(236 days)
The MHLX7EC Transducer is intended for use in ultrasonic imaging of the human body. The Indications for Use table shows specific uses as abdominal, fetal, transrectal, and transvaginal.
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Transrectal, Transvaginal.
The Microhelix MHLX7EC is a replacement ultrasound transducer designed to be used with the Acuson 128XP and Acuson Aspen Systems. It consists of a lens and associated circuitry, a handle which fits around the lens, a cable with strain relief devices on both ends, and a connector to attach the transducer to the ultrasound console.
The provided text describes a 510(k) summary for the Microhelix MHLX7EC Transducer, a replacement ultrasound transducer. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for a novel device. Therefore, much of the requested information regarding detailed study design, sample sizes, ground truth establishment, and expert involvement is not present in the provided document.
Here's an analysis based on the available information:
Acceptance Criteria and Device Performance for Microhelix MHLX7EC Transducer
The primary acceptance criteria for this 510(k) submission are based on demonstrating "substantial equivalence" to legally marketed predicate devices, specifically the TETRAD TC-EC7-ACP transducer (K013849) and the Acuson EC7 transducer (K991805). This means the device must share similar intended use, technological characteristics, and safety and effectiveness profiles as its predicates.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicit for Substantial Equivalence) | Reported Device Performance (Summary) |
|---|---|---|
| Intended Use | Must be for ultrasonic imaging of the human body, with specific applications (abdominal, fetal, transrectal, transvaginal) consistent with predicate devices. | Intended for use in ultrasonic imaging of the human body, with indications for abdominal, fetal, transrectal, and transvaginal applications, identical to the predicate devices. |
| Technological Characteristics | Must be "very similar" to predicate devices, using existing technology. | Described as "very similar" to predicate devices, used on the same ultrasound systems, with the same indications for use. "No new technology is involved." |
| Safety | Must meet electrical, mechanical, and thermal safety standards for medical devices. Acoustic output must be comparable to predicate devices and within approved levels. | Electrical, mechanical, and thermal safety testing was conducted and results included. Comparative performance testing showed acoustic output of MHLX7EC and Acuson EC-7 to be "comparable." (A post-clearance special report for acoustic output measurements based on production units was required as a condition of clearance). |
| Effectiveness (Performance) | Acoustic output and general performance must be comparable to predicate devices. | Comparative performance testing showed acoustic output to be "comparable" to the Acuson EC-7. The device is intended to be used with the Acuson 128XP and Aspen Systems, implying it performs effectively within those systems. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in the context of clinical studies with human subjects. The testing described is primarily focused on engineering and performance comparisons with predicate devices.
- Sample Size for Comparative Performance Testing: Not explicitly stated. The text mentions "comparative performance testing was conducted" and that "the MHLX7EC and the Acuson EC-7 were tested for acoustic output." This implies a comparison between at least two devices (the new device and its predicate). However, the number of units or measurements performed is not given.
- Data Provenance: Not explicitly stated, but given the nature of a 510(k) premarket notification in the US, the testing would have been submitted to the FDA (Food and Drug Administration) in the United States. The testing is likely retrospective in the sense that it's performed on pre-production or early production units to demonstrate equivalence. It's not a prospective clinical trial.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The submission does not detail a study involving human subjects or clinical experts establishing a ground truth for diagnostic accuracy, as it focuses on direct device-to-device comparison and safety.
4. Adjudication Method for the Test Set
Since there is no mention of a test set involving human interpretation tasks or clinical outcomes requiring adjudication, an adjudication method is not applicable and therefore not described in this document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC study was not performed, or at least not described, in this 510(k) submission. This type of study would typically assess human reader performance with and without an AI-assisted device. The Microhelix MHLX7EC is a basic ultrasound transducer, not an AI-enabled device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This is not applicable as the Microhelix MHLX7EC is an ultrasound transducer that requires human operation and interpretation. It is not an algorithm or an AI system that could be evaluated in a standalone manner.
7. Type of Ground Truth Used
The "ground truth" in this context is implicitly the established performance and safety characteristics of the predicate devices (TETRAD TC-EC7-ACP and Acuson EC7 transducers). The new device's performance (e.g., acoustic output) is compared directly against the known, approved characteristics of the predicate devices. There is no mention of pathology, outcomes data, or expert consensus in relation to a diagnostic accuracy claim for the device itself, as the claim is one of equivalence.
8. Sample Size for the Training Set
This information is not applicable as the Microhelix MHLX7EC is an ultrasound transducer, not an AI or machine learning algorithm. Therefore, there is no "training set" in the conventional sense for algorithm development.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as point 8.
§ 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.