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The iView™ is intended to be used by or under the direction of qualified medical personnel during prenatal monitoring, to visualize fetal features in a reconstructed 3D image that they may wish to exam more closely during routine 2D fetal diagnostic ultrasound imaging examinations, and to assist patient's understanding in communicating diagnostic results in a form that may be more easily understood. It does not provide quantitative measurements or diagnostic interpretations.

The subject device may only be used in an adjunctive capacity with standard diagnostic ultrasound imaging techniques and that no clinical decisions or diagnostic interpretations should be made based solely on the use of this device.

3D image reconstructed from this software is referring use only and is not responsible for any diagnosis.

Adds 3D imaging capability to commercial 2D ultrasound imaging systems

I am sorry, but the provided text does not contain the detailed information necessary to answer your request about the acceptance criteria and the study proving the device meets those criteria.

The document is a 510(k) summary for the OnDemandSoft iView, which focuses primarily on establishing substantial equivalence to a predicate device (SonoReal system). It includes a comparison table of features between the two devices, but it does not specify any acceptance criteria, performance metrics, or details of a clinical study designed to demonstrate the device meets acceptance criteria.

Specifically, the document lacks information for the following points:

1. A table of acceptance criteria and the reported device performance: This is entirely missing. The comparison table is for features, not performance metrics against acceptance criteria.
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method: Not mentioned.
5. Multi reader multi case (MRMC) comparative effectiveness study: Not mentioned.
6. Standalone (i.e. algorithm only without human-in-the loop performance) performance: Not mentioned.
7. Type of ground truth used: Not mentioned.
8. Sample size for the training set: Not mentioned.
9. How the ground truth for the training set was established: Not mentioned.

The 510(k) summary generally highlights the device's technical specifications and how they compare to a previously cleared device, focusing on "substantial equivalence" rather than presenting detailed performance study results against predefined acceptance criteria.

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The FOS iView EPID, as with the predicate SKI 100, is intended to be used with radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical practitioner.

The iView EPID is an enhancement to the existing SRI 100 electronic portal imaging device which has previously been cleared for commercial distribution. The primary reason for the introduction of this device is to address obsolescence issues associated with the image acquisition components and the computer hardware/operating system.

This document is a 510(k) submission for the Elekta Oncology Systems iView Electronic Portal Imaging Device (EPID). It primarily focuses on demonstrating substantial equivalence to a predicate device (SRI 100 EPID) rather than presenting a detailed study with specific acceptance criteria and performance metrics for the new device.

Therefore, for many of your requested items, the information is not explicitly provided in the furnished text. The submission relies heavily on the established safety and effectiveness of the predicate device and the fact that the iView EPID addresses obsolescence issues without introducing new safety or effectiveness concerns.

Here's an analysis based on the provided text:

1. Table of acceptance criteria and the reported device performance

This information is not explicitly stated in the provided text. The submission focuses on demonstrating substantial equivalence to an existing device rather than presenting specific performance metrics against pre-defined acceptance criteria for the iView EPID itself. The "reported device performance" is implied to be equivalent to the predicate device.

2. Sample sized used for the test set and the data provenance

Not applicable/Not provided. The document does not describe a new study with a test set of data for the iView EPID's performance. The basis for safety and effectiveness is primarily the predicate device's track record and the assertion that the iView EPID does not raise new issues.

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

Not applicable/Not provided. No new test set data or ground truth establishment is described for the iView EPID's performance.

4. Adjudication method for the test set

Not applicable/Not provided. No new test set data or adjudication method is described.

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/Not provided. This device is an Electronic Portal Imaging Device (EPID), which is a hardware and software system used in radiation therapy for imaging, not an AI-assisted diagnostic tool for human readers. No MRMC study is mentioned.

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

Not applicable/Not provided. This is not an algorithmic diagnostic device in the sense of AI; it's an imaging device. The document states that it's an enhancement to an existing device, implying its performance is comparable to the predicate.

7. The type of ground truth used

Not applicable/Not provided. No new ground truth is described for the iView EPID. The "ground truth" for its safety and effectiveness relies on the established use of the predicate device (SRI 100) in treating malignant neoplastic diseases, as determined by a licensed medical practitioner.

8. The sample size for the training set

Not applicable/Not provided. There is no mention of a training set as this is not an AI/machine learning device in the context of image analysis or diagnostics that requires a separate training set.

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

Not applicable/Not provided. As there is no mentioned training set, this question is not applicable.

Summary of what the document does provide regarding acceptance criteria and studies:

The document demonstrates that the Elekta Oncology Systems iView EPID meets acceptance criteria primarily through:

• Substantial Equivalence: The core argument is that the iView EPID is an "enhancement" to the existing SRI 100 EPID, which has already been cleared and has a "proven track record for safety." This implies the acceptance criteria for safety and effectiveness are met by virtue of being similar to or better than the predicate.
• Addressing Obsolescence: The primary reason for the new device is to update components and address obsolescence, not to fundamentally change its function or performance in a way that would require new clinical effectiveness studies.
• Compliance with Standards:
  • Safety Standards: The iView EPID has been subject to compliance testing as defined in IEC 601-1 and IEC 601-2-1. Proprietary IT equipment complies with IEC 950 and/or UL 1950.
  • Quality System Standards: Elekta Oncology Systems is a registered medical device manufacturer assessed against ISO 9001, EN 46001, and the Medical Device Directive, 93/42/EEC Annex II. Their software quality system meets ISO 9001, EN 46001, the Medical Device Directive, and US 21 CFR 820 GMP.
  • Regulatory Compliance: The device bears the CE mark, affirming compliance with relevant European Directives (Medical Device Directive, Electromagnetic Compatibility Directive).
• Hazard Analysis: Elekta Oncology Systems conducted a hazard analysis and concluded that the device does not introduce new types of safety or effectiveness considerations.
• Audits: The quality system is subject to periodic internal quality audits and regular, planned, and documented GMP audits by external auditors (SGS Yarsley and FDA).

In essence, the "study" proving the device meets acceptance criteria is a documentation of substantial equivalence, compliance with established safety and quality standards, and internal hazard analysis, rather than a clinical performance study with explicit test sets and ground truth.

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