(434 days)
UltraPhonic® Conductivity Gel is intended for general use as a non-sterile transmission media for acoustically coupling a transducer to a human body surface during external therapeutic and diagnostic ultrasound imaging procedures. It is placed on the patient's skin or on the transducer prior to initiating an ultrasound examination.
Ultra/Phonic® Conductivity Gel is an aqueous, non-sterile ultrasound conducting medium for use during non-invasive ultrasonic medical procedures. It is placed between the ultrasound transducer and the patient, eliminating air at the contact surface while providing lubrication. This provides an acoustic pathway between the transducer and the skin. This uninterrupted pathway allows the transducer to send sound waves which enter the body, and to receive echoes from tissues and structures without unexpected interference. When the echoes are received by the scanner, it analyzes them to determine how strong they are, and how long they took to be received after transmission. That information is then processed and outputted to a display as an image which is used for diagnostic and therapeutic purposes by health care professionals. It is packaged in 4L Cubitainers, 5L Cubitainers, 250 mL bottles, and 250 mL tubes.
The request asks for specific details about the acceptance criteria and the study proving the device meets them. However, the provided document describes an ultrasonic conductivity gel, not an AI/ML device, and therefore does not contain information typically found in a study for AI/ML device performance.
Therefore, most of the requested fields cannot be filled from the provided text as they are not applicable to the type of device described.
Here's a breakdown of what can and cannot be extracted:
Device Type: Ultrasonic Conductivity Gel (not an AI/ML device)
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Acoustic properties "virtually identical to human skin" | Sound velocity: 1594.2 ms-1 at 22.5°C (compared to predicate's 1497 ms-1 at 30°C) |
| Acoustic properties "similar to other coupling gels" | Density: 1061 kg/m3 at 22.5°C (compared to predicate's 1023 kg/m3 at 30°C) |
| Acoustic impedance: 1.69 MRayls at 22.5°C (compared to predicate's 1.53 MRayls at 30°C) | |
| Attenuation coefficient a/f (dB/(cm-MHz)): 0.05 + 0.01148 f^1.213 (compared to predicate's 0.04 ± 0.0042 f) | |
| Antimicrobial effectiveness (USP Category 2) | Passed with log reductions greater than 5 for bacterial counts (Staphylococcus aureus ATCC 6538, Escherichia coli ATCC 8739, Pseudomonas aeruginosa ATCC 9027) at 14 and 28 days. Yeasts and molds (Aspergillus brasiliensis ATCC 16404, Candida albicans ATCC 10231) did not increase. |
| Non-sensitizing (ISO 10993-10) | Found to be non-sensitizing. |
| Non-irritating (ISO 10993-10) | Found to be non-irritating. |
| Not cytotoxic (ISO 10993-5:2009) | Meets the requirement of the test and is not considered cytotoxic. |
| pH level (Product Characteristic) | 6.25 ± 0.25 @ 25°C (compared to predicate Sonishield™ 100: 4.5 - 6.5; Ecogel 100: 6.5 ± 0.75) |
| Viscosity (Product Characteristic) | 600,000 ± 300,000 CPS (compared to predicate Sonishield™ 100: 80,000 - 120,000 CPS; Ecogel 100: 35,000 - 40,000 CPS) |
| Density (Product Characteristic) | 1.061 g/mL (compared to predicate Sonishield™ 100: 1.009 g/mL; Ecogel 100: 0.99 g/mL) |
| Boiling point (Product Characteristic) | > 200°C (compared to predicate Sonishield™ 100: > 200°C; Ecogel 100: 100°C) |
| Other characteristics (non-sensitizing, non-irritating, etc.) | Non-sensitizing, non-irritating, water-soluble, non-staining, easily cleanable, no oil or fatty matter, no odor, does not damage the probe, resists thinning, shear-thinning gel, high viscosity for thick application. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable. The performance data for this product is based on physicochemical and biological testing in a laboratory setting, not on a test set of patient data.
- Data Provenance: The acoustic testing used the Ultra/Phonic® Conductivity Gel and the predicate Sonishield™ 100 Antimicrobial Ultrasound Gel. Biocompatibility and cytotoxicity tests were conducted on the Ultra/Phonic® Conductivity Gel. The document does not specify the country of origin for the testing data. The studies are non-clinical performance evaluations.
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. This is not an AI/ML device that requires expert ground truth labeling.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable in the context of AI/ML. The "ground truth" for this device's performance is based on established laboratory testing standards (e.g., USP for antimicrobial effectiveness, ISO 10993 for biocompatibility and cytotoxicity) and physical property measurements.
8. The sample size for the training set
- Not applicable.
9. How the ground truth for the training set was established
- 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.