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Dynarex Ultrasound Gel is intended for use as an ultrasound coupling media for use with the any Ultrasound System, Ultrasound procedures including diagnostic and elective prenatal scans.

Dynarex Ultrasound Gel is an electroconductive gel media used with ultrasonic pulsed echo imaging system. The gel is intended to facilitate projecting 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.

Apply the ultrasound gel to the treatment area. Remove after treatment with a tissue or towel. For external use only.

Contraindications: Not for use with defibrillators.

Dynarex Ultrasound Gel is a viscous, clear blue, water soluble gel. Typical packaging configurations for the Dynarex Ultrasound Gel is 250 ml plastic bottle, 1 Liter plastic bottle and 5liter plastic container. Other sizes may become available.

The provided text describes a 510(k) premarket notification for Dynarex Ultrasound Gel, seeking substantial equivalence to a predicate device, LiquaSonic Ultrasound Gel. The study focuses on demonstrating the new device's technological characteristics are comparable to the predicate.

Here's an analysis based on your requested information:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria Notes: For the performance metrics (Acoustic Speed, Acoustic Attenuation, Acoustic Impedance, and Electroconductivity), the acceptance criteria are not explicitly stated with a range or threshold. Instead, the comparison relies on demonstrating that the Dynarex Ultrasound Gel's performance is "substantially equivalent" to the predicate device's measured values, implying that the predicate's values serve as the de facto acceptance target. For qualitative characteristics like "Indications for use" and "Materials," the acceptance criterion is "Substantially Equivalent."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "Avg. 3 Lots" for Acoustic Attenuation Coefficient and Electroconductivity measurements for the Dynarex Ultrasound Gel, implying testing across three production lots. For the predicate device, it only lists a single value or a range.

• Test Set Sample Size: For quantitative performance metrics, at least 3 lots were tested for the Dynarex product. The sample size for the predicate device's data is not specified beyond a single reported value or range.
• Data Provenance: Not explicitly stated. The tests were performed as part of a 510(k) submission by Dynarex Corporation, an American company. The "Test Report for ISO 10993 and Test Report Number HIA_DYN_GEL_AM Dated August 27, 2008" suggests laboratory testing was conducted, but the location or whether it was internal or external is not specified. It is prospective testing performed for the purpose of the submission.

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)

This study involves the physical and acoustic characteristics of an ultrasound gel, not diagnostic interpretations of medical images. Therefore, the concept of "experts establishing ground truth" in the diagnostic sense (e.g., radiologists interpreting images) is not applicable here. The "ground truth" for the performance metrics would have been established by standard laboratory testing methodologies and equipment, presumably operated by qualified technicians or engineers, but no specifics are provided regarding the number or qualifications of such personnel.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is a scientific and engineering performance comparison of physical properties, not a diagnostic study requiring human adjudication of results.

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 a study involving human readers, AI assistance, or diagnostic performance on cases. It's a comparison of a medical device's physical and acoustic properties.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This product is an ultrasound gel, not an algorithm or a software device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" for the test set is based on objective laboratory measurements of physical and acoustic properties (Acoustic Speed, Acoustic Attenuation, Acoustic Impedance, Electroconductivity) using standard scientific methods and equipment. For biocompatibility, the ground truth would be established by the results of ISO 10993 testing.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not a machine learning or AI algorithm.

9. How the ground truth for the training set was established

Not applicable, as there is no training set.

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