(175 days)
Diagnostic ultrasound imaging or Doppler analysis of the human body as follows: Abdominal, Cardiac Adult, Cardiac Pediatric, Fetal, Small Organ (Thyroid, Testicles, Breast), Neonatal Cephalic, Adult Cephalic, Peripheral vessel, Trans-rectal, Trans-vaginal. Modes of Operation: A, B, M, PWD, CWD, Color Doppler, Power (Amplitude) Doppler, Color Velocity Imaging, Combined (B/M, B/PWD, Color/PWD, B/PWD/M, Color/M and Color/PWD/M mode).
Diagnostic Ultrasound System SDU-2000 with various transducers: 2.5 MHz PA SECTOR, 3.5 MHz PA SECTOR, 5.0 MHz PA SECTOR, 3.5 MHz R40 CA CONVEX, 3.5 MHz R76 CA CONVEX, 7.5 MHz LA LINEAR ARRAY, 5.5 MHZ TV CONVEX.
This document is a 510(k) premarket notification decision letter for the Shimadzu Medical Systems Echo View SDU-2000 Diagnostic Ultrasound System. It outlines the FDA's determination of substantial equivalence and lists the intended uses for various transducers.
Based on the provided text, there is no specific study described that proves the device meets acceptance criteria. The document is a regulatory approval letter, not a clinical study report. It grants permission to market the device based on a determination of substantial equivalence to existing devices, implying that the device is expected to meet certain performance characteristics indirectly through that equivalence.
The letter mentions a "postclearance special report" containing "acoustic output measurements based on production line devices" which implies that further performance data would be collected and submitted after clearance but does not detail acceptance criteria or study results for initial approval.
Therefore, many of the requested details cannot be extracted from this document because it is not a study report.
Here's what can be gathered, with caveats:
1. A table of acceptance criteria and the reported device performance:
This information is not provided in the document. The document is an FDA clearance letter based on substantial equivalence, not a detailed technical report with performance metrics or acceptance criteria. It focuses on intended uses and regulatory classification.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not provided in the document. No test set or study is 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):
This information is not provided in the document. No information on ground truth establishment or experts is present.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided in the document.
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. The device is a diagnostic ultrasound system, not an AI-assisted device, and no MRMC study is described.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This information is not provided in the document. The device is a diagnostic ultrasound system, not an algorithm being tested in standalone mode.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
This information is not provided in the document.
8. The sample size for the training set:
This information is not provided in the document. No training set is mentioned as this is a traditional medical device, not an AI/ML model for which a training set would typically be described in this context.
9. How the ground truth for the training set was established:
This information is not provided in the document.
Summary of what the document does provide regarding the device:
- Device Name: Echo View SDU-2000 Diagnostic Ultrasound System
- Manufacturer: Shimadzu Medical Systems
- FDA K Number: K970508
- Regulatory Class: II (21 CFR 892.1550/Procode: 90 IYO)
- Date of Clearance: June 20, 1997 (Received June 23, 1997)
- Transducers covered:
- 2.5 MHz PA SECTOR
- 3.5 MHz PA SECTOR
- 5.0 MHz PA SECTOR
- 3.5 MHz R40 CA CONVEX
- 3.5 MHz R76 CA CONVEX
- 7.5 MHz LA LINEAR ARRAY
- 5.5 MHZ TV CONVEX
- Intended Use (General): Diagnostic ultrasound imaging or Doppler analysis of the human body.
- Specific Clinical Applications and Modes (Vary by transducer model, see tables in Input):
- 2.5 MHz PA SECTOR: Abdominal (PWD, Color, Power Doppler), Cardiac Adult (A, B, M, PWD, CWD, Color, Power Doppler, Color Velocity Imaging, Combined), Cardiac Pediatric (A, B, M, PWD, CWD, Color, Power Doppler, Color Velocity Imaging, Combined)
- 3.5 MHz PA SECTOR: Abdominal (PWD, Color, Power Doppler), Cardiac Adult (B, M, PWD, CWD, Color, Power Doppler, Color Velocity Imaging, Combined), Cardiac Pediatric (B, M, PWD, CWD, Color, Power Doppler, Color Velocity Imaging, Combined)
- 5.0 MHz PA SECTOR: Abdominal (PWD, Color, Power Doppler), Cardiac Adult (B, M, PWD, CWD, Color, Power Doppler, Color Velocity Imaging, Combined), Cardiac Pediatric (B, M, PWD, CWD, Color, Power Doppler, Color Velocity Imaging, Combined)
- 3.5 MHz R40 CA CONVEX: Fetal (B, M, PWD, Color, Power Doppler, Color Velocity Imaging, Combined), Abdominal (A, B, M, PWD, Color, Power Doppler, Color Velocity Imaging, Combined)
- 3.5 MHz R76 CA CONVEX: Fetal (B, M, PWD, Color, Power Doppler, Color Velocity Imaging, Combined), Abdominal (B, M, PWD, Color, Power Doppler, Color Velocity Imaging, Combined)
- 7.5 MHz LA LINEAR ARRAY: Small Organ (A, B, M, PWD, Color, Power Doppler, Color Velocity Imaging, Combined - specifically Thyroid, Testicles, Breast), Peripheral Vessel (A, B, M, PWD, Color, Power Doppler, Color Velocity Imaging, Combined)
- 5.5 MHz TV CONVEX: Fetal (B, M, PWD, Color, Power Doppler, Color Velocity Imaging, Combined), Small Organ (B, M, PWD, Color, Power Doppler, Color Velocity Imaging, Combined), Trans-rectal (B, M, PWD, Color, Power Doppler, Color Velocity Imaging, Combined), Trans-vaginal (B, M, PWD, Color, Power Doppler, Color Velocity Imaging, Combined)
The document is primarily a regulatory clearance indicating the device is substantially equivalent to legally marketed predicate devices, not a study detailing specific performance acceptance criteria or results.
§ 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.