(96 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, Lung. Lumify is a transportable ultrasound system intended for use in environments where healthcare is provided by healthcare professionals.
Lumify Diagnostic Ultrasound System is a mobile, general, software-control medical device, which is intended to acquire high-resolution ultrasound data and to display the data in various modes of operation. It is intended to be used by trained professionals at various clinical settings including point-of-care. The Lumify Diagnostic Ultrasound System provides various imaging features including guided scan protocol for comprehensive lung exam. The introduction of the subject B-lines Feature enables the automated detection and counting of B-lines during a lung exam; the subject feature also provides the users the capabilities of reviewing the detected B-lines and editing the number of B-lines for each scanned lung zone. Clinically, B-line is a lung ultrasound artifact that can aid users in the assessment of patients with a variety of pulmonary conditions and diseases such as pneumonia, pulmonary edema, lung contusion, and acute respiratory distress syndrome (ARDS). The Lumify Diagnostic Ultrasound System includes: - A commercial off-the-shelf (COTS) mobile device l - I Philips Ultrasound software running as an app on the COTS device - I The C5-2 Curved array USB transducer - I The L12-4 Linear array USB transducer - I The S4-1 Sector array USB transducer - I 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.
The provided text describes the Philips Lumify Diagnostic Ultrasound System and its new B-lines Feature. However, it does not contain specific acceptance criteria, detailed study results, or information about sample sizes, ground truth establishment, or expert qualifications for the B-lines Feature.
Instead, the document primarily focuses on regulatory approval (510(k) submission) and states generally that "all pre-determined acceptance criteria were met" and "performance test data is provided to support the introduction of the subject software algorithm."
Therefore, I cannot fulfill your request for a detailed table of acceptance criteria, reported performance, sample sizes, ground truth details, expert qualifications, or MRMC study information based solely on the provided text.
Here's what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | "all pre-determined acceptance criteria were met" |
2. Sample size used for the test set and the data provenance:
- Sample Size (Test Set): Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified.
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:
- An MRMC study is not explicitly mentioned. The document states the B-lines Feature provides "automated detection and counting of B-lines," while the predicate had "manual counting," implying a standalone algorithm. However, no comparative effectiveness study with human readers and AI assistance is described, nor an effect size.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- The description of the B-lines Feature ("Automated detection and counting of B-lines from lung ultrasound images") suggests a standalone algorithm component. However, specific standalone performance metrics are not provided. The phrasing "the subject feature also provides the users the capabilities of reviewing the detected B-lines and editing the number of B-lines for each scanned lung zone" indicates a human-in-the-loop interaction, where the user can review and edit the device's output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not specified.
8. The sample size for the training set:
- Not specified.
9. How the ground truth for the training set was established:
- Not specified.
Summary of what is present in the document:
- The device is called the "Lumify Diagnostic Ultrasound System" with a new "B-lines Feature."
- The B-lines Feature provides "automatic detection and counting of B-lines during a lung exam."
- Users can review and edit the detected B-lines.
- Clinically, B-lines are lung ultrasound artifacts that aid in assessing pulmonary conditions.
- The study conducted was "non-clinical testing" addressing the change and performance, following Philips' internal processes (Requirements Review, Risk Analysis and Management, Product Specifications, Design Reviews, Product Performance testing).
- The conclusion states that "all pre-determined acceptance criteria were met" and the device "does not raise new questions of safety or effectiveness and is substantially equivalent to the predicate device."
- The predicate device involved "manual counting of B-lines from lung ultrasound images."
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.