(109 days)
The Gyrus ACMI PKS Plasma Morcellator is intended for cutting, coring, and extracting tissue in various operative laparoscopy procedures, including laparoscopic general surgical procedures, laparoscopic urological procedures, and laparoscopic gynecologic procedures.
The Gyrus ACMI PKS Plasma Morcellator consists of two main elements: a Morcellator that includes a cutting shaft and handle with an integrated electrical cable that connects to a Gyrus Medical generator; and a Grasper that passes through the hollow shaft of the Morcellator, to grasp tissue and retract it toward the cutting element on the Morcellator shaft tip. An obturator may also be used to assist in the introduction of the device in laparoscopic procedures, and like the grasper, is positioned through the shaft of the Morcellator tube when being utilized
The provided text describes a 510(k) submission for the Gyrus ACMI PKS Plasma Morcellator, focusing on substantial equivalence to predicate devices rather than detailed performance studies with specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, sample sizes, expert involvement, and ground truth cannot be extracted directly from this document.
However, I can provide what is available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (from predicate) | Reported Device Performance (Gyrus ACMI PKS Plasma Morcellator) |
|---|---|---|
| Tissue Cutting Technology | Bipolar electrosurgical energy to cut tissue (from Gyrus Medical Inc. PlasmaCision Laparoscopic Spatula) | Utilizes the same bipolar electrosurgical energy to cut tissue. |
| Generator Compatibility | Connects to Gyrus PlasmaKinetic SuperPulse System and Gyrus General Purpose Electrosurgical System generators (from Gyrus Medical Inc. PlasmaCision Laparoscopic Spatula) | Connects to the same electrosurgical generators. |
| Dimensional Similarity | Similar Morcellator shaft diameters (from Ethicon Gynecare Laparoscopic Morcellator) | Dimensionally similar, having similar Morcellator shaft diameters. |
| Mechanism of Action | Pistol grip Morcellator with a hollow shaft through which a grasper passes to grasp tissue to be resected (from Ethicon Gynecare Laparoscopic Morcellator) | Utilizes a pistol grip Morcellator with a hollow shaft through which a grasper is passed to grasp tissue to be resected. |
| Intended Use | Cutting, coring, and extracting tissue in various operative laparoscopy procedures, including laparoscopic general surgical, urological, and gynecologic procedures (from Ethicon Gynecare Laparoscopic Morcellator) | Indicated for cutting, coring, and extracting tissue in various operative laparoscopy procedures, including laparoscopic general surgical, urological, and gynecologic procedures. |
| Patient-Contacting Materials | Utilized in predicate devices and other legally marketed Gyrus ACMI devices | Uses patient-contacting materials that are utilized in the predicate devices, as well as other legally marketed devices manufactured by Gyrus ACMI. |
Study Proving Acceptance Criteria:
The document states: "During design verification, the performance of the PKS Plasma Morcellator was compared against the known performance characteristics of the predicate Gynecare Laparoscopic Morcellator using the bipolar tissue cutting technology of the predicate Gyrus PlasmaCision Laparoscopic Spatula. Testing demonstrated that the performance requirements were met, and that the PKS Plasma Morcellator exhibited comparable performance characteristics to both the predicate care Laparoscopic Morcellator and predicate Gyrus PlasmaCision Laparoscopic Spatula."
2. Sample size used for the test set and the data provenance:
This information is not provided in the document. The study described is a "design verification" which compared the new device against predicate devices' known characteristics, implying bench testing and comparison, not clinical trials with human subjects or specific data sets with provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The study described does not appear to involve human experts establishing ground truth in the context of diagnostic or interpretive tasks.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided in the document. The study described does not appear to involve adjudication of expert readings.
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 provided in the document. This is a medical device (morcellator) and not an AI or diagnostic imaging device that would typically involve human readers or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable as the device is a medical instrument (morcellator), not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" implicitly used for comparison was the "known performance characteristics" of the predicate devices. This would likely stem from previously established performance data, design specifications, and clinical experience with those predicate devices. Formal "ground truth" in the sense of pathology or outcomes data from a prospective study specifically for this device comparison is not mentioned.
8. The sample size for the training set:
This information is not provided in the document. This device does not use machine learning, so a "training set" is not relevant.
9. How the ground truth for the training set was established:
This information is not applicable as the device does not use machine learning, so there is no training set.
§ 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.