(14 days)
Protective cover or sheath placed over diagnostic ultrasound transducer / probe / scanhead instruments. The cover allows use of the transducer in scanning and needle guided procedures for body surface, endocavity, central nervous system, and intra-operative diagnostic ultrasound, while helping to prevent transfer of microorqanisms, body fluids, and particulate material to the patient and healthcare worker during reuse of the transducer. The cover also provides a means for maintenance of a sterile field. The cover is single use patient / procedure, nonpyrogenic, and disposable.
The Non-Pyrogenic Ultrasound Transducer Cover provides a thin, conformal covering to fit a variety of ultrasound transducer geometries. The cover is made of polyurethane, polyethylene, and/or synthetic polyisoprene materials. The cover is manufactured as either a one-or two-piece design that helps prevent the transmission of pathogens as the ultrasound transducer is reused from one patient to another. The Non-Pyrogenic Ultrasound Transducer Cover is provided sterile and is single patient / procedure and disposable.
Ultrasound imaging is not impaired by use of the cover as it is intended. As adequate coupling between the cover and the transducer is required, the Non-Pvrogenic Ultrasound Transducer Cover is utilized by applying sterile saline or other non-pyrogenic coupling media onto the transducer face or into the closed end of cover, inserting the ultrasound transducer into the closed end of cover, and unrolling the cover over the length of the transducer as desired. The open end is secured with elastic bands and nylon clips as necessary. The removal process is accomplished by pulling the cover off the transducer in a reverse method from the application.
It seems there's a misunderstanding about the nature of the provided document. This document is a 510(k) Premarket Notification Summary for a medical device (Non-Pyrogenic Ultrasound Transducer Cover), not a study report demonstrating the performance of an AI algorithm or a diagnostic device that outputs specific measurements.
Therefore, the requested information about acceptance criteria for an AI device, sample sizes for test/training sets, expert ground truth, MRMC studies, or standalone algorithm performance, does not apply to this document.
This document is primarily concerned with demonstrating substantial equivalence of a physical medical device (transducer cover) to previously cleared predicate devices, and justifying an expanded indication for use (central nervous system and non-pyrogenic claim) through specific non-clinical tests.
However, I can extract the information that is relevant to the document concerning the device's safety and effectiveness for its intended use based on the non-pyrogenic and implantation claims.
Here's an interpretation based on the document's content, focusing on what could be considered acceptance criteria and how the device met them, with caveats that this is not an AI device:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (for expanded claims) | Reported Device Performance |
|---|---|
| Non-Pyrogenic: Pyrogen levels acceptable for medical devices. | Endotoxin testing per USP Bacterial Endotoxins Test demonstrated that pyrogen levels are acceptable in accordance with USP Transfusion and Infusion Assemblies and Similar Medical Devices. |
| Biocompatibility for CNS use: Non-reactive when implanted in muscle. | Implant testing per ISO 10993-06 Tests for Local Effects After Implantation demonstrated that the device materials are non-reactive when implanted in muscle for one week. |
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 for testing: The document does not specify the exact sample size (number of units tested) for the endotoxin or implant testing. It states "test data" was used.
- Data Provenance: The tests were conducted to support a 510(k) submission to the US FDA, implying the data would adhere to relevant US regulatory standards. However, the country of origin of the actual testing facilities or samples is not specified in this summary. The testing appears to be prospective laboratory testing of the device itself.
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 concept is not applicable as this is a physical medical device undergoing non-clinical laboratory testing, not a diagnostic device requiring expert interpretation of results for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The testing methods (USP and ISO 10993-06) involve objective laboratory measurements, not subjective interpretation requiring adjudication among experts.
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 an AI diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" here would be the objective measurements obtained from standardized laboratory tests:
- For pyrogenicity: Detection of bacterial endotoxins below a specified limit as defined by USP and USP.
- For biocompatibility: Observation of local tissue reactions after implantation in muscle, evaluated against criteria defined by ISO 10993-06.
8. The sample size for the training set
Not applicable. This device does not have a "training set" as it is not an AI/machine learning model.
9. How the ground truth for the training set was established
Not applicable.
In summary: The provided document is a regulatory submission for a physical medical device. It details non-clinical testing to demonstrate the safety and effectiveness of a transducer cover for expanded indications, specifically regarding its non-pyrogenic nature and biocompatibility for central nervous system use. The "acceptance criteria" and "device performance" in this context refer to the successful completion and results of these specific laboratory tests against established standards.
§ 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.