method

Not applicable. The tests performed are laboratory-based and would involve measurements against established standards, not interpretation by multiple human readers requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is a 510(k) submission for a physical medical device (catheter introducer sheath), not an AI/ML-driven diagnostic or assistive technology. Therefore, no MRMC study, human reader improvement effect size, or human-in-the-loop performance is relevant or discussed.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This submission is for a physical device, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" for the tests described is based on established engineering standards for medical device performance, material science specifications, biocompatibility guidelines (e.g., ISO standards), and internal performance specifications derived from the predicate device characteristics. For example, "Valve leak" would have a maximum allowable leakage rate, which is the ground truth for that test.

8. Sample Size for the Training Set

Not applicable. This document describes a physical medical device, not a machine learning model, so there is no concept of a "training set" in this context.

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

Not applicable, as there is no training set mentioned.

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The [Reinforced Catheter Introducer System]* is indicated for use in arterial and venous procedures requiring percutaneous introduction of therapeutic or diagnostic intravascular devices.

The RCIS consists of a spiral reinforced sheath introducer and an appropriately sized dilator packaged in a tyvek/polymylar pouch.

Each reinforced introducer sheath features an integrated hemostasis valve system with a sideport extension and a 3-way stopcock. Fach introducer also has a radiopaque distal tip to aid the physician is correct placement of the device.

The RCIS dilator is lockable to the mating reinforced introducer sheath. The dilator has a straight curve configuration that extends approximately 2.5cm beyond the matching sheath when the dilator is locked to the sheath. The dilator is compatible with an up to 0.038" diameter guidewire.

This document is a 510(k) summary for the submission of a Reinforced Catheter Introducer System (RCIS) by Thomas Medical Products, Inc. It aims to demonstrate substantial equivalence to legally marketed predicate devices.

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

The provided document does not outline specific numerical acceptance criteria or quantitative performance metrics typically found in a study for a diagnostic AI device. Instead, it focuses on qualitative technological characteristics and claims substantial equivalence to predicate devices based on these features. The "acceptance criteria" here are implicitly the shared technological characteristics with the predicate devices.

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

This document describes a medical device (catheter introducer system), not an AI/diagnostic software. Therefore, there is no "test set" in the context of AI performance evaluation, and thus no information on sample size, data provenance, or data type for such a test set. The evaluation is based on a comparison of device features.

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. As noted above, this submission is for a physical medical device, not an AI/diagnostic software that requires expert-established ground truth.

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

Not applicable. This submission is for a physical medical device, not an AI/diagnostic software.

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 for a physical medical device, not an AI product. No MRMC study or comparative effectiveness study comparing human performance with and without AI assistance would be conducted for this type of submission.

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

Not applicable. This document is for a physical medical device, not an AI algorithm.

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

Not applicable. For a physical medical device like a catheter introducer, "ground truth" would relate to its physical properties, biocompatibility, sterility, and mechanical performance, which are evaluated through engineering tests, material analysis, and pre-clinical/clinical studies (though no full clinical study report is part of this 510(k) summary). The document indicates evaluation of "similar technological characteristics, and indications for use."

8. The sample size for the training set

Not applicable. This document is for a physical medical device, not an AI/machine learning model, so there is no training set.

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

Not applicable. As there is no AI/machine learning aspect, there is no training set and no ground truth establishment for it.

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The Sheath Introducer system is indicated for use in percutaneous introduction of catheters and other intravascular devices into the vasculature.

The materials of construction are consistent with introducers presently in Device Description. The product is available in 4 French to 9 French. The sheath lengths are 5cm to 110cm.

This document describes a 510(k) premarket notification for a Catheter Introducer. The information provided heavily focuses on substantial equivalence to predicate devices rather than a direct performance study with acceptance criteria.

The acceptance criteria described in the document are implicitly based on demonstrating that the Galt Medical Catheter Introducer is "substantially equivalent" to predicate devices. This means that its functionality and performance should be comparable to these existing, legally marketed devices.

Based on the provided text, there is no explicit statement of numerical acceptance criteria (e.g., minimum accuracy, sensitivity, or specificity thresholds) that would typically be seen for a device that relies on a direct performance evaluation against a defined ground truth. Instead, the "acceptance criteria" are met by demonstrating equivalence through non-clinical testing and shared technological characteristics and indications for use.

Here's an attempt to structure the information based on the request, acknowledging the limitations of the provided text for certain categories:

Acceptance Criteria and Device Performance

Study Proving Acceptance Criteria:

The study that proves the device meets the (implicit) acceptance criteria is a non-clinical comparative testing program and a review of technological characteristics against predicate devices.

Detailed Breakdown of Study Information:

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

   • Test Set Sample Size: Not explicitly stated. The tests mentioned are "tensile strength, and valve leakage," which would involve a certain number of manufactured units of the Galt Medical Catheter Introducer. However, the specific quantity is not reported.
   • Data Provenance: The tests were performed on the Galt Medical Catheter Introducer itself. There is no mention of external data or specific countries of origin beyond the company's location (Garland, TX). These were likely prospective tests performed on newly manufactured devices.

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

   • Not Applicable / Not Mentioned. For a device demonstrating substantial equivalence through non-clinical testing (tensile strength, valve leakage), "experts" for ground truth in the traditional sense (e.g., clinical diagnosis) are not required. The "ground truth" would be objective measurements of physical properties compared against established benchmarks or predicate device performance.

3. Adjudication method for the test set:

   • Not Applicable / Not Mentioned. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation (e.g., imaging, pathology). For non-clinical tests measuring physical properties, the results are quantitative and do not require expert adjudication to establish a "ground truth" among differing opinions.

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:

   • No. This is not an AI/imaging device. No MRMC study was conducted.

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

   • No. This is not an AI/algorithm device.

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

   • The "ground truth" for the non-clinical tests (tensile strength, valve leakage) would be objective physical measurements and engineering specifications for the device, benchmarked against the predicate devices' known performance or industry standards. It's not a clinical "ground truth" in the sense of diagnosis or patient outcomes.

7. The sample size for the training set:

   • Not Applicable. This is a physical medical device, not a machine learning model. There is no "training set."

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

   • Not Applicable. As there is no training set, this question is not relevant.

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The St. Jude Medical (SJM) Agilis™ Steerable Catheter Introducer is indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.

The Agilis™ Steerable Catheter Introducer set consists of a dilator, guidewire, and steerable sheath, 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 steerable introducer features distal vent holes to facilitate aspiration and minimize cavitation, and a radiopaque tip marker to improve fluoroscopic visualization. The device is provided sterile and is intended for single-use only.

The provided text is a 510(k) Summary for the Agilis™ Steerable Catheter Introducer. It includes information about the device, its intended use, and a comparison to predicate devices, but it does not contain any details about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or clinical study methodologies.

The document explicitly states: "Where dimensional and material differences exist between the proposed device and the predicate devices, mechanical and biocompatibility testing demonstrated that these differences do not adversely affect safety and effectiveness." This indicates that mechanical and biocompatibility testing were performed, but the details of these tests (e.g., acceptance criteria, specific results, sample sizes) are not provided in this summary.

Therefore, I cannot provide the requested information. The 510(k) Summary focuses on establishing substantial equivalence to a predicate device based on technological characteristics and general safety and effectiveness considerations, rather than detailing specific performance studies with acceptance criteria as typically found in clinical validation reports or more comprehensive technical documentation.

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The StealthStation® System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation® System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT or MR based model or fluoroscopy images of the anatomy.

Example procedures include, but are not limited to:

Cranial Procedures:
Cranial Biopsies Placement Tumor Resections Craniotomies/ Craniectomies Skull Base procedures Thalamotomies/Pallidotomies Pituitary Tumor Removal CSF Leak Repair Pediatric Catheter Shunt Placement General Catheter Shunt Placement

Spinal Procedures:
Spinal Implant Procedures, such as Pedicle Screw

ENT Procedures:
Transphenoidal Procedures Intranasal Procedures Orbital Nerve Decompression Procedures Optic Nerve Decompression Procedures Polyposis Procedures Endoscopic Dacryocystorhinostomy Encephalocele Procedures Sinus procedures, such as Maxillary Antrostomies, Ethmoidectomies, Sphenoidotomies/Sphenoid Explorations, Turbinate Resections.and Frontal Sinusotomies

Orthopedic Procedures:
Total Knee Arthroplasty (Primary and Revision) Unicompartmental Knee Arthroplasty Minimally Invasive Orthopedic Procedures Pediatric Orthopedics Total Hip Replacement (Primary and Revision) Periacetabular Osteotomies Tumor Resection and Bone/Joint Reconstruction Femoral Revision Stabilization and Repair of Pelvic Fractures (Including but not Limited to Acetabular Fractures)

This submission allows a surgeon an image guided instrument to place catheter shunts. The Catheter Introducer for the StealthStation® System is technically equivalent to the StealthStation® System. All systems use either active(LED's), passive reflective markers or electromagnetic coils to track surgical instruments in relation to an image guided reference frame. This information is correlated to the patient's CT, MR or fluoroscopic images of the anatomy.

The provided text is a 510(k) summary for a Catheter Introducer for the StealthStation® System. It describes the device, its indications for use, and a determination of substantial equivalence to predicate devices. However, it does not contain information about acceptance criteria, specific device performance metrics, or details of a study demonstrating fulfillment of such criteria.

The document primarily focuses on regulatory approval based on substantial equivalence, rather than a detailed performance study with defined acceptance criteria. Therefore, most of the requested information cannot be extracted from this text.

Here's a breakdown of what can and cannot be answered based on the provided input:

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

• Cannot be provided. The document does not define specific acceptance criteria (e.g., accuracy thresholds, failure rates) or report detailed device performance metrics from a study against such criteria. The "verification and validation activities" mentioned generally indicate testing was done but no specific results or targets are shared.

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

• Cannot be provided. The document does not describe a clinical study or a test set, hence no sample size, data provenance, or study design (retrospective/prospective) is available.

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)

• Cannot be provided. No information about ground truth establishment or experts involved is present, as no specific test set is detailed.

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

• Cannot be provided. No adjudication method is mentioned, as no test set or expert review process is described.

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

• Cannot be provided. This document is for a surgical navigation system, not an AI diagnostic tool. No MRMC study is mentioned, nor is there any AI component that would involve human readers improving with AI assistance.

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

• Cannot be provided. This device is an instrument for a surgical navigation system, which inherently involves human interaction (a surgeon using the instrument). The concept of "standalone" algorithm performance without human-in-the-loop is not applicable in this context.

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

• Cannot be provided. No ground truth type is mentioned as no specific performance study is detailed.

8. The sample size for the training set

• Cannot be provided. This document describes a medical device, not a machine learning model, so there is no concept of a "training set" in the context of this submission. "Verification and validation activities" were performed, but these are typically engineering tests, not machine learning model training.

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

• Cannot be provided. As there is no training set for a machine learning model, this question is not applicable.

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