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The Assert-IQ™ ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms that may be cardiac-related such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias such as bradycardia, tachycardia, and sinus pauses. The Assert-IQ™ ICM is also indicated for patients who have been previously diagnosed with atrial fibrillation (AF) or who are susceptible to developing AF. The Assert-IQ™ ICM is intended to be inserted subcutaneously in the left pectoral region, also described as the left anterior chest wall. The Assert-IQ™ ICM has not been specifically tested for pediatric use.

The Assert-IQ™ ICM system is intended to help physicians monitor, diagnose, and document the rhythm in patients who are susceptible to cardiac arrhythmias and unexplained symptoms, as indicated. The Assert-IQ™ Insertable Cardiac Monitor (ICM) family of Insertable Cardiac Monitor devices includes cleared models DM5000, DM5300, and DM5500. A fourth model is being included as the subject device within this 510(k)—the Assert-IQ™ 4 ICM, model DM5100.

Overview of Technological features relative to predicate (K251221) Assert-IQ™ ICM devices:

• Patient-initiated triggering of EGM storage using the myMerlin™ mobile application. This includes capability for the patient to identify symptoms, which are stored with the EGM for physician review which is identical in Assert-IQ™ ICM models DM5500 and DM5000.

• Automated triggering of EGM storage when tachycardia, bradycardia, or pauses are detected; with physician-programmable values for pause duration, bradycardia rate, tachycardia rate, and number of tachycardia intervals, which is identical in Assert-IQ™ ICM models DM5500 and DM5000.

• Automated triggering of EGM storage when atrial fibrillation (AF) is detected, with physician programmable values for AF duration. The ability to inhibit EGM storage due to noise and allow for detection and storage of AF and non-AF (pause, bradycardia, and tachycardia) arrhythmias after noise exit, which is identical Assert-IQ™ ICM models DM5500 and DM5000.

• Collection and display of diagnostic trends, including AF burden, which is identical in Assert-IQ™ ICM models DM5500 and DM5000 and PVC burden, available in the subject device DM5100 and in model DM5500

• Remote monitoring capability, which is identical in Assert-IQ™ ICM models DM5500 and DM5000

• Remote Programming capability, which is available in the subject device DM5100 and in model DM5500.

• The subject device model DM5100 has a 4-year battery longevity, positioned between the longevity of) model DM5500 (6 years) and model DM5000 (3 years). This design change does not raise new or different questions of safety or effectiveness.

• Accelerometer in subject device model DM5100 is 1D configuration which is identical to that in model DM5000 and differs from model DM5500 (3D configuration). This configuration does not raise new or different questions of safety or effectiveness.

The provided FDA 510(k) Clearance Letter for the Assert-IQ™ Insertable Cardiac Monitor System (K253516) does not contain the detailed information necessary to fully answer all aspects of your request.

The clearance is for a Special 510(k), which indicates that the changes made to the device (model DM5100) are minor and do not introduce new indications for use or alter the fundamental scientific technology compared to a previously cleared predicate device (K251221). As such, the submission primarily leverages testing and validation from the predicate device and focuses on demonstrating that the new model performs equivalently and does not raise new questions of safety or effectiveness.

Therefore, much of the information you requested regarding new acceptance criteria, performance studies, sample sizes, ground truth establishment, or MRMC studies for this specific submission (K253516) is not present. The document explicitly states "No new clinical functionality, user needs, or intended use introduced," and "Existing validation activities from predicate (K251221) models (e.g., usability, algorithm performance, cybersecurity, compliance) remain applicable and sufficient."

However, I can extract the available information and highlight what is missing based on your prompts.

Acceptance Criteria and Device Performance (Based on available information)

The document refers to verification activities to confirm the DM5100 meets design specifications and performs equivalently to predicate models. It also mentions "algorithm performance" being leveraged from the predicate. Without access to the predicate device's 510(k) submission (K251221), specific performance criteria for the AI algorithms are not explicitly stated in this document.

Study Details (Based on available information)

This 510(k) submission is a Special 510(k), and therefore, a primary performance study on the AI algorithm was not conducted for this specific submission (K253516). The document explicitly states that "Existing validation activities from predicate (K251221) models (e.g., usability, algorithm performance, cybersecurity, compliance) remain applicable and sufficient."

To get answers to many of the following questions, one would need to review the original 510(k) submission for the predicate device (K251221).

1. Sample size used for the test set for AI algorithm performance: Not provided in this document. It leverages previous validation from K251221.

   • Data provenance (e.g., country of origin of the data, retrospective or prospective): Not provided in this document.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided in this document. It leverages previous validation from K251221.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not provided in this document. It leverages previous validation from K251221.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not provided in this document. It is unlikely for a Special 510(k) which primarily relies on equivalence to a predicate. The document implies the AI is for automated detection and presumably works in conjunction with a physician review, but doesn't detail reader studies.

   • If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not provided in this document.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The document mentions "Automated triggering of EGM storage when tachycardia, bradycardia, or pauses are detected," and "Automated triggering of EGM storage when atrial fibrillation (AF) is detected." This implies a standalone algorithm for detection. However, specific standalone performance metrics (e.g., sensitivity, specificity, PPV for these detections) are not provided in this document for this specific K253516 submission, as they are leveraged from the predicate K251221.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not provided in this document. It leverages previous validation from K251221.

7. The sample size for the training set: Not provided in this document. It leverages previous validation from K251221.

8. How the ground truth for the training set was established: Not provided in this document. It leverages previous validation from K251221.

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The Amplatzer Piccolo™ Delivery System is indicated to facilitate the delivery of an Amplatzer Piccolo™ Occluder through the heart of a patient with a patent ductus arteriosus.

The Amplatzer Piccolo Delivery System is designed to facilitate the delivery of an Amplatzer Piccolo™ Occluder into a patent ductus arteriosus (PDA). The Amplatzer Piccolo Delivery System consists of a delivery catheter, loader, Tuohy-Borst hemostasis valve with extension tube and stopcock, and self-sealing hemostasis valve. The Amplatzer Piccolo Delivery System is available in a 4 Fr size with a usable length of 45 cm. The delivery system components have the following performance characteristics:

• Delivery catheter: Provides a pathway through which an occluder is delivered. The body of the catheter is radiopaque for visibility under fluoroscopy. The distal end of the catheter has a curve that is optimized to allow co-axial placement of the delivery catheter within the PDA. A curve indicator is located on the hub as an additional reference for the direction of the curvature.
• Tuohy-Borst hemostasis valve with extension tube and stopcock: Allows flushing of the delivery catheter and controls blood backflow.
• Loader: Introduces an occluder into the delivery catheter.
• Self-sealing hemostasis valve: Allows flushing of the loader and delivery catheter and controls blood backflow.

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The Seguin Annuloplasty Ring is indicated for use in the repair of mitral valves that are diseased or damaged due to acquired or congenital processes.

The Seguin Annuloplasty Ring (SARP) is a semi-rigid or semi-flexible annuloplasty ring designed to support mitral valve repair. The ring is constructed from a polyethylene core covered by a knitted polyester sewing cuff. The Seguin Ring is sterilized by EO sterilization and supplied sterile. The Seguin ring is offered in sizes 24-40mm in increments of 2 mm.

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The Amplatzer™ Guidewire is intended to facilitate the introduction and exchange of a delivery system or catheter within the vasculature and chambers of the heart.

The Amplatzer™ Guidewire is 0.035-inch in diameter and made of a stainless steel core and a full length stainless steel spring coil coated with low-friction polytetrafluoroethylene (PTFE). The stainless steel core extends to the distal tip of the guidewire for one model (9-GW-001). Two models (9-GW-002 and 9-GW-003) have a stainless steel core that does not extend to the distal end of the wire. These models have an additional ribbon wire that runs parallel to the stainless steel core and extends to the distal end of the guidewire. The stainless steel core for all three models is tapered at the distal end of the guidewire to provide a smooth transition to the distal floppy segment.

The guidewires are available in two working lengths, 260 cm (9-GW-001 and 9‑GW‑002) and 300 cm (9-GW-003). The distal tip of the guidewire is available in two designs: a Modified J-Tip (9-GW-001) and a J-Tip (9-GW-002 and 9-GW-003). The J-straightener can be used to straighten the distal tip for all models. Model 9-GW-003 can also be manually straightened. The guidewire is sterile and for single use only.

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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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