(157 days)
The SC1 Handheld Ultrasound Imaging System (Model: SC1) is intended for diagnostic ultrasound echo imaging, measurement, and analysis of the human body for general clinical applications including musculoskeletal (MSK), vascular, small parts (breast, thyroid) through B mode.
SC1 is a transportable ultrasound system intended for use in environments where healthcare is provided by appropriately trained healthcare professionals.
The SC1 Handheld ultrasound imaging system, Model: SC1, is a general purpose, software-controlled, diagnostic ultrasound system that uses pulsed-echo technology (B Mode (2D); Frequency: 5 - 13 MHz; module: linear; depth max: 10 cm) to transmit ultrasound images via wired communication to a mobile device that utilizes the Android operating system. Its function is to acquire ultrasound data and to display the data in operation.
The SC1 Handheld ultrasound imaging system is a portable, general-purpose, software-controlled, hand-held diagnostic ultrasound system that consists of (i) the battery-operated, SC1L (Linear type Ultrasound Probe) that communicates wired with Android mobile device, (ii) the software that runs as an app on the mobile device, (ii) batteries, charger (Cradle), cable, power cord, and magnetizers (option), (iv) the instructions for use manual.
The SC1 App software can be downloaded to an Android mobile device and utilizes an icon touch-based user interface. The software enables ultrasound image review, controls for depth, gain, linear measurement.
The SC1 App software allows the user to image in real time and review freeze-frame images on the screen in a B-Mode, 2-dimensional scan format.
SC1 Handheld ultrasound system is only intended for acquisition and real time diagnosis. SC1 Handheld ultrasound system (SC1 probe and SC1 app) is not intended to provide any function on patient data (entering new patient information, editing patient data saving, or transferring or exporting patient information). It does not have capability to connect to the PACS or equivalent DICOM network or export any patient data via USB cable.
Physician who is responsible for interpreting ultrasound images must be available in the room to provide diagnosis in real time.
The SC1 Handheld ultrasound imaging system utilizes pulsed-echo technology to determine the depth and location of tissue interfaces, and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. Ultrasound waves are emitted from the transducer, propagate through tissues, and return to the transducer as reflected echoes. The returned echoes are then converted into electrical impulses by transducer crystals and further processed in order to form the ultrasound image presented on the screen.
The device components are not supplied sterile and do not require sterilization prior to use.
The provided text describes the SC1 Handheld Ultrasound Imaging System (Model: SC1) and its comparison to predicate devices for a 510(k) premarket notification. However, it does not contain information about a study that establishes acceptance criteria for device performance or proves the device meets those criteria, especially in the context of an AI/algorithm-driven device.
The document primarily focuses on:
- Substantial Equivalence: Comparing the SC1's technological characteristics, indications for use, and safety features to legally marketed predicate devices (K170085 and K192226).
- Non-Clinical Testing: Detailing compliance with electrical safety, EMC, software validation, cybersecurity, biocompatibility, and general performance testing (axial/lateral resolution, distance, B-mode display, max depth).
- Lack of Clinical Studies: Explicitly stating that "No clinical studies were considered necessary and performed."
Therefore, I cannot fulfill the request for information regarding acceptance criteria and a study proving their fulfillment, as this information is not present in the provided text.
Based on the provided text, here's what can be extracted, assuming the request is for mechanical/electrical performance rather than AI performance (which isn't discussed):
1. Table of Acceptance Criteria and Reported Device Performance
The document lists performance tests but does not explicitly state quantitative acceptance criteria or detailed results beyond "compliance" and "supported."
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Compliance with IEC 60601-1 (Electrical Safety) | Met |
| Compliance with IEC 60601-1-2 (EMC) | Met |
| Compliance with IEC 60601-1-6 (Usability) | Met |
| Software Validation | Verified and Validated |
| Cybersecurity Management | Compliant |
| Biocompatibility (ISO 10993-5, ISO 10993-10) | Verified and demonstrated safety |
| Axial Resolution | Performance defined |
| Lateral Resolution | Performance defined |
| Axial Distance Measurement | Performance defined |
| Lateral Distance Measurement | Performance defined |
| B-mode Display | Performance defined |
| Max Depth | Performance defined |
| Acoustic Output Levels | Below Track 3 FDA limits |
2. Sample size used for the test set and the data provenance
The document does not mention a test set, sample size, or data provenance related to AI/algorithm performance. The "performance testing" mentioned refers to engineering bench tests for resolution, distance, etc., not a clinical test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not mention experts or ground truth establishment for a test set.
4. Adjudication method for the test set
The document does not mention an adjudication method.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, the document explicitly states, "No clinical studies were considered necessary and performed."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document does not describe an algorithm or AI functionality that would warrant standalone performance evaluation. The device is a "software-controlled, diagnostic ultrasound system" which implies software for image acquisition and display, not AI for interpretation or diagnosis.
7. The type of ground truth used
The document does not mention any ground truth for performance evaluation of an AI algorithm. The "performance testing" described (e.g., resolution, distance) would typically use phantoms or calibrated targets as "ground truth" for those specific measurements, but this is not an AI-driven system needing medical ground truth.
8. The sample size for the training set
The document does not mention a training set, as it does not describe an AI/algorithm-driven device requiring one.
9. How the ground truth for the training set was established
The document does not mention a training set or ground truth establishment for one.
§ 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.