(19 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Imaging: Fetal, Abdominal, 3-D Visualization (non-measuring), Small organ (thyroid and breast), Musculoskeletal (Conventional), Peripheral Vessel and Needle Guidance.
The devices referenced in this submission represent a highly portable, software-controlled, diagnostic ultrasound system with accessories. This submission does not include technology or indications for use different from those demonstrated for B-Mode, inclusive of the predicate devices so claimed.
The devices included in this submission are as follows:
Voyager Ultrasound System utilizing as hardware and firmware an ultrasound engine contained in a very small in-line enclosure with only an 'image-freeze' control button;
A probe, C-4, of a mechanical configuration providing a single crystal sector scan of approximately 8 frames per second at an ultrasonic frequency of approximately 4 MHz;
A probe, C-10, a mechanical configuration providing a single crystal sector scan of approximately 8 frames per second at an ultrasonic frequency of approximately 10 MHz;
Software able to reside in a laptop inclusive of a non-metrological 3-D image rendering capability and, a means to enable the use of needle guidance techniques on each probe model.
The provided text is a 510(k) Premarket Submission for the Voyager™ Compact Imaging Device, an ultrasound system. It primarily focuses on demonstrating substantial equivalence to predicate devices and provides details on the device's technical characteristics, and intended uses.
However, the submission explicitly states that no additional clinical testing was required, as "the indications for this system are limited to B-mode exclusively" and are not novel. Therefore, there is no study described in this document that proves the device meets specific acceptance criteria based on clinical performance metrics. The demonstration of safety and effectiveness relies on conformance to safety standards (acoustic output, safety, EMC, etc.) and substantial equivalence to existing, legally marketed devices.
Given this, I cannot provide a table of acceptance criteria and reported device performance from a clinical study, nor answer questions requiring information from such a study (like sample size, ground truth establishment, MRMC studies, or standalone performance).
Here's what can be extracted based on the provided text, addressing the relevant points:
1. A table of acceptance criteria and the reported device performance:
As no clinical efficacy study proving device performance against specific acceptance criteria is presented in the document, this table cannot be generated from the given text. The acceptance criteria primarily revolve around compliance with established safety standards and substantial equivalence to predicate devices.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable. No clinical test set or data provenance is mentioned as no clinical studies were performed.
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):
Not applicable. No clinical test set requiring ground truth establishment by experts is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No clinical test set requiring adjudication is mentioned.
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. No MRMC study was done, nor is AI assistance mentioned for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. No algorithm-only standalone performance study was done.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
Not applicable. Since no clinical studies were conducted, no ground truth data was established. The basis for safety and effectiveness is compliance with technical standards and comparison to predicate devices, not clinical performance against a gold standard.
8. The sample size for the training set:
Not applicable. No training set is mentioned as no clinical studies or machine learning development are described.
9. How the ground truth for the training set was established:
Not applicable. No training set or ground truth for it is mentioned.
Summary of Device Compliance (from the provided text, fulfilling the spirit of "acceptance criteria" but not clinical performance):
The device is deemed to meet safety and effectiveness requirements based on:
- Compliance with identified standards:
- IEC 60601-1 (General requirements for safety)
- IEC 60601-1-2 (Electromagnetic compatibility)
- IEC 60601-1-4 (Programmable electrical medical systems)
- IEC 60601-2-37 (Safety of ultrasonic medical diagnostic and monitoring equipment)
- Acoustic Testing: "all medical devices, so designed, are tested and determined to be in full compliance with acoustic output..."
- Biocompatibility and Disinfection Effectiveness Testing: "...biocompatibility, and disinfection effectiveness."
- Conformance to 21 CFR Good Manufacturing Practices.
- Substantial Equivalence: Demonstrated against predicate devices (DIASUS, AU5, AU5/3D) for the intended clinical applications (B-mode operation for Fetal, Abdominal, 3-D Visualization (non-measuring), Small organ (thyroid and breast), Musculoskeletal (Conventional), Peripheral Vessel and Needle Guidance).
Conclusion from the text:
The submission explicitly states that "No additional clinical testing is required" because the indications for use are limited to B-mode exclusively and are not novel, as demonstrated by the predicate devices. Therefore, the "study that proves the device meets the acceptance criteria" refers to the engineering and regulatory compliance documentation, rather than a clinical trial.
§ 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.