(141 days)
Endoscopic surgical procedures. It is a family of instruments which includes graspers, Linsectors, and scissors, which are intended to be used to grasp, manipulate, cut, and cauterize soft tissue.
The GENICON disposable electrosurgical instruments are single use sterile instruments made from biocompatible plastic and stainless steel with a working length of 33cm. Current may be supplied by an approved electrosurgical generator which provides the ability for the coagulation of tissue when used with an appropriate ground electrode.
The provided text describes the Genicon Disposable Electrosurgical Instrumentation device, its intended use, and its substantial equivalence to a predicate device. However, it does not include specific acceptance criteria for performance metrics in the way one would expect for an AI/ML device, nor does it detail a study proving the device meets such criteria through quantitative performance measures.
Instead, the document states that Genicon electrosurgical instruments were "designed to meet the following voluntary standards." These standards are related to electrical safety, surgical instrument materials, and sterilization, rather than performance metrics like sensitivity, specificity, or reader improvement.
Therefore, many of the requested information points (e.g., acceptance criteria for specific performance, sample sizes for test/training sets, ground truth establishment, MRMC study details) are not applicable or cannot be extracted from this document, as it pertains to a traditional medical device (electrosurgical instruments) and not an AI/ML device.
Here's a breakdown of what can be extracted based on the provided text, and where information is missing or not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Voluntary Standards Met) | Reported Device Performance (Implied by meeting standards) |
|---|---|
| AAMI/ANSI HF18:2001, Electrosurgical Devices | Implies electrical safety and performance as per standard. |
| IEC 60601-2-2:2000, Medical electrical equipment - Particular requirements for the safety of high frequency surgical equipment | Implies electrical safety for high-frequency surgical equipment. |
| EN 12011:1998, Instrumentation to be used in association with non-active surgical implants - General requirements | Implies suitability for use with non-active surgical implants. |
| ISO 7153-1:1991, Surgical Instruments -- Metallic Materials -- Part 1: Stainless Steel | Implies use of appropriate stainless steel for surgical instruments. |
| ISO 4957:1999, Tool Steels | Implies use of appropriate tool steels. |
| EN 868-1:1997, Packaging materials and systems for medical devices which are to be sterilized - Part 1: General requirements and test methods | Implies appropriate packaging for sterilization. |
| EN 552:1994, Sterilization of medical devices - Validation and routine control of sterilization by irradiation | Implies validated sterilization process for irradiation. |
Device Performance: The document states, "The technological characteristics of the new device are the same as the predicate device." The conclusion further states, "Based on the indications for use and technological characteristics, we conclude that the new device is substantially equivalent to the predicate device under the Federal Food, Drug, and Cosmetic Act." This implies that the device performs equivalently to the predicate device (Ethicon Endopath K984240) in its intended use, based on the adherence to the listed voluntary standards. No specific quantitative performance metrics (e.g., cutting force, coagulation time, tissue dissection efficiency) are provided in this summary.
2. Sample size used for the test set and the data provenance
- Not Applicable. This document does not describe a clinical study with a "test set" in the context of an AI/ML device. The "performance" section refers to adherence to voluntary engineering and safety standards, not a clinical data-driven performance study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. No ground truth establishment by experts for a test set is described.
4. Adjudication method for the test set
- Not Applicable. No adjudication method is mentioned as there is no "test set" in the context of an AI/ML performance study.
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/ML device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI/ML device.
7. The type of ground truth used
- Not Applicable. For this traditional device, "ground truth" as pertaining to a performance study with data is not detailed. The "ground truth" for demonstrating safety and efficacy is essentially adherence to the listed engineering and safety standards, and demonstrating substantial equivalence to a legally marketed predicate device.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device, and no training set is mentioned.
9. How the ground truth for the training set was established
- Not Applicable. This is not an AI/ML device, and no training set is mentioned.
Summary of what the document primarily focuses on:
The 510(k) summary for the Genicon Disposable Electrosurgical Instrumentation focuses on demonstrating substantial equivalence to a predicate device (Ethicon ENDOPATH K984240). This is achieved by:
- Stating that the technological characteristics of the new device are the same as the predicate device.
- Listing adherence to a series of voluntary industry standards related to electrical safety, materials, and sterilization, which are relevant to electrosurgical devices.
The "study" in this context is the comparison against technical specifications and adherence to standards, rather than a clinical performance study with defined performance metrics and a patient dataset.
§ 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.