(82 days)
The Influence Clip System is indicated for permanent securing of two strands of surgical suture for soft tissue approximation in open or laparoscopic surgical procedures.
The Influence Clip System has two components, a suture clip and an applier. To fixate sutures, the stainless steel clip is inserted into the applier. Two strands of suture are threaded through the clip and the applier inserted into the trocar (if a laparoscopic procedure is performed). The applier's handle is then tightly squeezed which causes a rod within the applier's shaft to crimp the clip around the sutures. The sutures' ends are cut close to the clip (alternative version of applier with suture cutter may be used). The system is provided sterile and the applier is disposable, for single patient use.
The provided document is a 510(k) summary for the Influence Clip System, which focuses on the regulatory clearance process for a medical device. It does not contain a study that proves the device meets specific acceptance criteria in terms of performance metrics like accuracy, sensitivity, or specificity. Instead, the document states that the device's safety and effectiveness were demonstrated through bench testing and that its performance is substantially equivalent to a previously cleared 510(k) device.
Therefore, it is not possible to fill out all the requested information concerning acceptance criteria, study details, ground truth establishment, sample sizes, or expert adjudication for a performance study from this document.
However, based on the information provided, we can infer the primary "acceptance criterion" from a regulatory perspective:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Inferred from regulatory context) | Reported Device Performance |
|---|---|
| Safety (Biocompatibility, lack of adverse effects) | All materials commonly used or proven biocompatible. |
| Effectiveness (Ability to permanently secure sutures for soft tissue approximation) | Bench testing demonstrated safety and effectiveness. |
| Substantial Equivalence to Predicate Devices (Safety and effectiveness profile) | Performance substantially equivalent to a 510(k)-cleared device. |
Missing Information (Not available in the provided text):
- 2. Sample sizes used for the test set and the data provenance: Not mentioned. The testing was "bench testing," meaning lab-based, not clinical data involving patients.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This refers to expert review of clinical cases, which was not the nature of the testing described.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no clinical test set requiring adjudication by experts is described.
- 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: Not applicable. This device is a surgical clip, 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 not an algorithm. Bench testing would assess the device's physical performance.
- 7. The type of ground truth used: For a medical device like this, the "ground truth" for bench testing would likely be based on engineering specifications and physical measurements (e.g., tensile strength tests, slip resistance tests for the clip on sutures), rather than expert consensus on clinical findings or pathological diagnoses. The document vaguely states "bench testing has demonstrated that the device is safe and effective."
- 8. The sample size for the training set: Not applicable, as this is a physical device, not an AI algorithm requiring a training set.
- 9. How the ground truth for the training set was established: Not applicable.
In summary: The provided document is a regulatory submission focused on substantial equivalence based on bench testing. It does not describe a clinical study with detailed performance metrics, ground truth establishment, or human reader involvement as would be typical for an AI/diagnostic device.
§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.