(385 days)
Ultra Ease Ultrasound Gel Pad is indicated for use as an ultrasound transmission gel to be used in conjunction with an Ultrasonic Blood Flow Detector to auscultate peripheral vascular perfusion.
Ultra Ease Ultrasound Gel Pad is a non-irritating, rectangular shaped pad, that consists of a medical grade foam tape ring, a solid hydrogel transmission layer, and a polyester film cover. The pads are individually packaged in heat sealed paper/poly/foil/poly pouches.
Here's an analysis of the provided text regarding the "Ultra Ease Ultrasound Gel Pad" in the context of your request for acceptance criteria and study details:
The provided document, K950943, serves as a "Summary of Safety and Effectiveness" (SSE) for the Ultra Ease Ultrasound Gel Pad. It's important to note that this document is from 1995, an era where the requirements for clinical studies and detailed performance metrics, especially for Class I or II devices like gel pads, were significantly less stringent than for complex AI/ML-driven diagnostics.
Based on the document, here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety: Device materials are non-irritating to skin. | Passed Primary Skin Irritation Test. Passed Repeated Insult Patch Tests. Passed Agarose Overlay Cytotoxicity Test. |
| Effectiveness: Pad is effective for ultrasound transmission. | Clinical evaluation shows the pads are effective for the intended use (auscultating peripheral vascular perfusion). |
Explanation of Implied Criteria: The document doesn't explicitly state "acceptance criteria" in a quantitative, pre-defined manner typical for modern device approvals. Instead, the "Summary of Studies" section implicitly outlines the tests conducted to demonstrate safety and effectiveness. Passing these tests constitutes meeting the unstated acceptance criteria for a device of this type at that time.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set:
- Repeated Insult Patch Tests: 50 human subjects.
- Clinical Evaluation: Unspecified number of subjects/cases. The term "clinical evaluation" is very general and does not provide a specific sample size.
- Data Provenance: Not specified. It's generally assumed for such submissions that studies are conducted in the country of the applicant (USA, in this case), but this is not explicitly stated. The studies would have been prospective as they involve testing the device on subjects to assess irritation and effectiveness.
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)
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
- For the skin irritation tests, the "experts" would likely be dermatologists or medical professionals trained in assessing skin reactions.
- For the "clinical evaluation" of effectiveness for auscultation, it would have been clinicians (e.g., vascular specialists, nurses, or technicians) using the ultrasound device and the gel pad. No specific details are provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not specified. Given the nature of the device and the era, it's highly probable that a formal adjudication method (like 2+1 or 3+1) was not used for these types of studies. Decisions on skin irritation would likely be made by the administering clinician/researcher. Effectiveness would be a subjective assessment by the user.
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
- No, an MRMC comparative effectiveness study was not done.
- Effect Size: Not applicable. This device is an ultrasound gel pad, not an AI diagnostic tool involving "human readers" or "AI assistance."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, a standalone (algorithm only) study was not done.
- This device is an inert material (gel pad) and does not involve any algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For Safety (Skin Irritation): The "ground truth" was the direct observation and assessment of skin reactions (e.g., erythema, edema) by qualified personnel following standardized dermatological testing protocols.
- For Effectiveness (Ultrasound Transmission): The "ground truth" was the subjective clinical judgment of the user regarding the quality of the ultrasound signal for auscultating peripheral vascular perfusion. This is a functional assessment rather than a diagnostic 'truth' like pathology.
8. The sample size for the training set
- Not applicable. This document describes a medical device (ultrasound gel pad) and does not involve machine learning or a "training set."
9. How the ground truth for the training set was established
- Not applicable. As stated above, there is no training set for this type of device.
Overall Conclusion from the Provided Document:
The K950943 document details the safety and effectiveness for a relatively low-risk medical device (an ultrasound gel pad). The studies conducted (skin irritation tests and clinical evaluation) were appropriate for the device type at the time of submission (1995). The level of detail regarding sample sizes, expert qualifications, and ground truth establishment is much lower than would be expected for a complex diagnostic device or an AI-driven system today. The document confirms that the device passed basic safety tests and was deemed effective for its intended purpose based on clinical assessment.
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device 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. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.