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Philips Lumify Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging in B (2D), Color Doppler, and Combined (B + Color) modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications:

• Fetal/Obstetric Abdominal Urology Gynecological Cardiac Fetal Echo Small Organ Musculo-skeletal Peripheral Vessel Carotid
  Lumify is intended for use in environments where bealthcare is provided by healthcare professionals, with the exception of home, ambulance, or air.

Lumify with the L12-4 transducer is a mobile, general purpose, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data in various modes of operation. Lumify supports wireless network connectivity to allow the user to export ultrasound images.

The Lumify Diagnostic Ultrasound System includes:

• o A commercial off-the-shelf Android device (COTS)
• o Philips ultrasound software running as an app on the off-the-shelf device
• o The C5-2 Curved linear array USB transducer
• o The L12-4 Linear array USB transducer

Eumify provides customers with a smaller, lower cost, and more easily leveraged ultrasound system.

The provided document is a 510(k) premarket notification for the Philips Lumify Diagnostic Ultrasound System. It details the device's indications for use and compares it to predicate devices to establish substantial equivalence. However, it does not contain explicit acceptance criteria or a study dedicated to proving the device meets specific performance criteria in terms of accuracy or efficacy.

The document claims that the Lumify system "introduces no new indications for use, modes, features, or technologies relative to the predicate devices (Nuvis/ClearVue) that require clinical testing. The clinical safety and effectiveness of ultrasound systems with these characteristics are well accepted for both predicate and subject devices." This means that the regulatory submission primarily relies on the equivalency to previously cleared devices rather than providing a new performance study.

Therefore, the following information cannot be extracted from the provided text:

• A table of acceptance criteria and reported device performance (as no specific performance metrics are given for a new study).
• Sample size used for a test set.
• Data provenance for a test set.
• Number of experts used to establish ground truth.
• Qualifications of experts.
• Adjudication method for a test set.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done.
• Effect size of human reader improvement with AI assistance (as this is an ultrasound system, not an AI-assisted diagnostic tool in this context, and no such study is mentioned).
• Whether a standalone performance study was done.
• The type of ground truth used for a performance study.
• Sample size for the training set.
• How ground truth for the training set was established.

Information that can be extracted related to criteria and studies, though not a performance study as requested:

1. Acceptance Criteria and Reported Device Performance:

The primary "acceptance criterion" for this 510(k) submission appears to be demonstrating substantial equivalence to predicate devices. The performance data presented are non-clinical, focusing on compliance with safety and technical standards rather than clinical accuracy for specific diagnostic tasks.

2. Study/Test Information (Non-Clinical):

The document mentions "non-clinical performance data" for regulatory compliance, not a clinical performance study.

• Test Set/Sample Size & Provenance: Not applicable for a clinical performance study for this submission. The "tests" mentioned are for compliance with standards.
• Experts and Adjudication: Not applicable, as no clinical performance study for diagnostic accuracy is described. The "experts" would be those testing compliance with the listed engineering and safety standards.
• MRMC Study: No MRMC study was done, as the submission explicitly states no clinical testing was required due to substantial equivalence.
• Standalone Performance: No standalone clinical performance study was done for diagnostic accuracy. Performance relies on the established safety and efficacy of the predicate devices.
• Ground Truth: Not applicable in the context of a clinical performance study, as none was performed. For the non-clinical tests, ground truth refers to the specifications and requirements of the standards being met.
• Training Set (for algorithms): Not applicable. The document describes a medical device, not an AI/algorithm being trained on a dataset.
• Ground Truth for Training Set: Not applicable.

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