(30 days)
The Boris Platform system and transducers are intended for diagnostic ultrasound imaging and fluid flow analysis of the human body. The clinical applications include: ophthalmic, fetal, abdominal, intra-operative, laparoscopic, pediatric, small organ, neonatal/adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal, cardiac, transesophageal, peripheral vessel and cerebral vascular applications.
The Boris system is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data in various modes of operation. The device consists of two parts: the system console and the transducer. The system console contains the user interface, a display, system electronics and optional peripherals (printers, VCR). In addition to the physical knobs and buttons of the main control panel, the user interface consists of a Touch Panel, to access additional less-frequently-used controls, and the Alphanumeric Keyboard to enter patient data and other text. The removable transducers are connected to the system using standard technology. The Boris system uses standard transducer technology, and supports phased, linear, and curved linear arrays, TEE, motorized 3D curved linear arrays as well as Non-Imaging (Pencil) probes. The Boris system gives the operator the ability to measure anatomical structures, and offers analysis packages that provide information used by competent health care professionals to make a diagnosis. Clinical data storage consists of a local repository as well as off-line image storage via the network or DVD. The images are stored in industry-standard formats (Ex. JPEG. A VI, DICOM) and are intended to be readable using industry-standard hardware and software. On-line review of the images is available. Secure access tools are provided to restrict and log access to the clinical data repository according to HIPAA.
This document is a 510(k) Summary of Safety and Effectiveness for the Boris Platform Diagnostic Ultrasound System, dated January 16, 2003. It primarily focuses on demonstrating substantial equivalence to a predicate device (Philips HDI® 5000 ultrasound system), rather than reporting on specific acceptance criteria and detailed study results. Therefore, much of the requested information regarding acceptance criteria, study design, and performance metrics is not present in the provided text.
Here is an analysis of what information can be extracted from the provided text, and where the requested information is absent:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the document. The document primarily asserts substantial equivalence to a predicate device, meaning it aims to show similar performance rather than meeting specific quantifiable acceptance criteria that are explicitly stated.
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. The submission does not detail any specific clinical studies or test sets with sample sizes or data provenance. The focus is on technical characteristics being "essentially the same" as the predicate.
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. As no detailed clinical study is described, there is no mention of ground truth establishment or expert involvement for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document. No test set or adjudication method is 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
This information is not provided in the document. The device in question is a diagnostic ultrasound system from 2003, predating the widespread integration and specific evaluation of AI for human reader improvement in medical imaging.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided in the document. As noted above, this device is a traditional diagnostic ultrasound system and not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided in the document. No specific ground truth methodology is mentioned as a detailed clinical study is not presented.
8. The sample size for the training set
This information is not provided in the document. As this is not an AI/ML device, the concept of a "training set" in that context does not apply.
9. How the ground truth for the training set was established
This information is not provided in the document. This is not an AI/ML device, thus no training set or its ground truth establishment is discussed.
Summary of available information related to equivalence, which is the basis of this submission rather than specific acceptance criteria for novel performance:
The document serves as a 510(k) premarket notification, seeking clearance based on substantial equivalence to existing legally marketed predicate devices.
Predicate Device: Philips HDI® 5000 ultrasound system and transducers (cleared in K961459, K991671, and K002003).
Substantial Equivalence Claims (Conclusion Section):
- Intended Use: Both the Boris Platform system and predicate are intended for diagnostic ultrasound imaging and fluid flow analysis.
- Technology: Both systems use "essentially the same technologies for imaging, Doppler functions and signal processing."
- Acoustic Output: Both systems have "acoustic output levels below the applicable FDA limits." (This implicitly acts as an acceptance criterion for safety, but specific performance values are not given, just compliance).
- Materials: Both systems are manufactured of "materials that have been evaluated and found to be safe for its application."
In essence, the "study" that proves the device meets (implicitly, for substantial equivalence) acceptance criteria is the comparison of its technical characteristics and intended use to a legally marketed predicate device, as presented in the 510(k) submission. No new clinical trials or performance studies with specific statistical outcomes against predefined acceptance criteria seem to have been performed or are detailed in this summary.
The provided "Indications for Use Statement" tables for each transducer list various clinical applications and modes of operation (B, M, PWD, CWD, Color Doppler*, Combined*, Other*) with "N" indicating a new indication. These tables outline the claimed capabilities but do not provide performance metrics or acceptance criteria for these indications. The "Other" column often refers to features like SonoCT, Harmonic Imaging, and 3D Imaging, which are additional functionalities.
§ 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.