(9 days)
The device is intended for use by a qualified physician for ultrasound evaluation of Fetal: Abdominal: Intra-operative (abdominal, thoracic, and vascular); Intra-operative Neuro; Pediatric; Small Organ (Thyroid, Breast, Testes, etc.); Neonatal Cephalic; Adult Cephalic; Trans-rectal; Trans vaginal; Trans-esoph. (non-cardiac); Cardiac Adult; Cardiac Pediatric; Trans-esoph (Cardiac), Peripheral Vessel.
The SuperNova is a general purpose diagnostic ultrasound system. It consists of a Personal Display Unit approximately 4 inches wide and 3 inches high that can be held by the user in one hand and includes buttons for controlling the system and a screen that display ultrasound mages and user interface . The Imaging Unit can be held by the user in one hand accommodates a removable transducer module. Signals received from the transducer module are digitized and preprocessed. The transducer module comes into contact with the patient and both transmits and receives ultrasound energy. The docking station provides holders for the Personal Display Unit, the Imaging Unit, and transducer modules, as well as battery chargers.
The provided text is a 510(k) Summary of Safety and Effectiveness for the Novasonics SuperNova Ultrasound System and its associated transducers. This document primarily focuses on establishing substantial equivalence to predicate devices for regulatory clearance, rather than presenting a performance study with detailed acceptance criteria and results.
Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not explicitly available in the provided text. The document is a regulatory submission demonstrating equivalency for market clearance, not typically a detailed report of a clinical efficacy trial.
Here's a breakdown of what can be extracted and what is not present:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table of acceptance criteria with specific performance metrics (e.g., sensitivity, specificity, accuracy) or quantitative reported device performance in the way a clinical study report would.
Instead, the acceptance criteria are implicitly met by demonstrating substantial equivalence to predicate devices. The "performance" mentioned is in terms of the range of clinical applications and operating modes the device supports, which are stated to be a "subset of these approved devices."
The tables in the "Indications For Use" sections (pages 5-9) list the modes of operation for various clinical applications for each transducer type (Union of all, Curvilinear, Phased Array, Endo-Vaginal, Linear). The "N" in these tables indicates a "new indication" for the SuperNova system in those specific modes for those applications. This implies that the device is capable of performing these functions, and its performance for these functions is considered substantially equivalent to the predicate devices.
Acceptance Criteria (Implicit - Substantial Equivalence):
The device must be substantially equivalent to legally marketed predicate devices (Phillips ATL HDT® 5000 or GE Logiq 9™ systems) in terms of:
- Intended Uses
- Functional Modes
- Technological Characteristics (design, construction, materials)
Reported Device Performance (Implicit - Functional Equivalence):
The SuperNova system, with its various transducers, is functionally capable of various modes (B-Mode, M-Mode, PWD-Mode, CWD, Color Doppler, Combined Modes, Color M-Mode) across a wide range of clinical applications (Fetal, Abdominal, Intra-operative, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Cardiac Adult, Cardiac Pediatric, Peripheral Vessel). The "N" indicates that these are "new indications" for this specific device, implying that its performance for these indications is deemed equivalent to the predicates.
2. Sample size used for the test set and the data provenance
The document does not specify a sample size for a test set or data provenance (e.g., country of origin, retrospective/prospective). This is a 510(k) submission, which relies on demonstrating substantial equivalence to existing devices, often through engineering analysis and comparison of technical specifications, rather than a new clinical study with a test set of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided. Since there's no mention of a clinical test set with patient data, there's no mention of experts establishing ground truth for such a set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. Without a test set and ground truth establishment, adjudication methods are not applicable here.
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
An MRMC comparative effectiveness study was not done. The device described is a general-purpose diagnostic ultrasound system, not an AI-powered image analysis tool. Therefore, the concept of human readers improving with AI assistance is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance study was not done in the context of an algorithm or AI. This is a hardware diagnostic imaging device. Its "performance" refers to its ability to generate images and Doppler signals, which are then interpreted by a human operator (physician).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Ground truth, in the context of a clinical study, is not explicitly mentioned as being used for performance evaluation in this 510(k) submission. The basis for clearance is substantial equivalence to predicate devices, which implies that the device can produce images/data comparable to those accepted as diagnostically valid from the predicate devices.
8. The sample size for the training set
The concept of a "training set" is not applicable to this type of device (a diagnostic ultrasound system without AI/machine learning components).
9. How the ground truth for the training set was established
Not applicable, as there is no training set for an AI/ML algorithm.
Summary of the K022858 510(k) Clearance:
The K022858 application for the Novasonics SuperNova Ultrasound System (with Doppler and Harmonic Imaging modes) was cleared by the FDA based on substantial equivalence to existing predicate devices (Phillips ATL HDT® 5000 and GE Logiq 9™ systems). The device is a general-purpose diagnostic ultrasound system, and its "performance" for regulatory purposes in this context is demonstrated by its technological equivalence and ability to perform the same (or a subset of) clinical functions as the cleared predicate devices. The FDA letter requests a postclearance special report that should contain "complete information, including acoustic output measurements based on production line devices," as an additional control for this Class II device, but this is a condition of clearance, not part of the initial performance study for substantial equivalence.
§ 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.