(190 days)
The LOGIQ α200 diagnostic ultrasound system is intended for use in diagnostic ultrasound imaging using B, M, and B/M combination modes in the following areas:
- Fetal
- Abdominal
- Intraoperative
- Pediatric
- Small organs including breast, neck, chest, male and female reproductive organs, limbs, and extremities
- Adult Cephalic
- Neonatal cephalic
- Adult cardiac
- Pediatric cardiac
- Trans-vaginal
- Trans-rectal
The LOGIQ α200 diagnostic ultrasound system consists of a mobile console approximately 40 cm wide, 60 cm deep and 125 cm high, weighing approximately 70 kg. The user interface consists of a keyboard and monochrome video monitor. The system is designed for use in linear and convex scanning modes and supports linear, convex and micro convex probes. Optional image storage or hard-copy devices are integrated into the design.
I am sorry, but based on the provided 510(k) summary for the GE LOGIQ α200 Diagnostic Ultrasound System, there is no information available regarding acceptance criteria, device performance studies, or clinical validation data as you've requested.
The document primarily focuses on:
- Identification of the submitter and product.
- A general description of the device.
- Stated Indications for Use.
- Comparison to a predicate device (GE Medical Systems RT2800).
- A summary of studies related to acoustic output, biocompatibility, and safety (thermal, electrical, mechanical) demonstrating conformity with medical device safety standards.
- A conclusion of substantial equivalence based on safety and effectiveness to predicate devices.
This type of 510(k) summary, especially from 1996, typically focuses on demonstrating substantial equivalence to a previously cleared device by showing similar technological characteristics and performance for safety aspects. It does not generally include detailed clinical performance studies, such as those that would establish specific acceptance criteria for diagnostic accuracy (sensitivity, specificity, AUC, etc.) or report detailed device performance metrics in a clinical context.
Therefore, I cannot populate the table or answer the specific questions about sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as this information is not present in the provided text.
510(k) Summary of Safety and Effectiveness
GE LOGIQ α200 Premarket Notification - February 19, 1996
This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.87(h).
Identification of Submitter:
GE Medical Systems
PO Box 414
Milwaukee, WI 53201
Contact:
D. Duersteler, Safety/Regulatory Engineer
414-647-4385
Date Prepared: February 19, 1996
Product Identification: GE LOGIQ α200 Diagnostic Ultrasound System
Marketed Devices: The GE LOGIQ α200 is of a comparable type and substantially equivalent to the GE Medical Systems RT2800 diagnostic ultrasound system, 510(k) Number K873700, currently in commercial distribution.
Device Description: The LOGIQ α200 diagnostic ultrasound system consists of a mobile console approximately 40 cm wide, 60 cm deep and 125 cm high, weighing approximately 70 kg. The user interface consists of a keyboard and monochrome video monitor. The system is designed for use in linear and convex scanning modes and supports linear, convex and micro convex probes. Optional image storage or hard-copy devices are integrated into the design.
Indications for Use: The LOGIQ α200 diagnostic ultrasound system is intended for use in diagnostic ultrasound imaging using B, M, and B/M combination modes in the following areas:
- Fetal
- Abdominal
- Intraoperative
- Pediatric
- Small organs including breast, neck, chest, male and female reproductive organs, limbs, and extremities
- Adult Cephalic
- Neonatal cephalic
- Adult cardiac
- Pediatric cardiac
- Trans-vaginal
- Trans-rectal
Comparison with Predicate Device: The GE LOGIQ α200 is comparable in key safety and effectiveness features, uses similar design, construction, and materials, and has the same intended uses and operating modes as the predicate device.
Page 2
Summary of Studies: The device has been evaluated for acoustic output, biocompatibility, and thermal, electrical and mechanical safety, and has been found to conform with applicable medical device safety standards.
Conclusion: Intended uses and other key features are consistent with traditional clinical practice, FDA guidelines, and established methods of patient examination. The design and development process of the manufacturer conforms with GMP standards. The product is designed to conform with applicable medical device safety standards and compliance is verified through independent evaluation. Diagnostic ultrasound has accumulated a long history of safe and effective performance. Therefore, it is the opinion of GE Medical Systems that the GE LOGIQ α200 is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.
§ 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.