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EnSite™ X EP System

The EnSite™ X EP System is a suggested diagnostic tool in patients for whom electrophysiology studies have been indicated.

The EnSite™ X EP System provides information about the electrical activity of the heart and displays catheter location during conventional electrophysiological (EP) procedures.

EnSite™ X EP System Contact Force Software License

When used with the TactiSys™ Quartz Equipment, the EnSite™ X EP System Contact Force Module is intended to provide visualization of force information from compatible catheters.

EnSite™ X EP System Surface Electrode Kit

The EnSite™ X EP Surface Electrode Kit is indicated for use with the EnSite™ X EP System in accordance with the EnSite™ X EP System indications for use.

The EnSite™ X EP System is a catheter navigation and mapping system. A catheter navigation and mapping system is capable of displaying the 3-dimensional (3-D) position of conventional and Sensor Enabled™ (SE) electrophysiology catheters, as well as displaying cardiac electrical activity as waveform traces and as three-dimensional (3D) isopotential and isochronal maps of the cardiac chamber.

The contoured surfaces of the 3D maps are based on the anatomy of the patient's own cardiac chamber. The system creates a model by collecting and labeling the anatomic locations within the chamber. A surface is created by moving a selected catheter to locations within a cardiac structure. As the catheter moves, points are collected at and between all electrodes on the catheter. A surface is wrapped around the outermost points.

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The EnSite X EP System is a suggested diagnostic tool in patients for whom electrophysiology studies have been indicated.

The EnSite X EP System provides information about the electrical activity of the heart and displays catheter location during conventional electrophysiological procedures.

The EnSite™ X EP System is a catheter navigation and mapping system. A catheter navigation and mapping system is capable of displaying the 3-dimensional (3-D) position of conventional and Sensor Enabled™ (SE) electrophysiology catheters, as well as displaying cardiac electrical activity as waveform traces and as three-dimensional (3D) isopotential and isochronal maps of the cardiac chamber.

The contoured surfaces of the 3D maps are based on the anatomy of the patient's own cardiac chamber. The system creates a model by collecting and labeling the anatomic locations within the chamber. A surface is created by moving a selected catheter to locations within a cardiac structure. As the catheter moves, points are collected at and between all electrodes on the catheter. A surface is wrapped around the outermost points.

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The EnSite X EP System is a suggested diagnostic tool in patients for whom electrophysiology studies have been indicated.

The EnSite X EP System provides information about the electrical activity of the heart and displays catheter location during conventional electrophysiological procedures.

The EnSite™ X EP System is a catheter navigation and mapping system. A catheter navigation and mapping system is capable of displaying the 3-dimensional (3-D) position of conventional and Sensor Enabled™ (SE) electrophysiology catheters, as well as displaying cardiac electrical activity as waveform traces and as three-dimensional (3D) isopotential and isochronal maps of the cardiac chamber.

The contoured surfaces of the 3D maps are based on the anatomy of the patient's own cardiac chamber. The system creates a model by collecting and labeling the anatomic locations within the chamber. A surface is created by moving a selected catheter to locations within a cardiac structure. As the catheter moves, points are collected at and between all electrodes on the catheter. A surface is wrapped around the outermost points.

The provided FDA 510(k) clearance letter for the EnSite™ X EP System (K251234) details the device's regulatory pathway and general testing conducted. However, it does not contain the specific information required to populate a table of acceptance criteria and reported device performance. It focuses on the regulatory aspects, substantial equivalence to a predicate device, and the general types of testing performed (e.g., software verification, amplifier design verification, system design validation) to demonstrate that the device meets user requirements and its intended use.

The document states: "Design verification activities were performed and met their respective acceptance criteria to ensure that the devices in scope of this submission are substantially equivalent to the predicate device." However, the specific acceptance criteria (e.g., a numerical threshold for accuracy or precision) and the reported device performance values against those criteria are not presented in this public clearance letter.

Similarly, the letter does not provide details regarding:

• Sample sizes used for test sets (beyond stating "design verification" and "system design validation" were performed).
• Data provenance (country of origin, retrospective/prospective).
• Number of experts, their qualifications, or adjudication methods for establishing ground truth for any test set.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or any effect size for human readers.
• Whether standalone (algorithm-only) performance was assessed.
• The type of ground truth used (expert consensus, pathology, outcomes data).
• The sample size for the training set.
• How ground truth for the training set was established.

This type of detailed performance data is typically found within the confidential 510(k) submission itself, not routinely published in the public clearance letter.

Therefore,Based on the provided FDA 510(k) clearance letter for the EnSite™ X EP System, the following information can be extracted regarding the device's acceptance criteria and the study that proves it meets those criteria:

Key Takeaway: The provided FDA 510(k) clearance letter asserts that acceptance criteria were met through various design verification and validation activities, demonstrating substantial equivalence to a predicate device. However, it does not disclose the specific numerical acceptance criteria or the quantitative results of the device's performance against those criteria. The details below are based on what is stated or can be inferred from the document.

1. Table of Acceptance Criteria and Reported Device Performance

As per the provided document, specific numerical acceptance criteria and reported device performance data are not explicitly stated or detailed. The document generally states:

"Design verification activities were performed and met their respective acceptance criteria to ensure that the devices in scope of this submission are substantially equivalent to the predicate device."

And

"System Design Validation to confirm the system could meet user requirements and its intended use after modifications"

Without specific numerical cut-offs or performance metrics (e.g., accuracy, precision, error rates), a table cannot be populated as requested. The clearance indicates that internal testing demonstrated the device met pre-defined acceptance criteria, but those criteria and the actual performance results are not publicly available in this document.

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

• Sample Size Used for Test Set: Not specified in the provided document. The document mentions "Design verification activities" and "System Design Validation" but does not give the number of cases, patients, or data points used for these tests.
• Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not specified in the provided document.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.
  • (It's common for electrophysiology systems that ground truth would be established by electrophysiologists, but this document does not confirm that.)

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified. (e.g., 2+1, 3+1, none)

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

• MRMC Study: No indication that an MRMC comparative effectiveness study was performed or required for this 510(k) clearance. The focus of this submission is on substantial equivalence to a predicate device, which often relies on non-clinical testing for software updates or minor changes, rather than clinical efficacy studies comparing human readers with and without AI assistance.
• Effect Size of Human Readers Improvement with AI vs. Without AI Assistance: Not applicable/Not provided, as an MRMC study is not mentioned.

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

• Standalone Performance: The document describes "Software Verification at unit, software and system level" and "Amplifier Design Verification," which are types of standalone-like algorithmic or component-level testing. However, the exact metrics and results for pure "algorithm-only" performance (e.g., for automated mapping or analysis features if present) are not detailed. The system is described as a "diagnostic tool" that "provides information" and "displays catheter location," implying human interaction is integral.

7. The Type of Ground Truth Used

• Type of Ground Truth: Not explicitly stated. Given the nature of an EP system, ground truth would likely involve a combination of:
  • Validated phantom models: For physical accuracy of catheter tracking and mapping.
  • Clinical expert consensus: For validating the interpretation of electrical activity and the accuracy of generated 3D maps or anatomical models.
  • Reference measurements: From other validated systems or direct measurements during testing.
  • The document implies ground truth was used for "Design verification" and "System Design Validation," which "confirm the system could meet user requirements."

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable/Not specified. This 510(k) is for a software update (v5.0) to an existing system (EnSite™ X EP System, predicate K242016). The document describes changes related to compatibility with new catheters and ultrasound systems, rather than the development of entirely new AI/ML algorithms requiring a "training set" in the conventional sense of deep learning. While software is involved, the primary testing discussed is verification and validation, not model training.

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

• Ground Truth for Training Set Establishment: Not applicable/Not specified, as the document does not indicate the use of a "training set" in the context of machine learning model development. The 'ground truth' concept would apply more to the test and validation steps, as discussed in point 7.

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The Hi-Torque Command™ 14 ST Guide Wire and Hi-Torque Command™ 14 MT Guide Wire are indicated to facilitate the placement of balloon dilatation catheters during percutaneous transluminal angioplasty (PTA), in arteries such as the femoral, popliteal and infra-popliteal arteries. The guide wires may also be used with compatible stent devices during therapeutic procedures.

The guide wires may also be used to reach and cross a target lesion, provide a pathway within the vessel structure, facilitate the substitution of one diagnostic or interventional device for another, and to distinguish the vasculature.

The Hi-Torque Command™ 14 ST Guide Wire (guide wire with short taper) and Hi-Torque Command™ 14 MT Guide Wire (guide wire with medium taper) have a maximum diameter of 0.0144" (0.366 mm) and are provided in 210 cm and 300 cm lengths. The distal tip of the guide wire is available as a straight tip or an angled tip, both of which are shapeable.

The provided FDA 510(k) clearance letter pertains to guide wires, which are physical medical devices, not AI/software systems. Therefore, the questions related to AI/software performance (e.g., ground truth establishment, MRMC studies, training/test sets, expert adjudication) are not applicable to this document.

For a physical device like a guide wire, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" refer to non-clinical performance testing to demonstrate that the device performs as intended and is substantially equivalent to a predicate device, ensuring its safety and effectiveness.

Here's an analysis based on the provided document for the guide wires:

Analysis of Acceptance Criteria and Performance for Abbott Medical Guide Wires (K250552)

The substance of this 510(k) clearance is that the subject devices are identical to predicate devices, and the submission is primarily for a labeling change. This means extensive new performance testing demonstrating equivalence to a new set of criteria beyond what was already established for the predicate is not explicitly detailed as part of "new" acceptance criteria in this document. Instead, the testing listed serves to confirm that the labeling changes do not negatively impact the device's safe and effective use, and that the subject device remains substantially equivalent to its predicate.

Given that the device design, materials, and technological characteristics are identical between the subject and predicate devices, the "acceptance criteria" for this specific 510(k) are implicitly tied to confirming that the existing performance characteristics (established for the predicate) are maintained and that the labeling changes introduce no new risks or compromises to performance.

1. Table of Acceptance Criteria and Reported Device Performance

Since this 510(k) is for a device identical to its predicate and addressing labeling changes, the "acceptance criteria" are implied to be meeting established performance standards for guide wires and demonstrating no negative impact from labeling updates. Actual numerical performance data is not typically a part of the publicly available 510(k) summary, but rather part of the internal design verification and validation report submitted to the FDA.

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

• Sample Size: The document does not specify the sample sizes used for each of the non-clinical tests (Friction, Kink resistance, etc.). These details are typically found in the full test reports submitted to the FDA, not in the 510(k) summary.
• Data Provenance: The document does not specify the country of origin of the data. For physical device performance testing, this often occurs in internal labs or contract research organizations. It is inherently prospective for the specific tests performed to support the 510(k) submission, as new data is generated to demonstrate compliance.

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

This question is not applicable. For physical device testing (mechanical, durability, etc.), "ground truth" is established by direct measurement against engineering specifications and industry standards, not by expert human interpretation like in medical imaging AI.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods (like 2+1, 3+1) are relevant for subjective human interpretations of data, such as medical image readings, typically in AI/software performance studies. They are not used for objective physical device performance testing.

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 software or imaging systems, often comparing human readers with and without AI assistance. This is a physical guide wire, so such a study is irrelevant.

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

This question is not applicable. "Standalone performance" refers to the performance of an algorithm or software system without human interaction. This document describes a physical medical device.

7. The Type of Ground Truth Used

For physical device testing, the "ground truth" is based on:

• Engineering Specifications: The design parameters and tolerances the device is intended to meet.
• Industry Standards: Recognized standards for guide wire performance (e.g., ISO, ASTM).
• Predicate Device Performance: The established, acceptable performance of the legally marketed predicate device.
  Data from the listed tests (Friction, Kink resistance, etc.) are measured and compared against these objective criteria.

8. The Sample Size for the Training Set

This question is not applicable. "Training set" refers to data used to train AI models. This document describes a physical medical device.

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

This question is not applicable for the same reason as above.

In summary, the provided 510(k) clearance letter is for a physical medical device (guide wires) that is stated to be identical in design, materials, and characteristics to a legally marketed predicate device, with the clearance primarily relating to labeling changes. Therefore, the "acceptance criteria" and "proof" focus on demonstrating that these labeling changes do not adversely affect the device's established safety and performance, and that the device remains substantially equivalent to its predicate through standard non-clinical performance testing. The concepts of AI/software-specific studies, ground truth establishment by experts, and training/test sets are not relevant to this type of device and clearance.

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ViewFlex™ Xtra ICE Catheter
The ViewFlex™ Xtra ICE Catheter is indicated for use in adult and adolescent pediatric patients to visualize cardiac, structures, blood flow and other devices within the heart.

ViewFlex™ Eco Reprocessed ICE Catheter
The ViewFlex™ Eco Reprocessed Catheter is indicated for use in adult and adolescent pediatric patients to visualize cardiac structures, blood flow and other devices within the heart.

Advisor™ HD Grid Mapping Catheter, Sensor Enabled™
The Advisor™ HD Grid Mapping Catheter, Sensor Enabled™, is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart.

Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™
The Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™, is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart.

Agilis™ NxT Steerable Introducer
The Agilis™ NxT Steerable Introducer is indicated for the introduction of various cardiovascular catheters into the heart, including the left side of the heart, during the treatment of cardiac arrhythmias.

Agilis™ NxT Steerable Introducer Dual-Reach™
The Agilis™ NxT Steerable Introducer Dual-Reach™ is indicated for the introduction of various cardiovascular catheters into the heart, including the left side of the heart, during the treatment of cardiac arrhythmias.

The Agilis™ NxT Steerable Introducer Dual-Reach™ is a sterile, single-use device that con-sists of a dilator and steerable introducer, which is designed to provide flexible catheter positioning in the cardiac anatomy. The inner diameter of the steerable introducer is 13F. The steerable introducer includes a hemostasis valve to minimize blood loss during catheter intro-duction and/or exchange. It has a sideport with three-way stopcock for air or blood aspiration, fluid infusion, blood sampling, and pressure monitoring. The handle is equipped with a rotating collar to deflect the tip clockwise ≥180° and counterclockwise ≥90°. The steerable introducer features distal vent holes to facilitate aspiration and minimize cavitation and a radiopaque tip marker to improve fluoroscopic visualization.

This FDA 510(k) clearance letter (K251211) and its accompanying 510(k) summary pertain to a change in workflow for several existing cardiovascular catheters, specifically allowing for a "Zero/Low Fluoroscopy Workflow."

The key phrase here is "Special 510(k) – Zero/Low Fluoroscopy Workflow". This type of submission is for modifications to a previously cleared device that do not significantly alter its fundamental technology or intended use, but rather introduce a change in how it's used or processed.

Crucially, this submission does NOT describe a new AI/software device that requires extensive performance testing against acceptance criteria in the manner you've outlined for AI/ML devices. Instead, it's about demonstrating that existing devices, when used with a new, less-fluoroscopy-dependent workflow, remain as safe and effective as before.

Therefore, many of the questions you've asked regarding acceptance criteria, study details, ground truth, and expert adjudication are not applicable to the information provided in this 510(k) document. The document explicitly states:

• "Bench-testing was not necessary to validate the Clinical Workflow modifications."
• "Substantial Equivalence of the subject devices to the predicate devices using the zero/low fluoroscopy workflow has been supported through a summary of clinical data across multiple studies in which investigators used alternative visualization methods."

This indicates that the "study" proving the device (or rather, the new workflow) meets acceptance criteria is a summary of existing clinical data where alternative visualization methods were already employed, rather than a prospective, controlled study of a new AI algorithm.

Based on the provided document, here's what can be answered:

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

• Acceptance Criteria: The implicit acceptance criterion is that the devices, when used with "zero/low fluoroscopy workflow," maintain substantial equivalence to their predicate devices in terms of safety and effectiveness. This means they must continue to perform as intended for visualizing cardiac structures, blood flow, mapping, or introducing catheters.
• Reported Device Performance: The document states that "Substantial Equivalence... has been supported through a summary of clinical data across multiple studies in which investigators used alternative visualization methods." This implies that the performance (e.g., adequate visualization, successful mapping, successful catheter introduction) was maintained. Specific quantitative metrics of performance (e.g., accuracy, sensitivity, specificity, or inter-reader agreement for a diagnostic AI) are not provided or applicable here as this is not an AI/ML diagnostic clearance.

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

• Sample Size: Not specified. The document refers to "a summary of clinical data across multiple studies." This suggests an aggregation of results from existing (likely retrospective) patient data where alternative visualization techniques (allowing for "zero/low fluoroscopy") were already utilized clinically. It's not a new, single, prospectively designed test set for an AI algorithm.
• Data Provenance: Not specified regarding country of origin or specific patient demographics. It is implied to be clinical data collected from studies where these types of procedures were performed using alternative visualization. The data would be retrospective as it's a "summary of clinical data" that already exists.

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

• Not applicable in the context of this 510(k). Ground truth in an AI/ML context typically refers to adjudicated labels for images or signals. Here, the "ground truth" is inferred from standard clinical practice and outcomes in the historical data summarized. There's no mention of a specific expert panel for new ground truth establishment for a diagnostic AI.

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

• Not applicable. This is not a study requiring adjudication of diagnostic outputs by multiple readers.

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. This is not an AI-assisted diagnostic device. The workflow change is about using alternative non-fluoroscopic imaging modalities (e.g., intracardiac echocardiography, electro-anatomical mapping systems), not about AI improving human reader performance.

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

• No. This is not an AI algorithm. The predicate devices are physical catheters.

7. The type of ground truth used:

• The "ground truth" is inferred from clinical outcomes and established clinical practice using the devices with alternative visualization methods in real-world scenarios. It's not a specific, adjudicated dataset for an AI algorithm. The performance of the devices (such as successful navigation, visualization, and mapping) under the "zero/low fluoroscopy" workflow is assumed to be equivalent to their performance under full fluoroscopy, as demonstrated by prior clinical use where such methods were employed.

8. The sample size for the training set:

• Not applicable. There is no AI model being trained discussed in this document.

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

• Not applicable. No training set for an AI model.

In summary:

This 510(k) is for a workflow modification for existing medical devices (catheters), not for an AI/ML diagnostic or assistive software. Therefore, the detailed data performance evaluation typically required for AI models against specific acceptance criteria (as requested in your template) is not presented or relevant in this clearance letter. The "proof" relies on the concept of substantial equivalence to previously cleared predicate devices, supported by a summary of existing clinical data that used alternative visualization methods, implying that the devices function safely and effectively even with reduced fluoroscopy.

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The ViewFlex™ X ICE Catheter Sensor Enabled™ is indicated for use in adult and adolescent pediatric patients for intra-cardiac and intra-luminal visualization of cardiac and great vessels anatomy and physiology, as well as visualization of other devices in the heart. When used with a compatible three-dimensional mapping system, the catheter provides location information.

The ViewFlex™ X ICE Catheter Sensor Enabled™ (SE) is a sterile, single use, temporary, radiopaque, intracardiac ultrasound catheter. The catheter shaft is a 9 French (F) catheter constructed with flexible tubing with a useable length of 90 cm. The shaft is compatible with a 10 French or larger introducer for insertion into the femoral or jugular veins. The catheter tip is a 64‑element linear phased array transducer. The distal portion of the shaft is deflectable utilizing two handle mechanisms which create four deflection directions including left, right, anterior and posterior. The distal tip contains an ultrasound transducer and 3-D location sensor providing 2-D imaging and 3-D location and orientation information when used with a compatible ultrasound system and the EnSite X Cardiac Mapping System.

This document is a 510(k) clearance letter for the ViewFlex™ X ICE Catheter, Sensor Enabled™. The provided text does not contain any information regarding acceptance criteria or the study that proves the device meets those criteria, especially in the context of an AI/ML-enabled device as implied by the prompt's request for information about human readers, AI assistance, ground truth, and training sets.

The device described is an intracardiac ultrasound catheter that provides 2-D imaging and 3-D location/orientation information. The mention of "Sensor Enabled™" and "3-D location sensor" suggests a technological upgrade, but there is no indication that this involves the use of artificial intelligence or machine learning for diagnostic interpretation.

Therefore, I cannot provide the requested information based on the provided text. The prompt's questions (acceptance criteria, study details, sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth types, training set details) are all relevant to the evaluation of AI/ML-enabled medical devices, which is not what this 510(k) summary describes.

In summary, the provided document explains the ViewFlex™ X ICE Catheter, Sensor Enabled™ as a traditional medical device (an intravascular ultrasound catheter) with an added 3-D location sensor for mapping systems. It details the substantial equivalence to a predicate device based on non-clinical testing (bench design verification, biocompatibility, mechanical integrity, etc.). It does not mention any AI or ML components, nor does it describe studies with human readers, AI assistance, or data sets for machine learning model evaluation.

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The Amulet™ Steerable Delivery Sheath is indicated to facilitate the delivery of the Amplatzer™ Amulet™ Left Atrial Appendage Occluder.

The Amulet™ Steerable Delivery Sheath is designed to provide a pathway through which a device may be delivered. The sheath is provided in one size (14F), with a working length of 75 cm and a bi-directional distal tip to provide positioning in the cardiac anatomy. The handle is equipped with a deflection knob to deflect the tip clockwise 120° and counterclockwise 0°. The body of the sheath is radiopaque for visibility under fluoroscopy and has a marker band located in the distal tip. The dilator eases penetration of tissue. The sheath and dilator utilize a dual curve in two dimensions, resulting in a three-dimensional geometry. The 14F flush adapter facilitates the attachment of additional components.

This document is a 510(k) clearance letter for a medical device called the "Amulet™ Steerable Delivery Sheath." The purpose of a 510(k) is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This process does not typically involve comprehensive clinical studies or complex AI performance evaluations.

Based on the provided text, the changes to the device are primarily related to manufacturing processes:

• "The difference between the subject device and predicate is the in-process solvent used to prepare the surface of the distal tip PEBAX extrusions."
• "Additionally, a tip bond tensile specification and in-process tensile test method are being implemented."

Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to non-clinical performance testing designed to show that these manufacturing changes do not negatively impact the device's function or safety, and that the new device remains substantially equivalent to the predicate. There is no mention of AI, human-in-the-loop studies, multi-reader multi-case studies, or complex ground truth establishment in this document.

Here's a breakdown of the information that can be extracted or inferred from the provided text, presented in the requested format, while acknowledging the severe limitations of this specific document for an "AI" type of study.

Acceptance Criteria and Device Performance for Amulet™ Steerable Delivery Sheath

Summary of Device Modification: The primary difference between the subject device and the predicate device is the "in-process solvent used to prepare the surface of the distal tip PEBAX extrusions." Additionally, a new "tip bond tensile specification and in-process tensile test method are being implemented." The submitted 510(k) is a "Special 510(k)," which is used for modifications to a manufacturer's own legally marketed device where the modified device does not raise new questions of safety and effectiveness.

Study Type: Non-clinical (benchtop) performance testing, process qualifications, and re-evaluation of biocompatibility and sterilization profiles for substantial equivalence demonstration. This is not a clinical study involving human patients, nor an AI performance study.

Table of Acceptance Criteria and Reported Device Performance (Non-Clinical):

Important Note: The provided document is for a medical device modification, not an AI or diagnostic device. Therefore, many of the requested bullet points regarding AI-specific evaluation are not applicable. I will address them by stating their non-applicability.

1. Sample sizes used for the test set and the data provenance:

   • Sample Size: Not explicitly stated as a numerical value (N) for each test. For "Process Qualification," it refers to "Product performance qualification (PPQ) testing." This typically involves a defined number of units tested per batch or according to a statistical sampling plan (e.g., AQL tables), but the specific numbers are not disclosed in this summary.
   • Data Provenance: This is non-clinical benchtop testing conducted by the manufacturer, Abbott Medical, in a laboratory setting. It is not patient data; therefore, "country of origin of the data" and "retrospective or prospective" are not applicable in their clinical sense. The testing is essentially "prospective" in that it's performed on newly manufactured samples of the modified device prior to marketing.

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

   • Not Applicable. This is non-clinical benchtop testing of a physical medical device. "Ground truth" in the context of expert review (e.g., for AI image analysis) is not relevant here. Performance is measured against engineering specifications and industry standards by qualified engineers and technicians.

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

   • Not Applicable. As this is non-clinical engineering testing, there are no human "readers" or clinical "adjudication" in the sense of consensus on medical findings. Test results are compared against predefined acceptance criteria from engineering specifications.

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:

   • Not Applicable. This document describes the clearance of a physical medical delivery sheath, not an AI-powered diagnostic device or a device intended for clinical interpretation improvement. No human reader studies or AI assistance are mentioned or relevant to this 510(k).

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

   • Not Applicable. This is a physical medical device; there is no "algorithm only" performance to evaluate.

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

   • Engineering Specifications and Standardized Test Methods: The "ground truth" for this device's performance is established by predefined engineering specifications (e.g., tensile strength values, deflection angles, number of cycles) and adherence to recognized industry standards (e.g., ISO, ASTM). For biocompatibility, it's based on ISO 10993 standards and the assessment of material properties. For sterilization, it's based on ISO 11135 and a Sterility Assurance Level (SAL).

7. The sample size for the training set:

   • Not Applicable. This device is not an AI model requiring a training set. The "training" for the device's performance is its design and manufacturing process, and its "experience" is validated through the non-clinical tests described.

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

   • Not Applicable. As there is no AI training set, this question is not relevant. The device's foundational "ground truth" (its design and intended performance) is established through extensive engineering design, development, and risk assessment processes preceding this specific 510(k) modification.

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