(79 days)
The Reusable Laparoscopic Electrodes are intended to be used in general laparoscopic surgical procedures requiring the use of electrosurgical cutting and/or coagulation. The electrodes are reusable; they are intended to be cleaned, sterilized, and reused.
The Reusable Uncoated Laparoscopic Electrodes are stainless steel electrosurgical electrodes insulated over the majority of their length to protect against unwanted current paths. The insulation has a patented indication layer that aids in determining the electrode's end-of-life. The reusable uncoated laparoscopic electrode tip has the intended geometry for cutting and coagulation and is offered in several configurations. The electrodes are intended for general laparoscopic electrosurgical use, and designed to fit into industry standard electrosurgical pencils and/or foot cables distributed by various manufacturers.
The provided document is a 510(k) summary for the Megadyne Medical Products, Inc. "Laparoscopic Electrode, Reusable Indicator Shaft (LERIS)." This document is for a traditional medical device, not an AI/ML-driven device. Therefore, the specific questions regarding AI/ML performance (e.g., training set, test set, ground truth experts, MRMC studies, standalone algorithm performance) are not applicable.
The document focuses on demonstrating substantial equivalence to predicate devices by ensuring the new device meets established safety and performance standards for electrosurgical accessories.
Here's an analysis of the provided information, framed within the limitations of the document's scope:
1. A table of acceptance criteria and the reported device performance:
The acceptance criteria are derived from the voluntary standard ANSI / AAMI HF 18-2001, Electrosurgical Devices, specifically the clauses applicable to accessories. The reported device performance indicates conformance with these standards.
| Acceptance Criteria (from ANSI / AAMI HF 18-2001, Electrosurgical Devices - applicable clauses for accessories) | Reported Device Performance |
|---|---|
| Sterilization of reusable accessories | Conforms (well within requirements) |
| Dielectric withstand of accessories | Conforms (well within requirements) |
| Shipping temperature | Conforms (well within requirements) |
| Mechanical shock | Conforms (well within requirements) |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify a distinct "test set" sample size in terms of the number of devices or data points used for these tests. It implies that "extensive testing of the device" was conducted.
- Data Provenance: The testing was conducted by Megadyne Medical Products, Inc. (the manufacturer). The provenance is internal company testing, presumably in a laboratory setting, to demonstrate compliance with the referenced standard. This is not clinical data, and thus concepts like "country of origin" or "retrospective/prospective" don't directly apply in the typical sense for AI/ML studies.
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. For this type of traditional medical device, "ground truth" is established through engineering and performance testing against objective, measurable standards (e.g., electrical insulation properties, mechanical durability), not through expert clinical consensus on images or other diagnostic data.
4. Adjudication method for the test set:
This information is not applicable. As "ground truth" is not established by human experts, there is no adjudication method in the sense of expert review for this type of device. Performance is determined by objective measurements against a standard.
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:
This information is not applicable. This is a traditional electrosurgical electrode, not an AI/ML device. Therefore, no MRMC study or AI assistance evaluation was performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used:
The "ground truth" (or more appropriately, the performance standard) used is the voluntary standard ANSI / AAMI HF 18-2001, Electrosurgical Devices. The device's performance is measured against the objective criteria and limits defined within this standard for characteristics like dielectric withstand, sterilization robustness, shipping temperature resilience, and mechanical strength.
8. The sample size for the training set:
This information is not applicable. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established:
This information is not applicable. There is no "training set" or corresponding "ground truth" for training an algorithm.
§ 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.