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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 Rithm ID™ Electrophysiology Catheter can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.

The Rithm ID™ Electrophysiology Catheters have been designed to facilitate electrophysiological mapping of cardiac structures in 115 models and 17 kind of curves.

The catheter has a high-torque shaft with an array of platinum electrodes at the distal tip that can be used for recording. The high-torque shaft allows the plane of the distal curve to be manually rotated to assist in positioning the catheter tip at the desired site.

The Rithm IDM Electrophysiology Catheters have to connect with the EP by interface cables, model CI8RS04S, C25S04S, C18RS10S and C25RS10S with different trunk length, leadwire and equipment connector for the different Electrophysiology Catheters.

The provided text does not contain information about specific acceptance criteria, reported device performance metrics, or the details of a study demonstrating the device meets such criteria. Instead, it details a 510(k) submission for the "Rithm ID™ Electrophysiology Catheter," which focuses on establishing substantial equivalence to a predicate device.

Therefore, I cannot fulfill the request to provide:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test sets, data provenance, number of experts for ground truth, or adjudication methods for a test set.
3. Information about an MRMC comparative effectiveness study or its effect size.
4. Details of a standalone algorithm performance study.
5. The type of ground truth used.
6. Sample size for the training set or how its ground truth was established.

What the document does provide is:

• Non-Clinical Test Conclusions: The submission 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. These tests assessed compliance with various standards (IEC, ISO, ASTM) and included specific bench tests relating to the catheter's physical and electrical properties.
  • Bench Test 1: Surface, Dimensions, and Shape Keeping of Tip Curve
  • Bench Test 2: Buckling Force, Tip Fatigue, Shaft Fatigue, Torsional Strength, Tensile Strength, Connector Retention Force
  • Bench Test 3: Electrode Isolation, Electrode Conductor Resistance, Insulation Resistance
  • Bench Test 4: Corrosion Resistance and Radio-detectability
  • Bench Test 5: Freedom from leakage
  • Bench Test 6: Shape Keeping of Tip Curve, Electrode Conductor Resistance on Simulation Test
  • Bench Test 7: Acquiring Clear Intracardiac Electrograms Test
  • Bench Test 8: Stimulating Capability Test
• Clinical Test Conclusion: "No clinical study is included in this submission." This indicates that the device's clearance was based on demonstrating substantial equivalence through non-clinical testing and comparison to a predicate device, rather than through a clinical performance study.

The acceptance criteria here are implicitly linked to compliance with the listed standards and satisfactory performance in these bench tests, demonstrating similar characteristics and safety profiles to the predicate device. However, specific quantitative acceptance criteria or detailed performance metrics are not provided in this summary.

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