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Indications for Use
Focal seizure detection (with or without secondary generalization) in patients with epilepsy age 6 years and older.

160 MHz 802.11ax Wi-Fi and Bluetooth 5.0 (Dual Band)

The provided FDA 510(k) clearance letter and summary for the Philips Lumify Diagnostic Ultrasound System (K242519) primarily focus on demonstrating substantial equivalence to predicate and reference devices, rather than detailing a specific study to prove the device meets acceptance criteria in a comprehensive clinical performance sense for a new AI/software feature.

The submission is for the addition of a new transducer (C9-4ec) and a "Fertility Package" feature. The primary change is the addition of the Trans-vaginal clinical indication, enabled by the C9-4ec transducer.

Therefore, many of the requested points regarding acceptance criteria, specific studies, sample sizes, and ground truth establishment for a clinical performance study are not explicitly detailed in the provided documents, as the application relies more on non-clinical performance data and comparison to already cleared devices.

Here's a breakdown of the information that can be extracted and what is not available:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not contain a table of specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy targets) for clinical performance of the Fertility Package or the C9-4ec transducer, nor does it report specific clinical performance metrics. Instead, "acceptance criteria were met" is a general statement from non-clinical testing.

The document indicates that non-clinical verification testing was conducted to address system-level requirements and design specifications, and that the device complies with referenced standards.

2. Sample size used for the test set and the data provenance

The document explicitly states: "The proposed Lumify Diagnostic Ultrasound System with C9-4ec transducer did not require clinical data for determination of substantial equivalence."

Therefore, there is no mention of a clinical "test set" sample size or data provenance (country of origin, retrospective/prospective) for a clinical performance study. The evaluation focused on non-clinical performance and substantial equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable, as no clinical test set requiring expert-established ground truth for performance metrics is described.

4. Adjudication method for the test set

Not applicable, as no clinical test set requiring adjudication is described.

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. The document does not describe an AI-assisted diagnostic feature that would warrant an MRMC study comparing human readers with and without AI assistance. The "Fertility Package" provides measurement tools and a summary page, which are productivity/workflow enhancements rather than AI-driven diagnostic interpretations.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. The "Fertility Package" appears to be a set of measurement and reporting tools, not a standalone diagnostic algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable for a clinical performance study since none was conducted or reported. For the non-clinical testing, the "ground truth" would be the engineering specifications and recognized industry standards against which the device's hardware and software performance were verified.

8. The sample size for the training set

Not applicable, as no clinical data-driven "training set" for a new algorithm is described or implied. The Fertility Package seems to be functionality built upon established ultrasound principles and measurement techniques found in reference devices.

9. How the ground truth for the training set was established

Not applicable, as no training set for a new algorithm is described or implied.

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Philips CX50 Diagnostic Ultrasound Systems is intended for diagnostic ultrasound imaging in B (or 2-D), M-mode (including Anatomical M-mode), Pulse Wave Doppler, Continuous Wave Doppler, Color Doppler, Tissue Doppler Imaging and Harmonics (Tissue and Contrast) modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Ophthalmic Intraoperative Laparoscopic Fetal Abdominal Pediatric Small Organ Adult Cephalic Neonatal Cephalic Trans-vaginal Musculo-skeletal Gynecological Cardiac Adult Cardiac Pediatric Trans-Esoph. (Cardiac) Intracardiac echo Peripheral Vessel Other (Carotid)

Philips Sparq Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging in B (or 2-D), M-mode (including Anatomical M-mode), Pulse Wave Doppler, Continuous Wave Doppler, Color Doppler, Tissue Doppler Imaging and Harmonics (Tissue and Contrast) modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Ophthalmic Fetal Abdominal Pediatric Small Organ Adult Cephalic Trans-vaginal Trans-rectal Musculo-skeletal Gynecological Cardiac Adult Trans-Esoph. (Cardiac) Peripheral Vessel

The modified CX50 and Sparq Diagnostic Ultrasound Systems are general purpose, software controlled, diagnostic ultrasound systems. Their function is to acquire ultrasound data and to display the data in various modes of operation. The devices consist of two parts: the system console and the transducers. The system console contains the user interface, a display, system electronics and optional peripherals (ECG, printers). In addition to the physical knobs and buttons of the main control panel. The CX50 Diagnostic Ultrasound System is a compact, AC or battery powered, 128 -channel, diagnostic ultrasound imaging system. It is housed in a portable, laptop-style chassis. An optional cart is available that allows the user to place the laptop on the cart for a more mobile application. The Sparq Diagnostic Ultrasound System uses the same technology, but is a cart based mobile system. It provides a capacitive touch user interface and an articulating monitor arm. The removable transducers are connected to the system using a standard technology, multi-pin connectors. The modified CX50 and Sparq systems use standard transducer technology, and support phased, linear, curved linear array, TEE, and non-imaging (pencil) probes. Clinical data storage consists of a local repository as well as off-line image storage via the network, DVR, DVD, and USB storage devices. The images are stored in industry-standard formats (e.g. JPEG, AVI, DICOM) and are intended to be readable using industry-standard hardware and software. On-line review of the images is available. Secure access tools are provided to restrict and log access to the clinical data repository according to HIPAA. The system circuitry generates an electronic voltage pulse, which is transmitted to the transducer. In the transducer, a piezo electric array converts the electronic pulse into an ultrasonic pressure wave. When coupled to the body, the pressure wave transmits through body tissues. The Doppler functions of the system process the Doppler shift frequencies from the echoes of moving targets such as blood to detect and graphically display the Doppler shifts of these tissues as flow. The modified CX50 and Sparq systems give the operator the ability to measure anatomical structures and offer analysis packages that provide information used by competent healthcare professionals to make a diagnosis.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Philips CX50 and Sparq Diagnostic Ultrasound Systems (K162329).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Philips CX50 and Sparq Diagnostic Ultrasound Systems are implicitly defined by compliance with several international and FDA-recognized consensus standards, as well as the FDA's specific guidance for diagnostic ultrasound systems. The reported device performance is that it complies with these standards and guidances, and meets the acceptance criteria.

• Indication for use
• Technological characteristics
• Non-clinical performance testing
• Safety and effectiveness
  These devices share the same gray-scale and Doppler capabilities, fundamentally identical scientific technology, same materials (bio-safety), equivalent quality systems, and same electrical and physical safety standards. | This is the primary conclusion of the submission, based on the non-clinical testing, confirming that the device meets the acceptance criteria for substantial equivalence to the predicate devices. |

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states: "The modified CX50 and Sparq Diagnostic Ultrasound Systems did not require clinical data since substantial equivalence to the primary currently marketed predicate CX50 Diagnostic Ultrasound System and reference predicate EPIQ Diagnostic Ultrasound System was demonstrated with the following attributes: • Indication for use; • Technological characteristics; • Non-clinical performance testing; and • Safety and effectiveness." (Page 39)

Therefore, there appears to be no separate clinical test set in the traditional sense for evaluating the performance of the modified device against specific clinical metrics. Instead, the performance was established through non-clinical testing and comparison to legally marketed predicate devices.

The data provenance for the modifications is based on the previously cleared predicate device (CX50, K123754) and reference device (EPIQ/Affiniti, K160807), which would have undergone their own testing. The current submission relies on the established safety and effectiveness of these predicates.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Since no clinical test set was required for the modified device, there's no information provided about experts establishing ground truth for a test set. The evaluation was primarily non-clinical and comparative.

4. Adjudication Method for the Test Set

Not applicable, as no dedicated clinical test set with human interpretation was conducted for this specific 510(k) submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size

No MRMC comparative effectiveness study was mentioned or indicated as being performed for this submission. The submission explicitly states "did not require clinical data."

6. If a Standalone (algorithm only without human-in-the-loop performance) was done

This refers to a diagnostic ultrasound system, which is a hardware device with software, not typically a standalone algorithm like AI software. The performance assessment was based on the system's ability to acquire and display ultrasound data in various modes, complying with established physical and safety standards. Therefore, an "algorithm only" standalone performance study in the context of an AI-driven system is not applicable here.

7. The Type of Ground Truth Used

For the non-clinical testing, the "ground truth" would be established by the engineering and quality control standards defined in the referenced IEC and ISO standards. This includes:

• Engineering specifications and measurements for acoustic output (e.g., ISPTA, MI, TI).
• Compliance with electrical and physical safety requirements.
• Biocompatibility testing against ISO 10993 standards for materials.
• Verification and validation against system requirements and risk controls.

The ground truth for the predicate devices (K123754 and K160807) would have involved comprehensive testing for their initial clearances, which may have included a combination of phantom studies, animal studies, and potentially clinical studies to establish their diagnostic capabilities. However, this submission specifically highlights that additional clinical data was not required due to the substantial equivalence argument.

8. The Sample Size for the Training Set

Not applicable. This device is a diagnostic ultrasound system, not an AI/ML algorithm that undergoes a "training" phase with a large dataset. The system's functionalities are based on established ultrasound physics and engineering principles, not statistical learning from data.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no "training set" for this type of device.

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Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Abdominal, Cardiac Adult, Cardiac other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetabl/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal (Superficial), Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transvaginal.

The clinical environments where the EPIQ 5, EPIQ 7, Affiniti 50 Diagnostic Ultrasound Systems can be used include Clinics, Hospitals, and clinical point-of-care for diagnosis of patients.

The proposed EPIO and Affiniti Diagnostic Ultrasound Systems, which includes EPIO 5. EPIQ 7, Affiniti 50 and Affiniti 70 systems, are general purpose, software controlled, diagnostic ultrasound systems. Their function is to acquire ultrasound data and to display the data in various modes of operation.

The devices consist of two parts: the system console and the transducers. The system console contains the user interface, a display, system electronics and optional peripherals (ECG, printers). In addition to the physical knobs and buttons of the main control panel, the user interface consists of a touch screen with soft key controls. EPIO also has a QWERTY keyboard.

The removable transducers are connected to the system using a standard technology, multipin connectors. The proposed EPIQ and Affiniti systems use standard transducer technology, and supports phased, linear, curved linear array, TEE, motorized 3D curved linear arrays as well as non-imaging (pencil) probes.

Clinical data storage consists of a local repository as well as off-line image storage via the network, DVR, DVD, and USB storage devices. The images are stored in industry-standard formats (e.g. JPEG. AVI, DICOM) and are intended to be readable using industry-standard hardware and software. On-line review of the images is available. Secure access tools are provided to restrict and log access to the clinical data repository according to HIPAA.

The system circuitry generates an electronic voltage pulse, which is transmitted to the transducer. In the transducer, a piezo electric array converts the electronic pulse into an ultrasonic pressure wave. When coupled to the body, the pressure wave transmits through body tissues. The Doppler functions of the system process the Doppler shift frequencies from the echoes of moving targets such as blood to detect and graphically display the Doppler shifts of these tissues as flow.

The proposed EPIQ and Affiniti systems give the operator the ability to measure anatomical structures and offer analysis packages that provide information used by competent healthcare professionals to make a diagnosis. The proposed EPIQ and Affiniti systems enable image guided navigation and image fusion via the optional PercuNav feature (K121498).

The document describes the Philips EPIQ 5 and EPIQ 7 Diagnostic Ultrasound Systems, and Affiniti 50 and Affiniti 70 Diagnostic Ultrasound Systems. It primarily details their indications for use and compares their technological characteristics to a previously cleared predicate device (Philips EPIQ Diagnostic Ultrasound System K132304).

Based on the provided text, a "study that proves the device meets the acceptance criteria" in terms of clinical performance or specific statistical metrics is not explicitly described. The document explicitly states: "Clinical data was not required to demonstrate safety and effectiveness of the proposed EPIQ and Affiniti Diagnostic Ultrasound Systems since the proposed EPIQ or Affiniti system introduces no new indications for use, modes or features that have not been previously cleared with the predicate device EPIQ system (K132304). The clinical safety and effectiveness of ultrasound systems with these characteristics are well accepted for both predicate and subject devices."

Therefore, the acceptance criteria are demonstrated through substantial equivalence to a predicate device, and compliance with recognized safety and performance standards, rather than a de novo clinical study for this specific submission.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria (from Standards) and Reported Device Performance (Compliance Statement)

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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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