(28 days)
The Gyrus Medical Inc. Open Forceps are intended for electrosurgical coagulation, mechanical grasping and dissection of tissue, and sealing of vessels up to 7mm, during the performance of open general surgical procedures.
Electrosurgical Instruments
The provided document is a 510(k) summary for the Gyrus Medical Inc. Open Forceps, which is a regulatory submission to the FDA. It does not contain a study that proves the device meets specific acceptance criteria in the way one would expect for a diagnostic or AI-driven device.
This document is for an electrosurgical device and focuses on establishing substantial equivalence to a predicate device based on its intended use and general performance characteristics. It outlines the device's function (electrosurgical coagulation, mechanical grasping, dissection, and vessel sealing) and compares it to a previously cleared device (K024286).
Therefore, I cannot provide the requested information in the format of acceptance criteria and a study proving those criteria were met, as that information is not present in the provided text.
Here is what can be extracted from the document:
1. A table of acceptance criteria and the reported device performance:
This information is not explicitly stated in the document. For an electrosurgical device like the Gyrus Medical Inc. Open Forceps, acceptance criteria would typically involve engineering specifications, safety standards (e.g., electrical safety, biocompatibility), and performance benchmarks (e.g., sealing strength, reliable coagulation). However, the 510(k) summary provided does not detail these specific criteria or report performance against them. It relies on the concept of "substantial equivalence" to a predicate device (K024286).
2. Sample size used for the test set and the data provenance:
Not applicable. The document does not describe specific clinical or technical studies with test sets in the context of accuracy, sensitivity, or specificity that would involve sample sizes or data provenance for a diagnostic device. Substantial equivalence for this type of device usually relies on design comparisons, bench testing, and potentially animal studies, but details of these are not provided in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth establishment for a test set is relevant for diagnostic devices that classify or measure a condition, requiring expert adjudication. This device is an electrosurgical instrument.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable.
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 not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable.
8. The sample size for the training set:
Not applicable. This device does not have a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established:
Not applicable.
Summary of what the document does provide:
- Device Name: Gyrus Medical Inc. Open Forceps
- Intended Uses: Electrosurgical coagulation, mechanical grasping and dissection of tissue, and sealing of vessels up to 7mm, during open general surgical procedures.
- Predicate Device: Gyrus Medical Open Forceps (K024286)
- Regulatory Class: Class II (Electrosurgical cutting and coagulation device and accessories, 21 CFR 878.4400)
- Regulatory Mechanism: 510(k) Premarket Notification based on "substantial equivalence" to a legally marketed predicate device.
The 510(k) process for this type of device focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device, often through engineering comparisons and general performance characteristics rather than detailed clinical outcome studies with predefined acceptance criteria as would be seen for a new diagnostic or AI-powered medical device.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.