(70 days)
Reprocessed unipolar laparoscopic/endoscopic instruments, including scissors, dissectors, and graspers are intended for use in minimally invasive surgical procedures. Reprocessed unipolar laparoscopic/endoscopic instruments, including scissors, dissectors, and graspers, are to be used for patients requiring minimally invasive surgical procedures to manipulate and manage internal soft tissue by grasping, cutting, dissecting, cauterizing, or coagulating tissue.
Unipolar laparoscopic/endoscopic instruments are electrosurgical instruments consisting of a rigid plastic handpiece with loop handles connected to the distal end effector jaw by an elongated, narrow-diameter insulated barrel or shaft. The devices are designed to be inserted through an appropriately sized trocar sleeve or cannula. The jaws are operated by the handpiece loop handles and may be shaped as scissors, dissectors or graspers. The jaws of some models may be rotated by manipulating controls on the handpiece. The blades or jaws of unipolar laparoscopic/endoscopic instruments can deliver a cauterizing current that enters the instrument through the unipolar cautery connector on the handpiece, runs down the insulated shaft and through the tissue in the blades or jaws.
The provided documentation describes the reprocessing of laparoscopic/endoscopic instruments, not an AI/ML device. Therefore, the questions related to AI/ML specific criteria (e.g., sample sizes for training/test sets, ground truth establishment for training, number of experts, adjudication methods, MRMC studies, standalone performance, effect size of AI assistance) are not applicable.
The document does, however, provide information regarding performance testing to ensure the reprocessed devices meet their acceptance criteria and perform as originally intended.
Acceptance Criteria and Device Performance (Reprocessed Unipolar Laparoscopic/Endoscopic Instruments)
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Electrical Continuity | All reprocessed unipolar laparoscopic/endoscopic instruments are tested for electrical continuity. (Implicitly, they must pass this test to be deemed reprocessed successfully). |
| Cutting Function (for Scissors) | Reprocessed unipolar laparoscopic/endoscopic scissors are tested for cutting function. (Implicitly, they must demonstrate effective cutting). |
| Grasping Function (for Graspers and Dissectors) | Graspers and dissectors are tested for the ability of the jaws to grasp appropriately. (Implicitly, they must demonstrate appropriate grasping). |
| Removal of Adherent Visible Soil | Alliance Medical Corporation's reprocessing process includes removal of adherent visible soil. (This is a procedural step that leads to meeting a cleanliness criterion). |
| Decontamination | Alliance Medical Corporation's reprocessing process includes decontamination. (This is a procedural step that leads to meeting a sterility/disinfection criterion, though specific metrics are not provided). |
| Performance as Originally Intended | "Performance data demonstrates that Reprocessed Unipolar Laparoscopic/Endoscopic Instruments perform as originally intended." This is an overarching conclusion based on the testing performed. The intended use includes manipulating and managing internal soft tissue by grasping, cutting, dissecting, cauterizing, or coagulating tissue. |
| Substantial Equivalence to Predicate Devices | The conclusion states that the reprocessed device is "safe, effective and substantially equivalent to the predicate devices" based on the information provided. This implies that the performance characteristics are comparable to those of the new, legally marketed predicate devices. |
Since this document describes reprocessed medical devices and not an AI/ML device, the following points are not applicable and thus cannot be filled in from the provided text:
- Sample size used for the test set and the data provenance: Not applicable for a reprocessed medical device's functional testing. The testing likely involves a sample of reprocessed devices, but specific numbers and provenance are not detailed as they would be for a dataset in an AI study.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth in this context would be objective functional performance (e.g., does it cut, does it grasp, is it electrically continuous).
- Adjudication method for the test set: Not applicable. Functional tests typically have objective pass/fail criteria.
- 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 for AI/ML devices.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is for AI/ML devices.
- The type of ground truth used: For reprocessed devices, the "ground truth" is the established functional specification of the original device and the objective criteria for cleanliness, electrical integrity, and mechanical function.
- The sample size for the training set: Not applicable. There is no AI model being trained.
- How the ground truth for the training set was established: Not applicable. There is no AI model being trained.
§ 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.