(63 days)
ULTRAEKOGEL™ is an electroconductive gel media used with ultrasonic pulsed echo imaging system. The gel -once applied on the defined area of the body- facilitates the intended use of the system, which is intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver.
ULTRAEKOGEL™ is an electroconductive gel media used with ultrasonic pulsed echo imaging system. The gel -once applied on the defined area of the body- facilitates the intended use of the system, which is intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. It is supplied in 250 grams and 5 Kilograms containers with a 3-year shelf life.
The provided text describes a 510(k) submission for a medical device called ULTRAEKOGEL™, an ultrasound gel. The submission claims substantial equivalence to a predicate device, AQUASONIC 100.
Here's an analysis of the acceptance criteria and the study (or lack thereof) proving device performance, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in terms of numerical performance metrics. Instead, it claims identicality across a range of technological characteristics when compared to the predicate device, AQUASONIC 100 (510k # K802146). The underlying acceptance criterion for this 510(k) submission is that the device is substantially equivalent to the predicate.
| Acceptance Criteria (Stated/Implied by Substantial Equivalence Claim) | Reported Device Performance (ULTRAEKOGEL™) |
|---|---|
| Indications for use (Identical to predicate) | Identical |
| Target population (Identical to predicate) | Identical |
| Design (Identical to predicate) | Identical |
| Materials (Identical to predicate) | Identical |
| Performance (Identical to predicate) | Identical |
| Sterility (Identical to predicate) | Identical |
| Biocompatibility (Identical to predicate) | Identical |
| Mechanical safety (Identical to predicate) | Identical |
| Chemical safety (Identical to predicate) | Identical |
| Anatomical sites (Identical to predicate) | Identical |
| Human factors (Identical to predicate) | Identical |
| Energy used and/or delivered (Identical to predicate) | Identical |
| Compatibility with environment and other devices (Identical to predicate) | Identical |
| Where used (Identical to predicate) | Identical |
| Standards met (Identical to predicate) | Identical |
| Electrical safety (Identical to predicate) | Identical |
| Thermal safety (Identical to predicate) | Identical |
| Radiation safety (Identical to predicate) | Identical |
Study to prove the device meets acceptance criteria:
The study proving the device meets the acceptance criteria is generally implied to be a comparison of technological characteristics against the predicate device. The document explicitly states: "Indeed, this device is IDENTICAL to the predicate device." This is the core of their argument for substantial equivalence.
2. Sample size used for the test set and the data provenance
The document does not describe a "test set" in the traditional sense of a clinical or performance study involving a sample of patients or physical measurements. The claim of "identical" performance is based on the assertion that the technological characteristics, including performance, are the same as the predicate device. Therefore, no specific sample size for a test set is mentioned. The data provenance would be derived from the specifications and characteristics of both the proposed device (ULTRAEKOGEL™) and the predicate device (AQUASONIC 100), likely through internal testing and material analysis to confirm the stated identicality. The country of origin of this internal data is not specified, nor is whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
As no distinct "test set" or clinical study is described, no information is provided regarding the number of experts or their qualifications used to establish a ground truth.
4. Adjudication method for the test set
Since no test set is described, no adjudication method is mentioned.
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 device is an ultrasound gel, not an AI-powered diagnostic system. Therefore, no MRMC comparative effectiveness study was done, and the concept of human readers improving with or without AI assistance is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This device is an ultrasound gel and does not involve an algorithm. Therefore, no standalone algorithm performance study was conducted.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For an ultrasound gel, the "ground truth" for performance would likely revolve around its physical and chemical properties that enable effective ultrasound imaging (e.g., acoustic impedance, viscosity, stability, biocompatibility). The document implies that these properties are identical to the predicate device's established characteristics. There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for this type of device in this submission.
8. The sample size for the training set
This device is an ultrasound gel and does not involve machine learning or AI. Therefore, there is no training set and no sample size is applicable or mentioned.
9. How the ground truth for the training set was established
As there is no training set, this question is not applicable.
§ 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.