(353 days)
Olympus EU-M30 Endoscopic Ultrasound center is designed to be used in combination with the Olympus GF-UM20/JF-UM20/CF-UM20 ultrasonic endoscopes, Olympus UM-2R/UM-3R ultrasonic probes, and Olympus MH-908 esophageal ultrasonic probe for observation of real-time, ultrasonic images of upper GI tract, lower GI tract, and adjacent structures.
The EU-M30 Endoscopic Ultrasound Center allows the connection of a keyboard, monitor, video printer, video cassette recorder (VCR), Endoscopic Video Image System (EVIS), foot switch, and magnetic card reader. The front panel of the EU-M30 allows the connection of endoscope via a specially designed connector. It produces ultrasonic images using the 7.5MHz. or 20.0 MHz transducers and provides a B-Mode display on a monitor. The EU-M30 is recommended to be used in conjunction with the Olympus GF-UM20/JF-UM-20/CF-UM20 ultrasonic endoscopes, UM-2R/UM-3R ultrasonic probe, and MH-908 esophageal ultrasonic probe. When Olympus EVIS-100 or EVIS-200 Video System is connected to the EU-M30 Center, it offers a sub-screen feature that allows the user to view both ultrasonic and video images simultaneously on a monitor. It also provides the ability to switch between ultrasonic and video images, as desired.
No components of the Olympus EU-M30 Endoscopic Ultrasound Center (Standard Set) come in contact with patient. For instructions on operation and maintenance, the user must refer to the Instruction Manual accompanied with the equipment.
This document, a 510(k) summary for the Olympus EU-M30 Endoscopic Ultrasound Center, does not contain the detailed information required to answer your request about acceptance criteria and a study proving device performance.
Here's why and what's missing:
- Type of Document: This is a premarket notification (510(k)) summary. The primary purpose of a 510(k) is to demonstrate that a new device is "substantially equivalent" to a predicate device already on the market. It often relies on comparisons to existing devices rather than extensive new clinical performance studies with specific acceptance criteria that would be found in a Premarket Approval (PMA) application or a detailed clinical study report.
- Focus on Equivalence: The summary explicitly states: "The Olympus EU-M30 Endoscopic Ultrasound Center is substantially equivalent in design, material, intended use, operation, performance, and energy source to the Olympus EU-M20 Endoscopic Ultrasound Center which was cleared in 510(k) # K926514. Additionally, it is also substantially equivalent to the Aloka SSD-550 Ultrasound System marketed by Corometics Medical System." This indicates that performance is inferred from the predicate devices, not demonstrated through a new, specific performance study with "acceptance criteria" in the way you've defined them.
- Safety Compliance, not Performance Criteria: The document mentions "Safety" and compliance with "IEC-601-1, Class-I, Type BF" and "FDA's 510(k) Diagnostic Ultrasound Guidance for 1993 and 1985." These are standards for electrical safety and fundamental ultrasound output parameters (e.g., thermal and mechanical indices), which ensure the device operates safely within regulatory limits. These are not performance acceptance criteria related to diagnostic accuracy (e.g., sensitivity, specificity, AUC, human reader improvement) that would typically be found in studies for AI/CADe devices.
- Lack of Performance Data: There is no mention of any clinical study involving patient data, expert readers, ground truth establishment, sample sizes for training or testing, or performance metrics like sensitivity, specificity, or reader improvement.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and a study based on the provided text.
If this were a document describing a clinical performance study for an AI/CADe device, the requested information would typically be present. For an ultrasound system like this, "performance" in a 510(k) context primarily refers to its ability to generate images of certain characteristics (e.g., frequency, resolution, penetration) consistent with the predicate device, not its diagnostic accuracy in specific clinical scenarios, which would usually be shown in a separate clinical study report.
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.