Search Results

The Flash Ultrasound System 5100 Point of Care (5100 POC and 5100 POC Pro) is indicated for diagnostic ultrasound imaging and fluid flow analysis of the human body, with the following indications for use:

Abdominal, Adult Cephalic, Cardiac Adult, Cardiac Pediatric, Cerebral Vascular, Fetal/OB, Lung, Musculoskeletal (Conventional), Musculoskeletal (Superficial), Neonatal Cephalic, Ophthalmic, Other: Carotid, Other: GYN, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Trans-Esophageal (Cardiac), Trans-Vaginal.

Modes of operation include B Mode (or 2D), Color Doppler, Color Power Angio Doppler, Continuous Wave Doppler, Pulse Wave Doppler, Tissue Doppler, M-Mode (including anatomical M-Mode), Harmonics (Tissue), and Combined modes.

The clinical environments where the Flash Ultrasound System 5100 POC may be used are: hospitals, surgery centers, clinics, physicians' offices, diagnostic centers, critical care and emergency room environments, and point-of-care clinical settings for diagnosis of patients.

The systems are intended to be installed, used, and operated only in accordance with the safety procedures and operating instructions given in the product user information. Systems are to be operated only by appropriately trained healthcare professionals for the purposes for which they were designed. However, nothing stated in the user information reduces the user's responsibility for sound clinical judgment and best clinical procedure.

The Flash Ultrasound System 5100 Point of Care (POC) device is constructed with assets from the previously cleared 5000 Compact Series hardware platform (K222648) and a new Rhythm software platform that is new to the POC environment.

The Flash Ultrasound System 5100 POC supports a full touch screen interface on the main display as the primary means of directing the system, leveraging customer familiarity with smart devices and the ease of cleaning and maintenance of a pure glass surface.

Additionally, Flash Ultrasound System 5100 POC is designed to fit into tight spaces in a crowded Emergency Room (ER) with its small footprint, sleek design, and a large vertical tablet with ergonomic controls. The new Rhythm software offers point-of-contact workflow enhanced with assisted needle visualization, streamline point-of-care workflows such as flexible patient data management and AutoStrain EF. In addition to these POC workflows, the Rhythm software provides enhanced responsiveness with an easy-to-learn user interface as all controls are located in the same plane as the user's eye and hand for working more efficiently with the patient. The Flash Ultrasound System 5100 POC has two models, the 5100 POC and the 5100 POC Pro. The 5100 POC version does not support two transducers, C5-1 and X8-2t; however, the 5100 POC Pro supports all the transducers listed for the system.

The provided FDA 510(k) clearance letter and summary for the Flash Ultrasound System 5100 Point of Care do not include detailed information about specific acceptance criteria related to its performance as a diagnostic imaging device (e.g., sensitivity, specificity, resolution), nor does it describe a study specifically designed to prove these performance metrics.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices through a combination of design features, intended use, fundamental scientific technology, and a comprehensive suite of non-clinical performance and safety testing.

Here's an analysis based on the provided text, addressing the requested information to the extent possible:

Acceptance Criteria and Study Proving Device Meets Criteria

The submission primarily emphasizes compliance with recognized standards and verification testing against system and design specifications, rather than clinical performance metrics in a sense that would typically involve sensitivity, specificity, or human reader improvement with AI assistance.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, the "acceptance criteria" are broad compliance with international standards and internal design specifications, and the "reported device performance" is that these criteria were met.

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

• Not explicitly stated for clinical performance. The document states: "The proposed Flash Ultrasound System 5100 POC did not require clinical data for determination of substantial equivalence." This implies that no clinical test set (patient data) was used in a comparative effectiveness study for this submission. The testing was primarily non-clinical.
• Data Provenance: N/A for clinical performance. For non-clinical testing, the provenance would be internal Philips Ultrasound LLC laboratory testing.

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

• Not applicable. Since clinical data was not required for substantial equivalence, there was no independent expert panel establishing ground truth on patient cases for performance evaluation.

4. Adjudication Method for the Test Set

• Not applicable. No clinical test set requiring adjudication was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• No. The document explicitly states: "The proposed Flash Ultrasound System 5100 POC did not require clinical data for determination of substantial equivalence." Therefore, no MRMC study was conducted to evaluate human reader improvement with AI assistance (as AI assistance is not mentioned as a feature of the device's diagnostic performance, but rather "assisted needle visualization" is a workflow enhancement).

• Effect size of human readers improve with AI vs without AI assistance: Not applicable, as no such study was performed or needed for this clearance. The "assisted needle visualization" is a feature mentioned, but its impact on reader performance is not quantified in this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

• Not applicable for diagnostic performance metrics. The device is an ultrasound system with various imaging modes and "assisted needle visualization." While there is a "new Rhythm software platform," the submission does not present it as a standalone diagnostic algorithm requiring performance metrics like sensitivity/specificity on its own. Its performance is integrated into the ultrasound system's overall functionality.

7. The Type of Ground Truth Used

• For non-clinical testing: The ground truth would be defined by the specifications and expected outputs of the system based on physical and engineering principles, verified through testing against known inputs or reference standards (e.g., phantom measurements, electrical signals, safety limits).
• For diagnostic clinical performance: No clinical ground truth (e.g., expert consensus, pathology, outcomes data) was used or required for this 510(k) submission.

8. The Sample Size for the Training Set

• Not applicable. The submission does not describe the development or training of a de-novo AI algorithm that would require a "training set" in the context of generating diagnostic performance metrics. The "Rhythm software" is mentioned, and "assisted needle visualization" is a feature, but the document focuses on its equivalence and compliance, not on a machine learning training paradigm.

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

• Not applicable. As no training set for a diagnostic AI algorithm in the context of performance evaluation was described, the method for establishing its ground truth is not provided.

Ask a specific question about this device