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510(k) Data Aggregation
(21 days)
Philips Lumify Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging in B (2D), Color Doppler, Combined (B+Color), and M modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications:
Fetal/Obstetric, Abdominal, Pediatric, Cephalic, Urology, Gynecological, Cardiac Fetal Echo, Small Organ, Musculoskeletal, Peripheral Vessel, Carotid, Cardiac.
Lumify is a transportable ultrasound system intended for use in environments where healthcare professionals.
The Lumify Diagnostic Ultrasound System is a mobile, general purpose, softwarecontrolled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data in various modes of operation. Lumify is a portable system facilitating point of care ultrasound applications.
The Lumify Diagnostic Ultrasound System includes:
- A commercial off-the-shelf (COTS) Android or iOS mobile device ●
- Philips Ultrasound software running as an app (Android or iOS) on the COTS device ●
- The C5-2 Curved array USB transducer
- The L12-4 Linear array USB transducer
- The S4-1 Sector array USB transducer
- The Lumify Power Module (LPM) to convert the USB interface used on the family of Lumify transducers to Apple's iAP2 Lightning interface standard used on iPhones and iPads, and to provide battery power to the transducers when using an iOS mobile device
This Philips Healthcare K192226 submission is for a Diagnostic Ultrasound System. The information provided does not detail specific acceptance criteria and performance data for an AI/ML component or a standalone algorithm. Instead, it focuses on the substantial equivalence of the Lumify Diagnostic Ultrasound System to a predicate device, primarily addressing hardware and software expansion to support iOS mobile devices.
Therefore, many of the requested data points (such as sample sizes for test and training sets, number of experts for ground truth, adjudication methods, MRMC studies, and standalone algorithm performance) are not applicable or not provided in the given document. The document explicitly states: "The Lumify Diagnostic Ultrasound System did not require clinical studies because substantial equivalence to the currently marketed predicate Lumify Ultrasound System (K162549) has been established."
However, I can extract the information related to the overall system's safety and nonclinical performance testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Standard/Guidance | Reported Device Performance |
|---|---|---|
| Acoustic Output | IEC 60601-2-37 Ed 2.1 (Particular requirements for the basic safety and essential performance of ultrasonic medical and monitoring equipment) | Complies with the referenced standard and FDA ultrasound guidance document, "Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" (June 27, 2019). System acoustic output limits are identical to the predicate device (K162549): Ispta.3 ≤ 720 MW/cm2, MI < 1.9, TI < 6.0 |
| Electrical Safety | AAMI / ANSI ES60601-1:2005/(R)2012 And A1:2012. C1:2009/(R)2012 ■ And A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment -Part 1: General Requirements For Basic Safety And Essential Performance | Compliant |
| Medical Ultrasound Equipment Safety | IEC 60601-2-37: Medical electrical equipment. Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment, 2015 | Compliant |
| Home Healthcare Environment | IEC 60601-1-11:2015: Medical Electrical Equipment - Part 1-11: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment | Compliant |
| Emergency Medical Services Environment | IEC 60601-1-12:2015: Medical Electrical Equipment Part 1-12: General Requirements for Basic Safety and Essential Performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment. | Compliant |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2 Medical Electrical Equipment - Part 1-2, General Requirements for Basic Safety and Essential Performance - Collateral Standard Electromagnetic Compatibility, 2014 | Compliant |
| Biological Evaluation | AAMI ANSI ISO 10993-1:2009/(R)2013 Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process | Compliant |
| Overall Safety and Effectiveness | Risk analysis, product specifications, design reviews, verification testing | Test results supported a determination of substantial equivalence to the predicate device and demonstrated that the Lumify Diagnostic Ultrasound System: - complies with the aforementioned international and FDA-recognized consensus standards and FDA ultrasound guidance document. - meets the acceptance criteria and is adequate for its intended use. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable, as no clinical studies or specific test set for AI performance are described. The evaluation was based on nonclinical performance testing against established standards and substantial equivalence to a predicate device.
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, as no clinical studies or specific test set requiring expert-established ground truth are described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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 device is not described as having an AI-assisted interpretation component for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This submission concerns a diagnostic ultrasound system, not a standalone AI algorithm for interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. For the nonclinical performance testing, the "ground truth" would be the specifications and requirements set forth by the cited international and FDA-recognized consensus standards.
8. The sample size for the training set
Not applicable, as no AI/ML algorithm requiring a training set is described in the context of this submission.
9. How the ground truth for the training set was established
Not applicable.
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