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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.

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The Biim™ Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging of the human body. Specific clinical applications include:

• · Musculo-skeletal (conventional and superficial)
• Needle guidance
• · Pediatric
• · Peripheral Vessel
• · Small Organ (breast, thyroid, parathyroid, testicles)

The Biim Diagnostic Ultrasound System is a portable, general-purpose, software-controlled sonography system based on a digital architecture used to acquire and display high-resolution, real-time ultrasound data through a commercial off-the-shelf iOS or Android device. The Biim Diagnostic Ultrasound System supports wireless transducer connectivity of the ultrasound images to the display device.

The Biim Diagnostic Ultrasound System consists of:
A commercial off-the-shelf iOS or Android display device
Biim Ultrasound software running as an app on the display device
The wireless Biim linear array transducer with Biim Ultrasound firmware.
Lithium-Ion rechargeable battery
Battery charger

The Biim Diagnostic Ultrasound System underwent non-clinical tests to assess its substantial equivalence to predicate devices, namely the Clarius Ultrasound System (K163138) and the Philips Healthcare Lumify Diagnostic Ultrasound System (K162549).

Acceptance Criteria and Device Performance:

The primary acceptance criteria for the Biim Diagnostic Ultrasound System are based on its compliance with established technical specifications, safety standards, and performance characteristics comparable to its predicate devices. The study essentially demonstrates that the Biim system meets these criteria by showing its similarity in:

1. Clinical Uses and Indications for Use: The Biim system shares the same specific clinical applications including Pediatric, Small Organ (breast, thyroid, testicles), Musculo-skeletal (Convent. and Superfic.), Peripheral vessel, and Needle guidance applications, as well as the same patient groups (both sexes, adult, pediatric) as its primary predicate device.
2. Technical Features: Key technical specifications and modes of operation are compared to demonstrate equivalence.

Here's a table summarizing the acceptance criteria (implied by the predicate device's characteristics) and the reported performance of the Biim system:

Study Information:

1. Sample size used for the test set and the data provenance:

   • No specific clinical test set details (sample size, data provenance like country of origin, retrospective or prospective nature) are provided for the Biim Diagnostic Ultrasound System. The submission states, "The Biim Diagnostic Ultrasound System introduces no new indications for use, modes, features, or technologies as compared to the currently marketed and predicate device that require clinical testing." This implies that the testing relied on established performance parameters of the predicate devices and extensive non-clinical testing.

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

   • Since no clinical testing was deemed necessary due to the device introducing no new indications or technologies, there is no mention of experts establishing ground truth for a test set. The validation relies on equivalence to predicate devices, supported by non-clinical engineering and safety tests.

3. Adjudication method for the test set:

   • Not applicable, as no dedicated clinical test set with adjudicated ground truth is described.

4. 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:

   • No MRMC comparative effectiveness study was done. This device is a diagnostic ultrasound system, not an AI-assisted diagnostic tool, and the submission focuses on hardware and software equivalence.

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

   • Not applicable. This is a diagnostic ultrasound imaging system; its performance is inherently tied to human operation and interpretation. The performance evaluation focuses on the system's ability to produce images comparable to predicate devices and adherence to safety standards.

6. The type of ground truth used:

   • The "ground truth" for this submission is implicitly established by the performance and safety profiles of the predicate devices. The Biim system demonstrates substantial equivalence through non-clinical testing against recognized national and international standards (e.g., AAMI/ANSI/ES 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62304, ISO 10993 series, ISO 14971). This approach to "ground truth" validates that the device performs as expected for its intended use, similar to its legally marketed counterparts, and is safe.

7. The sample size for the training set:

   • Not applicable as this is not an AI/machine learning device that requires a training set in the conventional sense.

8. How the ground truth for the training set was established:

   • Not applicable.

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