(444 days)
The Q64XXX ultrasound imaging system is intended for the following applications: General Radiology; Abdomen; Intraoperative; Small Parts; Transcranial; OB/GYN; Neonatal Cephalic; Urology; Vascular; Peripheral Vascular: Vascular Doppler.
The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.
The Q64XXX is a general purpose, mobile, software-controlled, diagnostic ultrasound system with an on-screen display for thermal and mechanical values related to potential bioeffect mechanisms.. Its function is to acquire ultrasound data and display it in B-Mode, M-Mode, Color Flow Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, or in a combination of modes, on a CRT display.
This appears to be a 510(k) summary for a diagnostic ultrasound system from 1995. Medical device submissions from this era do not typically contain the detailed performance study information that is now standard for submissions involving AI/ML.
Based on the provided text, a conventional "acceptance criteria and study" as one would expect for an AI/ML device is not present. The document focuses on regulatory compliance and comparisons to predicate devices in terms of technical specifications and safety standards, rather than clinical performance metrics that would be associated with AI/ML diagnostic output.
Therefore, most of the requested information cannot be extracted from this document because it describes a diagnostic ultrasound system and not an AI-powered diagnostic device.
Here's a breakdown of why and what little can be inferred:
1. A table of acceptance criteria and the reported device performance
- Not Applicable / Not Available. The document describes a general diagnostic ultrasound system. Acceptance criteria mentioned are related to safety standards (UL 544, CSA 22.2 No. 601-1), electromagnetic compatibility (EMC), and quality systems (EN29001, EN46001). There are no performance metrics like sensitivity, specificity, or AUC that would apply to an AI diagnostic output.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not Applicable / Not Available. This information pertains to a performance study of a diagnostic algorithm, which is not described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not Applicable / Not Available. This information pertains to a performance study of a diagnostic algorithm, which is not described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable / Not Available. This information pertains to a performance study of a diagnostic algorithm, which is not described.
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
- Not Applicable / Not Available. The device is a diagnostic ultrasound system itself, not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable / Not Available. The device is a diagnostic ultrasound system itself, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable / Not Available. This information pertains to a performance study of a diagnostic algorithm, which is not described.
8. The sample size for the training set
- Not Applicable / Not Available. There is no mention of a training set for an AI algorithm.
9. How the ground truth for the training set was established
- Not Applicable / Not Available. There is no mention of a training set for an AI algorithm.
Summary of what is present:
The document describes the Q64XXX Diagnostic Ultrasound System as a "general purpose, mobile, software-controlled, diagnostic ultrasound system." The "acceptance criteria" here refer to compliance with various safety, quality, and electromagnetic compatibility standards, which the device was designed to meet. The "study" referenced would be the internal testing and documentation showing compliance with these standards (e.g., UL 544, CSA 22.2 No. 601-1, AIUM/NEMA standard for thermal/mechanical indices).
The pivotal "performance" claim mentioned is that the system "provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes," implying its diagnostic utility is similar to the predicate devices and generally accepted for ultrasound imaging. The key "technological comparison" is the incorporation of on-screen display of Mechanical (MI) and Thermal (TI) Indices in compliance with a 1992 standard, which was a regulatory requirement at the time to ensure safety related to potential bioeffect mechanisms, rather than a diagnostic performance improvement.
{0}------------------------------------------------
SECTION 7
Ultrasound Group
ﻓﻲ ﺍﻟﻤﺴﺎ
ﻟﺴﻤﺴﺎ
4-R . 5 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5750157
Q64XXX 510(K) SUMMARY
This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with the Safe Medical Device Act of 1990 revisions to 21 CFR, Part 807.92, Content and Format of a 510(k) Summary.
1. Submitted By:
Siemens Medical Systems, Inc., Ultrasound Group 22010 S.E. 51st Street Issaquah, WA 98027-7002
Contact Person:
Steve Hesler Manager of Regulatory Affairs (206) 557-1629
Date Prepared:
January 16, 1995
-
- Proprietary Name: Q64XXX Diagnostic Ultrasound System
Common/ Usual Name:
Diagnostic Ultrasound System with Accessories
Classification Name:
Ultrasonic Pulsed Doppler Imaging System (Product Code 90 IYN, 21 CFR 92.1550)
Diagnostic Ultrasonic Transducer:
(Product Code 90 ITX, 21 CFR 892.1570)
3. Predicate Device:
- Siemens Quantum™ 2000 Ultrasound System (K904019/A) .
- . Assorted Diagnostic Ultrasound Transducers (K904019/A)
- Siemens SONOLINE™ SI1200 Ultrasound System (K904564/A) •
{1}------------------------------------------------
Device Description: 4.
The Q64XXX is a general purpose, mobile, software-controlled, diagnostic ultrasound system with an on-screen display for thermal and mechanical values related to potential bioeffect mechanisms.. Its function is to acquire ultrasound data and display it in B-Mode, M-Mode, Color Flow Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, or in a combination of modes, on a CRT display .
The Q64XXX, has been designed to meet the following product safety standards:
- UL 544, Safety Requirements for Medical Equipment .
- CSA 22.2 No. 601-1. Safety Requirements for Medical Equipment .
- Standard for Real Time Display of Thermal and Mechanical Indices on . Diagnostic Ultrasound Equipment, AIUM/NIEMA, 1992.
- . CE Mark and CB Certificate Certifying Compliance To:
EN29001. Quality Systems
EN46001. Quality Systems for Medical Device Manufacturers
- 89/336/EEC EMC Directive .
EN 50081-2. Electromagnetic Emissions Requirements
EN 55011B, Group 1 = CISPR 11B, Group 1, RF Radiated/Conducted Emission Limits
EN 50082-2, Electromagnetic Immunity Requirements
IEC 801-2. Electrostatic Discharge Immunity
IEC 801-3. Radiated RF Field Immunity
IEC 801-4, Power Line Fast Transient/Burst Immunity
- 93/94/EEC Medical Devices Directive .
EN60601 = (IEC 601-1-1 + IEC 601-1-2), Safety and EMC Requirements for Medical Equipment
CISPR11B, Group 1 = EN55011B, Group 1 CISPR14, subclause 4.2 (clicks) = EN 55014, Intermittent Radiated RF Emissions Limits
IEC 801-5 (draft), Power Line Surge Immunity
{2}------------------------------------------------
کي س
Intended Uses: 5.
The Q64XXX ultrasound imaging system is intended for the following applications: General Radiology; Abdomen; Intraoperative; Small Parts; Transcranial; OB/GYN; Neonatal Cephalic; Urology; Vascular; Peripheral Vascular: Vascular Doppler.
The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.
Technological Comparison to Predicate Device: 6.
The Q64XXX is similar to the Quantum™ 2000 and the SONOLINE® SI1200 in that all three incorporate software controlled electronics to transmit ultrasonic pulses, via an applicator/transducer, into a patient, then receive return (echo) pulses and to convert those pulses into a visual display, to be used for diagnosis of various disease states. The operating principles of all three systems are the same. However, the Q64XXX incorporates an on-screen display of Mechanical (MI) and Thermal (TI) Indices, in compliance with the Standard for Real Time Display of Thermal and Mechanical Indices on Diagnostic Ultrasound Equipment, AIUM/NEMA, 1992.
END OF SECTION 7
§ 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.