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Philips Xperius Ultrasound system is intended for diagnostic Ultrasound imaging in B (2D) and Color Doppler modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Abdominal Peripheral Vessel

The clinical environments where the Xperius Ultrasound system can be used for are: hospitals, surgery centers, clinics, and physician offices.

The 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 Xperius Ultrasound System is substantially equivalent to the currently marketed and predicate Philips CX50 and Sparq Diagnostic Ultrasound System K162329 and ClearVue 850 K153480 in terms of design and fundamental scientific technology. The Xperius Ultrasound System is provided with additional indications.

The provided document is a 510(k) summary for the Philips Xperius Ultrasound System. It is a premarket notification for a medical device seeking substantial equivalence to legally marketed predicate devices, not a study that proves the device meets specific acceptance criteria.

The document primarily focuses on demonstrating substantial equivalence to predicate devices (Philips CX50 and Sparq Diagnostic Ultrasound System K162329, and ClearVue 850 K153480) for its intended use, design, and technological characteristics. It does not contain information about specific acceptance criteria and a study proving the device meets those criteria in the way a clinical performance study would for a novel AI-powered diagnostic device.

Here's a breakdown of why the requested information cannot be fully provided from this document and what can be inferred:

The document explicitly states:
"The Xperius Ultrasound System introduces no new indications for use, features, or technologies as compared to the currently marketed and predicate devices Philips CX50 and Sparq Diagnostic Ultrasound System (K162329) and ClearVue850 (K153480) the reference systems K101757 that require clinical testing. The clinical safety and effectiveness of ultrasound systems with these characteristics are well accepted for both the currently marketed predicate and subject devices." (Page 20)

This statement indicates that a de novo clinical study with specific acceptance criteria and performance metrics for an AI algorithm was not performed, nor was it required for this 510(k) submission. The device is being cleared based on its similarity to existing, cleared ultrasound systems. Therefore, most of your requested points related to AI performance, ground truth, expert consensus, and multi-reader studies are not applicable to this 510(k) submission as presented.

However, I can extract information related to the device's indications for use and operational modes as they reflect the intended performance of the device, which is foundational to any future performance evaluation if it were a novel device requiring such studies.

Inferred Information from the 510(k) Submission:

Since this is a 510(k) for an ultrasound system, not explicitly an AI/ML device requesting de novo clearance with novel performance claims, the concepts of "acceptance criteria" and "study proving the device meets the acceptance criteria" are typically handled differently. The acceptance criteria essentially align with demonstrating substantial equivalence to predicate devices and adherence to relevant performance standards for diagnostic ultrasound equipment.

1. A table of acceptance criteria and the reported device performance

The "acceptance criteria" for a 510(k) submission when demonstrating substantial equivalence are typically:

• Intended Use Equivalence: The new device has the same intended use as the predicate device(s).
• Technological Characteristics Equivalence: The new device has the same technological characteristics as the predicate, or if there are differences, those differences do not raise different questions of safety and effectiveness.
• Performance Data: Non-clinical (and sometimes clinical) performance data demonstrate that the device performs as intended and is as safe and effective as the predicate.

For this specific submission, the reported "performance" is implicitly its ability to perform diagnostic ultrasound imaging in the specified modes and applications, which is assumed to be equivalent to the predicate devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable / Not Provided. The document explicitly states, "The Xperius Ultrasound System introduces no new indications for use, features, or technologies... that require clinical testing." Therefore, there was no independent test set or study data described in the traditional sense for assessing novel performance.
• The "test set" implicitly refers to the rigorous non-clinical testing against standards (IEC 60601 series) described in the "Non-clinical performance data" section, but no sample sizes or data provenance are relevant for these types of engineering and safety tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable. Since no clinical test set requiring ground truth establishment was performed, this information is not provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable. No clinical test set requiring adjudication was performed.

5. 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. An MRMC comparative effectiveness study was not performed. The device is a diagnostic ultrasound system, not an AI-assisted interpretation tool. The document states it is "a general purpose, software controlled, diagnostic ultrasound system."

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

• Not Applicable. The device is a hardware and software integrated ultrasound imaging system intended for human-in-the-loop operation, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not Applicable. No clinical study requiring ground truth was performed.

8. The sample size for the training set

• Not Applicable / Not Provided. The document describes a general-purpose ultrasound system. It is not an AI/ML device in the context that would typically require a "training set" for a diagnostic algorithm with specific performance claims. While internal software development would involve testing, it's not described as an AI training set.

9. How the ground truth for the training set was established

• Not Applicable. No training set ground truth description is relevant or provided for this type of 510(k) submission.

In summary: The provided document is a 510(k) premarket notification for a new ultrasound system, Xperius, demonstrating its substantial equivalence to previously cleared predicate devices. It explicitly states that no new clinical testing was required because the device does not introduce new indications, features, or technologies that raise new questions of safety or effectiveness. Therefore, the detailed information typically requested for evaluating a novel AI/ML device's performance against specific acceptance criteria in a clinical study is not present in this document. The "acceptance criteria" for this submission are met by demonstrating equivalence to predicates and compliance with standard electrical and medical device safety requirements.

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The DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ (breast, thyroid, testes), neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), cardiac adult, cardiac pediatric, peripheral vessel and urology exams.

DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasound diagnostic system. Its function is to acquire and display ultrasound images in B-Mode, M-Mode, PW-Mode, CW mode, Color-Mode, Color M-Mode, Power/Dirpower Mode, TDI mode, 4D mode or the combined mode (i.e. B/M-Mode).This system is a Track 3 device that employs an array of probes that include linear array, convex array and phased array with a frequency range of approximately 3 MHz to 10.0 MHz.

The provided text is a 510(k) summary for the Shenzhen Mindray Bio-medical Electronics Co., LTD DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System. This document focuses on demonstrating substantial equivalence to predicate devices and adherence to medical safety standards rather than establishing new performance criteria through clinical studies.

Therefore, the document does NOT contain information regarding:

• Specific acceptance criteria framed as quantitative metrics (e.g., sensitivity, specificity, accuracy).
• Details of a study proving the device meets acceptance criteria in terms of clinical performance.
• Sample sizes used for test or training sets for an AI/algorithm.
• Data provenance, number or qualifications of experts, or adjudication methods for establishing ground truth related to clinical performance.
• Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes for human readers with/without AI assistance.
• Standalone algorithm performance studies.
• The type of ground truth used as it relates to clinical performance studies.
• The sample size for the training set or how ground truth was established for a training set.

The document primarily outlines the device's technical specifications, intended uses, and lists applicable safety and electrical standards it conforms to. It states that the device has been evaluated for "acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical and mechanical safety" and found to conform with applicable medical safety standards.

However, based on the provided text, I can infer the "acceptance criteria" and "study" in a regulatory context, which is demonstrating substantial equivalence to predicate devices and compliance with recognized standards.

Here's a breakdown of what can be extracted based on that understanding:

1. Table of "Acceptance Criteria" and "Reported Device Performance":

In the context of a 510(k) submission for a diagnostic ultrasound system like this, the "acceptance criteria" are not reported as specific performance metrics (like sensitivity/specificity) but as conformance to established safety and performance standards, and substantial equivalence to legally marketed predicate devices. The "reported device performance" is the statement of conformity.

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

The document does not detail specific clinical studies with test sets, sample sizes, or data provenance (country, retrospective/prospective) for proving diagnostic performance. The evaluations mentioned are primarily for safety, electrical, and mechanical conformity.

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

Not applicable, as no described clinical performance study with a test set requiring expert-established ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable.

5. 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:

Not applicable. The device described is a general diagnostic ultrasound system, not an AI-powered diagnostic algorithm aiding human readers.

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

Not applicable. This is a diagnostic ultrasound system, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not applicable in the context of clinical diagnostic performance. For technical evaluations, the "ground truth" would be the specifications and requirements defined by the applicable standards (e.g., standard measures for acoustic output, material properties for biocompatibility testing).

8. The sample size for the training set:

Not applicable, as no described AI/algorithm training process.

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

Not applicable.

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