(29 days)
The USGI g-Prox Endoscopic Grasper is intended for use in minimally invasive procedures to facilitate tissue grasping and manipulation.
The g-Prox Endoscopic Grasper is a sterile, single patient use device used for tissue grasping and mobilization. It includes a lumen that can accept the g-Cath Tissue Anchor Delivery Catheter and other small diameter instruments.
The provided document is a 510(k) summary for a medical device (USGI g-Prox Endoscopic Grasper) and primarily focuses on regulatory approval based on substantial equivalence to predicate devices, rather than a detailed study proving performance against acceptance criteria in the context of AI or advanced analytical devices. As such, most of the requested information (related to AI performance, sample sizes for test/training sets, ground truth establishment, expert adjudication, MRMC studies, and standalone performance) is not available or applicable to this type of submission.
The relevant information from the document is summarized below:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Intended Use | Device performs as intended for tissue grasping and mobilization in minimally invasive procedures. |
| Technology | Comparable to predicate devices. |
| Materials | Comparable to predicate devices. |
| Safety & Effectiveness | Deemed substantially equivalent to predicate devices, implying similar safety and effectiveness profiles. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "Bench testing was conducted to ensure that the modified device performs as intended." However, it does not specify the sample size, type of data (e.g., in vitro, ex vivo, in vivo), country of origin, or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This device is a surgical instrument, and its performance is evaluated through bench testing and comparison to predicate devices, not typically through expert-established ground truth in the context of diagnostic or analytical performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The document refers to "Bench testing," but provides no details on adjudication methods.
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 is a surgical instrument, not an AI-assisted diagnostic or analytical device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a surgical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For bench testing, the "ground truth" would likely be engineering specifications, material properties, and functional performance benchmarks (e.g., grasping force, durability, tissue damage assessment), rather than clinical ground truth like pathology or expert consensus. No specific type is mentioned.
8. The sample size for the training set
Not applicable. The device is not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable. The device is not an AI algorithm requiring a training set.
§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.
(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.