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The Philips Lumify Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging in B (2D), Color Doppler, Combined (B+Color), Pulsed Wave Doppler (PWD), 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.

The Lumify system is a transportable ultrasound system intended for use in environments where healthcare is provided by healthcare professionals.

The Philips Lumify Diagnostic Ultrasound System (Lumify) is a mobile, durable, software-controlled medical device, which is intended to acquire high-resolution ultrasound data and to display the data in B (2D), Pulsed Wave Doppler, Color Doppler, Combined (B+ Color), and M modes. It is intended to be used by trained professionals at various settings of patient point of care such as clinical admission, periodic evaluations, and prior to hospitalization discharge,

The Lumify system is compatible with iOS or Android operating systems. The B-lines feature is compatible only with Android operating systems and utilizes:

• A commercial off-the-shelf (COTS) Android mobile device (smart phone or tablet)
• The Philips Ultrasound Lumify software running as an application on the COTS device
• The Philips C5-2 Curved array USB transducer
• The Philips L12-4 Linear array USB transducer
• The Philips S4-1 Sector array USB transducer
• Lumify Micro B Transducer Cable
• Lumify Micro C Transducer Cable

The Lumify system software provides various imaging features, including an Android-specific feature with a guided scan protocol for comprehensive exams and real-time automated B-line assessment during lung exams.

Acceptance Criteria and Device Performance Study for Philips Lumify Diagnostic Ultrasound System (K223771)

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Philips Lumify Diagnostic Ultrasound System with the Expanded B-lines Software Feature were pre-defined success criteria for the AI algorithm's agreement with clinician readings (ground truth).

Note: The lower confidence limit of 0.746 for both sensitivity and specificity was explicitly determined through a pilot study to assess clinician agreement, forming the basis for the acceptance criteria for merged B-line detection. While an explicit numerical acceptance criterion for ICC in B-line counting isn't provided, the conclusion states the device met clinical user needs as intended, implying satisfactory performance against an internal threshold.

2. Sample Size and Data Provenance for Test Set

• Sample Size: 416 lung ultrasound (LUS) video loops.
• Data Provenance:
  • Collected from 157 subjects presenting with shortness of breath in a hospital setting.
  • Each subject may have contributed up to 4 video loops.
  • The study data were collected to ensure full coverage of the lung (posterior and anterior, left and right).
  • Representative of videos collected from three different transducers (C5-2, L12-4, S4-1).
  • The study used previously collected clinical ultrasound images.
  • Retrospective: The phrasing "previously collected clinical ultrasound images" suggests the data was retrospective, gathered before the specific performance study was conducted.

3. Number of Experts and Qualifications for Ground Truth

The document does not explicitly state the number of experts used to establish the ground truth for the test set. However, it indicates that the ground truth was established by "clinicians" and refers to "clinician readings."

The qualifications of these clinicians are not specifically detailed (e.g., "radiologist with 10 years of experience").

4. Adjudication Method for the Test Set

The adjudication method is described as "majority agreement" among clinicians. The document states: "ground truth: majority agreement target was determined through pilot study conducted to assess clinician's agreement". This suggests a method where ground truth was established by the consensus of multiple clinicians, likely a 2+1 or similar majority-based approach, though the exact number of clinicians involved in each decision is not specified.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not describe a multi-reader, multi-case (MRMC) comparative effectiveness study designed to measure the effect size of human readers improving with AI vs. without AI assistance. The study focuses solely on the standalone performance of the AI algorithm against clinician-established ground truth.

6. Standalone (Algorithm Only) Performance

Yes, a standalone performance study was conducted. The "Artificial Intelligence Summary" explicitly states: "A study using previously collected clinical ultrasound images with prospective reads by clinicians was conducted to evaluate the performance (including merged B-lines and B-line counting)." The reported sensitivity, specificity, and ICC values represent the algorithm's performance independent of real-time human intervention or assistance.

7. Type of Ground Truth Used

The type of ground truth used was expert consensus, specifically "clinician readings" based on "majority agreement."

8. Sample Size for the Training Set

The document explicitly states: "The data used for clinical performance study were completely distinct from that used during training of the algorithm, and there was no overlap between the two data sets." However, it does not provide the sample size for the training set.

9. How Ground Truth for the Training Set Was Established

The document does not provide details on how the ground truth for the training set was established. It only mentions that the training data was distinct from the test data. Given that the algorithm uses machine learning, it is highly probable that the training data also had a ground truth established by experts, but the specifics are not included in this document.

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The VistaScan™ USB Ultrasound Imaging System is intended for diagnostic ultrasound imaging in B mode for the following applications: Fetal/obstetric Gynecology Abdominal Pediatric Small organ Musculo-skeletal (conventional) Musculo-skeletal (superficial) Urology Pelvic floor Neuro-muscular Peripheral vessel

Indications for use vary by probe type. The VistaScan™ USB Ultrasound Imaging System is indicated for Rx (prescription) use and intended for use by appropriately trained healthcare professionals such as physicians and ultrasound technologists. The VistaScan™ USB Ultrasound Imaging System is intended for use in healthcare facilities such as hospitals, clinics and facilities where ultrasound testing is performed.

The VistaScan™ USB Ultrasound Imaging System is a self-contained portable single-mode and multiple-application ultrasound imaging system. The system comprises a series of handheld probes containing an ultrasound generator/receiver, analog to digital converter, microcontroller, control logic, USB 2.0 interface, and software-based controls offering B operating mode, parameter controls, and recording functions. The selection of transducers offered with the system permit a wide range of clinical applications including Fetal/Obstetric, Abdominal, Pediatric, Small Organ, Muscular-skeletal, Urology, Gynecology, Pelvic Floor, Neuromuscular, and Peripheral Vessel.

The initial operational settings for each transducer are preprogrammed in the system. User-customized parameter settings for each transducer may be set by the operator within a specific range which is controlled by the transducer hardwareffirmware and stored for recall as needed via the system control panel. Customization includes transmit power, images controls selection, and Time Gain Compensation (TGC). Controls are also provided to select display format and to utilize the Cine function.

The VistaScan™ USB Ultrasound Imaging System is a B-Mode scanner and supports a wide variety of applications. It is an ultrasound scanner providing high resolution and high penetration performance. Probes are supported in frequencies from 2.5 MHz to 10.0 MHz. The product family uses non-array, curved, and flat linear array transducers and includes two General Purpose (GP) probes and a Small Parts (SP) probe. The probes can be connected to a USB 2.0 port (micro USB and USB-C).

System Components:

• Android™ based device operating VistaScan™ application .
• Transducer GP-3.5 ●
• Transducer GP-C01 ●
• . Transducer SP-L01

This looks like a 510(k) summary for a medical device called "VistaScan™ USB Ultrasound Imaging System." Unfortunately, this document does not contain the details necessary to answer your specific questions about acceptance criteria and the comprehensive study that proves the device meets those criteria.

Here's why and what information is missing:

• No specific acceptance criteria: The document mentions "predetermined acceptance criteria" for verification testing but does not list what those criteria actually are (e.g., specific performance metrics like sensitivity, specificity, accuracy, image resolution values, etc.).
• No detailed study results: It states "VistaScan™ successfully passed verification testing" and "The results support substantial equivalence," but it does not provide the actual quantitative results of these tests against the acceptance criteria.
• No information on clinical validation studies: While it states "VistaScan™ USB Ultrasound Imaging System introduces no new indication for use, modes, features, or technologies relative to the predicate devices that require animal or clinical safety and effectiveness of ultrasound systems with these characteristics are well accepted for both predicate and subject devices," this means they did not conduct a new clinical study. They are relying on the known safety and effectiveness of the predicate devices. Therefore, there are no details on sample size, data provenance, ground truth, expert opinions, MRMC studies, or standalone performance for this specific device's clinical performance.

Based on the provided document, I cannot create the requested table or answer most of your detailed questions regarding acceptance criteria and the study proving the device meets them because that information is not present.

The document focuses on demonstrating substantial equivalence to a predicate device, which is a regulatory pathway in the US that often relies on comparison to existing legally marketed devices rather than extensive de novo clinical trials for performance metrics.

Here's what I can extract from the document related to testing, but it falls short of your request:

Non-Clinical Performance Testing Mentioned:

The VistaScan™ USB Ultrasound Imaging System underwent evaluation against relevant requirements in the "Marketing Clearance of Diagnostic Ultrasound Systems and Transducers: Guidance for Industry and Food and Drug Administration Staff, June 27, 2019." The areas of evaluation included:

• Acoustic Output
• Clinical measurement accuracy and system sensitivity
• Thermal, mechanical, and electrical safety
• Patient-contacting materials
• Cleaning, disinfection, sterilization, and pyrogenicity
• Software

Electrical Safety / Electromagnetic Compatibility:

• Standards referenced: IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007) and IEC/EN 60601-1-2:2014.
• Conditions: Evaluation was performed for use of the transducer with a specific computer model (HP Netbook).
• User Responsibility: Use of alternate USB 2.0 compatible computer hardware requires verification by the end user (as stated in the Instructions for Use).

Standards Conformity:

The device references the following FDA recognized standards:

• IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007) (FDA Recognition#: 19-4): Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
• IEC/EN 60601-1-2:2014 4th Ed. (FDA Recognition#: 19-8): Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.
• IEC 60601-2-37:2007 (FDA Recognition#: 12-293): Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment.

Regarding your specific questions, here's what the document indicates or lacks:

1. A table of acceptance criteria and the reported device performance: Not provided. The document states "predetermined acceptance criteria" were used and "VistaScan™ successfully passed verification testing," but does not list the criteria or the quantitative performance results.
2. Sample size used for the test set and the data provenance: Not provided. This document does not describe a performance study with a distinct test set of imaging data. The evaluations mentioned are primarily non-clinical engineering and safety tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not provided. No clinical ground truth establishment for a test set is described.
4. Adjudication method for the test set: Not applicable/Not provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No, this type of study was not done. The document states that clinical safety/effectiveness is "well accepted for both predicate and subject devices" due to similar indications/features, implying no new clinical trials were performed for this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable/Not provided. This is an ultrasound imaging system, not an AI-driven image analysis or diagnostic algorithm in the sense of standalone performance evaluation like an AI CADe/CADx device. The "Software control" is listed as "Standalone," which refers to the software being self-contained, not a standalone AI algorithm's diagnostic performance.
7. The type of ground truth used: Not applicable/Not provided. Clinical ground truth (pathology, expert consensus, outcomes) is not discussed because no clinical performance study for this device's imaging capabilities is detailed. The ground truth for engineering tests would be instrument readings or established safety limits.
8. The sample size for the training set: Not applicable/Not provided. There is no mention of a training set as this document doesn't describe an AI/machine learning model that requires a training set for clinical diagnostic performance.
9. How the ground truth for the training set was established: Not applicable/Not provided.

In summary, this document is a regulatory submission demonstrating substantial equivalence based on technical specifications and non-clinical testing against recognized standards, rather than a detailed report of a clinical performance study with defined acceptance criteria and results against those criteria.

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