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The MitraClip G5 Steerable Guide Catheter is used for introducing various catheters into the left side of the heart through the interatrial septum.
The TriClip G5 Steerable Guide Catheter is used for introducing various catheters into the right side of the heart.

The MitraClip G5 Steerable Guide Catheter consists of a distal and proximal catheter shaft, a radiopaque tip ring, a handle with a steering knob, a hemostasis valve with a luer lock flush port, an atraumatic distal tip, and a Dilator with a single central lumen. The device provides a conduit to access the left atrium. The SGC's primary function is to dilate the atrial septum, maneuver to the target location above the mitral valve, and position the CDS. The MitraClip G5 Steerable Guide Catheter is provided sterile and for single use only.
The TriClip G5 Steerable Guide Catheter (including a dilator) consists of a distal and proximal catheter shaft, a radiopaque tip ring, a handle with a steering knob, a hemostasis valve with a luer lock flush port, an atraumatic distal tip, and a dilator with a single central lumen. The device provides a conduit into the right side of the heart. The TriClip G5 Steerable Guide Catheter is provided sterile and for single use only.
The MitraClip G5 Steerable Guide Catheter and TriClip G5 Steerable Guide Catheter are equivalent in terms of design, material, principle of operation, and sterilization method. There are minor differences in design to facilitate access to different areas of the heart.

This FDA 510(k) summary for the MitraClip G5 Steerable Guide Catheter and TriClip G5 Steerable Guide Catheter focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific clinical performance acceptance criteria through the kind of study typically associated with AI/software as a medical device (SaMD) clearances.

Therefore, many of the requested elements (e.g., sample size for test sets, number of experts for ground truth, MRMC studies, standalone algorithm performance, training set details) are not applicable or not provided in this document as it pertains to a physical medical device (catheter) and its inherent performance characteristics (e.g., tensile strength, steering performance), not an AI algorithm.

However, I can still extract the information regarding the device's acceptance criteria and the engineering and bench testing performed to demonstrate that the device meets its design specifications, as this is the "study" proving the device meets the acceptance criteria for a physical device.

Device: MitraClip G5 Steerable Guide Catheter and TriClip G5 Steerable Guide Catheter

Type of Device: Percutaneous Catheter (Class II)

Purpose of the Submission: Demonstrate substantial equivalence to legally marketed predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

For this physical device, "acceptance criteria" relate to engineering, material, and functional specifications, and "reported device performance" refers to the results of bench and biocompatibility testing. The document states that testing was "conducted to demonstrate that the MitraClip G5 Steerable Guide Catheter and TriClip G5 Steerable Guide Catheter met all performance specifications." While specific numerical performance values are not detailed in this summary, the categories of tests act as implicit acceptance criteria.

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

• Sample Size: Not explicitly stated for each test. For physical device testing, sample sizes are typically determined by statistical methods for each specific test (e.g., a certain number of catheters for tensile strength, a certain number of packaging samples).
• Data Provenance: This is an internal company study (Abbott Medical). The data would be from controlled laboratory and manufacturing environments. This is retrospective in the sense that the testing is performed on manufactured devices to confirm their design and production quality before submission. There is no patient-specific data or country-of-origin context in this type of submission.

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

• Not Applicable in the context of this device. Ground truth for a physical catheter (e.g., whether it has adequate tensile strength) is established by engineering specifications, validated test methods, and measurement equipment, not by expert consensus in a clinical setting.

4. Adjudication Method for the Test Set

• Not Applicable. Adjudication typically applies to expert assessments of medical images or clinical outcomes. For device performance testing, results are typically objective measurements, passing/failing criteria, or standardized biological responses.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not Applicable. This is a physical medical device (catheter), not an AI/software. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant.

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

• Not Applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

• For biocompatibility: Established by international standards (ISO 10993 series) and validated analytical/biological testing methods.
• For design verification: Established by engineering design specifications and validated bench test methods.
• For sterilization: Established by international standards (ISO 11135).
• For packaging: Established by international standards (ISO 11607 series).

8. The Sample Size for the Training Set

• Not Applicable. "Training set" refers to data used to train AI models. This is a physical device and does not involve an AI component.

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

• Not Applicable. As above, there is no "training set" for this physical device.

Summary for this specific document:

This FDA submission is for a conventional medical device (a steerable guide catheter) and focuses on demonstrating substantial equivalence to existing predicate devices. The "acceptance criteria" and "proof" primarily involve a battery of bench tests and biocompatibility assessments to ensure the device meets engineering specifications, is safe for its intended biological contact, and can be reliably sterilized and packaged. The methodologies described are standard for physical medical devices and do not involve the types of clinical performance studies, reader studies, or AI algorithm validation typically discussed for AI/SaMD submissions.

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The Steerable Guide Catheter is used for introducing various cardiovascular catheters into the right side of the heart.

The TriClip Steerable Guide Catheter (including a dilator) consists of a distal and proximal catheter shaft, a radiopaque tip ring, a handle with a steering knob, a hemostasis valve with a luer lock flush port, an atraumatic distal tip, and a dilator with a single central lumen. The device provides a conduit into the right side of the heart. The distal shaft is steered using a handle and knobs.

The TriClip Steerable Guide Catheter is compatible with devices (e.g., catheters) with a maximum diameter of 5.2 mm (0.204"), and the Dilator is compatible with devices (e.g., needles or guidewires) with a maximum diameter of 0.9 mm (0.035").

The TriClip Steerable Guide Catheter consists of materials including nylon, stainless steel, polycarbonate, PVP coating, silicone, urethane, PVC, and Pebax. The distal shaft has a hydrophilic coating to provide a lubricated surface for ease of insertion.

The TriClip Steerable Guide Catheter is provided EO sterile and for single use only.

The provided text is a 510(k) summary for the TriClip Steerable Guide Catheter, a medical device. It does not describe a study involving an AI/Machine Learning device or a diagnostic algorithm. Therefore, I cannot extract the information required to answer your questions as they pertain to such a study (e.g., acceptance criteria for an AI, sample sizes for test/training sets, ground truth establishment methods, expert qualifications, MRMC studies, standalone performance, etc.).

The document describes the device, its intended use, comparison to predicate devices, and the bench testing performed to demonstrate its safety and effectiveness. This testing includes:

• Biocompatibility: In accordance with ISO 10993-1, covering cytotoxicity, hemocompatibility, sensitization, irritation, acute systemic toxicity, and materials-mediated pyrogenicity.
• Design Verification (Bench Testing): Visual inspection, catheter dimensions, curves and steering performance, tensile strengths, torsional strengths, hemostasis, particulate evaluation, and shelf-life verification.
• Sterilization: EO sterilization to achieve a SAL of 10-6 per ISO 11135, and EO/ECH residuals assessment per ISO 10993-7.
• Packaging: Verification studies in compliance with ISO 11607-1 and ISO 11607-2.

Since the provided text does not contain the information requested about an AI/Machine Learning diagnostic device, I will state that the information is not present in the document.

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The Steerable Guide Catheter is used for introducing various catheters into the left side of the heart through interatrial septum.

The Steerable Guide Catheter (including a dilator) consists of a distal and proximal catheter shaft, a radiopaque tip ring, a handle with a steering knob, a hemostasis valve with a luer lock flush port, an atraumatic distal tip, and a dilator with a single central lumen. The device provides a conduit into the left side of the heart through the interatrial septum. The Steerable Guide Catheter is provided EtO sterile and for single use only.

This document is a 510(k) Premarket Notification from the FDA regarding a MitraClip G4 Steerable Guide Catheter. It focuses on establishing substantial equivalence to a predicate device, rather than proving the performance of a novel AI/ML-driven device against specified acceptance criteria using a study.

Therefore, the requested information regarding acceptance criteria, device performance tables, sample sizes for test and training sets, expert ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, and types of ground truth cannot be extracted from this document.

This document primarily discusses:

• Regulatory Classification: Class II device, product code DRA.
• Device Description: A steerable guide catheter, including a dilator, used for introducing other catheters into the left side of the heart through the interatrial septum.
• Predicate Device: K190167 Steerable Guide Catheter.
• Comparison of Technological Characteristics: Stating that the subject device has the "same technological characteristics" as the predicate device in terms of intended use, indications for use, principles of operation, fundamental technology, materials, dimensions, and sterilization. Minor design modifications and shelf-life changes are noted.
• Performance Data: Only states that "Testing was performed to support substantial equivalence, including: Performance Shelf Life." It does not provide details of these tests, specific acceptance criteria, or performance results.
• Conclusion: The device is equivalent to the predicate device, with no differences raising new safety or effectiveness questions.

In summary, this document is a regulatory approval letter based on substantial equivalence, not a study report detailing performance metrics against specific acceptance criteria for an AI/ML-driven medical device.

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The Steerable Guide Catheter is used for introducing various catheters into the left side of the heart through the interatrial septum.

The Steerable Guide Catheter consists of a Guide and a Dilator provided EtO sterile and for single use only. The Steerable Guide Catheter consists of a distal and proximal catheter shaft, a radiopaque tip ring, a handle with a steering knob, a hemostasis valve with a luer lock flush port, an atraumatic distal tip, and a Dilator with a single central lumen. The central lumen of the Guide allows for aspiration of air and infusion of fluids such as saline, and serves as a conduit during introduction and or exchange of the Dilator and ancillary devices (e.g. catheters) that have a maximum diameter of 0.204". The atraumatic distal tip of the Steerable Guide Catheter is radiopaque to allow visualization under fluoroscopy. The Dilator consists of a radiopaque shaft, an echogenic feature at the distal tip, a hemostasis valve with a flush port and an internal lumen designed to accept ancillary devices that have a maximum diameter of 0.035" (e.g. needles or guidewires). The Steerable Guide Catheter, Dilator and accessories are packaged in a tray that is individually pouched in a Tyvek/Nylon corner peel pouch, heat-sealed one time, and the single sealed pouch is placed into a cardboard nest and top-loading box.

The provided document is a 510(k) premarket notification letter and summary for a medical device called a "Steerable Guide Catheter." It is used for introducing various catheters into the left side of the heart through the interatrial septum.

This document describes a physical medical device, not an AI/ML powered device or a software as a medical device (SaMD). Therefore, the requested information regarding acceptance criteria and a study proving an AI device meets those criteria is not present.

The document states that the device is substantially equivalent to a legally marketed predicate device (K172394 Steerable Guide Catheter). This equivalence is based on:

• Intended use
• Indications for use
• Principles of operation
• Fundamental technology
• Similar or identical materials of composition, dimensions, and sterilization

The "Performance Data" section (number 15) lists general categories of testing performed to support substantial equivalence:

• Biocompatibility
• Sterilization
• Packaging
• Performance (general term, specific details for the physical device would be in the full submission)
• Shelf Life

Without specific details on the "Performance" testing, it's impossible to define "acceptance criteria" and "reported device performance" in the context you've requested (which implies numerical metrics for an algorithm).

Therefore, I cannot provide the requested table or answer the specific questions related to AI/ML device performance and studies, as this document pertains to a physical medical device with no mention of AI or software components.

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The Steerable Guide Catheter is used for introducing various cardiovascular catheters into the left side of the heart through the interatrial septum.

The Steerable Guide Catheter consists of a Guide and a Dilator provided EtO sterile and for single use only. The Steerable Guide Catheter consists of a distal and proximal catheter shaft, a radiopaque tip ring, a handle with a steering knob, a hemostasis valve with a luer lock flush port, an atraumatic distal tip, and a Dilator with a single central lumen. The central lumen of the Guide allows for aspiration of air and infusion of fluids such as saline, and serves as a conduit during introduction and or exchange of the Dilator and ancillary devices (e.g. catheters) that have a maximum diameter of .204". The atraumatic distal tip of the Steerable Guide Catheter is radiopaque to allow visualization under fluoroscopy. The Dilator consists of a radiopaque shaft, an echogenic feature at the distal tip, a hemostasis valve with a flush port and an internal lumen designed to accept ancillary devices that have a maximum diameter of 0.035" (e.g. needles or guidewires). The Steerable Guide Catheter, Dilator and accessories are packaged in a tray that is individually pouched in a Tyvek/Nylon corner peel pouch, heat-sealed one time, and the single sealed pouch is placed into a cardboard nest and top-loading box.

The subject 510(k) pertains to a design change to the Steerable Guide Catheter. The proposed change to the Steerable Guide Catheter consists of a design and processing modification to the internal feature of the tip ring component at the distal tip.

This document describes K172394, the Steerable Guide Catheter, which is a design modification to an existing device. The performance data section is brief, focusing on a single test.

Here’s a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the sample size used for the tensile strength evaluation or the process validation. It also does not mention the country of origin of the data or whether it was retrospective or prospective.

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

This information is not applicable and not provided in the document. The study involved physical testing of a medical device, not interpretation of data by human experts to establish ground truth.

4. Adjudication Method for the Test Set

This information is not applicable and not provided in the document. The study involved physical testing of a medical device, not expert adjudication.

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

No, an MRMC comparative effectiveness study was not done. The study described is a physical performance test (tensile strength and process validation) of a medical device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This is not applicable as the device is a physical catheter, not an algorithm or AI system. The performance testing was of the physical device itself.

7. The Type of Ground Truth Used

For the tensile strength evaluation, the "ground truth" would be the measured tensile strength values compared against predetermined engineering specifications (though these specifications are not explicitly stated in the provided text). For process validation, the "ground truth" would be consistent manufacturing output that meets specified performance metrics.

8. The Sample Size for the Training Set

This is not applicable, as there is no "training set" for physical device testing in the context of an algorithm or AI.

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

This is not applicable, as there is no "training set."

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The Steerable Guide Catheter is used for introducing various catheters into the left side of the heart through the interatrial septum.

The Steerable Guide Catheter consists of a Guide and a Dilator provided EtO sterile and for single use only. The Steerable Guide Catheter consists of a distal and proximal catheter shaft, a radiopaque tip ring, a handle with a steering knob, a hemostasis valve with a luer lock flush port, an atraumatic distal tip, and a Dilator with a single central lumen. The central lumen of the Guide allows for aspiration of air and infusion of fluids such as saline, and serves as a conduit during introduction and or exchange of the Dilator and ancillary devices (e.g. catheters) that have a maximum diameter of .204". The atraumatic distal tip of the Steerable Guide Catheter is radiopaque to allow visualization under fluoroscopy. The Dilator consists of a radiopaque shaft, an echogenic feature at the distal tip, a hemostasis valve with a flush port and an internal lumen designed to accept ancillary devices that have a maximum diameter of 0.035" (e.g. needles or guidewires). The Steerable Guide Catheter, Dilator and accessories are packaged in a tray enclosed in a sealed Tyvek pouch and boxed in a cardboard shelf-carton.

This document is a 510(k) premarket notification for a medical device called the "Steerable Guide Catheter." It aims to demonstrate substantial equivalence to previously marketed predicate devices. The information provided heavily focuses on regulatory compliance and comparison to predicates rather than detailed performance study results of the new device against specific acceptance criteria.

Therefore, many of the requested details about acceptance criteria and study data are not explicitly stated in the provided text. The document asserts that the new device "meets the same performance specifications as the predicate device" due to "equivalent in fundamental scientific design," but it doesn't present the acceptance criteria or a dedicated study for the new device as an individual entity.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, specific performance acceptance criteria for the new Steerable Guide Catheter (K161985) are not explicitly defined, nor are detailed quantitative performance results reported. The document states that the new device "meets the same performance specifications as the predicate device." This implies an equivalence rather than a separate set of criteria and direct test results for K161985.

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

The document does not specify a sample size for a test set or data provenance for a performance study of the new Steerable Guide Catheter (K161985). It makes a claim of equivalence to predicates without detailing newly generated test data.

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

Not applicable. The document does not describe a study involving expert assessment of generated data for the new device's performance.

4. Adjudication Method for the Test Set

Not applicable. The document does not describe a study that would require an adjudication method.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done according to the provided text. The submission focuses on substantial equivalence to predicate devices, not on comparative effectiveness with human readers.

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

Not applicable. This device is a physical medical instrument (catheter), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

Not explicitly stated in the context of performance testing for the new device. The submission relies on "technological characteristics such as design, material, and indications for use" being substantially equivalent to predicates. The "ground truth" for the submission is the regulatory acceptance of the predicate devices based on their established performance and safety profiles.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical instrument, not a machine learning model, so there is no "training set."

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

Not applicable. As above, there is no "training set" for a physical medical device.

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The Steerable Guide Catheter is used for introducing various cardiovascular catheters into the left side of the heart through the interatrial septum.

The Steerable Guide Catheter consists of a Steerable Guide Catheter (Guide) and a Dilator provided EO sterile and for single-use only. The Steerable Guide Catheter consists of a distal and proximal catheter shaft, a radiopaque tip ring, a handle with a steering knob, a hemostasis valve with a luer lock flush port, an atraumatic distal tip, and a Dilator with a single central lumen. The central lumen of the Guide allows for aspiration of air and infusion of fluids such as saline, and serves as a conduit during introduction and or exchange of the Dilator and ancillary devices (e.g. catheters) that have a maximum diameter of .204". The atraumatic distal tip of the Steerable Guide Catheter is radiopaque to allow visualization under fluoroscopy. The Dilator consists of a radiopaque shaft, an echogenic feature at the distal tip, a hemostasis valve with a flush port and an internal lumen designed to accept ancillary devices that have a maximum diameter of 0.035" (e.g. needles or guidewires). The Steerable Guide Catheter, Dilator and accessories are packaged in a tray enclosed in two sealed Tyvek pouches, and boxed in a cardboard shelf-carton.

The provided text does not contain information about acceptance criteria or a study proving that an AI-based device meets these criteria. Instead, it is a 510(k) summary for a Steerable Guide Catheter, a physical medical device, and its associated FDA clearance letter.

Therefore, I cannot extract the requested information regarding acceptance criteria, reported device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details, as these concepts are not applicable to the clearance of this type of physical device as presented in the document.

The document discusses bench testing for the physical device to demonstrate substantial equivalence to predicate devices, focusing on various performance characteristics related to the catheter's physical integrity and function (e.g., Guide Hemostasis, Tensile test, Torque test).

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The Evalve Steerable Guide Catheter is used for introducing various cardiovascular catheters into the left side of the heart through the interatrial septum.

The Steerable Guide Catheter consists of a Steerable Guide (Guide) and a Dilator provided EO sterile and for single-use only. The Steerable Guide Catheter consists of a distal and proximal catheter shaft, a radiopaque tip ring, a handle with a steering knob, a hemostasis valve with a luer lock flush port, a Dilator with a single central lumen and an atraumatic distal tip. The central lumen of the Guide allows for aspiration of air and infusion of fluids such as saline, and serves as a conduit during introduction and or exchange of the Dilator and ancillary devices (e.g. catheters) that have a maximum diameter of .204". The atraumatic distal tip of the Steerable Guide Catheter is radiopaque to allow visualization under fluoroscopy. The Dilator consists of a radiopaque shaft, an echogenic feature at the distal tip, a hemostasis valve with a flush port and an internal lumen designed to accept ancillary devices that have a maximum diameter of 0.035" (e.g. needles or guidewires). The Steerable Guide Catheter, Dilator and accessories are packaged in two sealed Tyvek pouches, and boxed in a shelf-cardboard carton.

The provided text describes a 510(k) premarket notification for a medical device called the "Evalve Steerable Guide Catheter." This submission focuses on demonstrating substantial equivalence to predicate devices primarily through bench testing of performance characteristics and biocompatibility.

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

Acceptance Criteria and Reported Device Performance

Study Details

1. Sample size used for the test set and the data provenance:
   The document does not specify the sample sizes for the functional, mechanical, packaging, or biocompatibility tests. It only states that "Bench testing demonstrated that the subject device met performance specifications." The data provenance is not explicitly mentioned as being from a specific country, but the submission is to the U.S. FDA, and the manufacturer is based in Menlo Park, CA, USA, implying the testing likely occurred in or for a U.S. context. All testing described is retrospective (bench testing of manufactured devices) rather than prospective clinical data.

2. 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 the described study is bench testing of a physical device, not related to expert evaluation of medical images or patient data. Ground truth for these tests would be objective measurements against predefined engineering specifications.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
   This is not applicable as there is no human interpretation or adjudication involved in the objective bench tests described.

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 MRMC study was performed. This submission is for a physical medical device (a catheter) and does not involve AI or human readers for diagnostic interpretation.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
   Not applicable. This submission is for a physical medical device and does not involve an algorithm or AI.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   For the bench tests, the ground truth would be pre-defined engineering specifications, material standards, and industry-accepted testing methodologies for device performance (e.g., tensile strength values, force to bend within a certain range, biochemical test results).

7. The sample size for the training set:
   Not applicable. This submission is for a physical medical device and does not involve an AI algorithm with a training set.

8. How the ground truth for the training set was established:
   Not applicable. As there is no AI algorithm, there is no training set or ground truth for a training set.

In summary, the provided document describes a 510(k) submission for a steerable guide catheter, demonstrating substantial equivalence to predicate devices through a series of bench tests. The "study" is a compilation of these bench tests, which objectively evaluate the physical and functional properties of the device against engineering specifications and biocompatibility requirements. It does not involve clinical trials, human subject data, or AI components.

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The Evalve Steerable Guide Catheter is used for introducing various cardiovascular catheters into the left side of the heart through the interatrial septum.

The Steerable Guide Catheter consists of a Steerable Guide (Guide) and a Dilator provided EO sterile and for single-use only. The Steerable Guide Catheter consists of a distal and proximal catheter shaft, a radiopaque tip ring, a handle with a steering knob, a hemostasis valve with a luer lock flush port, a Dilator with a single central lumen and an atraumatic distal tip. The central lumen of the Guide allows for aspiration of air and infusion of fluids such as saline, and serves as a conduit during introduction and or exchange of the Dilator and ancillary devices (e.g. catheters) that have a maximum diameter of .204". The atraumatic distal tip of the Steerable Guide Catheter is radiopaque to allow visualization under fluoroscopy. The Dilator consists of a radiopaque shaft, an echogenic feature at the distal tip, a hemostasis valve with a flush port and an internal lumen designed to accept ancillary devices that have a maximum diameter of 0.035" (e.g. needles or guidewires). The Steerable Guide Catheter and Dilator are packaged in two sealed Tyvek pouches, and boxed in a shelf-cardboard carton.

The provided text describes a 510(k) submission for a medical device called the "Evalve Steerable Guide Catheter." This document primarily focuses on demonstrating "substantial equivalence" to predicate devices through bench testing. It does not describe an AI/ML-enabled device or a clinical study that proves the device meets specific performance criteria in a clinical setting with human readers.

Therefore, many of the requested elements are not applicable to the provided text.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in a table format that would typically be found for an AI/ML device's performance. Instead, it refers to "performance specifications" being met through bench testing. The general acceptance criterion implied is "substantial equivalence" to predicate devices, meaning it performs as well or better.

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

Not applicable. The study described is bench testing of a physical medical device, not an AI/ML algorithm evaluated on a data set. There is no "test set" in the context of image data.

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

Not applicable. This device is not an AI/ML algorithm requiring expert-established ground truth on a test set.

4. Adjudication Method for the Test Set

Not applicable. No test set of data with ground truth requiring adjudication is mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No. This document does not mention an MRMC study or any study involving human readers or AI assistance.

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

Not applicable. This is not an algorithm. The device is a physical catheter.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by bench testing against predetermined engineering specifications and comparison to the performance of predicate devices. This involves physical measurements and observations of the catheter's properties (e.g., steerability, lumen patency, material integrity, etc.) rather than medical ground truth like pathology or outcomes data.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML algorithm. There is no "training set."

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

Not applicable. This is not an AI/ML algorithm. There is no "training set" or corresponding ground truth.

Summary of the Study:

The "study" referenced in this document is a series of bench tests (laboratory testing) conducted on the physical "Evalve Steerable Guide Catheter." The purpose of these tests was to demonstrate that the device meets its own performance specifications and is "substantially equivalent" to two previously cleared predicate devices (K083793 and K091596). This approach is standard for 510(k) submissions of non-AI/ML medical devices where clinical efficacy studies may not be required if substantial equivalence to a legally marketed device can be shown through non-clinical means.

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The Evalve Steerable Guide Catheter is used for introducing various cardiovascular catheters into the left side of the heart through the interatrial septum.

The Steerable Guide Catheter consists of a Steerable Guide (Guide) and a Dilator provided EO sterile and for single-use only. The Steerable Guide Catheter consists of a distal and proximal catheter shaft, a radiopaque tip ring, a handle with a steering knob, a hemostasis valve with a luer lock flush port, a Dilator with a single central lumen and an atraumatic distal tip. The central lumen of the Guide allows for aspiration of air and infusion of fluids such as saline, and serves as a conduit during introduction and or exchange of the Dilator and ancillary devices (e.g. catheters) that have a maximum diameter of .204". The atraumatic distal tip of the Steerable Guide Catheter is radiopaque to allow visualization under fluoroscopy. The Dilator consists of a radiopaque shaft, an echogenic feature at the distal tip, a hemostasis valve with a flush port and an internal lumen designed to accept ancillary devices that have a maximum diameter of 0.035" (e.g. needles or guidewires). The Steerable Guide Catheter and Dilator are packaged in two sealed Tyvek pouches, and boxed in a shelf-cardboard carton.

I am sorry, but the provided text does not contain the information required to populate the acceptance criteria table or describe a study that proves the device meets specific acceptance criteria in the context of AI/ML performance.

The document is a 510(k) summary for a Steerable Guide Catheter, a physical medical device, not a software or AI/ML device. Therefore, it does not discuss:

• Acceptance criteria in terms of AI/ML performance metrics (like sensitivity, specificity, AUC).
• Any studies involving test sets, training sets, data provenance, ground truth establishment by experts, adjudication methods, or MRMC studies for AI/ML performance.

The "in vitro tests" mentioned in the document (overall dimensions, bend test, guide-to-dilator transition test, Echogenicity, and Radiopacity) are related to the physical characteristics and functionality of the catheter itself, not to the performance of any AI/ML algorithm.

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