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510(k) Data Aggregation
(33 days)
IMCO-STATTM is a software device that receives digital images and data from existing imaging equipment using DICOM 3.0 communication protocols. Images and data are stored on the IMCO-STATTM server in DICOM 3.0 Part 10 and JPEG format.
IMCO-STAT™ is designed to send reports. images, audio and video data to other workstations, Personal Digital Assistants (PDA) or Tablet PCs in wired or wireless environments. This is accomplished using an executable client application on a receiving entity with the appropriate hardware.
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.
IMCO-STAT™ is a software device that receives digital images and data from existing imaging equipment using DICOM 3.0 communication protocols. Images and data are stored on the IMCO-STAT™ server in DICOM 3 0 Part 10 and JPEG format.
IMCO-STAT™ is designed to send reports, images, audio and video data to other workstations, Personal Digital Assistants (PDA) or Tablet PCs in wired or wireless environments. This is accomplished using an executable client application on a receiving entity with the appropriate hardware.
The images may be embedded for reference in a DICOM image comprised report data, for distribution across a network and storage in a Picture Archive Communication System (PACS) with the original exam series data. Wavelet files can also be created and stored utilizing the same process. The algorithms used to create JPEG and wavelet images follow known and accepted protocols.
IMCO-STAT™ uses standard off-the-shelf hardware and commercially available IMOO-07/11-1650 and operating systems. The software communicates using computer plationne and operthe network used to support the TCP/IP stack is superfluous to IMCO-STAT™
The provided text describes the IMCO-STAT™ software, its intended use, and its substantial equivalence to other legally marketed devices, but it does not contain information about explicit acceptance criteria, performance metrics, or a study proving the device meets specific criteria.
Instead, the document focuses on:
- Substantial Equivalence: The primary method used to demonstrate safety and effectiveness is by showing that IMCO-STAT™ has the same intended uses and technical characteristics as two predicate devices: Medical Insight EasyViz system (K051809) and Marotech, Inc. Marosis PACS System (K012844).
- General Safety and Effectiveness Concerns: It mentions that the device labeling contains instructions for use and indications for use, and that device components are off-the-shelf.
- Validation and Effectiveness: It states that "Testing of the software and related hardware has been performed by programmers, non-programmers, quality control individuals and potential customers." However, it does not provide details on the specific tests conducted, their results, or any quantifiable performance metrics.
Therefore, many of the requested items cannot be directly answered from the provided text.
Here's a breakdown of what can and cannot be answered:
1. A table of acceptance criteria and the reported device performance:
Acceptance Criteria | Reported Device Performance |
---|---|
Not explicitly defined in the document. The primary "acceptance" mechanism is demonstrating substantial equivalence to predicate devices, implying that if it functions similarly and poses no new safety risks, it is acceptable. | Not explicitly defined in the document. The document states "Testing of the software and related hardware has been performed by programmers, non-programmers, quality control individuals and potential customers" but does not report specific performance metrics (e.g., accuracy, speed, uptime). |
2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified.
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):
- Number of Experts: Not applicable, as detailed information about a "test set" and "ground truth" establishment is not provided. The document mentions "programmers, non-programmers, quality control individuals and potential customers" performed testing, but does not detail their role in establishing ground truth for a formal test set for performance evaluation.
- Qualifications of Experts: Not specified.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication method: Not applicable, as no formal test set with adjudication 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:
- MRMC Study: No, an MRMC comparative effectiveness study is not mentioned or described. The IMCO-STAT™ is presented as a software device for image management and viewing, not explicitly as an AI assistant intended to improve human reader performance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not explicitly stated or detailed. The document focuses on the software's functionality in handling and transmitting images and data.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: Not applicable, as the document does not describe the establishment of ground truth for performance evaluation.
8. The sample size for the training set:
- Sample Size for Training Set: Not applicable. The IMCO-STAT™ is described as an image management and viewing software, not a machine learning or AI algorithm that requires a "training set" in the conventional sense.
9. How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable, as there is no mention of a training set or ground truth establishment for such a purpose.
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