(19 days)
The g-Cath Tissue Anchor Deliver Catheter is intended for approximation of soft tissue in minimally invasive gastroenterology procedures, e.g. fistula closure, perforation/leak closure and repair of dilated gastric tissue.
The g-Cath Tissue Anchor Delivery Catheter is a sterile, single patient use device that contains a nitinol/polyester/titanium tissue anchor pair within the catheter lumen. The anchor pair is deployed through the catheter lumen to compress and approximate tissue.
The provided text describes a 510(k) summary for the g-Cath Tissue Anchor Delivery Catheter. It focuses on the device's substantial equivalence to predicate devices and does not contain detailed information about acceptance criteria or a specific study proving device performance in the manner requested by the prompt (e.g., in a clinical setting with human readers, AI assistance, ground truth establishment, or training set details). Instead, it refers to "bench testing" to ensure the modified device performs as intended.
Based on the information provided, here's an attempt to answer the questions, highlighting where specific details are missing:
1. Table of Acceptance Criteria and Reported Device Performance
The document states: "Bench testing confirmed that the device met its performance specifications." However, the specific acceptance criteria (e.g., tensile strength, deployment force, tissue approximation efficacy) and the quantitative reported device performance values are not provided in this summary.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Specified | Met performance specifications (Specifics not provided) |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "Bench testing" but does not specify the sample size used for these tests. There is no information regarding the data provenance (e.g., country of origin) or whether the data was retrospective or prospective, as this was laboratory bench testing, not clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Since the testing was bench testing of a device's physical properties, there would not be "experts" establishing ground truth in the clinical sense (e.g., radiologists interpreting images). The "ground truth" would be established by the engineering specifications and measurement of physical properties. The document does not specify the number or qualifications of engineers or technicians involved in establishing the testing protocols or verifying results.
4. Adjudication Method for the Test Set
Not applicable. As the testing was bench testing of device performance against specifications, an adjudication method for a test set (like 2+1 or 3+1 for expert consensus) is not relevant.
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. An MRMC comparative effectiveness study is not mentioned. This type of study relates to the performance of human readers, potentially with AI assistance, in interpreting clinical cases. The document describes bench testing of a physical medical device (tissue anchor delivery catheter) and does not involve AI or human "readers" in this context.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This question is relevant to AI algorithms. The document describes a physical medical device (g-Cath Tissue Anchor Delivery Catheter) and its bench testing, not an algorithm.
7. The Type of Ground Truth Used
The ground truth for the bench testing would be the predefined engineering specifications and measurable physical properties of the device (e.g., material strength, deployment accuracy, tissue compression characteristics). The document states, "Bench testing confirmed that the device met its performance specifications," indicating that the "ground truth" was these specifications.
8. The Sample Size for the Training Set
Not applicable. This device is a physical medical instrument, not an AI algorithm. Therefore, there is no "training set" in the context of machine learning. The term "training set" is typically used for data that an AI model learns from.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for a physical device.
§ 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.