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Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Pediatric, Intracrdiac, Intraoperative, Musculo-skeletal, Peripheral Vascular, Small Organ, Cardiac (Adult, Pediatric, Trans-esoph), Endo-cavity (Trans-rectal, Trans-vaginal), Adult and Neonatal Cephalic, Gynecological.

The HD11 is a diagnostic ultrasound device. It consists of a system console containing the power supply and electronic circuitry required to generate the image, a display screen and a connection to the separate transducers.

The provided text is a 510(k) summary for the Philips HD11 Diagnostic Ultrasound System. This document focuses on demonstrating substantial equivalence to predicate devices for the purpose of FDA clearance, rather than presenting a standalone study with defined acceptance criteria and performance metrics for a novel AI device.

Therefore, the specific information requested in your prompt (acceptance criteria, reported device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training set details) is largely not present in the provided text.

The document highlights the following:

1. Acceptance Criteria and Reported Device Performance:

The document states that the HD11 is substantially equivalent to predicate devices based on:

• Indications for Use: Both the predicate and HD11 are indicated for diagnostic ultrasonic imaging and fluid flow analysis.
• Capabilities: Both have the same gray-scale and Doppler capabilities.
• Technology: Both use essentially the same technologies for imaging, Doppler functions, and signal processing.
• Acoustic Output: Both have acoustic output levels below Track 3 FDA limits.
• Quality Systems & Biosafety: Both are manufactured under equivalent quality systems and with materials of equivalent biosafety.
• Safety Standards: Both are designed and manufactured to the same electrical and physical safety standards.

No specific quantitative acceptance criteria or reported performance metrics (e.g., sensitivity, specificity, AUC) are provided for image quality or diagnostic accuracy in the way they would be for a new AI-powered diagnostic device. The "performance" demonstrated is adherence to existing regulatory frameworks and equivalence to already cleared devices.

2. Sample Size and Data Provenance:

• Test Set Sample Size: Not applicable/not provided. This document is not describing a performance study based on a test set of patient data in the context of AI.
• Data Provenance: Not applicable/not provided. The comparison is based on device features and regulatory compliance rather than clinical data from a specific country or retrospective/prospective collection.

3. Number of Experts and Qualifications:

• Not applicable/not provided. This type of information would be relevant for establishing ground truth in a clinical performance study, which is not described here.

4. Adjudication Method:

• Not applicable/not provided.

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

• No MRMC study is mentioned. This document predates the widespread regulatory push for MRMC studies for AI devices. The comparison is against predicate devices, implying similar fundamental imaging capabilities, not an improvement over human readers.

6. Standalone Performance:

• No standalone performance (algorithm only) is discussed. The device is a diagnostic ultrasound system designed for human operation and interpretation.

7. Type of Ground Truth Used:

• Not applicable in the context of the substantial equivalence claim. The "ground truth" here is the regulatory clearance and established safety/effectiveness of the predicate devices. For the technical aspects, the "ground truth" would be engineering specifications and compliance with standards.

8. Sample Size for Training Set:

• Not applicable/not provided. This is not an AI/ML device that requires a training set.

9. How Ground Truth for Training Set was Established:

• Not applicable/not provided for the same reason as above.

In summary, the provided document is a 510(k) summary demonstrating substantial equivalence for a diagnostic ultrasound system, not a study evaluating the performance of an AI-powered device with specific acceptance criteria and detailed study methodology. The "acceptance criteria" are effectively the regulatory requirements for substantial equivalence, and the "study" is the submission itself, asserting that the new device meets those equivalence criteria by having similar technical characteristics, indications for use, and safety profiles to existing cleared devices.

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The HD11 is intended for diagnostic ultrasound imaging and fluid flow analysis. Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body.

The HD11 is a diagnostic ultrasound device. It consists of a system console containing the power supply and electronic circuitry required to generate the image, a display screen and a connection to the separate transducers. It is substantially equivalent to other ultrasound systems including the Philips M2540A EnVisor and HDI-5000 series Ultrasound systems with transducers.

The 3D8-4 and L15-7io transducers are substantially equivalent to other Philips sector, linear and endo-cavity ultrasound transducers.

The HD11 system and transducers function in a manner identical to all ultrasound systems and transducers. 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 differing acoustic properties of the tissues in the body reflect some of the transmitted energy back to the transducer, where it is converted back to electrical signals and sent back to the system. In the system, advanced signal processing technologies convert the returned signals into images of the tissues. The Doppler functions of this 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 provided text describes the Philips Ultrasound HD11 Diagnostic Ultrasound System and its transducers as substantially equivalent to predicate devices. It does not contain information about specific acceptance criteria, study methodologies, or performance metrics beyond broad claims of "safety and effectiveness."

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance: No specific performance criteria or results are detailed. The document relies on substantial equivalence to predicate devices rather than proving performance against new criteria.
• Sample size used for the test set and data provenance: No test set information or data provenance is provided.
• Number of experts used to establish ground truth and their qualifications: Not applicable, as no a ground truth establishment process is described.
• Adjudication method: Not applicable.
• MRMC comparative effectiveness study: No such study is mentioned.
• Standalone performance study: No standalone performance study information is provided.
• Type of ground truth used: Not applicable, as no ground truth is described.
• Sample size for the training set: No training set information is provided.
• How the ground truth for the training set was established: Not applicable.

Summary of Device and Equivalence Claim (as provided in the document):

The Philips Ultrasound HD11 Diagnostic Ultrasound System is a diagnostic ultrasound device designed for imaging and fluid flow analysis. It is claimed to be substantially equivalent in safety and effectiveness to the Philips M2540A EnVisor and HDI-5000 series Ultrasound systems with transducers (predicate devices).

The basis for this substantial equivalence includes:

• Identical intended uses (diagnostic ultrasonic imaging and fluid flow analysis).
• Same gray-scale and Doppler capabilities.
• Essentially the same technologies for imaging, Doppler functions, and signal processing.
• Acoustic output levels below Track 3 FDA limits.
• Manufactured under equivalent quality systems.
• Manufactured with materials of equivalent biosafety.
• Designed and manufactured to the same electrical and physical safety standards.

The document lists various transducers and their specific indications for use, indicating which applications are "new indications" (N), "previously cleared by FDA" (P), or "added under Appendix E" (E) for different imaging modes (B, M, PWD, CWD, Color Doppler, Combined, Other). The modes listed under "Other" include advanced features like SonoCT, X-Res, Angio, Panoramic, 3-D/4-D Imaging, Directional Angio Imaging, Tissue Doppler Imaging, IMT Measures, iSCAN, 2D Doppler, Color Power Angio, Fetal Heart (Spatial Temporal Image Correlation), and Real Time Biopsy (for specific transducers).

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