(155 days)
Sono Image and Ultra Glide are coupling gels and will be used in conjunction with ultrasound transducers during medical diagnostic ultrasound to couple sound waves into the patient's body.
Sono Image is a high viscosity scanning gel suitable for echocardiography, vascular sonography and general ultrasound scanning procedures.
Ultra Glide is a low viscosity scanning gel suitable for abdominal, OB/GYN and general ultrasound scanning procedures.
Sono Image and Ultra Glide are medical diagnostic ultrasound scanning gels that transmit sound waves into the body through the skin and whose formulas are identical except for the polymer (thickener) content. Sono Image and Ultra Glide do not contain silicon, mineral oil, surfactants or any chemicals which are considered harmful to ultrasound transducer material (see Sono Image and Ultra Glide product formulation).
This 510(k) submission for "Sono Image and Ultra Glide" is for medical diagnostic ultrasound scanning gels, not an AI-powered device. Therefore, the requested information regarding acceptance criteria, study data, ground truth establishment, expert involvement, and MRMC studies, which are typically relevant for AI/ML device evaluations, is not applicable in this context.
The document primarily focuses on establishing substantial equivalence to previously cleared predicate devices for the intended use as coupling gels in ultrasound procedures. The core argument for acceptance is based on the identical formulation (except for thickener content which does not affect safety or performance), and the general understanding that viscosity preference is a user-dependent factor.
Here's an attempt to address the prompts based on the provided information, noting the limitations due to the nature of the device:
1. A table of acceptance criteria and the reported device performance
Based on the provided document, there are no specific quantified acceptance criteria for performance for these gels, as their primary function is sound wave transmission, which is inherent to their chemical composition as aqueous gels designed for ultrasound. The "performance" is primarily described as their ability to "transmit sound waves into the body through the skin" and to "couple sound waves into the patient's body," which is a fundamental requirement of such gels.
| Acceptance Criteria (Inferred from device description) | Reported Device Performance (Implied) |
|---|---|
| Transmit sound waves into the body through the skin | Sono Image and Ultra Glide are medical diagnostic ultrasound scanning gels that transmit sound waves into the body through the skin. |
| Couple sound waves into the patient's body | Sono Image and Ultra Glide are coupling gels and will be used in conjunction with ultrasound transducers during medical diagnostic ultrasound to couple sound waves into the patient's body. |
| Do not contain harmful chemicals to ultrasound transducer material | Sono Image and Ultra Glide do not contain silicon, mineral oil, surfactants or any chemicals which are considered harmful to ultrasound transducer material. |
| Viscosity suitable for intended applications | Sono Image: high viscosity for echocardiography, vascular sonography, general. Ultra Glide: low viscosity for abdominal, OB/GYN, general. (Note: viscosity does not affect safety or performance, selected by preference). |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The submission does not detail any clinical studies or "test sets" in the context of performance metrics that would require sample sizes. The "data" provided is primarily related to the chemical composition and intended use.
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)
Not applicable. There is no mention of a "test set" requiring ground truth establishment by experts for performance evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No "test set" or adjudication method 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
Not applicable. This is not an AI-powered device.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
Not applicable. This is not an AI-powered device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No specific ground truth related to performance evaluation is mentioned for this type of device. The "truth" lies in the chemical composition meeting the requirements for a coupling gel.
8. The sample size for the training set
Not applicable. This is not an AI-powered device and therefore does not have a "training set."
9. How the ground truth for the training set was established
Not applicable. As above, no training set.
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.