(29 days)
The Abbott Vascular Suture Anastomosis Device is intended for use in the delivery of 10 interrupted sutures to assist the surgeon in the creation of vascular anastomoses.
The Abbott Vascular Suture Anastomosis Device is a hand-held surgical device that simultaneously deploys 10 lengths of 7-0 polypropylene suture at the site of a vascular anastomosis via a hydraulic delivery mechanism. The Abbott Vascular Suture Anastomosis Device is available in two models for creating either side-to-side or end-to-side anastomoses. After deployment of the device, the surgeon completes the anastomosis by hand-tying the appropriate surgical knots. Optional accessories available for use with the Abbott Vascular Suture Anastomosis (AVSA) Device include the Heartflo™ Scissors and the Heartflo™ Handle.
The Abbott Vascular Suture Anastomosis Device is a prescription device, restricted to use by physicians trained in vascular surgery.
The Abbott Vascular Suture Anastomosis Device is EtO sterilized and nonpyrogenic in an unopened undamaged package, for single use only.
The provided document is a 510(k) Premarket Notification for the Abbott Vascular Suture Anastomosis Device, not a study report. Therefore, it does not contain the detailed clinical study information typically found in such reports that would allow a comprehensive description of acceptance criteria and a study proving those criteria are met for diagnostic or AI-assisted devices.
This document describes a surgical device designed to assist surgeons in creating vascular anastomoses, not a diagnostic device or an AI-based system. The "acceptance criteria" and "study" described in the prompt are more relevant to validating the performance of diagnostic algorithms or AI systems, particularly in image interpretation or data analysis.
However, based on the information provided in the 510(k) summary (Section K. Device Description and F. Summary of Substantial Equivalence), I can address some aspects relevant to device validation, even if they don't perfectly align with the diagnostic AI-focused questions:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative "acceptance criteria" for performance metrics like sensitivity, specificity, or accuracy, which are typical for diagnostic devices. Instead, the "acceptance criteria" for this surgical device would be considered to be met if it demonstrates substantial equivalence to predicate devices in terms of its intended use, design, materials, and principle of operation, and if it is safe and effective.
The reported device performance is described through various tests in the "Summary of Substantial Equivalence." These are qualitative and assurance-based rather than quantitative performance metrics:
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility | Scientifically tested to ensure different materials are biocompatible. (Specific tests mentioned: Dermal Sensitization, Cytotoxicity, Intracutaneous Reactivity, Systemic Toxicity, Hemolysis) |
| Physical Properties Appropriateness for Intended Use | Scientifically tested to ensure physical properties are appropriate for intended use. (Specific test mentioned: Attachment strength of critical components) |
| Functionality and Reliability under Simulated/Actual Conditions | "Questions regarding the effects of any new technological characteristics... have been answered through accepted scientific methods. These methods assessed the new characteristics with regard to functionality and reliability under simulated and actual conditions of use." |
| (Specific functional bench testing mentioned: suture deployment, suture spacing, suture management, tissue capture) | |
| Safety and Effectiveness | Demonstrated through scientific tests, including in vivo animal testing. |
| Substantial Equivalence to Predicate Devices | "The Abbott Vascular Suture Anastomosis Device has been shown to be substantially equivalent to the Class II predicates on which the device is based." |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document does not specify a "test set sample size" in the context of diagnostic performance. For the in vivo animal testing, the number of animals used is not provided. For bench testing (suture deployment, spacing, etc.), the number of tests or samples is also not specified.
- Data Provenance: The tests mentioned are internal validation tests (biocompatibility, functional bench testing, in vivo animal testing) conducted by Perclose/Abbott Laboratories. The document does not specify the country of origin of the data beyond being generated by the applicant company. It implies these were specifically conducted for the device submission, making them prospective in nature relative to the submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable to the type of device and validation described. "Ground truth" established by experts (e.g., radiologists) is relevant for diagnostic devices that interpret data (like images). For a surgical device, the validation focuses on its mechanical function, biocompatibility, and ability to perform its intended surgical action. The "ground truth" would be the successful deployment of sutures, proper anastomotic creation, and absence of adverse biological reactions, assessed by scientific and engineering methods, and potentially by veterinary surgeons in animal studies, but not "experts" in the sense of diagnostic interpretation.
4. Adjudication method for the test set:
Not applicable. Adjudication methods (like 2+1 or 3+1 consensus) are used to resolve discrepancies in expert interpretation for diagnostic ground truth establishment. This device's validation relies on objective physical, chemical, and biological testing, potentially observed and recorded by trained personnel, but not subject to multi-reader adjudication in the clinical diagnostic sense.
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 tool, not an AI-assisted diagnostic device. Therefore, no MRMC study for assessing human reader improvement with AI assistance would have been conducted or is relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a manual surgical tool that assists a human surgeon. It is not an algorithm and does not operate in a "standalone" fashion.
7. The type of ground truth used:
As mentioned, "ground truth" in the diagnostic sense is not directly applicable. For the various tests conducted:
- Biocompatibility: Ground truth is established by standardized biological tests (e.g., ISO 10993 series) and assessment of physiological responses.
- Functional Bench Testing: Ground truth is the successful and consistent operation of the mechanical features (e.g., correct suture deployment, spacing, tissue capture) according to design specifications and engineering measurements.
- Physical Properties: Ground truth is established by material testing standards (e.g., tensile strength, attachment strength).
- In vivo Animal Testing: Ground truth would be the successful creation of an anastomosis, tissue healing, and absence of complications, often assessed by veterinary observation, necropsy, and histological examination.
8. The sample size for the training set:
Not applicable. This is not an AI/machine learning device, so there is no concept of a "training set" for an algorithm.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for an algorithm.
§ 878.5010 Nonabsorbable polypropylene surgical suture.
(a)
Identification. Nonabsorbable polypropylene surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation. The polypropylene surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be undyed or dyed with an FDA approved color additive; and 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.