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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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Philips Lumify Ultrasound System is intended for diagnostic ultrasound imaging in B (2D), Color Doppler, Combined (B + Color), and M modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications:

Fetal/Obstetric. Abdominal, Pediatric, Cephalic, Urology, Gynecological, Cardiac Fetal Echo, Small Organ, Musculoskeletal, Peripheral Vessel, Carotid, Cardiac.

Lumify is a transportable ultrasound system intended for use in environments where is provided by healthcare professionals.

The Lumify Ultrasound System with the S4-1 transducer and new intended use environments is a mobile, general purpose, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data in various modes of operation. Lumify supports wireless network connectivity to allow the user to export ultrasound images.

The Lumify Ultrasound System includes:

• A commercial off-the-shelf Android device (COTS)
• Philips ultrasound software running as an app on the off-the-shelf device
• The C5-2 Curved array USB transducer
• The L12-4 Linear array USB transducer
• The S4-1 Sector array USB transducer

The Lumify Ultrasound System provides customers with a smaller, lower cost, and more easily leveraged ultrasound system.

The provided text focuses on regulatory approval (510(k) clearance) for a medical device, the Philips Lumify Ultrasound System. It primarily outlines the device's intended use, technological comparison to predicate devices, and compliance with various safety and performance standards. However, it does not contain information about specific acceptance criteria for a study, reported device performance metrics against those criteria, or details of a study designed to prove the device meets such criteria.

The document explicitly states: "The Lumify Ultrasound System introduces no new indications for use, modes, features, or technologies relative to the predicate devices (Lumify/ClearVue) that require clinical testing. The clinical safety and effectiveness of ultrasound systems with these characteristics are well accepted for both predicate and subject devices." This indicates that a de novo study with specific acceptance criteria and detailed performance metrics to prove device effectiveness was not conducted for the 510(k) clearance. Instead, the clearance relies on demonstrating substantial equivalence to already cleared predicate devices.

Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance, nor can I provide information on sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as this information is not present in the provided text.

The information that can be extracted relates to the device's intended use and the regulatory process:

1. A table of acceptance criteria and the reported device performance:
* Not provided in the document. The document states that clinical testing was not required as the device introduces no new indications, modes, features, or technologies that haven't been accepted with predicate devices.

2. Sample size used for the test set and the data provenance:
* Not provided in the document. As clinical testing was not deemed necessary for this 510(k) submission, there is no mention of a test set sample size or data provenance from such a study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Not provided in the document. No information about experts or ground truth establishment for a test set is included.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
* Not provided in the document.

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 provided in the document. The device is a diagnostic ultrasound system, not an AI-assisted diagnostic tool, and no MRMC studies are mentioned.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
* Not applicable/Not provided in the document. The device is a diagnostic ultrasound system that is operated by healthcare professionals, not a standalone AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
* Not provided in the document.

8. The sample size for the training set:
* Not applicable/Not provided in the document. The documentation indicates that clinical testing was not required. The device's substantial equivalence relies on established medical device technologies and predicates, rather than a new algorithm requiring a training set in the context of this submission.

9. How the ground truth for the training set was established:
* Not applicable/Not provided in the document. As above.

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