(172 days)
The device device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic(neonatal and adult), Trans-rectal, Trans-vaginal, Trans-esoph (Cardiac), Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), Urology and OB/Gyn.
The SonoScape SSI-8000 ultrasound system is an integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. The all digital architecture with progressive dynamic receive focusing allows the system to maximize the utility of all imaging transducers to enhance the diagnostic utility and confidence provided by the system. The exam dependent default setting allows the user to have minimum adjustment for imaging the patient, while the in-depth soft-menu control allows the advanced user to set the system for different situations. The architecture allows cost-effective system integration to a variety of upgrade-able options and features. This SonoScape system is a general purpose, software controlled, diagnostic ultrasound system. Its basic function is to acquire ultrasound data and display the image in-B-Mode (including Tissue Harmonic Image), M-Mode, TDI, Color-Flow Doppler, Pulsed Doppler and Power Doppler, or a combination of these modes, 3D/4D.
The provided document is a 510(k) Premarket Notification summary for the SonoScape SSI-8000 Mobile Digital Color Doppler Ultrasound System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with defined acceptance criteria and detailed device performance metrics typically found in efficacy studies.
Thus, based on the provided text, there are no acceptance criteria or studies with reported device performance (in terms of clinical metrics like sensitivity, specificity, accuracy, etc.) described to prove the device meets such criteria. The document states that the device has been tested as a "Track 3 Device per the FDA Guidance document 'Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers' issued September 9, 2008," and that "The acoustic output is measured and calculated per NEMA UD 2: 2004 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment and NEMA UD3: 2004 Standards for Real-time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment." It also mentions conformance to applicable medical device safety standards (IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-5, and ISO 10993-10). The conclusion states that the device is "as safe and effective as the legally marketed predicate devices."
This indicates that the evaluation primarily focused on technical safety standards and comparison to existing devices rather than a clinical performance study with acceptance criteria for specific diagnostic tasks. The tables within the document (e.g., in Tab 6 and subsequent transducer-specific tabs) list "Clinical Application" and "Mode of Operation" for various clinical uses, indicating intended uses but not performance metrics for those uses. The "N" indicates "new indication" for various modes and applications, meaning these are new intended uses compared to the predicate, but again, no performance data is provided for these new indications.
Therefore, the requested information (points 1-9) regarding acceptance criteria and performance data cannot be extracted from this document, as it does not contain details of such a study.
To directly answer each point:
- A table of acceptance criteria and the reported device performance: Not provided in the document. The document focuses on regulatory compliance and substantial equivalence to predicate devices, not clinical performance metrics against specific acceptance criteria.
- Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not provided in the document.
- 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): Not provided in the document.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided in the document.
- 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: Not applicable. This device is a diagnostic ultrasound system and transducers, not an AI-assisted diagnostic tool. No MRMC study is mentioned.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is a diagnostic ultrasound system, not an algorithm.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not provided in the document.
- The sample size for the training set: Not provided in the document. (Not relevant in this context anyway, as it's a hardware device, not an AI model requiring a training set).
- How the ground truth for the training set was established: Not provided in the document. (Not relevant for a hardware device).
§ 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.