(100 days)
The Gyrus ACMI PK® Superpulse® System is intended for use for ablation, removal, resection and coagulation of soft tissue and where associated hemostasis is required in open, endoscopic and laparoscopic surgical procedures.
The device is intended for use by qualified medical personnel trained in the use of electrosurgical equipment.
The proposed PK ® SuperPulse® System Generator and its software will be modified to allow the use of the Olympus TURis resectoscope and associated instruments. This functionality would be in addition to the existing released support for the Gyrus ACMI resectoscopes and compatible electrodes.
Modifications include:
- Modification to the Superpulse® software to add an additional instrument .
band to allow the connection of a TURis specific connector cable.Addition
of a saline monitoring facility to ensure that energisation is only applied to
the TURis connector cable when a saline environment is
sensed.Modification to User Manual to cover the above changes
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Gyrus ACMI PK® SuperPulse® System, based on your requested categories:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text focuses on demonstrating substantial equivalence to predicate devices rather than defining specific numerical acceptance criteria and then presenting performance data against those criteria. The primary "acceptance criteria" presented are the technological characteristics of the modified device being sufficiently similar to the predicate and not raising new questions of safety or efficacy.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Technological Characteristics: | |
| - Addition of an instrument band for TURis specific connector cable. | - A new ID band has been assigned for a new instrument connection cable that will support the range of Olympus TURis instruments. |
| - Saline monitoring facility to ensure energization only with saline. | - A new saline detection feature will be incorporated in the SuperPulse® software. This feature's purpose is to prevent activation in non-approved irrigants other than saline (e.g., glycine) and will result in a warning message if impedance is sensed above a fixed threshold. The performance is expected to be similar to the existing Olympus UES-40 generator. |
| Safety and Efficacy: | |
| - No new questions of safety or efficacy. | - The technical risk for the software release is low because it replicates a feature already available on the Olympus UES-40 generator, with readily available implementation information. - The power level for saline detection is similar to the clinically accepted low level of the UES-40. - The proposed Gyrus ACMI PK® SuperPulse® System will have the same indications for use as the existing/predicate device, with the only difference being support for the additional Olympus TURis cable and electrodes. - The FDA's 510(k) clearance states that the device is "substantially equivalent... and presents no new questions of safety or efficacy." |
| Intended Use: | |
| - Unchanged from previously marketed PK® Superpulse® System, but now supporting Olympus TURis electrodes. | - "The target applications and intended use for the PK® Superpulse® System Generator with the new software are unchanged from the previously marketed PK® Superpulse® System." - The intended use will differ only in that it will be intended to support the additional Olympus TURis cable and electrodes. The FDA's clearance confirms the device is substantially equivalent for the indications for use stated. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The submission is a 510(k) for a modified electrosurgical generator, focusing on substantial equivalence based on technological characteristics and previously accepted clinical performance of the predicate and similar technologies (Olympus UES-40). It does not describe a clinical study with a "test set" in the traditional sense of evaluating a diagnostic or predictive algorithm.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided. As noted above, there's no described "test set" or explicit ground truth establishment process involving experts for a study. The basis for safety and effectiveness relies on comparison to existing legally marketed devices.
4. Adjudication Method for the Test Set
This information is not provided. There is no "test set" or adjudication method described for a study in this submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not described or referenced in this 510(k) submission. This type of study is typically associated with evaluating reader performance (human or AI-assisted) in diagnostic imaging, which is not the nature of this electrosurgical device modification.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
N/A. The "algorithm" here refers to the software controlling the electrosurgical generator, specifically the saline detection feature. Its performance is evaluated in terms of its functional similarity to a predicate device (Olympus UES-40) and its ability to prevent activation in non-saline environments, rather than as a standalone diagnostic or predictive algorithm. The document emphasizes it's a "low technical risk" replication of an existing, clinically accepted feature.
7. The Type of Ground Truth Used
The "ground truth" implicitly used for the modifications (specifically the saline detection feature) is the established clinical acceptance and performance of the Olympus UES-40 generator's saline detection feature. The submission states: "The performance of the saline detection feature should be such that it operates in a similar manner to that of the existing Olympus UES-40 generator used for TURis accessories. The power level used to sense the impedance is to be kept similar to the same low level as the UES-40 as this has been clinically accepted in the marketplace."
8. The Sample Size for the Training Set
This information is not provided. This 510(k) is not about a machine learning algorithm that requires a "training set" in the conventional sense. The "training" for the software modifications comes from existing knowledge of the Olympus UES-40 system.
9. How the Ground Truth for the Training Set Was Established
This information is not provided as there is no traditional "training set" for an AI/ML algorithm. The "ground truth" equivalent for the development of the saline detection feature is the design and operational specifications of the equivalent feature in the Olympus UES-40 generator, which has been "clinically accepted in the marketplace." This implies that the UES-40's performance in distinguishing saline from non-saline environments was the established benchmark.
§ 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.