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The Delivery Catheter is indicated for the introduction of pacing and defibrillation leads to the right heart, inclusive of the Left Bundle Branch Area.

The subject Delivery Catheter (CPS Locator 3D Delivery Catheter) is a single-use percutaneous catheter intended for venous introduction of pacing or defibrillation leads.

The subject Delivery Catheter is packaged with a dilator for introduction into the vasculature. Proximally, the subject Delivery Catheter is equipped with a hemostatic valve, and the distal soft, rounded, radiopaque tip facilitates imaging under fluoroscopy. The subject Delivery Catheter is designed to be slittable, thereby allowing its removal after device placement. A variety of curves and lengths are available to accommodate various anatomies and different locations.

This FDA 510(k) clearance letter pertains to a medical device, not an AI/ML software. Therefore, the detailed acceptance criteria and study information requested, which are typical for AI/ML device evaluations, are not applicable in this context.

The document discusses the CPS Locator 3D Delivery Catheter, a physical medical device. The 510(k) process for such devices focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through performance testing (bench testing, biocompatibility, sterilization, etc.) and, in this case, some real-world usage data. It does not involve AI/ML performance metrics like sensitivity, specificity, or ground truth established by expert consensus for diagnostic accuracy.

Here's a breakdown of why many of your requested points are not applicable, followed by the information that can be extracted:

• Acceptance Criteria Table & Reported Performance: Not available in an AI/ML context. The document focuses on demonstrating the device's functional integrity and equivalence to a predicate.
• Sample Size (Test Set) & Data Provenance: Not applicable for an AI/ML test set. The clinical data mentioned is retrospective/real-world observational data on the previously cleared device.
• Number of Experts & Qualifications (Ground Truth): Not applicable as there's no diagnostic AI/ML algorithm requiring ground truth establishment by experts.
• Adjudication Method: Not applicable.
• MRMC Comparative Effectiveness Study: Not applicable.
• Standalone Performance: Not applicable as it's a physical catheter, not an AI/ML algorithm.
• Type of Ground Truth: Not applicable. The "ground truth" for a physical device is its functional performance and safety during use.
• Sample Size (Training Set): Not applicable as there's no AI/ML model to train.
• How Ground Truth for Training Set was Established: Not applicable.

Information that can be extracted from the provided document regarding the CPS Locator 3D Delivery Catheter:

The document describes the acceptance criteria and study to demonstrate substantial equivalence for a physical medical device, not an AI/ML system. Therefore, many of the requested fields related to AI/ML software evaluation are not directly applicable.

Here's a summary of the relevant information provided:

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

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

• Test Set (Bench/Performance Testing): Not explicitly stated as a separate "test set" for the new submission, but the document mentions "All testing was performed on test units representative of finished devices." The specific number of units for each bench test is not provided in this summary.
• Clinical Data (Real-World Evidence):
  • Post-market study: Data collected from 42 physicians at multiple US centers.
  • Retrospective Observational Study 1: Not explicitly stated sample size, but mentioned "patients."
  • Retrospective Observational Study 2: 66 patients.
  • HeartRhythm Publication: 8 patients.
• Data Provenance: Primarily United States (US) centers. The data is described as post-market, real-world observational, and retrospective from the previously cleared predicate device (K230363).

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

• Not Applicable. This is a physical medical device clearance, not an AI/ML diagnostic device requiring expert-established ground truth for performance metrics like sensitivity/specificity. The "ground truth" for the clinical data related to lead delivery success was based on actual surgical outcomes reported by physicians.

4. Adjudication method for the test set

• Not Applicable. No expert adjudication for an AI/ML algorithm's output was performed.

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, not an AI/ML system.

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

• Not Applicable. This is a physical medical device.

7. The type of ground truth used

• For the clinical data, the "ground truth" was based on observed clinical outcomes (e.g., successful lead delivery, achievement of LBBAP, reported complications/adverse events) as documented and reported by treating physicians and study investigators. This is akin to patient outcomes data in real-world settings.

8. The sample size for the training set

• Not Applicable. There is no AI/ML algorithm with a training set.

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

• Not Applicable. There is no AI/ML algorithm with a training set.

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The Delivery Catheter is indicated for the introduction of various types of catheters and pacing or defibrillator leads.

The modified Delivery Catheter (CPS Locator 3D Delivery Catheter) is a single-use percutaneous catheter indicated for the introduction of various types of catheters and pacing or defibrillation leads.

The modified Delivery Catheter is packaged with a dilator for introduction into the vasculature. Proximally, the modified Delivery Catheter is equipped with a hemostatic valve, and the distal soft, rounded, radiopaque tip facilitates imaging under fluoroscopy. The modified Delivery Catheter is designed to be slittable, thereby allowing its removal after device placement. A variety of curves and lengths are available to accommodate various anatomies and different locations.

This document describes the FDA 510(k) clearance for the CPS Locator 3D Plus Delivery Catheter, a medical device. Based on the provided text, the device is a percutaneous catheter used for introducing various types of catheters and pacing or defibrillator leads. The clearance is based on its substantial equivalence to a predicate device (CPS Locator 3D Delivery Catheter, K230363).

However, the provided text does not contain any information about an AI/ML-based device or any study that would typically be described with the requested criteria (e.g., sample sizes, expert adjudication, MRMC studies, ground truth establishment, training sets). The acceptance criteria mentioned are related to engineering and biological performance of a physical medical device (catheter) rather than the performance of an AI/ML algorithm.

Therefore, I cannot fulfill your request for information related to an AI/ML device's acceptance criteria and study data based on this document. The document describes a traditional medical device clearance, not an AI/ML software clearance.

**If your intention was to ask about the acceptance criteria and supporting studies for a physical medical device as described in the document, here is the information: **

1. Table of Acceptance Criteria and Reported Device Performance:

The document outlines performance tests conducted, implying these tests have acceptance criteria which the device met ("passed the following tests"). Specific quantitative acceptance criteria (e.g., "leak rate must be

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The Delivery Catheter is intended for the venous introduction of pacing or defibrillation leads.

The modified Delivery Catheter (FlexiGo 3D Delivery Catheter) is a single-use percutaneous catheter intended for venous introduction of pacing or defibrillation leads.

The modified Delivery Catheter is packaged with a dilator and two (2) trans vavular introducers for introduction into the vasculature. Proximally, the modified Delivery Catheter is equipped with a hemostatic valve, and the distal soft, rounded, radiopaque tip facilitates imaging under fluoroscopy. The modified Delivery Catheter is designed to be slittable, thereby allowing its removal after device placement. A variety of curves and lengths are available to accommodate various anatomies and different locations.

This document describes the FDA 510(k) Clearance Letter for the "FlexiGo 3D Delivery Catheter." This is a medical device, and the information provided details its intended use, comparison to a predicate device, and the performance data submitted for its clearance. However, the provided document does not contain any information related to an AI/ML (Artificial Intelligence/Machine Learning) device or study.

Therefore, I cannot provide a response that describes "Acceptance Criteria and the Study that Proves the Device Meets the Acceptance Criteria" in the context of an AI/ML device, nor can I fill in a table of acceptance criteria for an AI/ML device or discuss MRMC studies, training/test sets, or ground truth establishment relevant to AI/ML.

The provided text pertains to a traditional medical device (a catheter) and discusses its physical and functional characteristics, material compatibility, and standard medical device performance testing (biocompatibility, sterilization, dimensional verification, etc.).

To address your request, I would need a document describing an AI/ML medical device and its associated clinical study, statistical methodology, and performance metrics relevant to AI/ML algorithm evaluation.

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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 Delivery Catheter is intended for the venous introduction of pacing or defibrillation leads.

The modified Delivery Catheter (SSPC NXT Delivery Catheter) is a single-use percutaneous catheter intended for venous introduction of pacing or defibrillation leads. The modified Delivery Catheter is packaged with a dilator for introduction into the vasculature. Proximally, the modified Delivery Catheter is equipped with a hemostatic valve, and the distal soft, rounded, radiopaque tip facilitates imaging under fluoroscopy. The modified Delivery Catheter is designed to be slittable, thereby allowing its removal after device placement. A variety of curves and lengths are available to accommodate various anatomies and different locations.

The FDA 510(k) summary for the SSPC NXT Delivery Catheter (K243180) outlines performance testing to ensure substantial equivalence to its predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the numerical sample size for each specific test set. It mentions tests were performed on "test units representative of finished devices."

The provenance of the data is internal to the manufacturer (CenterPoint Systems LLC), as these are performance data generated to support the 510(k) submission. The type of study is a pre-market performance validation study for regulatory clearance. It is retrospective in the sense that the data is collected prior to the submission, but it's a prospective testing program for the purpose of demonstrating device safety and effectiveness.

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):

This information is not provided in the document. The document describes engineering and biological performance tests, not clinical studies involving human experts to establish ground truth in the context of diagnostic accuracy.

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

This information is not applicable to the type of performance testing described (engineering, mechanical, biocompatibility). These tests usually have objective pass/fail criteria based on standards and specifications, rather than requiring expert adjudication.

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:

No, an MRMC comparative effectiveness study was not done. This device is a delivery catheter, not an AI-assisted diagnostic or imaging 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 device is a physical medical device (catheter), not a software algorithm.

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

The "ground truth" for the performance tests described (biocompatibility, sterilization, mechanical, dimensional) are the established industry standards (e.g., ISO 10993-1, ISO 11137, ANSI/AAMI/ISO 11607-1) and internal design specifications for the device. For example, for tensile tests, the ground truth is the specified tensile strength the device must meet according to its design requirements.

8. The sample size for the training set:

Training set information is not applicable as this is a physical medical device, not a machine learning model requiring a training set.

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

Not applicable, as there is no training set for this device.

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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.

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The Dragonfly Pancreaticobiliary Scope is intended to provide direct visualization and to guide both optical and accessory devices for diagnostic and therapeutic applications during endoscopic procedures in the pancreaticobiliary system including the hepatic ducts.

The Dragonfly Digital Controller is intended to provide illumination power and receive, process and output images from the Dragonfly Pancreaticobiliary Scope for diagnostic applications during endoscopic procedures in the pancreaticobiliary system including the hepatic ducts.

The Dragonfly Instrument Channel Caps are used to cover the biopsy/suction channel inlet of an Olympus®, Fujifilm® or Pentax® duodenoscope. The Instrument Channel Caps are intended for exclusive use with the Dragonfly Pancreaticobiliary Scope to provide access for passage, while maintaining leakage of biomaterial from the biopsy port throughout the gastrointestinal endoscopic procedure.

The Dragonfly Pancreaticobiliary Scope is a sterile, single-use endoscope used for singleoperator per-oral 2holoangiopancreatoscopy. The Dragonfly Pancreaticobiliary System is comprised of two components: The Dragonfly Pancreaticobiliary Scope and the Dragonfly Digital Controller.

The Dragonfly Pancreaticobiliary Scope System is intended to provide direct visualization and to guide both optical and accessory devices for diagnostic and therapeutic applications during endoscopic procedures in the pancreaticobiliary system including the hepatic ducts. The Dragonfly Pancreaticobiliary Scope is a single-use catheter which provides direct visualization with a camera and illumination, and enables access and delivery of accessories to targeted pancreaticobiliary anatomy. The Dragonfly Pancreaticobiliary Scope comprises of a handle, a catheter, imaging and illumination elements, and a video connection mechanism. The Dragonfly Digital Controller is a reusable accessory which controls illumination and receives, processes, and outputs video signals from the Dragonfly Pancreaticobiliary Scope. The system does not treat or diagnosis conditions.

The Dragonfly Instrument Channel Caps, which are included in package with the Dragonfly Pancreaticobiliary Scope, are used to cover the opening to the biopsy/suction channel inlet of a Olympus®, Fujifilm® or Pentax® duodenoscope. The Instrument Channel Caps are intended for exclusive use with the Dragonfly Pancreaticobiliary Scope to provide access for passage, while maintaining insufflation and minimizing leakage of biomaterial from the biopsy port throughout the gastrointestinal endoscopic procedure.

This document is a 510(k) summary for the Dragonfly™ Pancreaticobiliary Scope, Digital Controller, and Instrument Channel Caps. As such, it focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study report of the new device's performance against specific acceptance criteria. This type of regulatory submission typically does not include the level of detail requested in your prompt regarding specific acceptance criteria, test set characteristics, expert involvement, or training data for AI/ML-based devices.

Based on the provided text, here's what can be extracted and what cannot:

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

The document lists performance tests conducted, implying that the device passed these tests. However, it does not explicitly state specific quantitative acceptance criteria for each test. Instead, it broadly states "All testing was performed on test units representative of finished devices. The device passed the following tests."

Here's a table based on the types of tests performed, as specific numerical acceptance criteria are not provided:

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

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 tests, nor does it provide information on data provenance (e.g., country of origin, retrospective/prospective nature). These tests are generally laboratory-based device performance tests, not clinical studies involving patient data.

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)

This information is not provided in the document. The listed tests are engineering and performance validation tests for a physical medical device, not AI/ML algorithm performance studies that would require expert-established ground truth. Expert involvement in defining test methods or interpreting results would be part of the manufacturer's internal quality system, but is not detailed here.

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

This information is not provided. Given the nature of the tests (engineering and device performance), formal adjudication methods like 2+1 or 3+1, which are common in clinical trial or AI model validation, are not typically applicable or detailed in this type of submission.

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

The document does not mention or imply that an MRMC comparative effectiveness study was done. The device is an endoscope system, not an AI-assisted diagnostic tool. Therefore, the question about human reader improvement with AI assistance is not relevant to this submission.

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

The document does not describe any standalone algorithm performance testing, as the device is a medical imaging and intervention tool, not an AI/ML algorithm.

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

For the physical device performance tests listed (e.g., dimensional verification, image quality, electrical safety), the "ground truth" is typically defined by engineering specifications, relevant international standards (e.g., ISO, IEC), and internal design requirements. This is not explicitly defined as expert consensus, pathology, or outcomes data in the context of this submission.

8. The sample size for the training set

This information is not provided. There is no indication in the document that the device incorporates an AI/ML component requiring a training set.

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

This information is not provided, as there is no mention of a training set or AI/ML components for which ground truth would need to be established.

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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 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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The ureteroscope is intended to be used to visualize organs, cavities and canals in the urinary tract (urethra, bladder, ureter, calyces and renal papillae) via transurethral or percutaneous access routes. It can also be used in conjunction with endoscopic accessories to perform various diagnostic and therapeutic procedures in the urinary tract.

The RenaNav Ureteroscope System is comprised of a single-use ureteroscope and a multi-use video processing unit (VPU). The RenaNav Single-Use Digital Flexible Ureteroscope is a sterile, single use device and is compatible with the multi-use System Video Processing Unit. The Ureteroscope is used by physicians to access, visualize, and perform procedures in the urinary tract. The flexible shaft of the ureteroscope includes one working channel which enables the delivery of therapeutic accessories and irrigation/ contrast solutions to the distal tip and desired anatomical location.

The provided text describes a 510(k) submission for the RenaNav Ureteroscope System, asserting its substantial equivalence to a predicate device (LithoVue System, K153049). It lists various performance tests conducted to assure this equivalence and functionality, but it does not include specific acceptance criteria values or the quantitative results of those tests. It also does not detail any comparative effectiveness studies (MRMC) with human readers or standalone algorithm performance, as the device is a medical instrument (ureteroscope) for visualization and procedures, not an AI/imaging analysis software.

Therefore, many of the requested details cannot be extracted from the given text. Below is an attempt to address the points based on the provided information, noting where information is absent.

1. Table of Acceptance Criteria and Reported Device Performance

The document lists performance tests, but it does not provide specific numerical acceptance criteria or the reported device performance for each metric. It generally states that "All test results met the requirements" or "The device passed the following tests."

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

The document states that "All testing was performed on test units representative of finished devices." However, it does not specify the exact sample size for each test (e.g., number of ureteroscopes tested). There is no mention of data provenance in terms of country of origin or whether testing was retrospective or prospective, as the tests relate to device performance rather than patient data.

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 therefore not provided in the document. The device is a ureteroscope for direct visualization and procedures, not an AI or imaging analysis system that generates diagnostic interpretations requiring expert ground truth for a test set. The "ground truth" for the device's performance would be established through engineering specifications and objective measurements (e.g., measuring dimensions, image quality metrics, deflection angles), not expert consensus on medical images.

4. Adjudication Method for the Test Set

This information is not applicable. As explained above, the tests are primarily engineering and functional assessments of the physical device, not an AI diagnostic system requiring adjudicated interpretations.

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

No such study was done or mentioned. This type of study is relevant for AI-powered diagnostic aids, not for a direct visualization medical device like a ureteroscope. The document focuses on demonstrating substantial equivalence to a predicate device through engineering and performance testing.

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

Not applicable. The device is a ureteroscope, a physical instrument for visualizing and performing procedures. It does not operate as a standalone algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the RenaNav Ureteroscope System's performance is established through engineering specifications, physical measurements, and industry standards (e.g., ISO, IEC). For example:

• Dimensional Verification: Measured against design specifications.
• Image Testing: Objectively measured against predefined optical and image quality parameters.
• Biocompatibility: Demonstrated through lab tests against ISO 10993-1.
• Electrical Safety & EMC: Verified against IEC 60601 series standards.

There is no "expert consensus, pathology, or outcomes data" as ground truth in the context of this device's performance testing for 510(k) clearance.

8. The Sample Size for the Training Set

Not applicable. The device is a physical medical instrument, not an AI model that requires a "training set."

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

Not applicable. As there is no AI model or training set, this question is not relevant.

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The Delivery Catheter is indicated for the introduction of various types of catheters and pacing or defibrillator leads.

The Delivery Catheter is a single-use percutaneous catheter intended to introduce various types of catheters and pacing or defibrillator leads. The Delivery Catheter is packaged with a dilator for introduction into the vasculature. Proximally, the Delivery Catheter is equipped with a hemostatic valve, and the distal soft, rounded, radiopaque tip facilitates imaging under fluoroscopy. The Delivery Catheter is designed to be slittable, thereby allowing its removal after device placement. The proposed modified Delivery Catheter include introduction of new models which incorporate different curves and lengths, which are available to accommodate various anatomies. The proposed Delivery Catheter has an inner diameter of 7F, an outer diameter of 9F, and the dilator is compatible with a 0.035" guidewire.

The provided text, a 510(k) summary for the CPS Locator 3D Delivery Catheter, does not contain the information requested about acceptance criteria or a study proving that an AI/device meets specific performance criteria.

This document describes a medical device (a delivery catheter) and its substantial equivalence to a predicate device, focusing on physical and functional characteristics, indications for use, and manufacturing/sterilization compliance, not on an AI-driven diagnostic or performance study.

Therefore, I cannot provide the requested information, which typically pertains to the validation of AI-based medical devices or diagnostic tools. The document's purpose is to demonstrate that the catheter itself is substantially equivalent to an already cleared device, not to present data on a new, AI-driven performance metric.

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