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The AtriClip LAA Exclusion System is indicated for the exclusion of the heart's left atrial appendage, performed under direct visualization and in conjunction with other cardiac surgical procedures.

Direct visualization, in this context, requires that the surgeon is able to see the heart directly, with or without assistance from a camera, endoscope, etc., or other appropriate viewing technologies.

The AtriClip PRO-Mini LAA Exclusion System consists of a single use, sterile, self-closing, implantable Clip (AtriClip Mini) preloaded on a Single Use Clip Applier along with a Selection Guide. When closed, the Clip applies uniform pressure over the length of the Clip to ensure consistent, reproducible, and secure exclusion of the left atrial appendage (LAA). The Clip is then deployed and is left as a permanent implant, and excludes the LAA, resulting in electrical isolation of the LAA. The Clip is available in the following lengths to accommodate different sizes of LAA: 35 mm, 40 mm, 45 mm, and 50 mm. The PRO-Mini device is a disposable device with a handle, leftright and up/down articulation knobs, articulation lock, deployment tab, shaft, suture anchors, and end effector containing the AtriClip Mini.

This document outlines the FDA's clearance for the AtriClip PRO-Mini LAA Exclusion System (PROM) based on its substantial equivalence to previously cleared predicate devices. The information provided primarily focuses on the device's technical characteristics and the non-clinical bench testing performed to demonstrate this equivalence. It does not describe a study involving algorithms, AI, human readers, or clinical performance metrics that would typically have acceptance criteria like sensitivity, specificity, or AUC when evaluating diagnostic or prognostic devices.

Therefore, many of the requested sections (2-6, 8-9) are not applicable or cannot be extracted from this document as they pertain to clinical or AI/algorithm-based studies, which are not described here.

Here's the information that can be extracted or inferred from the provided text, focusing on the device's substantial equivalence through bench testing:

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

Based on the provided text, the acceptance criteria are generalized as demonstrating "equivalence in performance" and not raising "any new issues of safety." The reported performance is that the device "met the predetermined acceptance criteria." Specific quantitative acceptance criteria are not detailed in this document, nor are specific quantitative performance results.

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

This information is not provided in the document. The document refers to "bench testing," which implies laboratory-based tests rather than 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 as the study is non-clinical bench testing, not a study requiring expert clinical interpretation for ground truth establishment.

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

This information is not provided as the study is non-clinical bench testing, and adjudication methods are typically used for expert clinical review of cases.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done and is not described in this document. This document pertains to the clearance of a physical medical device (implantable clip system) based on non-clinical bench testing, not an AI or imaging device involving human readers.

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

Not Applicable. This document describes a physical medical device, not an algorithm or AI system.

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

For the non-clinical bench testing, "ground truth" would likely be established by engineering specifications, material standards, and validated testing methodologies to measure mechanical properties, reliability, and tissue interaction. The document doesn't explicitly state the methodology for establishing this "ground truth" for each bench test, but it is implied by the nature of such testing.

8. The sample size for the training set

Not Applicable. This document describes the clearance of a physical medical device based on non-clinical bench testing, not an AI or algorithm-based device that would require a training set.

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

Not Applicable. As no training set is described or implied, the establishment of its ground truth is not relevant.

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The AtriClip® LAA Exclusion System is indicated for the exclusion of the heart's left atrial appendage, performed under direct visualization and in conjunction with other cardiac surgical procedures.

Direct visualization, in this context, requires that the surgeon is able to see the heart directly, with or without assistance from a camera, endoscope, etc., or other appropriate viewing technologies.

The AtriClip LAA Exclusion System consists of a single use, sterile, self-closing, implantable Clip preloaded on a Single Use Clip Applier along with a selection quide. When closed, the Clip applies uniform pressure over the length of the Clip to ensure consistent, reproducible, and secure exclusion of the left atrial appendage (LAA). The Clip is then deployed and is left as a permanent implant and excludes the LAA resulting in electrical isolation of the LAA. Preclinical animal studies (Kamohara 2005,2006) demonstrate that complete exclusion with the Clip also results in acute and chronic electrical isolation of the LAA. A human clinical study (Starck 2012) has demonstrated acute electrical isolation. Chronic electrical isolation has not been evaluated in human clinical studies. The Clip is available in the following lengths to accommodate difference sizes of LAA: 35 mm, 40 mm, 45 mm, and 50 mm. The Clip Appliers are disposable devices with a handle, shaft, suture anchors, articulation controls, and deployment loop/jaws which contain the Clip.

This document is a 510(k) premarket notification from the FDA, which focuses on demonstrating substantial equivalence of a modified medical device to a previously cleared predicate device. It explicitly states that no performance data was generated for the modified device as the changes were deemed not to significantly alter the device's design, performance, or intended use. Therefore, the document does not describe acceptance criteria for a new study or present results from such a study for the modified AtriClip LAA Exclusion System.

It states: "The proposed changes do not include any change to design or performance specifications of the AtriClip LAA Exclusion System. Additionally, the proposed changes did not modify the intended use, therefore the previously submitted bench and animal data remain valid for the AtriClip LAA Exclusion System."

This means that the substantial equivalence determination relies on the performance data of the predicate device (K210293), not new data from the modified device in this submission (K233407).

Therefore, I cannot provide the requested information about acceptance criteria or a study proving the modified device meets these criteria, as this document asserts no such new study was performed for K233407.

The document does not contain any of the following information:

• A table of acceptance criteria and reported device performance for the modified device.
• Sample size used for a test set or data provenance for a new study.
• Number of experts or their qualifications for establishing ground truth for a new study.
• Adjudication method for a new study.
• Information about a multi-reader multi-case (MRMC) comparative effectiveness study for the modified device.
• Information about a standalone performance study for the modified device.
• Type of ground truth used for a new study.
• Sample size for a training set (as no new AI/software component is mentioned).
• How ground truth for a training set was established (as no new AI/software component is mentioned).

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The LAA Exclusion System is indicated for the exclusion of the heart's left atrial appendage, performed under direct visualization and in conjunction with other cardiac surgical procedures.

Direct visualization, in this context, requires that the surgeon is able to see the heart directly, with or without assistance from a camera, endoscope, etc., or any other appropriate viewing technology.

The LAA Exclusion System consists of a single use, sterile, self-closing, implantable Clip preloaded on a single use delivery system. When closed, the implant applies pressure to ensure exclusion of the left atrial appendage (LAA). Once the clip is deployed, it remains as a permanent implant. The implantable clip is available in lengths of 35mm, 40mm, 45mm to accommodate different sizes of LAA. The LAA Selection Guide is a sterile, single use, disposable surgical accessory device to assist the physician in selecting the appropriately sized clip implant for each individual patient.

The provided text describes a 510(k) premarket notification for a medical device called the "LAA Exclusion System." This document is a submission to the FDA demonstrating that the modified device is substantially equivalent to a previously cleared predicate device.

The essential information related to acceptance criteria and performance data is found under the "Performance Data" section. However, it's crucial to understand that this document does not contain the detailed study results, specific numerical acceptance criteria, or the methodology (like sample size, number of experts, ground truth establishment) for proving the device meets these criteria in the way one would expect for an AI/ML medical device submission.

This document describes a mechanical device (an implantable clip and delivery system), not an AI/ML diagnostic or prognostic tool. Therefore, the questions related to MRMC studies, training/test set sample sizes for algorithms, number of experts for ground truth, and adjudication methods for AI models are not applicable to this type of device submission.

The "acceptance criteria" for this mechanical device are performance specifications met through engineering verification tests, not clinical performance metrics based on diagnostic accuracy.

Here's an attempt to answer the questions based on the provided text, acknowledging the limitations due to the nature of the device:

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

The document states that "All pre-determined acceptance criteria were met" for the following tests, indicating successful performance. The specific numerical acceptance criteria themselves are not detailed in this summary document, only the types of tests performed.

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

The document does not specify the sample size used for each of these engineering verification tests, nor does it explicitly state the data provenance (e.g., country) or whether the testing was retrospective or prospective. These are typically internal design verification tests conducted by the manufacturer.

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 question is not applicable to this type of mechanical device verification. Ground truth in this context is based on engineering specifications and measurements, not expert clinical interpretation.

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

This question is not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical imaging studies, typically for AI/ML performance evaluation, not for mechanical device testing.

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 study was not done. This device is a mechanical implantable clip and delivery system, not an AI-assisted diagnostic tool. Therefore, effects on human reader performance are not relevant or measured here.

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

No, a standalone algorithm performance evaluation was not done. This is a mechanical device, not an algorithm.

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

The "ground truth" for this device's performance demonstration relies on engineering specifications and physical measurements validated against those specifications. For example, "Implant Tip Opening" would be measured directly and compared to a pre-defined minimum opening distance. It's not based on expert consensus, pathology, or outcomes data in the clinical diagnostic sense.

8. The sample size for the training set

This question is not applicable. This device is not an AI/ML algorithm that requires a training set.

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

This question is not applicable, as there is no training set for an AI/ML model for this mechanical device.

Summary of Inapplicability due to Device Type:
The provided document describes a 510(k) submission for a mechanical medical device (LAA Exclusion System), focused on demonstrating substantial equivalence to a predicate device based on engineering performance specifications and biocompatibility. The framework of your questions (e.g., sample size for AI test/training sets, expert readers, ground truth for AI models, MRMC studies) is primarily relevant to the FDA's evaluation of Artificial Intelligence/Machine Learning (AI/ML) based medical devices. Since the device in question is not an AI/ML product, many of your specific inquiries are not addressed in this type of submission document.

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The Syntheon LAA Exclusion System is indicated for the exclusion of the heart's left atrial appendage, performed under direct visualization and in conjunction with other cardiac surgical procedures.

Direct visualization, in this context, requires that the surgeon is able to see the heart directly, with or without assistance from a camera, endoscope, etc., or any other appropriate viewing technology.

The Syntheon LAA Exclusion System consists of a single use, sterile, self-closing, implantable Clip preloaded on a single use delivery system. When closed, the implant applies pressure to ensure exclusion of the left atrial appendage (LAA). Once the clip is deployed, it remains as a permanent implant. The implantable clip is available in lengths of 35mm. 40mm, 45mm, and 50mm to accommodate different sizes of LAA. The Syntheon LAA Selection Guide is a sterile, single use, disposable surgical accessory device to assist the physician in selecting the appropriately sized clip implant for each individual patient.

This document describes the Syntheon LAA Exclusion System and its substantial equivalence to a predicate device, focusing on various performance and safety aspects rather than an AI/ML component. Therefore, several of the requested categories for AI/ML device studies are not applicable.

Here's the summary of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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The AtriClip LAA Exclusion System is indicated for the exclusion of the heart's left atrial appendage, performed under direct visualization and in conjunction with other cardiac surgical procedures.

Direct visualization, in this context, requires that the surgeon is able to see the heart directly, with or without assistance from a camera, endoscope, etc., or other appropriate viewing technologies.

The AtriClip LAA Exclusion System consists of a single use, sterile, self-closing, implantable Clip preloaded on a Single Use Clip Applier along with a selection guide. When closed, the Clip applies uniform pressure over the length of the Clip to ensure consistent, reproducible, and secure exclusion of the left atrial appendage (LAA). Preclinical animal studies (Kamohara 2005,2006) demonstrate that complete exclusion with the Clip also results in acute and chronic electrical isolation of the LAA. A human clinical study (Starck 2012) has demonstrated acute electrical isolation. Chronic electrical isolation has not been evaluated in human clinical studies.

The Clip is available in the following lengths to accommodate difference sizes of LAA: 35 mm, 40 mm, 45 mm, and 50 mm. The Clip Appliers are disposable device with a handle, shaft, suture anchors, articulation controls and deployment loop which contains the Clip.

The provided document is a 510(k) premarket notification for the AtriClip LAA Exclusion System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed acceptance criteria and a study to prove a device meets those criteria for a novel device.

The document does not contain acceptance criteria or performance data in the way typically expected for a new device's clinical or algorithmic performance. Instead, it aims to show that a modified version of an already cleared device (AtriClip LAA Exclusion System, K191413) is substantially equivalent to that predicate. This means the manufacturer did not conduct a new study to establish performance against acceptance criteria for a novel device.

Here's what can be inferred from the document regarding the information requested, with caveats:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated for this submission as it's a modification to an already cleared device. The "acceptance criteria" here are implicitly that the modified device's performance is equivalent to the predicate device and that the modifications do not introduce new safety or effectiveness concerns.
• Reported Device Performance: The document states that "verification and validation testing... Demonstrated equivalency in performance" to the predicate device. However, specific performance metrics or a table comparing them are not provided in this summary. The comparison table focuses on design and material characteristics, not performance data points.

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

• This is not a clinical study on a new device. The document mentions "preclinical animal studies (Kamohara 2005, 2006)" and a "human clinical study (Starck 2012)" to support the predicate device's description, confirming electrical isolation (acute and chronic for animal, acute for human). However, no new sample sizes or data provenance for a "test set" are provided for this specific 510(k) modification. The modification primarily concerns an alternate raw material supplier for titanium and minor proprietary name changes.

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

• Not applicable to this 510(k) submission. This type of information would be relevant for studies establishing ground truth for diagnostic devices or software, not for demonstrating substantial equivalence of a modified implantable clip.

4. Adjudication Method:

• Not applicable for this type of submission.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:

• No, a MRMC comparative effectiveness study was not done for this 510(k). This is an implantable clip, not an AI or imaging diagnostic device where MRMC studies are common.

6. Standalone Performance Study (Algorithm Only):

• No, this is an implantable medical device, not an algorithm.

7. Type of Ground Truth Used:

• For the predicate device, the "ground truth" for electrical isolation was established through "preclinical animal studies (Kamohara 2005, 2006)" (acute and chronic electrical isolation) and a "human clinical study (Starck 2012)" (acute electrical isolation). This implies physiological measurements and clinical observations.
• For this specific 510(k) submission, the "ground truth" for the modifications is demonstrating that the changes (e.g., alternate raw material supplier) do not alter the established performance and safety of the predicate device, likely through bench testing and material characterization, not patient-level "ground truth."

8. Sample Size for the Training Set:

• Not applicable. This is not a machine learning model.

9. How the Ground Truth for the Training Set was Established:

• Not applicable.

Summary of what the document focuses on instead:

The core of this 510(k) notification is a comparison of technological characteristics between the previously cleared AtriClip LAA Exclusion System (predicate) and the modified version. The comparison table (pages 4-5) highlights that almost all features (Proprietary Name, Device Classification, Regulatory Class, FDA Division, Performance Standards, Intended Use, Device Description, Software, Shelf Life, Biocompatibility, Sterilization, Sterility Assurance Level, Pyrogen, Suture Material, Preloaded Clip, Clip Opening) are "Same" between the predicate and the modified device. The only noted change regarding the clip itself is the addition of an "alternate raw material supplier of the titanium for the AOD1 clip."

The conclusion states that AtriCure "demonstrated that the modifications made to the AtriClip LAA Exclusion System are substantially equivalent in fundamental design, technology, function, device materials, packaging, sterilization, operating principle, and intended use / indication for use as the previously cleared AtriClip LAA Exclusion System (K191413)." This equivalency was supported by "verification and validation testing" which "Demonstrated equivalency in performance," "Device biocompatibility remains unchanged," and "Did not raise any new issues of safety." However, the details of these tests and their specific results against quantitative acceptance criteria are not provided in this public summary.

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The AtriClip LAA Exclusion System is indicated for the exclusion of the heart's left atrial appendage, performed under direct visualization and in conjunction with other cardiac surgical procedures.

Direct visualization, in this context, requires that the surgeon is able to see the heart directly, with or without assistance from a camera, endoscope, etc., or other appropriate viewing technologies.

The AtriClip Exclusion System contains a clip for exclusion of the heart's left atrial appendage (LAA). Preclinical animal studies (Kamohara 2005, 2006) demonstrate that complete exclusion with the Clip also results in acute and chronic electrical isolation of the LAA. A human clinical study (Starck 2012) has demonstrated acute electrical isolation. Chronic electrical isolation has not been evaluated in human clinical studies. The Clip is pre-loaded on a disposable Clip applier. The AtriClip Exclusion System does not contain natural rubber latex components.

The provided text describes the 510(k) premarket notification for the AtriClip LAA Exclusion System. It focuses on demonstrating substantial equivalence to a predicate device (K181474), primarily based on labeling changes (indications for use and device description in the instructions for use) rather than a new design or device performance study.

Therefore, many of the requested criteria related to a study proving device performance against acceptance criteria (e.g., sample sizes, expert ground truth, MRMC studies, standalone performance, training sets, etc.) are explicitly stated as not applicable or not performed because the submission is not for a new device design or a change in its intended use or function.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not detail specific quantitative acceptance criteria or performance metrics for the AtriClip LAA Exclusion System itself, as it's a 510(k) for a modified labeling of an existing, already cleared device. The "performance data" section explicitly states: "The proposed changes do not include any change to design or performance specifications of the AtriClip LAA Exclusion System. Additionally, the proposed changes did not modify the intended use, therefore the previously submitted bench and animal data remain valid for the AtriClip LAA Exclusion System."

Instead, the "acceptance criteria" here are implicitly about demonstrating that the labeling changes do not negate the device's substantial equivalence to its predicate. The "performance" is therefore the assertion that the device continues to meet the established performance parameters of its predicate.

Study Proving Device Meets Acceptance Criteria:

The "study" referenced in this submission is the 510(k) premarket notification process itself, which argues for substantial equivalence based on the updated labeling. The core argument is that the device's fundamental design, operating principles, and function have not changed. Therefore, previously submitted preclinical and clinical data from the predicate device (K181474) and referenced literature (Kamohara 2005, 2006; Starck 2012) are considered sufficient to support the device with its updated labeling.

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

• Test Set: No new "test set" in the context of device performance testing was used for this 510(k) submission, as it relates to labeling changes only.
• Data Provenance for Referenced Studies (Kamohara, Starck): The document does not specify the country of origin or whether these were retrospective or prospective studies. Kamohara (2005, 2006) are referred to as "preclinical animal studies," and Starck (2012) as a "human clinical study."

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

• Not applicable. This was not a study requiring expert ground truth for performance evaluation of a new or modified device. The "ground truth" here is regulatory compliance and a determination of substantial equivalence by the FDA.

4. Adjudication Method for the Test Set

• Not applicable. No new test set for device performance was used.

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

• Not applicable. No MRMC study was performed or required for this labeling update.

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

• Not applicable. This device is a mechanical implant, not an algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for this submission's approval is the established regulatory framework for 510(k) clearances, specifically demonstrating substantial equivalence to a predicate device. This is based on comparisons of design, materials, manufacturing, indications for use, and a demonstration that any changes (in this case, primarily labeling) do not raise new questions of safety or effectiveness. The supporting data for the claims made in the updated labeling (e.g., electrical isolation) come from previously published preclinical and clinical studies (Kamohara 2005/2006, Starck 2012).

8. The Sample Size for the Training Set

• Not applicable. This submission is not for an AI/ML algorithm or a device requiring a training set in that context.

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

• Not applicable.

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The AtriClip LAA Exclusion System is indicated for the occlusion of the heart's left atrial appendage, performed under direct visualization and in conjunction with other cardiac surgical procedures.

Direct visualization, in this context, requires that the surgeon is able to see the heart directly, with or without assistance from a camera, endoscope, etc., or other appropriate viewing technologies.

The LAA Exclusion System consists of a single use, sterile, self-closing, implantable Clip preloaded on a Single Use Clip Applier along with a selection quide. When closed, the Clip applies uniform pressure over the length of the Clip to ensure consistent, reproducible, and secure occlusion of the left atrial appendage (LAA). The clip is then deployed and is left as a permanent implant. The Clip is available in the following lengths to accommodate different sizes of LAA: 35 mm, 40 mm, 45 mm, and 50 mm.

The Clip Appliers are disposable device with a handle, shaft, suture anchors, articulation controls, and deployment loop which contains the Clip. This Special 510(k) contains an alternate to the PET suture supply sourcing used within the AtriClip implant and Clip Appliers of the LAA Exclusion system.

This is a 510(k) premarket notification for the AtriClip LAA Exclusion System, a medical device designed for occluding the heart's left atrial appendage during cardiac surgical procedures. This submission is for modifications to an already cleared device (K180010).

The provided text focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria with quantifiable performance metrics. The submission asserts that the modifications made do not change the intended use, operating principles, or function of the device, and therefore, the prior approval and equivalence still hold.

However, based on the information provided, we can infer and construct some of the requested details:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for substantial equivalence are not presented as numerical targets for performance metrics like sensitivity or specificity. Instead, they are based on demonstrating that the modified device is as safe and effective as the predicate device and that the changes do not raise new questions of safety or effectiveness.

Study Information (Based on Substantial Equivalence Submission)

Since this is a 510(k) for modifications to an already cleared device, the "study" proving acceptance is primarily a demonstration of equivalence through bench testing and biocompatibility assessment of the modified components, rather than a clinical trial with patient outcomes.

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

• Sample Size (Test Set): Not explicitly stated as "sample size" in the context of a clinical test set. The "test set" here refers to the materials and components of the modified device that underwent bench testing and biocompatibility evaluation. The quantity of items tested for Tensile, Elongation, Friction, and Biocompatibility (e.g., number of clips, appliers, or material samples) is not specified.
• Data Provenance: Not explicitly stated. Given that these are bench tests and biocompatibility tests, the data would originate from the manufacturer's internal testing facilities or contract labs. The country of origin is not mentioned. The data is prospective in the sense that the tests were conducted specifically for this submission on the modified materials.

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

This question is not directly applicable to a 510(k) based on bench testing and biocompatibility. There is no concept of "ground truth" derived from expert consensus on images or clinical cases in this submission. The "ground truth" in this context is the objective measurement from the specified engineering and biological tests demonstrating that the modified material performs equivalently and is biocompatible. The experts would be the engineers and toxicologists who designed, performed, and interpreted these tests, but their number and specific qualifications are not detailed.

4. Adjudication Method for the Test Set

Not applicable. There is no ambiguous data or expert disagreement requiring an adjudication method for the physical and chemical properties tested. The results are objective measurements from the tests 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 device is a physical implant, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance is not relevant.

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

Not applicable. This is a physical medical device, not a standalone algorithm.

7. The Type of Ground Truth Used

The "ground truth" for demonstrating equivalence is based on:

• Engineering Specifications: Testing the physical properties (tensile strength, elongation, friction) of the modified components against established engineering specifications and comparing them to the predicate device's performance.
• Biological Standards: Testing biocompatibility according to recognized international standards (ISO 10993-1) using established biological assays (Material Mediated Pyrogen, Genotoxicity, Cytotoxicity, Implantation, Sensitization, Irritation, Systemic Toxicity).

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of AI or machine learning for this physical device submission.

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

Not applicable, as there is no training set.

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The AtriClip LAA Exclusion System is indicated for the occlusion of the heart's left atrial appendage, performed under direct visualization and in conjunction with other cardiac surgical procedures.

Direct visualization, in this context, requires that the surgeon is able to see the heart directly, with or without assistance from a camera, endoscope, etc., or other appropriate viewing technologies.

The AtriClip LAA Exclusion System consists of a single use, sterile, self-closing, implantable Clip preloaded on a Single Use Clip Applier along with a selection guide. When closed, the Clip applies uniform pressure over the length of the Clip to ensure consistent, reproducible, and secure occlusion of the left atrial appendage (LAA). The clip is then deployed and is left as a permanent implant. The Clip is available in the following lengths to accommodate different sizes of LAA: 35 mm, 40 mm, 45 mm, and 50 mm. The PRO·V Clip Applier is a disposable device with a handle, shaft, suture anchors, articulation controls, and deployment end-effector containing the Clip.

This document is a 510(k) premarket notification for a medical device and therefore does not contain all the typical information one would expect from a full study report. The acceptance criteria and "study" described herein are primarily focused on demonstrating substantial equivalence to a previously cleared device, rather than proving efficacy or safety in a clinical setting in the way a clinical trial would.

Here's an analysis based on the provided text, addressing your points where possible:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of the "Study":
The "study" referenced in this document is a series of non-clinical bench tests designed to demonstrate that minor modifications to the AtriClip® LAA Exclusion System with Preloaded PRO-V™ Clip (K173031) did not affect its safety, effectiveness, or fundamental characteristics compared to its predicate device (K153500). The purpose was to prove substantial equivalence, not necessarily to establish new performance metrics against a clinical standard.

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

• Sample Size for Test Set: Not specified in the provided text. The document refers to "bench testing," which typically involves a number of units tested to statistical confidence levels, but the exact number is not detailed here.
• Data Provenance: Not explicitly stated as "country of origin," but "bench testing" implies laboratory-based testing conducted by the manufacturer (AtriCure, Inc.) or a contracted lab. This is retrospective in the sense that it evaluates a manufactured product, but it's not based on patient data provenance.

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

• Not applicable / Not provided. For this type of 510(k) submission, the "ground truth" for bench testing is typically adherence to engineering specifications, material properties, and functional performance as outlined in test protocols, rather than expert clinical consensus on patient data.

4. Adjudication Method for the Test Set

• Not applicable / Not provided. Adjudication methods like 2+1 or 3+1 are used for clinical trial endpoints or expert review of medical images/cases. For bench testing, the "adjudication" is typically a pass/fail against predetermined engineering and performance specifications.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. An MRMC study is a type of clinical comparative study, often used for diagnostic imaging devices to assess how human readers' performance improves with or without artificial intelligence (AI) assistance. This document describes a 510(k) for an implantable clip system and non-clinical bench testing, not an AI-assisted diagnostic device, and therefore no MRMC study was conducted or is relevant.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• No. This device is a physical, implantable medical device (an implantable clip and applicator), not a software algorithm or an AI product with standalone performance. Its function is to physically occlude the left atrial appendage, and its application inherently involves a human surgeon.

7. Type of Ground Truth Used

• Engineering Specifications and Performance Standards: For bench testing, the ground truth is established by design specifications, material standards, and functional performance requirements that the device must meet. This is verified through specific tests (reliability, mechanical, biologic compatibility). It is not expert consensus, pathology, or outcomes data, as those relate to clinical performance in patients.

8. Sample Size for the Training Set

• Not applicable / Not provided. The concept of a "training set" is relevant for machine learning algorithms. This device is a physical implantable device, and thus does not have a training set in the context of AI or data-driven model development. The design and manufacturing process involve various validated methods, but not a "training set" like an AI model would.

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

• Not applicable / Not provided. As there is no training set for this type of device, the method for establishing its ground truth is not relevant. Ground truth for the device itself (its design, materials, and functional performance) is established through established engineering principles, regulatory standards, and internal design controls.

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The AtriClip LAA Exclusion System is indicated for the occlusion of the heart's left atrial appendage, performed under direct visualization and in conjunction with other cardiac surgical procedures.

Direct visualization, in this context, requires that the surgeon is able to see the heart directly, with or without assistance from a camera, endoscope, etc., or other appropriate viewing technologies.

The AtriClip PRO2 LAA Exclusion System consists of a single use, sterile, self-closing, implantable Clip preloaded on a Single Use Clip Applier along with a selection guide. When closed, the Clip applies uniform pressure over the length of the Clip to ensure consistent, reproducible, and secure occlusion of the left atrial appendage (LAA). The clip is then deployed and is left as a permanent implant. The Clip is available in the following lengths to accommodate different sizes of LAA: 35 mm, 40 mm, 45 mm, and 50 mm.

The Clip Applier is a disposable device with a handle, shaft, suture anchors, articulation controls, and deployment loop which contains the Clip. This Special 510(k) contains modifications to the AtriClip LAA Exclusion System (PRO2) which are intended to 1.) mitigate inconsistencies of spring return force post deployment of the clip, and 2.) aid in manufacturability of the device.

The provided text is a 510(k) summary for the AtriClip® LAA Exclusion System with preloaded Gillinov-Cosgrove® Clip (PRO2). This document focuses on demonstrating substantial equivalence to a previously cleared device, rather than providing a detailed study that proves the device meets specific performance criteria. Therefore, much of the requested information regarding acceptance criteria, sample sizes, expert qualifications, and ground truth establishment is not present in this regulatory submission.

However, I can extract the following information and indicate where details are missing:

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

The document does not explicitly list quantitative acceptance criteria with reported device performance values. Instead, it states that the modifications "Demonstrated equivalency in performance" and "Did not raise any new issues of safety."

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

The document mentions "Non-clinical Bench Testing" including "Mechanical Testing" and "Reliability Testing." However, it does not specify the sample sizes used for these tests. Data provenance (e.g., country of origin, retrospective/prospective) is also not provided as these are described as non-clinical bench tests.

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 as the submission describes non-clinical bench testing for mechanical and reliability aspects of the device, not a study involving human assessment or interpretation where experts would establish ground truth.

4. Adjudication method for the test set

This information is not applicable for non-clinical bench testing.

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

An MRMC comparative effectiveness study was not performed as this submission relates to a mechanical implantable clip system, not an AI-assisted diagnostic or interpretive device.

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

This information is not applicable as the device is a mechanical implantable clip system, not an algorithm or AI.

7. The type of ground truth used

For the non-clinical bench testing, the "ground truth" would be established by objective, verifiable mechanical and reliability testing standards and measurements. The specific standards or methods used to define acceptable performance for these tests are not detailed in this summary.

8. The sample size for the training set

This information is not applicable as the device is a mechanical implantable clip system and does not involve AI or algorithms that require a "training set."

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

This information is not applicable as there is no training set for this type of device.

In summary, this 510(k) submission primarily focuses on demonstrating that minor modifications to an existing device (AtriClip® LAA Exclusion System, PRO2) do not alter its fundamental performance, safety, or effectiveness compared to the predicate device. The evidence provided is based on non-clinical bench testing.

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