(267 days)
Sonishield™ 100 Antimicrobial Ultrasound Gel is intended for general use as a non-sterile transmission media for acoustically coupling a transducer to a human body surface during external and therapeutic ultrasound imaging procedures. It is placed on the patient's skin prior to initiating an ultrasound examination. It is indicated for prescription use only.
Sonishield™ 100 Antimicrobial Ultrasound Gel consists of deionized water, hydroxyethylcellulose, propanediol and benzalkonium chloride. It is a type of conductive medium (i.e.) scanning gel used in ultrasound therapeutic and diagnostic imaging techniques. A scanning gel acts as a couplant that provides an acoustic pathway between the transducer and the skin. In addition, the gel eliminates air (a disruptive influence) from the interface and adapts the contours of the probe to the skin.
The major characteristics of Sonishield™ 100 Antimicrobial Ultrasound Gel include:
- Hypoallergenic, non-irritating
- Water soluble, non-staining and easily cleanable
- . Does not contain oil or fatty matter
- Free from formaldehyde and salt ●
- No toxic effects
- Produced as a completely harmless material
- Has no odor
- Vacuum treated production
- Does not damage the probe
- Does not contain air bubbles
- pH level ranges from 4.5 to 6.5 at 25°C ●
The document describes the Sonishield™ 100 Antimicrobial Ultrasound Gel and its substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria based on performance in a diagnostic task.
However, from the provided text, we can infer some "acceptance criteria" through the non-clinical performance tests and the comparison to predicate devices. The study detailed is primarily a non-clinical performance evaluation to demonstrate safety and functional equivalence, not a clinical trial evaluating diagnostic accuracy with human interpretation.
Here's the breakdown of information based on your request, extracting what's available from the provided text:
1. Table of Acceptance Criteria (Inferred from Non-Clinical Performance) and Reported Device Performance
| Acceptance Criteria (Inferred) | Reported Device Performance (Sonishield™ 100 Antimicrobial Ultrasound Gel) |
|---|---|
| Acoustic Properties: | |
| Sound velocity (m/sec) at 30°C | 1497 |
| Density (kg/m³) at 30°C | 1.023 X 10⁻³ |
| Acoustic impedance (kg/m² sec) at 30°C | 1.53 |
| Attenuation coefficient as a function of frequency, a/f (dB/cm-MHz) | 0.04 ± 0.0042 |
| Comparison to predicate gels | Virtually identical to predicate Konix® Ultrasound Gel (Konix® values: 1516 m/sec, 0.98X 10⁻³ kg/m³, 1.49 kg/m² sec, 4 from initial count at 14 days post-inoculation (for specified bacteria) |
| Biocompatibility - Skin Irritation (ISO 10993-10): | Non-irritating |
| Biocompatibility - Skin Sensitization (ISO 10993-10): | Non-sensitizing |
| Clinical Tolerance - Cutaneous Irritation: | No signs of cutaneous irritation |
| Clinical Hypoallergenic (Human Repeat Insult Patch Test - HRIPT): | Considered hypoallergenic; no pertinent reaction to test product during challenge phase. (Note: 9/55, 1/55, 2/55 volunteers showed 'barely noticeable' to Grade 2 erythema during induction phase, but this did not lead to a 'pertinent reaction' in the challenge phase for the overall conclusion of hypoallergenic.) |
2. Sample size used for the test set and the data provenance
- Acoustic Testing: Not explicitly stated, but the values are physical properties, likely measured in a lab setting. Data provenance is not specified beyond "Sonishield™ 100 Antimicrobial Ultrasound Gel was evaluated for its acoustic performance."
- Antimicrobial Effectiveness Testing: Not explicitly stated for specific sample counts of the gel, but performed using USP Category 2 as a guide. Data provenance is not specified.
- Animal Biocompatibility (Skin Irritation and Sensitization): Standard animal testing for ISO 10993-10. Not explicitly stated how many animals were used. Data provenance is not specified.
- Clinical Tolerance Study: "two part study." No specific number of participants mentioned. Data provenance is not specified.
- HRIPT (Hypoallergenic study): 55 volunteers. Data provenance is not specified.
All studies mentioned appear to be prospective in nature, as they were conducted to evaluate the performance of the Sonishield™ 100 gel. The country of origin for the data is not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable as the studies described are non-clinical performance evaluations and biocompatibility/tolerance tests for an ultrasound gel, not diagnostic accuracy studies involving medical image interpretation or human diagnoses. Therefore, "ground truth" in the diagnostic sense (e.g., confirmed disease status) and "experts" (e.g., radiologists) in that context are not relevant to the described tests.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This is not applicable for the reasons stated above (non-clinical performance and biocompatibility studies).
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 is not applicable. The device is an ultrasound gel, not an AI-powered diagnostic tool. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. The device is an ultrasound gel, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Acoustic Testing: The "ground truth" would be the physically measured acoustic properties of the gel.
- Antimicrobial Effectiveness Testing: The "ground truth" is the quantitative bacterial count reduction compared to a baseline, against established microbiological standards (USP ).
- Animal Biocompatibility: The "ground truth" is the observed biological reaction (or lack thereof) in living tissue, against the criteria of ISO 10993-10.
- Clinical Tolerance Study: The "ground truth" is the observed cutaneous reaction (or lack thereof) in human skin, assessed by study personnel.
- HRIPT (Hypoallergenic study): The "ground truth" is the observed skin reaction (or lack thereof) in human volunteers, assessed by study personnel, following a standardized protocol.
8. The sample size for the training set
This is not applicable. There is no "training set" as this is a physical product undergoing performance and safety testing, not a machine learning model.
9. How the ground truth for the training set was established
This is not applicable for the same reason as point 8.
§ 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.