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ZIPCLIP is indicated for use in surgical procedures to occlude blood vessels.

The GEM ZIPCLIP (ZIPCLIP) is a sterile, single-use automatic microclip applier. Each device contains 15 titanium microclips. When applied on a vessel, microclips remain with the patient as permanent implants. ZIPCLIP is for prescription use only and the use environment is the operating room. The ZIPCLIP device is a pre-loaded, disposable, single-patient use mechanical assembly comprised of plastic and metal components. The applier device has (2) scissor-like handles that, when driven medially, close the distal jaws forming a closed clip the device in the open configuration. When released, the handles return to their resting state and the closed clip disengages from the applier. Simultaneously, a new clip is automatically loaded into the distal jaws for consecutive firing. When ZIPCLIP is empty a lockout clip (anodized gold in color) deploys between the jaws, preventing them from closing. The ZIPCLIP is a mechanical assembly comprised of plastic and metal components. The clips are composed exclusively of titanium (Grade 1) and are supplied sterile in a preloaded channel that is incorporated into the number of clips per applier is fifteen (15). The clips are stacked and contained internal to the device. Clips cannot be reloaded once the stack is deployed and the applier is disposed of once emptied. Note, the ZIPCLIP preloaded microclips that can be used with the ZIPCLP device.

Here is an analysis of the provided text regarding the acceptance criteria and study for the device, organized according to your request.

Please note: The provided document is a 510(k) summary for a medical device (GEM ZIPCLIP, an implantable clip) and primarily focuses on demonstrating substantial equivalence to a predicate device. It describes performance testing but does not detail acceptance criteria in the format of specific thresholds for metrics like sensitivity, specificity, accuracy, or human reader improvement, which are typical for AI/ML-based medical devices or diagnostic tools. The document describes a traditional medical device (a surgical clip) and its mechanical performance rather than the performance of a software algorithm. Therefore, many of your requested points related to AI/ML device studies (e.g., ground truth establishment for training sets, MRMC studies, standalone algorithm performance, AI assistance effect size) are not applicable to this document's content.

Acceptance Criteria and Device Performance for GEM ZIPCLIP

As per the provided 510(k) Summary for the GEM ZIPCLIP, the device is a sterile, single-use automatic microclip applier containing titanium microclips for occluding blood vessels. The performance testing described is focused on the mechanical and functional aspects of the device, rather than the diagnostic capabilities typical of AI/ML software.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a formal table of specific, quantitative acceptance criteria (e.g., success rates, tensile strength thresholds) with corresponding numerical reported performance values. Instead, it states the purpose of the testing and implies successful meeting of implicit performance criteria necessary for safe and effective occlusion.

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

• Sample Size for Test Set: The document does not specify the exact number of test units (e.g., appliers, clips) or the number of vessels or simulations used in the bench testing. It broadly states that "bench performance testing" was performed.
• Data Provenance: The testing was "bench testing" conducted by Baxter (Synovis Micro Companies Alliance is part of Baxter, as indicated by the contact email). This implies a controlled laboratory environment.
  • Country of Origin: Not explicitly stated, but typically assumed to be the country of the manufacturer or its testing facilities (likely USA, given the FDA submission).
  • Retrospective or Prospective: Not applicable as this relates to clinical data. The bench testing would be considered prospective in its execution (i.e., tests were planned and executed to gather performance data).

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

This concept is not applicable to this type of device and study. The "ground truth" for a surgical clip is its physical performance (e.g., does it close properly, does it occlude a vessel, does it stay closed). This is assessed via engineering and mechanical testing, not by expert interpretation of images or clinical outcomes in the diagnostic sense.

4. Adjudication Method for the Test Set

Not Applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where multiple human readers or experts are involved in interpreting complex data (e.g., medical images) to establish a consensus "ground truth." For the mechanical testing of a surgical clip, direct measurements and observable outcomes determine performance.

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

No, a MRMC study was not done. This type of study is specifically designed for evaluating diagnostic devices, especially those involving AI, to measure the impact of AI assistance on human reader performance. As the GEM ZIPCLIP is a mechanical surgical device and not a diagnostic tool, an MRMC study is not applicable. Therefore, there is no effect size reported for human readers improving with AI assistance.

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

Not Applicable. The GEM ZIPCLIP is a physical medical device (surgical clip applier), not a software algorithm. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance testing is:

• Physical Verification/Measurement: Successful deployment, proper closure of clips, and effective occlusion on "simulated vessels" using "benchtop models."
• Material Properties Testing: Verification of titanium material (Grade 1) and MR-Conditional properties.
• Functional Observation: Observing the mechanical actions of the applier (e.g., automatic loading, lockout mechanism).

Essentially, the "ground truth" is established by direct engineering and biomechanical testing demonstrating the functional capabilities and material characteristics of the device.

8. The Sample Size for the Training Set

Not Applicable. This device is not an AI/ML algorithm, so there is no "training set."

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

Not Applicable. As there is no training set for an AI/ML algorithm, this question is not relevant to the GEM ZIPCLIP device.

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