(18 days)
The device is intended to be used for applications in fetal, abdominal, pediatric, small organ (defined as the thyroid, breast and testes, etc.), cardiac (adult and pediatric), transvaginal, peripheral vessel, and musculo-skeletal (Conventional and Superficial). The device incorporates built-in measurement and calculation packages that are to be used by competent health care professionals. The device is a prescription device intended to be use by or on the order of a physician or similarly qualified healthcare professional. The device is intended to be used on any patient; neonate, pediatric, or adult; where the placement and positioning of the transducer does not interfere with or complicate the treatment of the patient. This device is not intended for home use.
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Fetal, Abdominal, Pediatric, Small Organ (breast, thyroid, testes, etc.), Cardiac, Transvaginal, Peripheral Vessel, Musculo-skeletal Conventional, Musculo-skeletal Superficial.
The Fukuda Denshi Model FF Sonic UF-750XT Ultrasound System is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire and display ultrasound images in B-Mode, M-Mode, Color mode, PW mode, Power/DirPower mode or the combined mode (i.e. B/M Mode). The device consists of two parts: the scanner, and one of up to seven (7) different probes. In addition, the probe sclector unit provides two probes connection capability. The Fukuda Denshi Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates, and it is intended for use in abdominal, cardiac, small parts (breast, testes, thyroid, etc.), peripheral vascular, fetal, transvaginal, pediatric, and musculoskeletal (general and superficial) exams. This subject modified Ultrasound System also provides 3D imaging (Guided free hand 3D and Free hand 3D) with an optional 3D imaging unit (UF-750XT-3DU). New measurement functions have been added by the option 3D imaging unit (UF-750XT-3DU). No new transducers are being added and are not the subject of this submission.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Fukuda Denshi Model FF Sonic UF-750XT Diagnostic Ultrasound System:
1. Table of Acceptance Criteria and Reported Device Performance:
The document provided does not specify quantitative acceptance criteria for clinical performance (e.g., specific accuracy, sensitivity, or specificity thresholds). Instead, the primary "acceptance criterion" for this 510(k) submission is Substantial Equivalence to legally marketed predicate devices.
The device's performance is, therefore, demonstrated by:
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Safety: Device operates within established safety limits for medical ultrasound. | - Acoustic output measured and calculated per NEMA UD 2:2004. |
- All transducers are Track 3, and no transducer/system combination exceeded a Thermal or Mechanical Index of 1.0.
- All patient contact materials are biocompatible and identical to the predicate device.
- Conforms to electrical safety (IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-2-37).
- System hazard analysis and system validation addressed software safety issues. |
| Effectiveness/Functionality: Device performs its intended diagnostic ultrasound imaging functions, including B-Mode, M-Mode, Color, PW, Power/DirPower, and (newly added) 3D imaging, consistent with predicate devices. | - Laboratory testing verified the device met all design specifications. - Substantially equivalent to predicate devices (K#033209).
- Incorporated new 3D imaging (Guided free hand 3D and Free hand 3D) and associated measurement functions.
- Capable of full range of specified clinical applications (fetal, abdominal, pediatric, small organ, cardiac, transvaginal, peripheral vessel, musculoskeletal) with various transducers. |
| Substantial Equivalence: Device is as safe and effective as currently marketed predicate devices. | - "The conclusion drawn from the testing... demonstrates that the device is as safe and effective as the current legally marketed predicate devices." - FDA granted 510(k) clearance, indicating a finding of substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: The document explicitly states: "No clinical testing was required." Therefore, there is no sample size for a clinical test set. The review relies on laboratory testing and comparison to predicate devices.
- Data Provenance: Not applicable as no clinical data was generated for this submission. The "testing" primarily refers to laboratory and bench testing of the device's adherence to design specifications and recognized electrical/acoustic standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- Not applicable. Since "No clinical testing was required," there was no test set requiring expert-established ground truth. The evaluation focused on engineering performance and adherence to standards.
4. Adjudication Method for the Test Set:
- Not applicable. There was no clinical test set requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
- No. An MRMC comparative effectiveness study was not performed. The submission is for a general-purpose ultrasound system based on substantial equivalence, not a comparative effectiveness study of interpretation with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Not applicable. The device is a diagnostic ultrasound system, not an AI algorithm intended for standalone interpretation. It is a tool for human healthcare professionals. While it is software-controlled and includes some calculation packages, these are part of the overall system functionality, not a separate standalone AI.
7. The Type of Ground Truth Used:
- Not applicable for clinical ground truth. The "ground truth" for this submission was largely the established safety and performance standards (e.g., NEMA UD 2, IEC 60601 series) and the specifications of the predicate devices. The device was tested to ensure it conformed to these engineering and regulatory benchmarks.
8. The Sample Size for the Training Set:
- Not applicable. This submission does not describe a machine learning or AI algorithm that requires a training set in the conventional sense. The device is a hardware and software system based on established ultrasound physics and engineering principles, not statistical learning from a dataset.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As no training set for a machine learning algorithm was used, no ground truth needed to be established for it.
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.