(56 days)
Laparoscopic Electrodes and Handle are used to grasp, hold, coagulate, and cut tissue during laparoscopic surgical procedures
Laparoscopic electrodes and handles are surgical instruments with interchangeable tip inserts designed to be introduced through a 5.5mm diameter (or larger) cannula, during laparoscopic surgical procedures. The devices can be used with electrosurgical generators. The interchange ability of the tip inserts allows for three main benefits:
- . A removable insert allows for easier cleaning and disinfection of the instrument components.
- Versatility of the instrument is greatly increased as one handle can accept many tip configurations,
- Semi-disposability allows for multiple uses of one tip insert with cost effective replacement when worn or damaged.
The device consists of two components: an insulated, reusable handle and a series of reusable tips. Radiofrequency energy is passed to the tip through the handle and shaft by using a powered lead from an electrosurgical generator to a connector port on the handle. The insulated handle is the device that will be used by the physician or nurse to attach the tip and control the action of the tip via the grip. A rotary knob allows the tip to be positioned (rotated) while in the cannula.
The provided 510(k) summary for the Laparoscopic Electrodes and Handle does not contain the detailed information typically found in a study proving a device meets specific acceptance criteria based on performance metrics. Instead, this document focuses on demonstrating substantial equivalence to predicate devices.
Here's an analysis of why the requested information cannot be fully provided from the given text:
- Type of Device: This is a surgical instrument (electrosurgical cutting and coagulation device and accessories). For such devices, "acceptance criteria" are usually related to safety and functional performance (e.g., sterilization effectiveness, electrical safety, material compatibility, mechanical integrity, cutting/coagulation performance). The document confirms compliance with a safety standard but doesn't detail performance criteria.
- Substantial Equivalence (SE) Pathway: The entire document is a 510(k) submission, which is a premarket notification where the manufacturer demonstrates that their new device is "substantially equivalent" to a legally marketed predicate device. This pathway often relies on comparison to predicate device specifications and established standards, rather than extensive de novo clinical performance studies with specific acceptance criteria as might be seen for novel analytical or diagnostic devices.
Therefore, many of the requested fields are not applicable in the context of this 510(k) summary, as it does not describe a performance study in the way a diagnostic or AI-driven device's regulatory submission would.
However, I can extract what is available and explain why other information is absent:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from regulatory context) | Reported Device Performance (as stated in the document) |
|---|---|
| Safety and Effectiveness | "There are no significant differences in technology, performance, or intended use between the Aaron Laparoscopic Electrodes and Handle and the given predicate devices." |
| Technological Equivalence | "These devices use technology substantially equivalent to the Aesculap USA Modular Monopolar Electrodes (K970541) and the ACMI Circon Surgical Instrument for Minimally Invasive Surgery (K914883)." |
| Intended Use Equivalence | "Laparoscopic Electrodes and Handle are used to grasp, hold, coagulate, and cut tissue during laparoscopic surgical procedures" (Identical to intended use of predicate devices, as implied by SE). |
| Sterilization Compatibility | "Laparoscopic electrodes are reusable and are resterilized using steam sterilization." |
| Electrical Safety Standards Compliance | "Aaron Laparoscopic Electrodes and Handle conform to the requirements of safety standard ANSI/AAMI HF-18 Electrosurgical Devices." |
| New Safety/Effectiveness Questions | "There are no new questions raised regarding safety or effectiveness." |
| Cleaning/Disinfection | "A removable insert allows for easier cleaning and disinfection of the instrument components." |
Explanation:
The document primarily establishes substantial equivalence by stating that the device has no significant differences in technology, performance, or intended use from predicate devices (K970541 and K914883). It explicitly states compliance with a relevant safety standard (ANSI/AAMI HF-18). It does not provide quantitative performance metrics (e.g., specific cutting speeds, coagulation temperatures, or power outputs) against predefined numerical acceptance criteria for this specific device. Instead, the implicit acceptance criterion is "performance equivalent to legally marketed predicate devices."
2. Sample size used for the test set and the data provenance
- Test set sample size: Not applicable/Not provided. This 510(k) summary does not describe a clinical performance study with a distinct "test set" in the context of diagnostic accuracy or AI performance. The evaluation is based on comparison to predicate devices and compliance with standards.
- Data provenance: Not applicable. No specific data provenance (e.g., country of origin, retrospective/prospective) is provided as there isn't a performance study dataset.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not provided. This information is relevant for studies that require expert consensus for ground truth (e.g., image-based AI diagnostics). This document describes a surgical instrument, not a diagnostic or AI device that would require such ground truth establishment for performance evaluation.
4. Adjudication method for the test set
- Not applicable/Not provided. As there is no test set in the context of a diagnostic or AI performance study, no adjudication method is described.
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 device is a surgical instrument, not an AI-assisted diagnostic or imaging system. Therefore, an MRMC study comparing human readers with AI assistance is not relevant or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is an electrosurgical instrument; it does not involve algorithms or AI for standalone performance evaluation in this context.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable/Not provided in the traditional sense. For a medical device like this, "ground truth" for proving safety and effectiveness typically involves engineering verification and validation (e.g., material testing, electrical safety tests, sterilization validation, biocompatibility studies) and comparison to the known safe and effective performance of predicate devices. These are not explicitly detailed as "ground truth" types in this summary.
8. The sample size for the training set
- Not applicable/Not provided. This device does not use machine learning or AI that would require a "training set."
9. How the ground truth for the training set was established
- Not applicable/Not provided. As there is no training set for an AI model, this information is not relevant.
In summary, the provided 510(k) summary demonstrates that the Laparoscopic Electrodes and Handle meet regulatory requirements by establishing substantial equivalence to legally marketed predicate devices and conforming to a relevant safety standard (ANSI/AAMI HF-18). It does not present a detailed performance study with explicit acceptance criteria and corresponding results in the manner one would expect for a more complex diagnostic or AI-driven 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.