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510(k) Data Aggregation
(13 days)
U-CLIP DEVICE, MODEL NC65
The U-CLIP™ Device is intended for endoscopic and non-endoscopic general soft tissue and prosthetic material approximation/attachment and/or ligation and the creation of anastomosis in blood vessels, grafts and other tubular structures; including use in cardiovascular and coronary artery bypass grafting procedures.
The U-CLIP™ device is a self-closing clip for anastomosis and tissue and prosthetic material approximation or attachment applications. The device is a self-closing Nitinol clip that is constrained in an open position in a stainless steel hypotube until released by the surgeon after placement. This design allows precise placement of clips prior to closure, and facilitates the device is manufactured with a standard implantable grade of Nitinol.
Here's an analysis of the provided text regarding the U-CLIP™ device, focusing on the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, the specific quantitative acceptance criteria are not explicitly detailed. However, the qualitative performance objective was "substantially equivalent" to predicate devices.
| Acceptance Criteria (Qualitative) | Reported Device Performance (Qualitative) |
|---|---|
| Functional characteristics substantially equivalent to predicate device | "Verification and validation testing confirms that functional characteristics are substantially equivalent to the predicate device cited. This included clip strength and clip deployment angle. All test data obtained satisfied the documented product and performance specifications." |
| Substantially equivalent in terms of materials, use, and application to predicate devices | "The U-CLIP™ device is substantially equivalent to the U-CLIP™ Predicate Device(s): devices cleared in K031623, K024366, K060400, K023125, K021407, K013664, K012317, K994160, and K971588 in terms of materials, use and application." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample size used for the test set. It mentions "Verification and validation testing" which included "in vitro, in vivo, and clinical performance information." However, details on the number of clips tested or the number of subjects (for in vivo/clinical) are absent.
The data provenance is described as "in vitro, in vivo, and clinical performance information provided in previous vivo, and cimical performanos information." This suggests a mix of laboratory testing, animal studies, and potentially human clinical data, but the geographic origin of this data is not specified. It's described as "provided in previous... included in this submission," implying it was accumulated over time and presented for this submission. The nature of the studies (retrospective/prospective) is also not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The text focuses on the device's substantial equivalence to predicate devices and its functional performance, rather than an expert-driven ground truth assessment for a specific medical condition.
4. Adjudication Method for the Test Set
This information is not provided in the document. The testing described (clip strength, deployment angle, in vitro/in vivo/clinical performance) doesn't inherently suggest an adjudication process for subjective assessments, but rather objective measurements and functional evaluations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This information is not applicable and not provided. The U-CLIP™ is a physical surgical implant (a self-closing clip), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance would not be relevant in this context.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This information is not applicable and not provided. As explained above, the U-CLIP™ is a physical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" in this context is the functional performance specifications for the clip (e.g., clip strength, deployment angle) and the established safety and efficacy profile of the predicate devices for achieving tissue approximation/ligation. The testing aimed to demonstrate that the new U-CLIP™ met its own specifications and performed comparably to already-approved devices, suggesting the "ground truth" was a combination of engineering specifications and the historical performance of predicate devices. There is no mention of pathology, outcomes data, or expert consensus in relation to a specific diagnostic task.
8. The Sample Size for the Training Set
This information is not applicable and not provided. As the U-CLIP™ is a physical medical device, not an AI or machine learning algorithm, there is no "training set" in the conventional sense. The development of the device would involve engineering design, prototyping, and iterative testing, but not the training of a model on a dataset.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided for the same reasons mentioned in point 8.
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