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The AuST Steerable Sheath is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal or other peripheral placements. Do not use this device for neural placements.

The modified AuST Steerable Sheath is a single-use percutaneous catheter intended to provide a pathway through which diagnostic and therapeutic devices are introduced in the human vasculature. The catheter is not intended for neural placements.

The modified AuST Steerable Sheath product family consists of a variety of configurations to accommodate different anatomies and/or devices being introduced into the human vasculature. Each of the sheaths in the product family is comprised of a braid-reinforced catheter shaft, bi-directional deflectable segment, radiopaque distal tip, a handle with a 3-way stopcock for flushing and aspiration, and a hemostasis valve to prevent air and fluid leakage.

The provided FDA 510(k) Clearance Letter for the AuST Steerable Sheath (K251051) does not describe an AI/Software as a Medical Device (SaMD). Instead, it describes a physical medical device – a catheter introducer sheath.

Therefore, many of the requested criteria related to AI/SaMD performance studies, such as sample sizes for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, are not applicable to this type of device submission.

The clearance letter focuses on demonstrating substantial equivalence to a predicate physical device through engineering and performance testing rather than clinical effectiveness studies for an AI algorithm.

Here's an analysis based on the information provided for a physical medical device:

Acceptance Criteria and Device Performance for AuST Steerable Sheath (K251051)

Since this is a submission for a physical medical device (catheter introducer) and not an AI/SaMD, the "acceptance criteria" discussed are primarily related to general device safety and performance standards for such devices, demonstrating substantial equivalence to a predicate device. The study design described is engineering and bench testing, not a clinical trial involving patient data or expert interpretation of AI output.

1. Table of Acceptance Criteria and Reported Device Performance

The submission focuses on ensuring the modified device meets established safety and performance benchmarks for catheter introducers and is substantially equivalent to its predicate. The "acceptance criteria" are implied by the successful completion of the listed tests.

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

• Sample Size for Test Set: Not explicitly stated. The document mentions "test units representative of finished devices" for engineering tests. For physical device performance testing, sample sizes are typically determined by statistical methods for engineering verification, but specific numbers are not provided in this summary.
• Data Provenance: The data is generated from in-vitro (bench) testing of the manufactured medical device components and finished product, adhering to recognized standards (e.g., ISO, ANSI/AAMI). Since it's a physical device, there's no "country of origin of data" in the sense of patient data, nor is it retrospective or prospective clinical data.

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

This criterion is not applicable for this physical device. Ground truth, in the context of an AI/SaMD, refers to accurate diagnostic labels or measurements. For a physical device, "ground truth" is typically defined by engineering specifications, validated test methods, and industry standards. No human experts are described as establishing "ground truth" in this context.

4. Adjudication Method for the Test Set

This criterion is not applicable for this physical device. Adjudication methods (e.g., 2+1, 3+1) are common in clinical trials or AI performance evaluations where expert disagreement on ground truth or interpretation needs resolution. For engineering testing, adherence to a test protocol and meeting predefined specifications are the primary "adjudication."

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

No, an MRMC study was not done. MRMC studies are specific to evaluating the diagnostic performance of imaging systems or AI algorithms, often comparing human readers with and without AI assistance to measure reader improvement (effect size). This is a physical device, and such a study is not relevant.

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

No, this is not applicable. This is a physical medical device. "Standalone performance" refers to the performance of an AI algorithm without human input, which is not relevant to a catheter introducer sheath.

7. The Type of Ground Truth Used

The "ground truth" for this physical device is defined by:

• Engineering Specifications: The design parameters and performance characteristics that the device is designed to meet.
• Standard Test Methods: Validated methodologies (e.g., per ISO or AAMI standards) used to assess physical properties and performance (e.g., strength, leak resistance, dimensions, biocompatibility).
• Predicate Device Performance: The modified device is compared to a legally marketed predicate device (AuST Steerable Sheath, K242106), implying that the predicate's established performance serves as a benchmark for substantial equivalence.

8. The Sample Size for the Training Set

This criterion is not applicable. "Training set" refers to data used to train machine learning models. This device is a physical medical device, not an AI or software product.

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

This criterion is not applicable. As there is no AI component, there is no "training set" or ground truth establishment relevant to machine learning.

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The AuST Steerable Sheath is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal and other peripheral placements. Do not use this device for neural placements.

The modified AuST Steerable Sheath is a single-use percutaneous catheter intended to provide a pathway through which diagnostic and therapeutic devices are introduced in the human vasculature. The catheter is not intended for neural placements.

The modified AuST Steerable Sheath includes a longer catheter shaft, longer dilator, longer hydrophilic coating, modified hemostatic valve, and modified packaging.

The modified AuST Steerable Sheath product family consists of a variety of configurations to accommodate different anatomies and/or devices being introduced into the human vasculature. Each of the sheaths in the product family is comprised of a braid-reinforced catheter shaft, bidirectional deflectable segment, radiopaque distal tip, a handle with a 3-way stopcock for flushing and aspiration, and a hemostasis valve to prevent air and fluid leakage.

Here's a breakdown of the acceptance criteria and the study information based on the provided document:

The provided document is a 510(k) summary for a medical device (AuST Steerable Sheath) and does not describe a study involving an AI algorithm or human readers. It details the premarket notification process for a physical medical device, not a software or AI-driven diagnostic tool. Therefore, many of the requested points, such as expert consensus, MRMC studies, standalone algorithm performance, training set details, and specific performance metrics like sensitivity/specificity, are not applicable to this document.

The document primarily focuses on demonstrating substantial equivalence of a modified physical device to a previously cleared predicate device, rather than proving a diagnostic algorithm's performance.

Below is the information that can be extracted from the provided text, primarily focusing on the performance criteria for the device itself rather than AI performance.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a physical medical device (catheter introducer) and not an AI algorithm, the "acceptance criteria" are generally that the device passes specific engineering and safety tests, and performs as intended. Specific quantitative acceptance values are not always explicitly stated in this type of summary but are implied by meeting standard requirements.

Regarding AI-specific questions (2-9):

The provided document is a 510(k) premarket notification for a physical medical device (AuST Steerable Sheath), which is a catheter introducer. It does not describe an AI algorithm or a diagnostic study involving AI. Therefore, the following points are not applicable (N/A) to this document:

2. Sample size used for the test set and the data provenance: N/A (Not an AI study)
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (Not an AI study)
4. Adjudication method for the test set: N/A (Not an AI study)
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance: N/A (Not an AI study)
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: N/A (Not an AI study)
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): N/A (Not an AI study)
8. The sample size for the training set: N/A (Not an AI study)
9. How the ground truth for the training set was established: N/A (Not an AI study)

The performance data listed in the document (Section 1.7) refers to the physical and functional aspects of the steerable sheath itself, not the performance of an AI system.

Ask a specific question about this device

The AuST Steerable Sheath is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal and other peripheral placements. Do not use for neural placements.

The AuST Steerable Sheath is a single-use percutaneous catheter intended to provide a pathway through which diagnostic and therapeutic devices are introduced in the human vasculature. The catheter is not intended for neural placements.

The AuST Steerable Sheath product family consists of a variety of configurations to accommodate different anatomies and/or devices being introduced into the human vasculature. Each of the sheaths in the product family is comprised of a braid-reinforced catheter shaft, bidirectional deflectable segment, radiopaque distal tip, a handle with a 3-way stopcock for flushing and aspiration, and a hemostasis valve to prevent air and fluid leakage.

This looks like a 510(k) summary for a medical device. Based on the provided text, the device is a Catheter Introducer called the AuST Steerable Sheath.

Here's the analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a table of specific quantitative acceptance criteria for each performance test (e.g., "Tensile strength must be > X N"). Instead, it states that the device "passed" a series of tests. Therefore, the table below will list the tests performed and the reported outcome.

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

The document states, "All testing was performed on test units representative of finished devices." However, it does not specify the sample size for any of the individual tests.

Regarding data provenance: The studies are laboratory-based performance tests of the device itself, not human subject data. Therefore, concepts like "country of origin of the data" or "retrospective/prospective" don't directly apply in the usual clinical study sense. The testing would have been conducted by the manufacturer (CenterPoint Systems LLC) or a contract lab.

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

This information is not applicable and not provided for this type of device submission. The "ground truth" for catheter introducers is typically established by engineering specifications, international standards, and performance test methods, not by expert consensus on clinical images or diagnoses.

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

This is not applicable for this type of device and testing. Adjudication methods are typically used in studies involving human interpretation or clinical outcomes, where disagreements among experts need resolution. For physical device performance tests, the outcome is determined by objective measurements 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:

This is not applicable. The AuST Steerable Sheath is a physical medical device (catheter introducer), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study or AI-related effectiveness analysis would not be performed for this product.

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

This is not applicable as the device is not an algorithm or software. It is a physical medical device.

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

The "ground truth" for the performance tests of the AuST Steerable Sheath is based on engineering specifications, recognized international and national standards (e.g., ISO 10993-1, ANSI/AAMI/ISO 11135, ANSI/AAMI/ISO 11607-1), and the intended function of the device. For example, for a "Tensile test," the ground truth is a specific force value or range that the device must withstand without failure, as defined by its design and relevant standards.

8. The sample size for the training set:

This is not applicable. The device is not a machine learning model, so there is no "training set."

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

This is not applicable. There is no training set for this device.

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