(212 days)
The g-Cath Tissue Anchor Delivery Catheter is intended for approximation of soft tissue in minimally invasive gastroenterology procedures.
The g-Prox Endoscopic Grasper is intended for use in minimally invasive procedures to facilitate tissue grasping and mobilization.
The g-Prox Endoscopic Grasper is a sterile, single patient use device used for tissue grasping and mobilization. It is also used as an accessory to the g-Cath Tissue Anchor Delivery Catheter for placement of tissue anchors for soft tissue approximation in minimally invasive gastroenterology procedures. A nitinol/polyester tissue anchor pair is deployed through the g-Cath Tissue Anchor Delivery Catheter lumen and compressed to approximate soft tissue. Anchor tensile strength meets USP for a size 4-0 nonabsorbable suture. The anchor does not meet USP for diameter and is oversized by 100% compared to a 4-0 nonabsorbable suture.
The provided text describes a 510(k) submission for the g-Cath Tissue Anchor Delivery Catheter and g-Prox Endoscopic Grasper, focusing on their substantial equivalence to predicate devices. It does not present acceptance criteria or a study proving that the device meets specific acceptance criteria in the way a clinical performance study would for an AI/ML device.
Instead, the submission focuses on:
- Comparison with Predicate Devices: Demonstrating that the new devices are comparable to existing legally marketed devices in terms of intended use, technology, design, and materials.
- Preclinical Testing: Stating that "Bench and animal testing demonstrated satisfactory performance of the g-Prox Endoscopic Grasper and g-Cath Tissue Anchor Delivery Catheter." This is a general statement of satisfactory performance, not a detailed report against specific, quantified acceptance criteria.
- Compliance with Industry Standards: The g-Cath Tissue Anchor's tensile strength is stated to meet USP for a size 4-0 nonabsorbable suture, although its diameter is oversized. This is the closest thing to a specific performance metric mentioned.
Given this context, I cannot extract the information requested as it pertains to AI/ML device performance studies. The provided document is for a medical device clearance (510(k)) that relies on preclinical testing and substantial equivalence to predicate devices, not a human-in-the-loop or standalone AI/ML performance study.
Therefore, most of your requested table and points regarding sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies for AI performance cannot be answered from the provided text.
Here's a breakdown of what information can be extracted or inferred based on the document's nature:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| g-Cath Anchor tensile strength (similar to predicate sutures) | Meets USP for a size 4-0 nonabsorbable suture. |
| General satisfactory performance during preclinical testing | Bench and animal testing demonstrated satisfactory performance. |
| Material and design compatibility with intended use | Comparable to predicate devices in materials and design. |
| Functionality (grasping, mobilization, tissue approximation) | Performs grasping, mobilization, and tissue approximation as intended. |
| Sterility, single-patient use (implied from description) | Described as sterile, single-patient use. |
| Anchor diameter consistency with USP (implied, though not met) | Oversized by 100% compared to a 4-0 nonabsorbable suture (for diameter). |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified for bench or animal testing. The text only states "Preclinical testing was performed..."
- Data Provenance: The testing was "Bench and animal testing," indicating lab-based and in-vivo animal studies. Country of origin is not specified but implicitly US-based given the FDA submission. These are prospective tests for device validation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not provided. The "ground truth" here would relate to the physical and functional properties of the device, likely assessed by engineers and veterinarians/pathologists in animal studies, not human experts establishing ground truth for diagnostic AI.
4. Adjudication method for the test set
- Not applicable/Not provided. Adjudication methods are typically relevant for human reader studies or expert consensus, not for mechanical or animal performance testing.
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. This is not an AI/ML device, and no MRMC study was mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an AI/ML device. The "standalone performance" was the physical device independent of human assistance in a diagnostic context.
7. The type of ground truth used
- Bench Testing: Ground truth would be based on established engineering standards, physical measurements (e.g., tensile strength testing against USP standards), and functional tests.
- Animal Testing: Ground truth would be based on physiological observations, histological assessment of tissue approximation, and veterinary pathology.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device where a "training set" would be used in the same context.
9. How the ground truth for the training set was established
- Not applicable. (See #8)
§ 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.