(85 days)
The Olympus PSD-20 has been intended to cut and coagulate tissues within the gastrointestinal (GI) tract. The PSD-20 is designed to be used in conjunction with the electrosurgical accessories and the designated Olympus endoscopes that are applicable for electrosurgery.
The Olympus PSD-20 has been designed for use in medical facilities under the supervision of a trained physician. It has been designed for general and endoscopic electrosurgery (cutting and coagulation) in conjunction with Olympus designated electrosurgical accessories, endoscopes (fiberscopes, videoscopes, and rigid scopes) applicable to electrosurgery, light sources and ancillary equipment. Do not use the instrument for any purpose other than its intended use.
The Olympus PSD-20 has been designed for use in medical facilities under the supervision of a trained physician. It has been designed for general and endoscopic electrosurgery (cutting and coagulation) in conjunction with Olympus designated electrosurgical accessories, endoscopes (fiberscopes and videoscopes) applicable for electrosurgery, light sources and ancillary equipment.
This document describes the Olympus PSD-20 Electrosurgical System, a medical device. The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device, rather than outlining a study with acceptance criteria for device performance. Therefore, most of the requested information regarding acceptance criteria and performance studies is not available in the provided text.
Based on the provided information, I can offer the following:
1. Table of Acceptance Criteria and Reported Device Performance
Not available in the provided text. The 510(k) summary for the Olympus PSD-20 Electrosurgical System focuses on demonstrating substantial equivalence to a predicate device (Olympus PSD-10 Electrosurgical Unit K911904) rather than presenting specific acceptance criteria and performance data for the new device. The document indicates that the device has been reviewed and determined to be substantially equivalent to devices marketed prior to May 28, 1976.
2. Sample Size Used for the Test Set and Data Provenance
Not available in the provided text. The document does not describe a test set or data provenance for a performance study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not available in the provided text. The document does not mention the establishment of ground truth by experts for a test set.
4. Adjudication Method for the Test Set
Not available in the provided text. No adjudication method is described as there is no mention of a test set requiring such a process.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This device is an electrosurgical system, not an imaging or diagnostic device that would typically involve human readers for interpretation. Therefore, an MRMC study with AI assistance is not relevant to this type of device.
6. Standalone (Algorithm Only Without Human-in-the Loop Performance) Study
Not applicable. This device is an electrosurgical system, not an algorithmic diagnostic tool. It requires a trained physician for its operation, so a "standalone" algorithmic performance study without human involvement is not relevant.
7. Type of Ground Truth Used
Not available in the provided text. There is no mention of a performance study that would establish ground truth for the device's function in terms of diagnosing or interpreting medical conditions. The device performs cutting and coagulation.
8. Sample Size for the Training Set
Not applicable. The document describes a medical device, not an AI algorithm that would require a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set mentioned, the establishment of its ground truth is not relevant.
Summary of Device and its Equivalence Basis:
The Olympus PSD-20 Electrosurgical System is intended for general and endoscopic electrosurgery (cutting and coagulation) in the gastrointestinal (GI) tract. The 510(k) submission successfully demonstrated that this device is substantially equivalent to the predicate device, Olympus PSD-10 Electrosurgical Unit (K911904). This substantial equivalence determination means that the new device is as safe and effective as a legally marketed device and does not raise different questions of safety and effectiveness. The focus of the 510(k) process is typically on comparing the new device's technological characteristics, indications for use, and performance data to those of the predicate device, rather than conducting new, extensive clinical trials with specific acceptance criteria as would be expected for novel, high-risk devices.
§ 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.