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InstaRISPACS / InstaZFP / InstaMobi is a software device (Enterprise Server, Diagnostic Workstation, Physician Zerofoot print Viewer and a Mobile Viewer) used for viewing and manipulating digital images (including mammography and data from various sources (including CT, MR, US, RF units, computed and direct radiographic devices, secondary capture devices, scanners, imaging sources) can be displayed, processed, stored and communicated across computer networks using this software. InstaPACS modules can be integrated with an institution's existing Hospital Information System (HIS) or Radiology Information System (RIS) based on the study of the System, providing seamless access to reports for fully-integrated electronic patient records. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using an FDA cleared monitor that offers at least 5 Megapixel resolution and meets other technical specifications reviewed and accepted by FDA.

InstaRISPACS / InstaZFP / InstaMobi is not intended for diagnostic image review or diagnostic use on mobile devices.

InstaRISPACS / InstaZFP / InstaMobi, is a software application used for viewing and manipulating medical images. Digital images and data from various sources (including CT. MR. US, RF units, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways, or imaging sources) can be displayed, processed, stored and communicated across computer networks using this software. When viewing images, users can perform adjustments of window width and level, annotation and various image manipulations.

• . InstaRISPACS, is a server-based application for use by Physicians, which comes with the Diagnostic Viewer.
• InstaZFP, is a Zero Foot print viewer for use by Physicians to display images after ● fetching them from the InstaRISPACS server.
• . InstaMobi, is a Mobile application (for iOS & Android), for use by Physicians to fetch images from InstaRISPACS and display them on the mobile device.

In addition, InstaRISPACS, can be integrated with an institution's existing Hospital Information System or Radiology Information System (based on the study of the System), providing seamless access to reports for fully-integrated electronic patient records.

The provided text describes the Meddiff InstaRISPACS / InstaZFP / InstaMobi V5.0 system, a software application for viewing and manipulating medical images. However, it does not contain information about a study that specifically proves the device meets quantifiable acceptance criteria related to its performance metrics (e.g., sensitivity, specificity, accuracy) for image interpretation or against a clinical gold standard.

The document does describe non-clinical performance testing for compliance with standards and the device's functional requirements.

Here's an analysis based on the available information:

Acceptance Criteria and Reported Device Performance

The document clearly states the following under "VII. PERFORMANCE DATA":
"The test results in this 510(k), demonstrate that InstaRISPACS/ InstaZFP/InstaMobi:

• complies with the aforementioned international and FDA-recognized consensus standards and
• FDA guidance document, and
• Meets the acceptance criteria and is adequate for its intended use."

However, the specific "acceptance criteria" for quantifiable device performance (e.g., image quality metrics, processing speed thresholds, diagnostic accuracy) are not explicitly detailed or quantified in the provided text. The "reported device performance" is described as compliance with standards and meeting functional requirements, rather than clinical performance metrics.

Based on the provided text, a table of quantifiable acceptance criteria and device performance cannot be generated. The document focuses on showing substantial equivalence based on technical characteristics and compliance with regulatory standards, rather than a clinical performance study.

Study Details (Based on available information)

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

• Acceptance Criteria: Not explicitly quantifiable clinical or diagnostic performance metrics described. The acceptance criteria mentioned relate to compliance with regulatory standards and functional requirements.
• Reported Device Performance: "complies with the aforementioned international and FDA-recognized consensus standards and FDA guidance document, and Meets the acceptance criteria and is adequate for its intended use." No specific performance numbers (e.g., accuracy, sensitivity, specificity) are reported.

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

• Sample Size: Not specified.
• Data Provenance: Not specified. This was a non-clinical study focused on technical compliance and functional verification, not clinical data evaluation.

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

• Not applicable. This was a non-clinical study; no ground truth was established by experts for a test set of clinical images.

4. Adjudication method for the test set:

• Not applicable. This was a non-clinical study; no image interpretation or adjudication occurred.

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. The document explicitly states: "InstaRISPACS/ InstaZFP/InstaMobi does not require clinical studies to demonstrate substantial equivalence to the predicate device." Later, it also states: "Diagnosis is not performed by the software but by Radiologists, Clinicians and or referring Physicians. A physician, providing ample opportunity for competent human intervention interprets images and information being displayed and printed." This indicates the device is an image viewing and manipulation system, not an AI-powered diagnostic aid meant to directly improve human reader performance.

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

• No. The device is an image viewing and manipulation system, not an algorithm performing standalone diagnostic tasks. Its performance is assessed in terms of its functionality and compliance with standards.

7. The type of ground truth used:

• Not applicable. As a non-clinical study focusing on functional compliance and technical characteristics, there was no clinical "ground truth" (like pathology or outcomes data) involved in a diagnostic performance evaluation.

8. The sample size for the training set:

• Not applicable. This device is a PACS/RIS software for image management and viewing, not a machine learning model that requires a training set.

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

• Not applicable, as it's not a machine learning model requiring a training set.

Summary of the "Study" (Non-Clinical Performance Testing):

The "study" described in the document is limited to non-clinical performance testing to demonstrate compliance with international and FDA-recognized consensus standards (ISO 14971, IEC 62304, NEMA-PS 3.1 - PS 3.20 DICOM) and FDA guidance documents. It also involved Meddiff's internal verification and validation processes to address intended use, technological characteristics claims, requirement specifications, and risk management results.

The comparison table provided (pages 2-3) primarily highlights technological characteristics and feature parity/differences with predicate and reference devices, rather than a clinical performance study involving patient data. For instance, for "PET-CT fusion viewing" and "Embedded & basic Volume Rendering," it states the subject device was "tested and compared to Reference device #1, (K101342)" and "Data indicated that the subject device was found to be similar to the reference device." This indicates functional equivalence rather than a clinical performance claim.

Conclusion stated by the submitter: Based on these non-clinical tests, the subject device is considered "substantially equivalent" to the predicate device in terms of safety and effectiveness, and no clinical studies were deemed necessary.

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