(77 days)
The AMT Suture Delivery System is intended for anchoring the wall of a hollow viscus to the abdominal wall prior to the introduction of interventional catheters and stay in place for up to 14 days in child, adolescent, and adult populations.
The Suture Delivery System is a sterile, single use suturing device designed to pass suture percutaneously through tissues in order to anchor the wall of a hollow viscus to the abdominal wall prior to the introduction of interventional catheters. The non-absorbable suture meets requirements established by the United Stated Pharmacopeia (USP) for non-absorbable surgical suture. The suture is provided pre-loaded in a hand-held, manually operated, disposable suture application device. Only the suture and the anti-splay component are intended to remain in place while the wall of the viscous adheres to the abdominal wall; all other components of the delivery system are removed completely and discarded.
The provided text describes a 510(k) submission for the "AMT Suture Delivery System." This document is a regulatory submission for a medical device and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific performance criteria in a clinical setting.
Therefore, the information you are requesting about acceptance criteria and a study proving those criteria are met, particularly regarding AI performance, human reader improvement with AI, training set details, and ground truth establishment, is not present in this document. This document describes a traditional medical device (suture delivery system) and its regulatory clearance process through the FDA, which does not involve AI or the kind of performance studies typically associated with AI-driven devices.
Here's a breakdown of what is available related to performance, and why the other information is absent:
1. Table of Acceptance Criteria and Reported Device Performance:
The document summarizes performance testing, but it does not provide a table of acceptance criteria with corresponding device performance metrics in the way you've outlined. Instead, it states that "Testing found that all components and materials met or exceeded design specifications established by AMT" and "The AMT Suture Delivery System met or exceeded all the acceptance criteria and does not raise new questions of safety or effectiveness."
The types of "performance" mentioned are largely for engineering and manufacturing validation, not clinical efficacy in the context of an AI device.
| Performance Area | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Biocompatibility Testing | Compliance with ISO 10993 standards | Device is in compliance with ISO 10993-1, -5, -10, -11, -12, -17, and USP |
| Sterilization | Sterility Assurance Level (SAL) 10⁻⁶, compliance with ANSI/AAMI/ISO 11135 and ISO 10993-7, USP chromogenic method for Bacterial Endotoxin | Validated to confirm SAL of 10⁻⁶, complies with standards. |
| Shelf Life | Compliance with ASTM F1980-16, ISO 11607, and ISTA 3A | Packaging complies with standards. |
| Bench Testing | Conformance to AMT specifications (deployment force, tensile testing), ISO 7864 (needle hub bond, needle penetration), USP (suture bond), USP (suture tear strength), ISO 9626 (resistance to breakage, needle stiffness) | Met or exceeded all acceptance criteria. |
2. Sample size used for the test set and the data provenance: Not applicable. This is not an AI/software device that uses a "test set" in the context of machine learning. The performance tests mentioned are physical and chemical property tests of the device components.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth is not established in this manner for this type of device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set requiring expert adjudication is described.
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 device does not involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device does not involve algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of AI. The "ground truth" for this device's performance is objective measurements against established engineering and material science standards (e.g., tensile strength, sterility assurance level, biocompatibility).
8. The sample size for the training set: Not applicable. This device does not involve a training set.
9. How the ground truth for the training set was established: Not applicable. This device does not involve a training set.
Summary of Device and Performance Information Provided:
The document describes the AMT Suture Delivery System, a sterile, single-use suturing device for anchoring a hollow viscus to the abdominal wall. The regulatory submission emphasizes its substantial equivalence to a predicate device (K182832, Enterostomy Suture Anchor Set from Cook, Inc.) in terms of intended use, indications for use, sterilization, prescription status, and principles of operation, despite minor differences in material of retention and method of deployment.
Key Performance Data (not related to AI):
- Biocompatibility Testing: Demonstrated compliance with multiple ISO 10993 standards and USP Pyrogen Test.
- Sterilization: Validated for Ethylene Oxide sterilization to a Sterility Assurance Level (SAL) of 10⁻⁶, complying with ANSI/AAMI/ISO 11135 and ISO 10993-7, and Bacterial Endotoxin Testing (USP chromogenic method).
- Shelf Life: Packaging tested in accordance with ASTM F1980-16, ISO 11607, and ISTA 3A, indicating compliance.
- Bench Testing: Various tests performed according to AMT specifications (deployment force, tensile testing), ISO 7864 (needle hub bond, needle penetration), USP (suture bond), USP (suture tear strength), and ISO 9626 (resistance to breakage, needle stiffness). All stated to have met or exceeded acceptance criteria.
- No Software, Electromagnetic Compatibility, Electrical Safety, Animal, or Clinical Studies were performed or deemed applicable for this submission.
In conclusion, this document is for a traditional physical medical device and does not contain any information relevant to AI/ML device performance or study design.
§ 876.5980 Gastrointestinal tube and accessories.
(a)
Identification. A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).(b)
Classification. (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.