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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 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 FLEX:V device 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 AtriClip FLEX:V device is a disposable device with a handle, shaft, suture anchors, shaft rotation knob, and deployment end-effector containing the Clip.

The provided FDA document describes the AtriClip FLEX-V device, an implantable clip for occluding the heart's left atrial appendage. The document focuses on demonstrating substantial equivalence to a predicate device (AtriClip LAA Exclusion System with Preloaded PRO-V Clip, K173031) through non-clinical bench testing.

Therefore, the requested information regarding acceptance criteria and studies demonstrating device performance, as typically found in clinical trials or AI/software evaluations, is not fully available for this device within the provided document.

Here’s a breakdown of what is and is not present based on the provided text:

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

• Acceptance Criteria: The document states that the AtriClip FLEX V device "met the predetermined acceptance criteria". However, the specific criteria themselves (e.g., specific tensile strength values, deployment force ranges, etc.) are not detailed or quantified in the provided text.
• Reported Device Performance: The document generally states that "No new safety or performance issues were raising during testing" and that the device "met the predetermined acceptance criteria." However, specific numerical performance results from the bench tests are not provided.

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

• Sample Size: This information is not provided as the study described is non-clinical bench testing, not a human clinical trial.
• Data Provenance: This information is not applicable as the described study is laboratory-based bench testing.

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)

• Not applicable. This device is a physical implantable clip, and the testing described is engineering bench testing rather than a diagnostic device requiring expert interpretation of results to establish ground truth.

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

• Not applicable. This relates to human interpretation of data, which is not part of the described 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

• No. This is a physical medical device, not an AI or diagnostic tool. Therefore, an MRMC study is not relevant.

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

• Not applicable. This refers to AI algorithms.

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

• Not explicitly stated in terms of "ground truth" as typically used in diagnostic product evaluations. For bench testing of a physical device, the "ground truth" would be established engineering specifications, material properties, and functional requirements against which the device's performance (e.g., mechanical strength, deployment reliability) is measured. The document implies these engineering specifications were used as the basis for evaluation by stating the device "met the predetermined acceptance criteria."

8. The sample size for the training set

• Not applicable. This refers to AI/machine learning.

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

• Not applicable. This refers to AI/machine learning.

Summary of available information regarding performance:

• Study Type: Non-clinical bench testing.
• Purpose: To demonstrate substantial equivalence to a predicate device (AtriClip LAA Exclusion System with Preloaded PRO-V Clip, K173031) due to modifications made only to the clip applier design. The implantable clip itself is identical to the predicate.
• Tests Conducted:
  • Reliability Testing
  • Mechanical Testing
  • Drop Testing
  • Biocompatibility Testing
  • Transit Testing
  • Shelf Life Testing
• Outcome: The AtriClip FLEX V device "met the predetermined acceptance criteria ensuring substantial equivalence to the previously cleared PRO-V device." "No new safety or performance issues were raising during testing."

Essentially, the provided document is a 510(k) summary focused on demonstrating equivalence through engineering and materials testing for a physical device, not a report on clinical trial outcomes or a performance study for a diagnostic or AI product.

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