Search Results

MEDIP PRO is intended for use as a software interface and image segmentation system for the transfer of DICOM imaging information from a medical scanner to an output file. It is also used as pre-operative software for treatment planning.

The 3D printed models generated from the output file are meant for non-diagnostic use. MEDIP PRO should be used in conjunction with other diagnostic tools and expert clinical judgement.

MEDIP PRO is medial image processing software that provides 3D reconstruction and visualization of ROI, advanced image quality improvement, auto segmentation for specific target, texture analysis and etc. through loading DICOM file imaged from CT or MRI by user(doctors). Also, it supports exporting STL data for 3D printing.

The provided text describes the MEDIP PRO device, but it lacks detailed information regarding specific acceptance criteria and the comprehensive study results to explicitly prove the device meets these criteria. The document focuses on regulatory approval (510(k)) by demonstrating substantial equivalence to a predicate device, rather than presenting a detailed performance study with quantifiable acceptance criteria.

However, based on the available information, we can extract some relevant details and acknowledge the missing ones:

Acceptance Criteria and Reported Device Performance

Study Details Based on Provided Information:

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

• The document does not specify the sample size (number of cases or images) used for the "Comparative Performance Test" which included segmentation and measurement evaluation.
• The data provenance (e.g., country of origin, retrospective or prospective) for the test set is not mentioned.

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

• The document does not specify the number of experts or their qualifications used to establish ground truth for the test set. It only mentions that the device "should be used in conjunction with other diagnostic tools and expert clinical judgement."

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

• The document does not specify any adjudication method used for the test set.

5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• An MRMC comparative effectiveness study involving human readers with and without AI assistance was not mentioned or performed. The study mentioned is a "Comparative Performance Test" between MEDIP PRO and a predicate device, focusing on the device's inherent performance.

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

• Yes, a standalone performance assessment was done. The "Comparative Performance Test" and "Performance Test" sections describe evaluating the device's (MEDIP PRO application) functionalities and performance (segmentation, measurement) against a predicate device. This implies evaluating the algorithm's performance without direct human-in-the-loop interaction for performance improvement measurement within the study.

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

• The document does not explicitly state the type of ground truth used for the segmentation and measurement performance evaluations. It refers to a "Distance Phantom study" for measurements, implying physical phantoms as ground truth for that aspect. For segmentation, it's likely expert-derived segmentations, but this is not confirmed.

8. The sample size for the training set:

• The document does not provide any information regarding the sample size used for the training set for the MEDIP PRO software (if it uses machine learning/AI for features like auto-segmentation, which is implied by "auto segmentation for specific target").

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

• The document does not provide any information on how ground truth was established for the training set.

Ask a specific question about this device

Mimics inPrint is intended for use as a software interface and image segmentation system for the transfer of DICOM imaging information from a medical scanner to an output file. It is also used as pre-operative software for treatment planning. For this purpose, the Mimics inPrint output file can be used for the fabrication of the output file using traditional or additive manufacturing methods.

The physical replica can be used for diagnostic purposes in the field of orthopedic, maxillofacial and cardiovascular applications. Mimics inPrint should be used in conjunction with other diagnostic tools and expert clinical judgement.

Mimics inPrint is an image processing and segmentation software that was built on top of the Mimics application framework, an image processing and segmentation framework for the transfer of imaging information to an output file.

The provided text describes a 510(k) submission for the device "Mimics inPrint." However, it does not contain any information about acceptance criteria, device performance, data provenance, expert adjudication, MRMC studies, standalone performance, ground truth, or training set details. The "Performance Data" section briefly mentions "Non-clinical tests" and "measurement accuracy and calculate 3D study" but provides no specific results or methodologies for these tests.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided text. The text focuses on establishing substantial equivalence to a predicate device, as is common in 510(k) submissions, rather than providing detailed performance study results against specific acceptance criteria.

The 510(k) summary only states:

• "Measurement accuracy and calculate 3D study were performed and confirmed to be within specification." (No specific "specification" or acceptance criteria are provided, nor are the results of these studies.)
• "Validation of printing of physical replicas was performed and demonstrated that anatomical models for cardiovascular, orthopedic and maxillofacial cases can be printed accurately when using any of the compatible 3D printers." (Again, no specific "accuracy" metric or acceptance criteria are provided.)

To answer your questions, the provided text would need to contain a detailed performance study section with quantitative results against predefined acceptance criteria.

Ask a specific question about this device