(270 days)
Intraoperative Ultrasound Probe Cover can be used to minimize contamination between the probe during ultrasound scanning procedures for both intact skin and compromised tissue. The cover allows use of the transducer in scanning and needle guided procedures for body surface, Endo cavity, and intra-operative diagnostic ultrasound, while helping to prevent transfer of microorganisms, body fluids, and particulate material to the patient and healthcare worker during reuse of the transducer.
Intraoperative Ultrasound Probe Cover can be used to minimize contamination between the patient and the probe during ultrasound scanning procedures for both intact skin and compromised tissue. The cover allows use of the transducer in scanning and needle quided procedures for body surface, endocavity, and intra-operative diagnostic ultrasound, while helping to prevent transfer of microorganisms, body fluids, and particulate material to the patient and healthcare worker during reuse of the transducer.
The probe cover is designed for use in both invasive and non-invasive procedures. It comes in a sterile form only. The sterile cover made used in invasive procedures where it will come into direct contact with compromised tissue. The probe cover may be used with any multiple different probes including, but not limited to, an Endoscope re-usable, any rectal, vaginal, trans-urethral, gastro-entero probes, or pulmonary probe, In-vitro Fertilization instruments, biopsy probes, fiberoptic probes, catheter probes, any probe that is used during a surgical procedure, re-usable vascular (visualization) probes, and re-usable central nervous system (CNS) or cerebral probes.
The provided text describes a 510(k) premarket notification for an "Intraoperative Ultrasound Probe Cover." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel clinical effectiveness through a comparative effectiveness study. Therefore, the device's acceptance criteria are primarily related to its physical properties, sterility, and performance characteristics consistent with its intended use as a protective barrier, rather than diagnostic accuracy or direct patient outcomes. The study mentioned is a non-clinical performance testing study.
Here's a breakdown of the information requested based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Test/Property | Reported Device Performance |
|---|---|---|
| Barrier Properties | Viral penetration | Met acceptance criteria |
| Water resistance/hydrostatic pressure | Met acceptance criteria | |
| Water resistance/impact penetration | Met acceptance criteria | |
| Synthetic blood penetration | Met acceptance criteria | |
| Material Properties | Tensile strength | Met acceptance criteria |
| Elongation | Met acceptance criteria | |
| Linting | Met acceptance criteria | |
| Sterility | Sterility (via EO Gas, ISO 11135-1:2014) | Met acceptance criteria (SAL 10-6) |
| Ethylene oxide residuals | Met acceptance criteria | |
| Bacterial endotoxins | Met acceptance criteria | |
| Biocompatibility | Biocompatibility | Met acceptance criteria |
| Acoustics | Acoustics performance | Met acceptance criteria |
| Packaging & Shelf Life | Packaging | Testing completed (results applicable from predicate) |
| Shelf life | Testing completed (results applicable from predicate) |
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 does not explicitly state the specific sample sizes for each non-clinical test conducted. It generally states that "Non-clinical performance testing was conducted." The provenance of the data (country of origin, retrospective/prospective) is also not specified, beyond being part of the 510(k) submission from "Exact Medical Manufacturing" in Lancaster, NY.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to this type of non-clinical performance testing for a medical device cover. The "ground truth" for these tests would be established by standardized testing methods and their associated industry-recognized specifications (e.g., ISO standards for sterility, ASTM standards for material properties), not by expert human interpretation of diagnostic images or clinical data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This is not a study involving human interpretation or adjudication. The results are based on objective physical, chemical, and microbiological testing methods.
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. This device is an "Intraoperative Ultrasound Probe Cover," a physical barrier, not an AI-powered diagnostic tool. Therefore, the concept of human readers improving with AI assistance is not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone (algorithm only) performance study was not done. This device is not an algorithm or software; it is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the non-clinical tests were the established acceptance criteria for each specific test method, derived from recognized industry standards (e.g., ISO for sterility, unspecified standards for material properties, viral penetration, etc.). These criteria define what constitutes an acceptable performance level for the device's physical and barrier properties.
8. The sample size for the training set
Not applicable. This device is not an AI/machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
§ 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.