(39 days)
Philips Xperius Ultrasound system is intended for diagnostic Ultrasound imaging in B (2D), Color Doppler, M-Mode, and Color Power Angio (CPA) modes. It is indicated for diagnostic ultrasound imaging, and fluid flow analysis in the following applications: Abdominal Peripheral Vessel MSK Small Organ Pediatric
The modified/proposed Xperius Ultrasound System is a general purpose, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data in various modes of operation.
The provided text is a 510(k) summary for the Philips Xperius Ultrasound System (K182529). It details the device's indications for use and compares its technological characteristics to predicate devices. However, it explicitly states that no clinical studies were required or performed to determine substantial equivalence. Therefore, it is not possible to provide information about acceptance criteria, device performance from a test set, sample sizes, expert qualifications, adjudication methods, MRMC studies, or standalone performance, as these items are typically derived from clinical or performance studies.
The document indicates that substantial equivalence was demonstrated through non-clinical performance data and attributes such as design features, indications for use, and fundamental scientific technology.
Here's a breakdown of the requested information based only on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not available in the provided document. The submission explicitly states "The proposed Xperius Ultrasound System did not require clinical studies since substantial equivalence to the currently marketed predicate devices... was demonstrated with the following attributes: Design features; Indication for use; Fundamental scientific technology; Non-clinical performance testing; and Safety and effectiveness." As such, there are no reported device performance metrics against specific acceptance criteria from a clinical or performance study.
2. Sample Size Used for the Test Set and Data Provenance
This information is not available in the provided document. No clinical or performance test set was used according to the submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not available in the provided document. No clinical or performance test set was used, and therefore no experts were involved in establishing ground truth for such a test set.
4. Adjudication Method for the Test Set
This information is not available in the provided document. No clinical or performance test set was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
This information is not available in the provided document. No clinical studies, including MRMC studies, were performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not available in the provided document. The device is an ultrasound system with various modes, not an AI algorithm. No standalone performance study of an algorithm was mentioned.
7. The Type of Ground Truth Used
This information is not applicable as there were no clinical or performance studies generating results that would require ground truth for comparison. Substantial equivalence was based on non-clinical performance data and comparison to predicate devices, not on a new clinical evaluation requiring ground truth.
8. The Sample Size for the Training Set
This information is not available in the provided document. The document describes an ultrasound system, not a device that underwent machine learning training with a specific training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no mention of a training set for a machine learning model.
§ 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.