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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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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. 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 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).

Here's an analysis of the provided text regarding the acceptance criteria and study for the Steerable Guide Catheter, structured according to your request:

Acceptance Criteria and Study for the Steerable Guide Catheter (K083793)

This 510(k) summary describes a traditional device submission. For such medical devices, "acceptance criteria" typically refer to the successful completion of a series of performance tests against pre-defined specifications rather than algorithmic performance metrics found in AI/ML submissions. Similarly, the "study" is a set of bench tests confirming the device's physical and functional properties. Since this is a physical medical device and not an AI/ML algorithm, many of the requested fields are not applicable (N/A) or have interpretations in the context of device engineering rather than software performance.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: The document does not specify the exact number of devices tested for each bench test (torque, bending, leakage, etc.). However, for mechanical performance testing of physical devices, multiple units are typically tested to establish statistical confidence in meeting design specifications.
• Data Provenance: The testing was conducted by the manufacturer, Evalve, Inc., in the United States (Menlo Park, CA). The study is prospective in the sense that the tests were designed and executed to validate the performance of the newly manufactured device according to its design specifications.

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

This question is not applicable to this type of device submission. For a steerable guide catheter, "ground truth" is established by engineering specifications and objective measurements (e.g., measuring torque values, bending angles, or leakage rates against defined thresholds) rather than expert consensus on medical images or clinical outcomes. The "experts" involved would be the design engineers, quality assurance personnel, and test technicians who developed and executed the test protocols.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods (like 2+1 or 3+1) are used for resolving disagreements among human reviewers (e.g., radiologists, pathologists) when establishing a ground truth for diagnostic studies. For mechanical and performance bench testing of a physical device, results are typically objective measurements against predefined acceptance criteria, and any discrepancies would be resolved through re-testing or investigation into the testing methodology or device.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging systems or AI algorithms where human reader performance is being evaluated, often with and without AI assistance. The Steerable Guide Catheter is a physical instrument, and its performance is assessed via bench testing, not human interpretation of data.

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

This question is not applicable. The Steerable Guide Catheter is a physical medical device, not an algorithm. Its performance is inherent in its physical properties and mechanical function, which were tested in a "standalone" fashion (i.e., the device itself was subjected to tests).

7. The Type of Ground Truth Used

The "ground truth" for this device is based on engineering specifications and objective physical measurements. For example:

• Torque: Measured in units like N·cm, with acceptance based on a defined range.
• Bending Range: Measured in degrees or specific angles, with acceptance based on the ability to achieve a certain steerability.
• Leakage: Measured by observing fluid passage under pressure, with acceptance based on the absence of leakage.
• Biocompatibility: Confirmed through established biological safety tests (e.g., ISO 10993 series) which have defined pass/fail criteria.
• Sterilization: Validated through standard microbiological methods (e.g., ISO 11137 for radiation sterilization) with defined sterility assurance levels (SAL).

This "ground truth" is not derived from expert consensus, pathology, or outcomes data in the medical sense, but rather from scientific and engineering principles applied to device design and manufacturing.

8. The Sample Size for the Training Set

This question is not applicable. The device is a physical medical instrument, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The design and manufacturing process are informed by engineering principles, material science, and prior device knowledge, but not by a data-driven training set.

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

This question is not applicable, as there is no training set for this physical medical device. The "ground truth" for its design and performance specifications would be established through:

• Engineering design requirements: Based on the intended use and predicate device characteristics.
• Regulatory standards: Adhering to relevant ISO standards for medical devices, biocompatibility, and sterilization.
• Pre-clinical testing: Early prototypes undergoing various tests to optimize design.

The overall submission demonstrates that the device's design, dimensional and physical characteristics met predetermined specifications and are substantially equivalent to existing predicate devices based on the bench testing performed.

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