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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 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 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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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

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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 LAA Exclusion System consists of a single use, sterile, self-closing, implantable Clip preloaded on a Single Use Clip Applier. 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 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 manufacturing modifications to the proposed AtriClip LAA Exclusion System intended to provide AtriCure with an alternate raw material source for the Polyethylene terephthalate (PET) of the knit braid polyester used in the AtriClip implant.

This document describes a 510(k) premarket notification for the AtriClip LAA Exclusion System, specifically addressing a manufacturing modification related to an alternate raw material source for a component of the implant. This is not a study proving device performance against acceptance criteria in the typical sense of a clinical trial or algorithm validation. Instead, it demonstrates substantial equivalence to a predicate device through engineering and biocompatibility testing for a material change.

Therefore, many of the requested details about acceptance criteria, study design, and ground truth for device performance in a diagnostic or clinical efficacy context are not applicable to this submission.

Here's an attempt to answer the questions based on the provided document:

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

Based on the nature of this 510(k) submission (a manufacturing modification for an alternate raw material source), the "acceptance criteria" are related to maintaining the performance and safety characteristics of the original device. The document does not provide a table with specific numerical acceptance criteria for a new clinical performance study. Instead, it states that:

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 a "test set" in the context of clinical performance or algorithm validation. The testing described is chemical characterization and in vitro biocompatibility screening of the raw material. Details on sample sizes for these specific lab tests are not provided, nor is the country of origin or whether they were retrospective/prospective.

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 is not applicable. This submission concerns a manufacturing material change for a surgical implant, not a diagnostic device or AI algorithm requiring expert-established ground truth from clinical data.

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

This is not applicable for the reasons stated above.

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

This is not applicable. The device is a physical surgical implant, not an AI algorithm.

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

This is not applicable. The device is a physical surgical implant, not an AI algorithm.

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

For the material equivalence and functional equivalence, the "ground truth" would be established using validated chemical analysis techniques (e.g., spectroscopy, chromatography) and standard in vitro biological assays (e.g., cytotoxicity, sensitization tests) to compare the new material to the established material. For functional performance, it would involve engineering test standards and specifications. Clinical outcomes data or expert consensus on clinical findings are not the primary "ground truth" for this type of submission.

8. The sample size for the training set

This is not applicable. The device is a physical surgical implant, not an AI algorithm.

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

This is not applicable.

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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 Clip preloaded on a Single Use Clip Applier. 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 available in the following lengths to accommodate different sizes of LAA: 35 mm, 40 mm, 45 mm, and 50 mm. This Special 510(k) does not include any changes to the Clip.

The Clip Applier is a disposable device with a handle, shaft, suture anchors, and deployment loop which contains the Clip. This Special 510(k) includes modifications to the Clip Applier including a malleable aluminum alloy shaft.

The provided text pertains to a 510(k) premarket notification for a medical device called the AtriClip™ LAA Exclusion System. This document is a regulatory filing and as such, it does not describe a clinical study in the typical scientific sense with acceptance criteria for device performance in patients, human reader studies, or detailed ground truth establishment.

Instead, the document focuses on demonstrating substantial equivalence to previously cleared predicate devices through non-clinical bench testing and animal model deployment testing. It aims to show that modifications to the clip applier (a delivery tool) do not negatively impact the performance of the actual implantable clip.

Therefore, I cannot provide a table of acceptance criteria for typical device performance metrics (like sensitivity, specificity, accuracy) or details about human reader studies, training sets, or adjudication methods, as these types of studies were not conducted or reported in this 510(k) summary.

However, I can extract the information related to the performance data and "acceptance criteria" as described in the context of a 510(k) submission, acknowledging that these are not clinical performance criteria.

Acceptance Criteria and Device Performance (Based on 510(k) Document)

The "acceptance criteria" in this context are interpreted as the successful demonstration that the modifications to the AtriClip Applier do not compromise the fundamental function of the system, particularly the successful deployment of the Clip.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Description: The document refers to "an animal model" for deployment testing. Specific animal type, number of animals, or quantity of deployment attempts are not provided.
• Data Provenance: The testing appears to be internal to AtriCure, Inc. and is regulatory in nature for a 510(k) submission. No country of origin for external data is mentioned. The testing is prospective in the sense that it was conducted for this specific regulatory submission.

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

• Not applicable. This was a non-clinical/animal model study to assess mechanical function and deployment, not an AI model evaluating diagnostic images or clinical outcomes requiring human expert ground truth. The "ground truth" for successful deployment would be direct observation by the testing personnel.

4. Adjudication Method for the Test Set

• Not applicable. As above, this was a functional test, not a subjective assessment requiring adjudication among multiple experts.

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

• No. This type of study (comparing human readers with and without AI assistance) was not performed or reported in this 510(k) summary. The device is a surgical tool, not an AI diagnostic system.

6. Standalone (Algorithm Only) Performance Study

• No. This type of study is not applicable as the device is a physical surgical intervention system, not a standalone algorithm.

7. Type of Ground Truth Used

• For the deployment testing on an animal model, the ground truth was direct observation of successful (or unsuccessful) deployment of the Clip on the LAA by the device during surgical procedures.
• For bench testing, the ground truth was the measured adherence to design specifications and controls (e.g., mechanical properties, reliability, transit functionality).

8. Sample Size for the Training Set

• Not applicable. This document describes testing for a physical medical device, not the development or training of an AI algorithm. Therefore, there is no "training set" in the context of machine learning.

9. How Ground Truth for the Training Set Was Established

• Not applicable. As there is no AI algorithm training set, this question is not relevant to this document.

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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.

The AtriClip LAA Exclusion System consists of a single use, sterile, self-closing, implantable Clip preloaded on a Single Use Clip Applier. 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 available in the following lengths to accommodate different sizes of LAA: 35 mm, 40 mm, 45 mm, and 50 mm. This Special 510(k) does not include any changes to the Clip.

The Clip Applier is a disposable device with a handle, shaft, and an end effector which contains the Clip. This Special 510(k) includes modifications to the Clip Applier including both lateral and vertical articulation of the end effector and deployment via pulling a deployment tab at the proximal end of the handle.

The provided text describes a 510(k) submission for a modification to the AtriClip LAA Exclusion System, specifically for the Clip Applier. It is not an AI/ML device, therefore, many of the requested categories are not applicable.

Here's an analysis of the provided information:

1. Table of acceptance criteria and the reported device performance

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

• Sample Size: The text states "The modified Clip Applier was tested on the cadaver model." It does not specify the number of cadaver models used.
• Data Provenance: The testing was conducted internally by AtriCure, Inc. The data provenance is from cadaver models, which is a retrospective experimental setting for device functionality assessment.

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

Not applicable. This device is not an AI/ML device that requires human expert review for establishing ground truth. The "ground truth" here is the physical ability of the device to deploy the clip successfully on the cadaver model.

4. Adjudication method for the test set

Not applicable. This is a mechanical device, not an AI/ML system requiring adjudication of results. The testing involved direct observation of clip deployment.

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 not an AI/ML system, and therefore, no MRMC study was conducted.

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

Not applicable. This device is a surgical instrument and, by its nature, requires human intervention for its operation.

7. The type of ground truth used

The ground truth used was the successful physical deployment of the AtriClip on the left atrial appendage of a cadaver model, along with conformance to design controls and product specifications. This is a functional and engineering-based ground truth, not a diagnostic one.

8. The sample size for the training set

Not applicable. This device is not an AI/ML system and does not involve a "training set" in the computational sense. The "training" for such a device would involve engineering design, prototyping, and iterative development based on physical testing.

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

Not applicable (as it's not an AI/ML device with a training set). For a physical device like this, the "ground truth" during development would be established through engineering specifications, design requirements, and results from various stages of prototyping and bench testing, ensuring the device meets its intended functional performance and safety parameters.

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

The AtriClip LAA Exclusion System consists of a single use, sterile, self-closing, implantable Clip preloaded on a Single Use Clip Applier, and a Selection Guide to aid in appropriate Clip size selection. The frame assembly of the implantable Clip consists of two springs connecting two opposing tubes which are covered with pressure pads. This assembly is covered with a knit fabric. 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 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, and an end effector which contains the Clip. Both sides of the Clip are free to move within the end effector when activated. Pulling the thumb lever proximally opens the Clip. The bias of the Clip allows both the clip and the lever to return to the closed position when the lever is released.

Here's an analysis of the acceptance criteria and study information provided in the document for the AtriClip LAA Exclusion System:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria in a quantitative format (e.g., "efficacy must be X% or greater"). Instead, it presents the results of the clinical study and concludes that these results demonstrate excellent performance and support substantial equivalence.

Based on the descriptive statements, we can infer the following:

• Clinical Efficacy: 95.1% composite exclusion rate (intra-operative and 3 month).
• Clinical Efficacy (3 Months): 98% exclusion rate at 3-month follow-up. |
  | Safety: No device or procedure-related adverse events. | - Animal Safety: No adverse events attributed to the Clip device in non-clinical testing.
• Clinical Safety: 0% event rate for the primary safety endpoint. Independent physician adjudication found no events linked to the device or procedure. |
  | Biocompatibility: Materials suitable for intended use. | - All materials suitable for intended use, tested per ISO 10993-1. |
  | Functional Performance (e.g., proper LAA occlusion). | - Non-clinical testing demonstrated complete appendage exclusion.
• Post-implant verification confirmed no communication between LAA and left atrium in all animals (non-clinical). |
  | Substantial Equivalence to Predicate Devices | - Concluded to be "as safe, as effective and performs as well as or better than the predicate device," based on technological characteristics, non-clinical, and clinical data. |

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

• Clinical Study Test Set Sample Size: 70 subjects
• Data Provenance: The document explicitly states "a controlled clinical study," implying prospective data collection in humans. The country of origin is not specified, but the submission to the FDA for a US market device implies it would be relevant to the US regulatory context.

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

• The document states: "Independent physician adjudication has demonstrated that there were no events that were in any way linked to the device or the procedure."
• Number of Experts: Not specified.
• Qualifications of Experts: Described as "Independent physician adjudication," but specific qualifications (e.g., specialty, years of experience) are not provided.

4. Adjudication Method for the Test Set

• The document mentions "Independent physician adjudication" for safety events. The specific method (e.g., 2+1, 3+1, none) is not detailed. It implies a review process by independent physicians to determine the linkage of reported events to the device or procedure.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

• No, an MRMC comparative effectiveness study was not done.
• This device is an implantable medical device (a clip for LAA exclusion), not an AI-powered diagnostic or assistive tool. Therefore, the concept of human readers improving with AI assistance does not apply to this context.

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

• No, this is not applicable. As mentioned above, this is an implantable medical device, not an algorithm. The performance is the direct result of the device's physical interaction with tissue, not an independent algorithm.

7. The Type of Ground Truth Used

• Clinical Efficacy/Exclusion: Visual confirmation (intra-operative) and likely imaging modalities (e.g., transesophageal echocardiography) at 3-month follow-up to confirm no communication between the LAA and the left atrium.
• Clinical Safety: Adverse event reporting and subsequent "Independent physician adjudication" to determine causality.
• Non-Clinical (Animal) Efficacy/Exclusion: Direct observation, post-implant verification for communication, and likely pathological examination.

8. The Sample Size for the Training Set

• The document describes "non-clinical testing" on "acute and chronic models ranging from 7 days to 90 days." It refers to "all animals" being tested. However, a specific number for the animal "training" or "pre-clinical" sample size is not explicitly stated beyond "all animals."
• There's no mention of a separate training set for algorithm development, as this is not an AI device.

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

• For the non-clinical (animal) testing, the ground truth for LAA exclusion and safety was established through:
  • Direct observation during surgical procedures.
  • Post-implant verification (likely imaging and/or direct inspection) to confirm no communication between the LAA and left atrium.
  • Observation for adverse events.
  • The document implies that the "training set" (animal data) served as foundational evidence before human clinical trials.

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