Search Results

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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 Clip Appliers are disposable devices with a handle, shaft, suture anchors, and deployment end-effector containing the Clip.

Here's a breakdown of the acceptance criteria and study information for the AtriClip LAA Exclusion System based on the provided document:

Acceptance Criteria and Device Performance

The document does not explicitly state formal "acceptance criteria" as a pass/fail threshold. Instead, it presents performance results from clinical studies and a published literature review, which serve as evidence of the device's safety and effectiveness. The "reported device performance" in the table below is derived from these stated clinical outcomes.

Study Information

The information provided describes a combination of clinical study data and a published literature review.

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

• Total Patients Evaluated (Clinical Evidence): 129 patients
• LAA occlusion directly following Clip deployment: 129 patients
• LAA exclusion post-operatively (3-12 months): 58 patients
• Data Provenance: The document emphasizes "clinical evidence based on the multiple IDE clinical studies and published clinical literature." This suggests a combination of prospective data from AtriCure-sponsored IDE studies (e.g., IDE Stroke, Hybrid DEEP, Staged DEEP) and data from retrospective or prospective studies included in the literature review. The country of origin is not specified but is implicitly the US for the IDE studies.

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

• This information is not provided in the document. The studies refer to "LAA occlusion" and "LAA exclusion" as outcomes, but do not specify how these were determined (e.g., by human experts, imaging interpretation, etc.) nor the qualifications of those involved in assessing these outcomes.

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

• This information is not provided in the document.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No, an MRMC comparative effectiveness study was not done. The device being reviewed is an implantable clip, not an AI-powered diagnostic or assistive tool for human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable.

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

• Not applicable. The AtriClip LAA Exclusion System is a medical device (an implantable clip and applier), not an algorithm or AI system. Its performance is evaluated through its physical function in occluding the LAA in vivo.

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

• The ground truth appears to be based on clinical outcomes data from the clinical studies. For "LAA occlusion directly following Clip deployment," this would likely be immediate intraoperative assessment (visual or imaging). For "LAA exclusion post-operatively," this would typically involve follow-up imaging (e.g., transesophageal echocardiography) to confirm the complete closure or exclusion of the LAA.

8. The sample size for the training set:

• This information is not applicable/not provided as the device is not an AI/ML model that requires a training set in the conventional sense. The "training" for such a device would be its design, manufacturing, and preclinical testing phases.

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

• This information is not applicable/not provided for the same reason as above.

Ask a specific question about this device

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

Direct visualization, in this context, requires that the surgeon is able to see the heart directly, without assistance from a camera, endoscope, etc., or any other viewing technology. This includes performed by sternotomy (full or partial) as well as thoracotomy (single or multiple).

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, and deployment loop which contains the Clip. This Special 510(k) contains design modifications to the predicate AtriClip LAA Exclusion System (PRO1) intended to eliminate the End Effector Hoop configuration, allow for active articulation via articulation controls, and increase ease of deployment of the clip.

This appears to be a 510(k) summary for the AtriClip LAA Exclusion System with Preloaded Gillinov-Cosgrove Clip (PRO2). It's a submission for modifications to a previously cleared device (PRO1) and focuses on demonstrating equivalence rather than establishing new performance criteria against a disease or condition. Therefore, the traditional "acceptance criteria" and "study that proves the device meets the acceptance criteria" in terms of clinical diagnostic performance are not directly applicable in this context.

Instead, the submission aims to demonstrate that the modified device (PRO2) is substantially equivalent to the predicate device (PRO1) and does not raise new questions of safety or effectiveness. The "acceptance criteria" here, implicitly, are that the modified device's performance is at least as good as, and within acceptable limits of, the predicate device across defined engineering and biocompatibility tests.

Here's an attempt to structure the information based on the provided request, interpreting "acceptance criteria" as the performance benchmarks for demonstrating substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

Ask a specific question about this device

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

Direct visualization, in this context, requires that the surgeon is able to see the heart directly, without assistance from a camera, endoscope, etc., or any other viewing technology. This includes procedures performed by sternotomy (full or partial) as well as thoracotomy (single or multiple).

The AtriClip LAA Exclusion System consists of a single use, sterile, self-closing, implantable PRO-V Clip preloaded on a Single Use Clip Applier. When closed, the PRO·V Clip applies uniform pressure over the length of the clip to ensure consistent, reproducible, and secure occlusion of the left atrial appendage (LAA). The PRO-V Clip is available in the following lengths to accommodate different sizes of LAA: 35 mm (PROV35), 40 mm (PROV40), 45 mm (PROV45), and 50 mm (PROV50).

The PRO·V Clip Applier is a disposable device with a handle, shaft, suture anchors, and deployment loop which contains the PRO·V Clip.

I am sorry, but based on the provided document, I cannot answer the question as it pertains to acceptance criteria and the study that proves the device meets the acceptance criteria. The document is an FDA 510(k) clearance letter for a medical device (AtriClip LAA Exclusion System), which describes the device, its indications for use, comparison to a predicate device, and various performance tests conducted. However, it does not contain specific acceptance criteria (e.g., target accuracy, sensitivity, specificity values) for statistical-based performance claims, nor does it detail a study proving the device meets particular acceptance criteria in the manner typically associated with clinical performance studies for diagnostic AI devices.

Instead, the document focuses on demonstrating substantial equivalence to a previously cleared predicate device, and the performance data section describes various non-clinical tests (animal study, mechanical, reliability, leak, corrosion, MR compatibility, biocompatibility) to show safety and performance, not statistical performance against predefined acceptance criteria for a diagnostic measure.

Therefore, the requested information, particularly the numbered points 1-9 directly related to acceptance criteria, sample sizes, ground truth, expert involvement, and MRMC studies, is not present in this document.

Ask a specific question about this device