(54 days)
Intended to be used by or under the direction of a physician and in conjunction with a standard ultrasound system to provide 3D and Multi-planar clinical imaging in fetal and gynecological applications. SONOReal™ is intended to visualize features that the user may wish to examine more closely in routine 2D ultrasound diagnostic imaging examinations. The user is offered the capability to perform linear, area and volumetric measurements of the subject being scanned. SONOReal™ does not provide any diagnostic interpretations.
Adds 3D imaging capability to commercial 2D ultrasound imaging systems. Hardware includes Pentium III 833 MHz, Frame Grabber (VHS/S-VHS Input), Video out, and Handheld controller. Software features include Volume data acquisition w/frame grabbing of video data b/w while using a Gyroscopic sensor system, Conditioning & transformation of the acquired data into a Cartesian volume, Surface rendering, Segmentation of structures from 3D data, and Measurement and calculations Via this submission.
The provided 510(k) summary for the BioMediCom SONOReal 3D System focuses on the addition of a measurement function to an already existing 3D ultrasound system. The document does not contain a detailed study with acceptance criteria and reported device performance metrics in the way a typical clinical trial or performance study would.
Instead, the submission appears to be a substantial equivalency claim, comparing the new device (with the added measurement function) to predicate devices already on the market. The comparison chart primarily details hardware and software features, not specific performance metrics against pre-defined acceptance criteria for the measurement function itself.
Therefore, many of the requested details about acceptance criteria, study design, sample sizes, ground truth establishment, expert qualifications, and MRMC studies are not present in the provided text.
Based on the information available, here's what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state acceptance criteria or report performance data for the measurement function. The "Comparison Chart for Substantial Equivalence" implies that the new device's measurement capabilities are considered equivalent to those of the predicate devices. However, no quantitative performance metrics (e.g., accuracy, precision) for these measurements are provided, nor are specific acceptance criteria for these metrics.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the document. The submission focuses on functional equivalence to predicate devices, implying that the measurement accuracy and precision are considered acceptable based on the existing market. | No specific performance data (e.g., accuracy, precision of measurements) is reported for the new measurement function. The document primarily compares features and capabilities with predicate devices. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified.
- Data Provenance: Not specified. The document does not describe a test set or study conducted for the measurement function.
3. Number of experts used to establish the ground truth for the test set and qualifications of those experts:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication method for the test set:
- Adjudication Method: Not specified, as no test set or expert review process for performance is detailed.
5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done:
- MRMC Study: No, there is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study being performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not explicitly mentioned or detailed. The measurement function is integrated into a system intended for use by a physician, implying human interaction.
7. The type of ground truth used:
- Type of Ground Truth: Not specified, as no specific performance study with a defined ground truth is described.
8. The sample size for the training set:
- Sample Size for Training Set: Not specified. This submission is for an addition of a measurement function to an existing device, and the details of how that measurement function was developed or trained (if it involved machine learning which is unlikely given the date) are not provided.
9. How the ground truth for the training set was established:
- Ground Truth Establishment for Training Set: Not specified.
Summary of Study (Based on the Document's Content):
The document K020068 is a 510(k) Summary for the SONOReal 3D System - Addition of Measurement Function by BioMediCom, Ltd. It is a submission to demonstrate substantial equivalence to legally marketed predicate devices, not primarily a detailed performance study with quantitative acceptance criteria for the added measurement function.
The "study" presented is a comparison of features and intended use between the modified SONOReal 3D System (with measurement function) and existing predicate devices (EchoTech 3D FreeScan K980308 and BioMediCom Baby Face K994385, and the original SonoReal 3D K012084).
The core argument for equivalence is that:
- The basic function (adding 3D imaging capability to 2D ultrasound) is the same.
- The hardware specifications are similar or improved (Pentium III 833 MHz vs. Pentium II 400 MHz).
- The software features are largely comparable, with the key update being the addition of measurement and calculations to the SONOReal 3D system, making it functionally similar to the EchoTech 3D FreeScan which already had "Measurements & calculations".
- The intended uses for fetal and gynecological applications are maintained and aligned with the capabilities being added.
The FDA's letter (K020068) confirms that, based on this information, the device is considered substantially equivalent to already marketed predicate devices for the stated indications for use. This means the FDA did not require a separate, detailed clinical performance study with explicit acceptance criteria and corresponding data to be submitted for this particular modification, as the functional addition (measurements) was deemed comparable to existing, legally marketed devices.
§ 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.