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510(k) Data Aggregation
(146 days)
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.
| Acceptance Criteria Category (Bench Test) | Reported Device Performance (Implied) |
|---|---|
| Trocar Compatibility | Passed; demonstrated compatibility with targeted 12mm trocars. |
| Retention Strength of Unformed Clip in Jaws | Passed; demonstrated adequate retention. |
| Ratchet Mechanism Strength | Passed; demonstrated robust ratchet mechanism. |
| Ergonomic Torque to Fire Device | Passed; within acceptable ergonomic limits for firing. |
| Tactile Indication Torque for "No-Clip Lockout" Function | Passed; demonstrated functional and appropriate tactile lockout. |
| Low Clip Indicator Bar Performance | Passed; demonstrated accurate indication when 3 or fewer clips remain. |
| Clip Occlusion of the Formed Clip | Passed; demonstrated proper clip formation and occlusion. |
| Clip Security of the Formed Clip | Passed; demonstrated secure clip application. |
| Product Stability | Passed (leveraged from predicate device data). |
| Biocompatibility | Passed (leveraged from predicate device data, specifically rabbit pyrogenicity and LAL testing). |
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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