(15 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Ophthalmic, Fetal/Obstetric, Abdominal, Intra-operative (vascular/epicardial), Intra-operative (Neuro), Pediatric, Small Organ (thyroid, scrotum, prostate, breast), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Other (Gynecological), Cardiac Adult, Cardiac Pediatric, Peripheral vessel, Musculo-skel (conventional), Musculo-skel (superficial).
The FLYING is a diagnostic ultrasound device. It consists of a system console containing the power supply and electronic circuitry required to generate the image, a display screen, and a connection to the separate transducers.
Here's an analysis of the provided text regarding the "FLYING Diagnostic Ultrasound System" and its acceptance criteria and supporting studies:
It's important to note that the provided text is a 510(k) Premarket Notification summary from 2009. This document primarily focuses on demonstrating substantial equivalence to previously cleared devices rather than robust clinical trials establishing new performance metrics. Therefore, many of the typical acceptance criteria and study details you'd expect for a novel device, especially an AI-powered one, are not present. The device itself is a general diagnostic ultrasound system, not explicitly an 'AI device' as understood today.
Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state quantitative acceptance criteria or device performance metrics in the way a modern AI device submission would. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to predicate devices. This means the device met the regulatory bar by being as safe and effective as existing legally marketed devices.
The tables in the document list the intended uses and modes of operation for the FLYING Diagnostic Ultrasound System with various transducers. The "P" (previously cleared) and "E" (added under Appendix E to previously cleared) designations indicate that these applications and modes were considered acceptable because they were identical or very similar to those already approved for the predicate devices. The "N" (new indication) column is absent from most tables, and where present (Table 4.3.2), it is marked as "N" for all applications, indicating they are new for this specific 510(k) submission but are being cleared based on equivalence to the predicate.
Here's a summary table based on the provided indications for use, interpreted as "performance" in the context of substantial equivalence:
| Clinical Application (as per FDA Tables) | Mode of Operation (B, M, PWD, CWD, Color Doppler, Combined, Other Modes*) | Reported Device Performance (Implied by "P" - previously cleared, "E" - added under Appendix E for previous devices, "N" - new indication for this submission, inferred as equivalent) |
|---|---|---|
| Ophthalmic | All modes (B, M, PWD, CWD, Color Doppler, Combined, Other modes) | P (for S4-2, L12-3) / N (for system, based on previous clearances) |
| Fetal/Obstetric | All modes (B, M, PWD, CWD, Color Doppler, Combined, Other modes) | P (for S4-2, S8, L12-3, C5-2, C8-4v, E6509) / E (for L12-5 50) / N (for system, based on previous clearances) |
| Abdominal | All modes (B, M, PWD, CWD, Color Doppler, Combined, Other modes) | P (for S4-2, S8, L12-3, C5-2)/ E (for L12-5 50) / N (for system, based on previous clearances) |
| Intra-operative | All modes (B, M, PWD, CWD, Color Doppler, Combined, Other modes) | N (for system, based on previous clearances, for vascular/epicardial & neuro; specifically P for 15-6L) |
| Pediatric | All modes (B, M, PWD, CWD, Color Doppler, Combined, Other modes) | P (for S4-2, S8, L12-3, L12-5 50, C5-2, 15-6L) / N (for system, based on previous clearances) |
| Small Organ | All modes (B, M, PWD, CWD, Color Doppler, Combined, Other modes) | P (for S4-2, L12-3, L12-5 50, E6509, 15-6L) / N (for system, based on previous clearances) |
| Neonatal Cephalic | All modes (B, M, PWD, CWD, Color Doppler, Combined, Other modes) | P (for S4-2, S8) / N (for system, based on previous clearances) |
| Adult Cephalic | All modes (B, M, PWD, CWD, Color Doppler, Combined, Other modes) | P (for S4-2) / N (for system, based on previous clearances) |
| Trans-rectal | All modes (B, M, PWD, CWD, Color Doppler, Combined, Other modes) | P (for E6509) / N (for system, based on previous clearances) |
| Trans-vaginal | All modes (B, M, PWD, CWD, Color Doppler, Combined, Other modes) | P (for C8-4v, E6509) / N (for system, based on previous clearances) |
| Gynecological | All modes (B, M, PWD, CWD, Color Doppler, Combined, Other modes) | P (for S4-2, S8, C5-2, C8-4v) / N (for system, based on previous clearances) |
| Cardiac Adult | All modes (B, M, PWD, CWD, Color Doppler, Combined, Other modes) | P (for S4-2, S8) / N (for system, based on previous clearances) |
| Cardiac Pediatric | All modes (B, M, PWD, CWD, Color Doppler, Combined, Other modes) | P (for S4-2, S8) / N (for system, based on previous clearances) |
| Peripheral Vessel | All modes (B, M, PWD, CWD, Color Doppler, Combined, Other modes) | E (for S4-2) / P (for S8, L12-3, L12-5 50, C5-2, D5009V, 15-6L) / N (for system, based on previous clearances) |
| Musculo-skeletal (conventional & superficial) | All modes (B, M, PWD, CWD, Color Doppler, Combined, Other modes) | P (for L12-3, L12-5 50, 15-6L) / N (for system, based on previous clearances) |
*Other modes listed include: Color Power Angio, 3D, Panoramic, Harmonics (Tissue & Contrast), Directional Angio Imaging, Tissue Doppler Imaging, Amplitude Doppler, SonoCT, X-Res, Dual
Study Details
The submission is a 510(k) for a diagnostic ultrasound system, not an AI/ML-powered diagnostic aid software. The "study" proving it meets acceptance criteria is primarily a comparative analysis demonstrating substantial equivalence to predicate devices, rather than a standalone performance study in the modern sense of validating an algorithm.
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Sample size used for the test set and the data provenance:
- No specific "test set" or sample size for evaluating the device's diagnostic performance is mentioned. The clearance is based on the technological characteristics and intended uses being substantially equivalent to the predicate devices.
- Since no specific clinical performance study is described, there's no information on data provenance (country of origin, retrospective/prospective).
- The document mentions "Acoustic output levels below the Track 3 FDA limits" as a point of equivalence, which would likely have involved technical testing, but not a patient-based test set for diagnostic accuracy.
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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. There is no explicit "ground truth" used in a clinical performance study with expert readers described in this submission, as it relies on substantial equivalence.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No clinical performance study requiring adjudication is described.
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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 a general diagnostic ultrasound system, not an AI software intended to assist human readers.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an AI algorithm. Its performance is inherent in its hardware, software, and transducers as a diagnostic imaging system, which is deemed equivalent to predicate devices.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. No direct clinical ground truth was established for this device's performance in a de novo study. Its "ground truth" for regulatory clearance is its substantial equivalence to already cleared devices.
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The sample size for the training set:
- Not applicable. This is not an AI/ML device, so there is no training set in the AI sense.
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How the ground truth for the training set was established:
- Not applicable. See point 7.
In summary, the "FLYING Diagnostic Ultrasound System" gained 510(k) clearance by demonstrating that it is substantially equivalent to predicate ultrasound systems (Philips M2540 and Boris platform diagnostic ultrasound system). This typically involves showing that the device has the same intended use, similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness. The detailed tables of indications for use across various probes are part of establishing this equivalence by listing the previously cleared (P) or additionally cleared (E) applications and modes based on the comparison to the predicate devices. No specific clinical performance studies with acceptance criteria, test sets, or expert evaluations as one would expect for a modern AI-driven diagnostic device were required or provided in this 2009 submission.
§ 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.