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510(k) Data Aggregation
(27 days)
LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420); LIGACLIP Endoscopic Rotating Multiple
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 and 10mm M/L Endoscopic Rotating Clip Appliers are sterile, single-patient use instruments designed to provide a means of ligation through surgical trocars. The instruments deliver titanium clips that individually advance after each firing. The shafts of these devices are made of a low glare material that minimizes reflective distortion. The are designed to rotate 360 degrees in either direction. The configuration of the Subject devices, Ligaclip® 12mm Land 10mm M/L Endoscopic Rotating Multiple Clip Appliers consist of a pistion knob, and a shaft. The shaft is made of a low glare material that mininizes reflective distal end of the shaft are the jaws, which form ligating dips. The force to squeeze the trigger increases when no clips remain in the device. The shaft contains a yellow clip counter indicator bar, which appears yellow when only 3 clips or fewer remain in the device.
The provided document is a 510(k) Premarket Notification from the U.S. FDA for the LIGACLIP Endoscopic Rotating Multiple Clip Applier. It aims to demonstrate substantial equivalence to previously marketed predicate devices.
The document does not describe a study involving artificial intelligence or human readers for diagnostic purposes. Instead, it refers to a medical device that physically applies clips during surgery. Therefore, many of the requested items related to AI device performance, such as MRMC studies, ground truth establishment for AI models, and training/test set sample sizes for AI, are not applicable to this submission.
However, I can extract information related to the acceptance criteria and the study performed for this specific device, to the extent that it is described.
Acceptance Criteria and Study for LIGACLIP Endoscopic Rotating Multiple Clip Applier
The device under review is an endoscopic clip applier, not an AI-powered diagnostic tool. The "performance" in this context refers to the device's mechanical functionality and usability, not diagnostic accuracy.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Success Criteria) | Reported Device Performance |
|---|---|
| Usability of Instructions for Use (IFU) | The usability testing conducted to evaluate the usability and acceptance of the IFU met the success criteria. The study demonstrated that the evaluated IFU steps can be performed as intended by representative users without a pattern of use error, close calls, or use difficulty. |
| Device Functionality (Minor Component Design Change) | The verification testing conducted to evaluate the change to the device component met the success criteria. This testing demonstrated acceptable device functionality performance of the subject device and ensured it meets existing finished good specifications of the predicate device. |
2. Sample size used for the test set and the data provenance:
- Usability Study: The document mentions "representative users" but does not specify the exact sample size for the usability study.
- Verification Testing: No specific sample size is mentioned for the verification testing.
- Data Provenance: Not specified, but generally, such studies are conducted by the manufacturer. The submission is from Ethicon Endo Surgery, LLC in Guaynabo, Puerto Rico. The studies are non-clinical (usability and verification of a mechanical device). These would be prospective tests conducted for the purpose of this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Usability Study: The "ground truth" for the usability study is whether "representative users" can perform the IFU steps as intended without errors. This isn't about expert medical diagnosis. The number and qualifications of these "representative users" are not specified.
- Verification Testing: The "ground truth" for verification testing is meeting existing finished good specifications. This involves engineering and quality control, not medical experts.
4. Adjudication method for the test set:
- Not applicable in the context of this device. Adjudication methods like 2+1 or 3+1 are used for expert consensus on medical image interpretations, which is not relevant here.
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. An MRMC study is not applicable as this device is a surgical instrument and not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a mechanical surgical device, not an algorithm.
7. The type of ground truth used:
- Usability Study: The ground truth was the ability of representative users to successfully follow the Instructions for Use without significant errors or difficulties.
- Verification Testing: The ground truth was the ability of the device to meet existing finished good specifications, based on a minor design change to an internal component. This would involve objective measurements against predefined engineering specifications.
8. The sample size for the training set:
- Not applicable. This device does not use a "training set" in the context of machine learning or AI models. It's a physical medical device.
9. How the ground truth for the training set was established:
- Not applicable. As there is no training set for an AI model, there is no ground truth establishment in that sense. The device's design and functionality are based on engineering principles and prior predicate devices.
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