(15 days)
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.
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.