(44 days)
The Modular Monopolar Electrodes presented in this submission are intended for use in endoscopic surgery (laparoscopy, thoracoscopy) for coagulation and dissection of selected tissue.
The Modular Monopolar Electrodes are made up of 3 separate components: an insulated handle (GK382R), an insulated shaft (GK380R) and a working tip. The working tips come in several different styles (i.e. J-shaped hook electrode GK383R) which can be used interchangeably. All components are reusable and disassemble for cleaning and sterilization.
The assembled electrodes are 5 mm in diameter and 450 mm in length. They have no suction/irrigation feature.
This 510(k) summary for the Aesculap Modular Monopolar Electrodes does not contain the kind of detailed study information (acceptance criteria, performance metrics, sample sizes, ground truth establishment, expert qualifications, etc.) that would typically be found in a modern submission for AI/ML-based medical devices.
The document describes a medical device, but its focus is on design changes from an existing product line and demonstrating substantial equivalence to predicate devices, rather than a performance study with specific acceptance criteria that are quantitatively evaluated.
Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria and a "study that proves the device meets the acceptance criteria" in the way you've outlined for an AI/ML device.
Here's a breakdown of why and what information is available:
This document is for a non-AI/ML surgical tool (monopolar electrodes) and focuses on design changes and substantial equivalence, not performance metrics and studies as would be seen for an AI diagnostic device.
Unavailable Information (as per your request format for AI/ML devices):
- A table of acceptance criteria and the reported device performance: This document does not present quantitative performance metrics or explicit acceptance criteria in the manner expected for an AI/ML diagnostic system (e.g., sensitivity, specificity thresholds).
- Sample sized used for the test set and the data provenance: Not applicable; no such "test set" concept is discussed.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable; "ground truth" in the context of diagnostic accuracy is not relevant here.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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 device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
What is stated in the document regarding "performance" and "standards":
The document addresses "Performance Standards" by stating:
- "No applicable performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices."
- "However, Aesculap's Modular Monopolar Electrodes comply with the requirements of IEC 601-2-18 (Medical electrical equipment, Part 2: Particular requirements for the safety of endoscopic equipment.)"
- "The Modular Monopolar Electrodes will be manufactured in accordance with ISO and German Din Standards."
- "Furthermore, Aesculap AG has received ISO 9001 certification."
This means that the device's "performance" is implicitly deemed acceptable by its adherence to general safety and manufacturing standards and its substantial equivalence to previously cleared devices, rather than a specific, quantifiable, performance study against a strict set of criteria as would be the case for a diagnostic AI. The "study" in this context is the demonstration of compliance with these standards and the comparison to predicate devices.
§ 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.