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PACSPartner™ is software that receives digital images and data from various sources (e.g. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. Options make possible reading (including mammography), telecommunications; fast demonstration; etc ; and teleconferencing. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA. Typical users of this system are trained professionals, physicians, nurses, and technicians.

PACSPartner™ makes possible the capturing, storage, viewing, distribution, and networking of medical images at distributed locations. In cases where DICOM images are not directly available, the system can acquire medical images using a DICOM gateway, which generates DICOM-type files. For example, film digitizers obtain images from old film and convert them to meet DICOM standards and stored. Stored files are transmitted using a network and can be viewed or manipulated from an imaging workstation.

This PACSPartner™ 510(k) summary (K042311) describes a Picture Archiving Communications System (PACS). As a PACS system, its primary function is to capture, store, view, distribute, and network medical images. The provided document does not contain information about acceptance criteria or a specific study proving the device meets performance criteria in the way one would expect for an AI/CADe device.

Here's why and what information can be inferred:

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

This information is not available in the provided 510(k) summary. For a PACS system, performance criteria typically relate to:

• Image Fidelity: Ensuring images are displayed accurately without loss of diagnostic information.
• Data Integrity: Reliable storage and retrieval of image data.
• Speed/Throughput: Timely transmission and display of images.
• Interoperability: Compatibility with various imaging modalities and DICOM standards.
• Security: Protection of patient data.

The 510(k) process for a PACS system like PACSPartner™ primarily focuses on demonstrating substantial equivalence to a predicate device (PACSPlus™ K023460) based on technological characteristics and indications for use, rather than a specific performance study with pre-defined statistical acceptance criteria like sensitivity/specificity for a diagnostic algorithm.

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

This information is not applicable/not provided as there is no specific performance study testing image interpretation accuracy or diagnostic capabilities of the device in a clinical context described. The device itself is a system for managing images, not for interpreting them.

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):

This information is not applicable/not provided for the same reasons as above. Ground truth establishment is typically relevant for evaluating diagnostic or interpretive AI/CADe systems.

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

This information is not applicable/not provided.

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:

This information is not applicable/not provided. This device is not an AI/CADe system designed to assist human readers in interpretation. It's an infrastructure system for image management.

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

This information is not applicable/not provided. This device is not a standalone diagnostic algorithm. Physicians interpret images using the system, as stated: "A physician, providing ample opportunity for competent human interprets images and information being displayed and printed."

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

This information is not applicable/not provided.

8. The sample size for the training set:

This information is not applicable/not provided. The device is a software system, not a machine learning model that requires a training set.

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

This information is not applicable/not provided.

Summary of what the document does indicate about "meeting criteria":

The document demonstrates that PACSPartner™ meets the regulatory requirement for substantial equivalence to its predicate device, PACSPlus™ (K023460). This is the primary "acceptance criterion" for a 510(k) submission of this type. The study, in this case, is the comparison of technological characteristics and indications for use between PACSPartner™ and PACSPlus™.

The key statements supporting this are:

• "The 510(k) Pre-Market Notification for PACSPartner™ contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device."
• The FDA's letter states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent... to legally marketed predicate devices..."

The "proof" is the FDA's decision letter confirming substantial equivalence, which is based on the comparison presented in the 510(k) summary, primarily focusing on:

• Identical Indications for Use: Both devices manage and display digital medical images.
• Similar Technological Characteristics: Both are software products that handle digital images, do not contact the patient, do not control life-sustaining devices, and rely on human interpretation.

Therefore, for this specific 510(k) submission, the "acceptance criteria" are regulatory conformance and demonstrated equivalence to a legally marketed predicate device, and the "study" is the comparison outlined in the 510(k) summary leading to the FDA's substantial equivalence determination.

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