(50 days)
The Humanscan M5S-D is phased array ultrasound transducer, for the GE Vivid E9 Ultrasound System, and indicated primarily for ultrasonic evaluation of cardiology conditions. It is also indicated for evaluation of fetal/obstetrics, abdominal, pediatric, adult cephalic, and urology/prostate use.
The Cardiac Ultrasound Transducer (M5S-D) is a matrix array probe with 192 elements for GE's ultrasound diagnostic system, Vivid E 9.
The information provided is for the Humanscan M5S-D Transducer for use with the GE Vivid E9 Ultrasound System. This submission is a 510(k) premarket notification, which largely relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than extensive de novo clinical studies with acceptance criteria and performance metrics typically seen for novel devices.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not provide specific quantitative acceptance criteria or reported device performance metrics in the format of a table as typically seen for new diagnostic algorithms. Instead, the document focuses on demonstrating substantial equivalence to an existing predicate device, the GE Vivid E9 M5S-D transducer.
The "acceptance criteria" in this context are primarily related to safety and functionality, ensuring the new device performs equivalently to the predicate. The reported "performance" is that it conforms to these safety and functional standards and is substantially equivalent.
| Acceptance Criteria Category | Specific Criteria (Implicit/Explicit) | Reported Device Performance |
|---|---|---|
| Safety | Conformity with applicable medical device safety standards (acoustic output, disinfection effectiveness, biocompatibility, cleaning, electromagnetic compatibility, thermal, electrical, and mechanical safety). Limits are same as predicate. | "The Humanscan M5S-D was evaluated, by GE, for acoustic output, disinfection effectiveness, biocompatibility, cleaning a and electromagnetic compatibility, as well as thermal, electrical and mechanical safety, and has been found to conform with applicable medical device safety standards. The limits are the same as the predicate Track 3 devices." |
| Intended Use | The intended use and clinical applications should be consistent with the predicate device. | "The Humanscan M5S-D is a phased array ultrasound transducer... and is indicated primarily for ultrasonic evaluation of cardiology conditions and also for evaluation of fetal/obstetrics, abdominal, pediatric, adult cephalic and urology/prostate use." This matches the predicate's indications. |
| Technical Equivalence | The device is "identical to the GE, Vivid E9, M5S-D transducer and is, in fact, manufactured for GE by Humanscan Company, Ltd." | The device is explicitly stated to be identical to the predicate. |
| Classification | Consistent with the predicate device (Class II, Product Code ITX). | "Regulation Number: 21 CFR 892.1570, Regulation Name: Diagnostic ultrasonic transducer, Regulatory Class: II, Product Code: ITX" - This matches the predicate's classification. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not describe a test set with a specific sample size for evaluating performance metrics through a clinical study. The evaluation appears to be primarily technical and engineering-based, focusing on safety and equivalence to the predicate transducer. There is no mention of patient data, retrospective or prospective studies, or country of origin for a "test set."
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided because the submission does not detail a study involving expert-established ground truth for a test set. The evaluation is focused on technical specifications and substantial equivalence, not on diagnostic accuracy requiring human expert adjudication.
4. Adjudication Method
No adjudication method is described as there is no mention of a test set requiring expert review or ground truth establishment in this type of 510(k) submission.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done or mentioned. This type of study typically assesses the impact of AI on human reader performance, which is not applicable to an ultrasound transducer as described here, especially in a 510(k) submission demonstrating substantial equivalence.
6. Standalone Performance Study
No standalone performance study (i.e., algorithm only without human-in-the-loop performance) was done or mentioned. The device is a transducer, which is a component of an ultrasound system and requires a human operator for its intended use.
7. Type of Ground Truth Used
No specific "ground truth" (e.g., pathology, outcomes data) as understood in the context of diagnostic accuracy studies is mentioned. The ground for acceptance is primarily the technical specifications and safety standards aligned with the predicate device, confirmed through non-clinical tests. The "ground truth" is that the device is manufactured to the same specifications and meets the same safety profiles as the predicate.
8. Sample Size for the Training Set
No training set is mentioned as this is an ultrasound transducer, not an AI algorithm requiring training data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set mentioned.
§ 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.