(118 days)
AED Bipolar Forceps are reusable devices (bipolar forceps/scissors and electrodes) that facilitate grasping, cutting and manipulation of soft tissue during laparoscopic procedures with the use of high frequency electrical current (bipolar electrocautery). AED Bipolar Forceps have not been shown to be effective for tubal sterilization or tubal ligation/coagulation for sterilization procedures. Do not use these bipolar forceps for these procedures.
AED Bipolar Forceps consist of
• Standard insulated bipolar handles
• Outer shaft with insulated tip
• Jaw inserts (forceps, scissors)
The device is reusable and provided non-sterile. The device must be cleaned and sterilized before use. All forceps are of the same basic design with differences in tip configurations.
This document is a 510(k) summary for the AED Bipolar Forceps, which is a medical device. The information provided focuses on demonstrating substantial equivalence to predicate devices, rather than a detailed performance study directly comparing the device against specific acceptance criteria for a new and innovative technology. Therefore, many of the typical questions for AI/algorithm performance studies are not directly applicable or available in this specific document.
However, I will extract the relevant information and indicate where details are not provided due to the nature of this type of regulatory submission.
1. A table of acceptance criteria and the reported device performance
For a medical device like the AED Bipolar Forceps, the "acceptance criteria" and "reported device performance" are framed in terms of meeting recognized safety and performance standards, and demonstrating substantial equivalence to legally marketed predicate devices. The document does not provide a table of numerical performance metrics for the device itself as one would expect for an AI algorithm. Instead, it refers to compliance with established electro-medical and sterilization standards.
| Acceptance Criteria (Standards Met) | Reported Device Performance (Compliance/Equivalence Claim) |
|---|---|
| IEC 60601-2-2: Medical electrical equipment - Part 2-2: Particular requirements for the safety of high frequency surgical equipment (Fourth Edition, 2006) | The implication is that the AED Bipolar Forceps meet the safety requirements for high-frequency surgical equipment as outlined in this standard. The "Conclusion" section states: "Based on the technical information provided, intended use and performance information provided in this premarket notification, AED Bipolar Forceps have been shown to be substantially equivalent to the current legally marketed predicate devices." This substantial equivalence claim implies that its electrical safety and performance characteristics are comparable to predicate devices which would have also met such standards. |
| ISO 14937:2000: Sterilization of health care products – General Requirements for Characterization of a Sterilizing Agent and the Development, Validation, and Routine Control of a Sterilization Process for Medical Devices | The device is described as "reusable and provided non-sterile. The device must be cleaned and sterilized before use." Compliance with ISO 14937 indicates that the device's materials and design are compatible with and capable of being effectively sterilized according to validated processes, thus ensuring its safety for reuse. The "Conclusion" of substantial equivalence also implies that its sterilizability and reprocessing characteristics are comparable to predicate devices. |
Study that proves the device meets the acceptance criteria:
The document describes a "Design analysis and comparison" that confirms the basic functional characteristics are substantially equivalent to the predicate devices (Richard Wolf Medical Instruments, K023813; Stryker Endoscopic Instruments and Accessories, Stryker Endoscopy, K935237). This comparison is the primary "study" or evidence provided to the FDA for substantial equivalence. It is not a clinical trial or an AI performance study with a test set, experts, and ground truth in the typical sense for an AI/CADe device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable/provided in this 510(k) summary. For a traditional medical device demonstrating substantial equivalence, a "test set" in the context of an AI algorithm is not used. The evaluation relies on engineering design, material specifications, and comparison to existing devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable/provided. The ground truth concept, as it applies to expert consensus or pathology for an AI algorithm's test set, is not relevant to this type of device submission. The "ground truth" here is the established safety and performance of the predicate devices and the compliance with international standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/provided for the reasons stated above.
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/provided. MRMC studies are used for evaluating the impact of AI/CADe systems on human reader performance, which is not the scope of this 510(k) for a physical surgical instrument.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/provided. There is no algorithm or AI component in the AED Bipolar Forceps to evaluate in standalone mode.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context refers to the established safety and effectiveness of the predicate devices and general medical device standards. This is not based on expert consensus, pathology, or outcomes data in the way it would be for an AI algorithm. Instead, it's based on engineering specifications, material science, and regulatory compliance frameworks for electrosurgical devices.
8. The sample size for the training set
This information is not applicable/provided. There is no "training set" as the device is a physical instrument, not an AI algorithm.
9. How the ground truth for the training set was established
This information is not applicable/provided. As there is no training set, there is no ground truth established for one.
§ 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.