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 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).

Ask a specific question about this device

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.

Ask a specific question about this device

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 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.

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, 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

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

The document does not explicitly state the sample sizes for the mechanical, reliability, animal model, or MR testing. It refers generally to "testing" being performed. Data provenance is not specified beyond "Non-clinical Bench Testing" and "Bench Testing on an Animal Model." This implies controlled laboratory and animal studies rather than human clinical data.

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

This information is not applicable. This is not a study requiring expert consensus on diagnostic imaging or clinical outcomes. The "ground truth" for these engineering tests is established by physical measurements, material properties, and biological responses according to established standards.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication is typically used in clinical studies when there's ambiguity in classifying clinical endpoints or imaging findings. For engineering and biocompatibility tests, results are typically quantitative or directly observable against established pass/fail criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that assist human readers in tasks like interpreting medical images. The AtriClip is an implantable medical device, and the submission focuses on its physical and biological performance, not its interpretive assistance to clinicians.

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

This information is not applicable. This device is not an algorithm or AI system. It's a surgical implant and delivery system.

7. The Type of Ground Truth Used

For the non-clinical tests:

• Mechanical and Reliability Testing: The "ground truth" is defined by the physical and engineering specifications and performance characteristics of the predicate device (PRO1) and relevant industry standards.
• Magnetic Resonance Testing: The "ground truth" is adherence to the safety and compatibility requirements outlined in FDA Guidance (December 11, 2014) for passive implants in an MR environment.
• Biocompatibility Testing: The "ground truth" is established by the International Standard ISO 10993-1, which defines acceptable biological responses to medical devices.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" as this is not a machine learning or AI-based device. The development and design of the PRO2 were likely based on engineering principles, predicate device experience (PRO1), and iterative testing, not a formal training set for an algorithm.

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

This information is 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, 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

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.

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 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.

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.

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.

Ask a specific question about this device