(126 days)
The SONIX MDP Ultrasound System is intended for the following applications: Ophthalmic, Abdominal, Cardiac, Intraoperative (specific), Intraoperative Neurological, Fetal, Pediatric, Small Parts, Neonatal/ Adult Cephalic, OB/GYN, Transesophageal, Transrectal, Transvaginal, Peripheral Vascular, Musculoskeletal conventional, Musculoskeletal superficial, Pelvic, Nerve Block, Vascular Access.
The system also provides the ability to measure anatomical structures {fetal, abdominal, pediatric, small organ, cardiac, transvaginal, peripheral vessel, musculoskeletal} and provides calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
The SONIX MDP Ultrasound System indication(s) for use are the same as the predicate devices.
The ultrasound plateform is similar to the predicate devices in terms of operation. A transducer is applied to the patient and the system generates ultrasound waves then transmit the wave into human body. The system then receives echoes back from human body, processes them to yield an image on a display.
The provided document is a 510(k) summary for the "Sonix MDP Ultrasound Scanner". This type of document is a premarket notification to the FDA to demonstrate that the device is at least as safe and effective as a legally marketed predicate device.
**Key sections that are usually part of a study proving acceptance criteria and device performance (like clinical trials or performance studies) are explicitly stated as "N/A" or simply not present in this 510(k) summary because: **
- This submission is for a "New product clearance" for an ultrasound system and its transducers, where the primary pathway to clearance is demonstrating substantial equivalence to predicate devices, not by conducting independent clinical efficacy studies in the same way a novel therapeutic or diagnostic device would.
- The approval is based on comparison to existing, legally marketed ultrasound systems and transducers.
- For diagnostic ultrasound systems, the "device performance" in a 510(k) is usually about technical specifications (e.g., acoustic output, image quality parameters, safety standards compliance) rather than diagnostic accuracy against a ground truth.
- A "Name change request" is also part of this submission, further indicating a focus on equivalence rather than new performance claims. The clearance is granted conditional on submission of a post-clearance special report with acoustic output measurements, which are technical performance criteria, not clinical.
Therefore, the typical metrics for an AI/ML device (sensitivity, specificity, accuracy, etc., against a ground truth) and the experimental setup to test them (sample size, expert ground truth, adjudication, MRMC studies) are not applicable or detailed in this 510(k) summary. The "acceptance criteria" here refer to the criteria for substantial equivalence to predicate devices and adherence to relevant standards.
Based on the provided text, here's a breakdown of what can be extracted, acknowledging the limitations for an ultrasound scanner 510(k):
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied by 510(k) process) | Reported Device Performance (Summary) |
|---|---|
| Substantial Equivalence: Device must be at least as safe and effective as legally marketed predicate devices. | The FDA reviewed the premarket notification and "determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." This is the primary "performance" metric for a 510(k) of this nature. |
| Indications for Use: Device must support a specified range of clinical applications and modes of operation, consistent with predicate devices. | The SONIX MDP Ultrasound System is intended for a broad range of applications including Ophthalmic, Abdominal, Cardiac, Intraoperative, Fetal, Pediatric, Small Parts, Neonatal/Adult Cephalic, OB/GYN, Transesophageal, Transrectal, Transvaginal, Peripheral Vascular, Musculoskeletal, Pelvic, Nerve Block, and Vascular Access. It supports various modes: B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Color Velocity Doppler, and Combined modes. The indications for use "are the same as the predicate devices." Specific transducers (SA4-2/24, C5-2/60, EC9-5/10, L14-5/38) also have detailed, "new" (N) indications, meaning these specific applications and modes are being claimed for these new transducers within this new system. |
| Acoustic Output & Safety Standards Compliance: Device must meet established safety limits for acoustic output. | The FDA grants substantial equivalence "on the condition that prior to shipping the first device, you submit a postclearance special report" containing "complete information, including acoustic output measurements based on production line devices." This indicates that initial clearance relies on meeting these future safety criteria. The submission would have included declarations of conformity to relevant electrical safety and biocompatibility standards, though these are not detailed in the summary. |
| Technical Specifications: Transducers must meet specified technical parameters (e.g., frequency ranges, dimensions, focal lengths, scan depths, etc.). | Tables detailing transducer specifications (e.g., SA4-2/24 Phased Array 2.8 MHz, C5-2/60 Convex 3.2 MHz 60mm Radius, EC9-5/10 Microconvex Endocavity 6.6 MHz 10mm Radius, L14-5/38 Linear 8 MHz 38mm) are implicitly accepted as meeting the technical requirements for ultrasound systems. |
| General Controls Provisions: Compliance with annual registration, device listing, GMP, labeling, and prohibitions against misbranding and adulteration. | The FDA states the manufacturer "must comply with all the Act's requirements" regarding general controls. |
2. Sample size used for the test set and the data provenance:
- Not applicable (N/A) / Not provided. This 510(k) summary for an ultrasound system does not describe a "test set" in the context of clinical images or data being analyzed by the device for diagnostic accuracy. The substantial equivalence determination is based on the device's technical specifications, design, and intended uses being comparable to previously cleared devices. Device performance tests would involve engineering and safety verification rather than clinical data sets.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A / Not provided. There is no mention of experts establishing a ground truth for a test set, as this is not a study focused on diagnostic accuracy of an AI/ML algorithm against a ground truth. The 'ground truth' here is essentially the technical and clinical performance established for the predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A / Not provided. No test set requiring adjudication of findings 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:
- No. This is a clearance for a diagnostic ultrasound imaging system itself, not an AI-assisted diagnostic tool. Therefore, no MRMC study or AI assistance effect size is mentioned or applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No. This device is an ultrasound scanner, which is inherently a human-operated imaging tool. It does not perform "standalone" algorithmic diagnosis.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- N/A / Not provided. As no diagnostic accuracy study is described, no specific "ground truth" for diagnostic evaluation exists in this document. The "ground truth" for substantial equivalence is the existing, legally marketed predicate devices and their established safety and effectiveness.
8. The sample size for the training set:
- N/A / Not provided. This is not a submission for an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
- N/A / Not provided. As no AI/ML device or training set is discussed, this information is not applicable.
In summary, the provided 510(k) is for a new general-purpose ultrasound imaging system. The "study" proving it meets acceptance criteria is the 510(k) process itself, which involves demonstrating substantial equivalence to predicate devices through technical comparisons, adherence to performance standards (like acoustic output), and verifying that its indications for use are consistent with those of already cleared devices. It is not an AI/ML device, and therefore, typical AI/ML clinical study metrics are not relevant here.
§ 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.