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The Ligaclip® Endoscopic Rotating Multiple Clip Applier is intended for use on tubular structures or vessels wherever a metal ligating clip is indicated. The tissue being ligated should be consistent with the size of the clip.

The Ligaclip® 12mm L Endoscopic Rotating Multiple Clip Applier is a sterile, single-patient use device designed to provide a means of ligation through Endopath surgical trocars. The device delivers 20 large titanium clips that individually advance after each firing. The shaft is made of a low glare material that minimizes reflective distortion. It is designed to rotate 360° in either direction. The rotating knob is located to allow for a one-handed technique.

This document describes the premarket notification for the LIGACLIP 12mm L Endoscopic Rotating Multiple Clip Applier. The nature of the device (a clip applier) means that the "acceptance criteria" and "study" described in the document primarily relate to bench testing and pre-clinical studies confirming its physical performance and substantial equivalence to existing devices, rather than a clinical study involving human patients or an AI-based system.

Therefore, the requested information about AI model performance, expert ground truth, adjudication methods, MRMC studies, training/test set sample sizes for AI, etc., does not apply to this specific medical device filing. The "performance data" here refers to mechanical and material characteristics.

Here's a breakdown of the relevant information provided:

1. Table of Acceptance Criteria and Reported Device Performance (as interpreted from the document):

The document doesn't provide a strict "acceptance criteria" table with numerical values that can be directly mapped to "reported device performance" in a quantitative sense for each criterion, as one might see for an AI model. Instead, it lists the types of bench tests performed to verify that the device meets design requirements and is substantially equivalent to predicate devices. The "reported device performance" is implied to have met these criteria to demonstrate substantial equivalence.

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

• Sample Size: The document does not specify the exact sample sizes for each bench test (e.g., how many devices were tested for trocar compatibility, or how many clips were checked for occlusion). It states that ex-vivo tests were performed.
• Data Provenance: The tests were "ex-vivo," meaning performed outside of a living organism, typically in a lab setting using bench models or simulators.
  • Country of Origin: Not explicitly stated, but presumable US-based as the submitting company is Ethicon Endo-Surgery, LLC (Guaynabo, PR) and Ethicon Endo-Surgery, Inc. (Cincinnati, Ohio).
  • Retrospective or Prospective: These are prospective tests carried out specifically for this submission.

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

• Not Applicable. This is a mechanical device, not an AI or imaging diagnostic. "Ground truth" in this context is defined by engineering specifications and physical measurements, not expert consensus on medical images.

4. Adjudication Method for the Test Set:

• Not Applicable. See point 3. Testing involves objective measurements against predefined specifications.

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

• No. This type of study is for evaluating human reader performance with or without AI assistance, which is not relevant for a surgical clip applier.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Analysis:

• Not Applicable. This device is a manual medical instrument. There is no algorithm or AI component to test in a standalone manner.

7. The Type of Ground Truth Used:

• Engineering Specifications and Physical Measurements: The "ground truth" for this device involved precise measurements of mechanical properties, forces, dimensions, and visual checks against design specifications (e.g., clip dimensions, rotation, lockout function). For biocompatibility, it relied on established test standards (e.g., rabbit pyrogenicity, Limulus amoebocyte lysate (LAL) testing).

8. The Sample Size for the Training Set:

• Not Applicable. There is no "training set" as this is not an AI/machine learning device. The "training" in the context of device development is the iterative design and testing process.

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

• Not Applicable. See point 8.

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The Ligaclip® Endoscopic Rotating Multiple Clip Applier is intended for use on tubular structures or vessels wherever a metal ligating clip is indicated. The tissue being ligated should be consistent with the size of the clip.

The Ligaclip® 10mm M/L Endoscopic Rotating Multiple Clip Applier is a sterile, single-patient use device, designed to provide a means of ligation on tubular structures or vessels through an appropriately-sized trocar. The device contains 20 medium-large titanium clips that individually advance after each firing. The device shaft rotates 360° in either direction. The rotating knob is located on the handle to allow for a one-handed technique.

The provided FDA 510(k) summary for the LIGACLIP 10mm M/L Endoscopic Rotating Multiple Clip Applier details performance testing. Here's a breakdown based on your request, keeping in mind that this document focuses on demonstrating substantial equivalence rather than a clinical effectiveness study.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample sizes (number of devices, number of clips, number of tests) for each individual ex-vivo test. It broadly states "Ex-vivo tests were performed."

• Data Provenance: The tests are described as "Ex-vivo tests" and "hydrodynamic testing on excised porcine vessels." This indicates the data is from laboratory bench testing using non-human biological material (porcine vessels) and the device itself.
• The document explicitly states: "This submission does not include data from Clinical Studies." This confirms the data is retrospective in the sense that it's laboratory-generated and not from human clinical trials. The country of origin of this lab data is not specified, but given the manufacturer is Ethicon Endo-Surgery, LLC (with an address in Puerto Rico, USA), it's highly likely to be U.S.-based or internally generated by the company.

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

• This information is not provided in the document.
• For ex-vivo bench testing of this nature, "ground truth" is typically established by engineering specifications, validated test methods, and potentially comparison to predicate device performance, rather than expert clinical consensus as might be the case for image interpretation.

4. Adjudication Method for the Test Set

• This information is not provided as it's not relevant for this type of ex-vivo mechanical and biological performance testing. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or studies involving human interpretation of data.

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

• No, an MRMC comparative effectiveness study was not done.
• The document states: "This submission does not include data from Clinical Studies." An MRMC study would be a type of clinical study.
• Therefore, no effect size for human readers improving with or without AI (as the device is a mechanical clip applier, not an AI diagnostic tool) can be reported.

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

• This question is not applicable as the device is a mechanical clip applier, not an algorithm or AI system.

7. The Type of Ground Truth Used

• For the performance tests: Engineering design requirements and specifications serve as the ground truth/acceptance criteria for mechanical and functional aspects.
• For the hydrodynamic testing: The successful demonstration of clip leak resistance in excised porcine vessels serves as the "ground truth" for that functional aspect.
• For biocompatibility: Compliance with specified international standards (ISO 10993-1) and FDA guidance serves as the ground truth.

8. The Sample Size for the Training Set

• This question is not applicable because the device is a mechanical clip applier and does not involve AI or algorithms that require a "training set."

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

• This question is not applicable for the same reason as point 8.

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