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510(k) Data Aggregation
(87 days)
G-CINCH SUTURE GRASPER
The g-Cinch is intended for use with the g-Cath Tissue Anchor Delivery Catheter for suture grasping and cinching of g-Cath Tissue Anchors
The g-Cinch Suture Grasper is a sterile, single patient use device used as an accessory to the g-Cath Tissue Anchor Delivery Catheter for grasping and cinching g-Cath Tissue Anchors. It is comprised of a proximal polycarbonate/ABS handle, flexible shaft made of medical grade polymers and a distal metal snare. It has a nominal working length of 159 cm and can be introduced through either an endoscopic access device or endoscope with a > 2.8 mm nominal channel diameter and working length of
Here's an analysis of the provided text regarding the g-Cinch Suture Grasper, focusing on acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Device Integrity (Bond joint strength) | "Test data showed that the device performs as intended when used according to its instructions for use." |
| Performance (as intended) | "Test data showed that the device performs as intended when used according to its instructions for use." |
| Biocompatibility | Met ISO 10993-1 requirements. |
| User Ergonomics | "Test data showed that the device performs as intended when used according to its instructions for use." |
| Equivalence to Predicate Device (g-Cath) | "Test data also showed that the g-Cinch met the same acceptance criteria as the g-Cath predicate device, and thereby demonstrated equivalent safety and performance to the predicate device." |
Study Information:
The provided document describes a non-clinical performance testing study.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the sample size used for the non-clinical performance testing. It refers generally to "Test data."
- Data Provenance: The study was a non-clinical performance testing and therefore did not involve human subjects or patient data. It describes internal testing conducted by USGI Medical.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not applicable. This was a non-clinical engineering/performance study, not a study evaluating diagnostic accuracy or requiring expert-established ground truth in the traditional sense of clinical or image-based studies. The "ground truth" would be the engineering specifications and performance standards.
4. Adjudication Method for the Test Set
- Not applicable. As a non-clinical engineering performance study, there was no need for expert adjudication of results. Performance was measured against predefined engineering and material specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No. An MRMC study was not conducted as this was a non-clinical device performance study, not a clinical study involving human readers or AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
- Not applicable. This device is a mechanical medical instrument, not an algorithm or AI system. Therefore, the concept of "standalone algorithm performance" does not apply.
7. The Type of Ground Truth Used
- The "ground truth" for this non-clinical study was based on engineering specifications, material properties, and predefined performance standards for the device itself and its predicate (g-Cath Tissue Anchor Delivery Catheter). For example, bond joint strength would have objective measurement criteria.
8. The Sample Size for the Training Set
- Not applicable. This was a physical device performance study, not an AI/algorithm study that involves "training sets."
9. How the Ground Truth for the Training Set was Established
- Not applicable. As this was not an AI/algorithm study, there was no training set or ground truth established for a training set.
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