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The device is intended for the manipulation and displaying of medical images. It can show images from different modalities and interfaces to various image storage and printing devices using DICOM or similar interface standards.

The device assists orthopedic surgeons when doing preoperative planning and post-operative follow-up.

Typical users of this system are trained professionals, for example orthopedic surgeons, physicians, and radiologists.

Sectra Orthopedic Package is intended to assist orthopedic surgeons when doing preoperative planning and post-operative follow-up. The device has functionality for overlaying prosthesis templates on radiological images, tools for repositioning the templates, and tools for measurements in the images.

More specifically the Sectra Orthopedic Package shall: (1) assist the orthopedic surgeons in choosing which implants to use, (2) assist the orthopedic surgeons in choosing were to place cut lines etc., and (3) assist the orthopedic surgeons in following-up of surgical procedures.

The provided text does not contain information about specific acceptance criteria or a study designed to prove the device meets such criteria.

The "Performance Data" section states: "The subject device is developed according to ISO 9001:2000 and complies with ACR/NEMA Digital Imaging Communications in Medicine version 3.0." This indicates adherence to quality management standards and DICOM communication protocols, but these are general compliance statements, not specific performance metrics or a study demonstrating clinical effectiveness.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study results for novel performance claims.

Therefore, I cannot provide the requested information from the given text.

Here's how I would present the information if it were available in the text:

1. Table of acceptance criteria and the reported device performance:
(No information available in the provided text.)

2. Sample sized used for the test set and the data provenance:
(No information available in the provided text.)

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
(No information available in the provided text.)

4. Adjudication method for the test set:
(No information available in the provided text.)

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size:
(No information available in the provided text.)

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
(No information available in the provided text.) However, the "Conclusion" section mentions "Images and information being reviewed, processed, relayed, and or transmitted are interpreted by an orthopedic surgeons or trained medical personnel, providing ample opportunity for competent human intervention," which suggests a human-in-the-loop workflow.

7. The type of ground truth used:
(No information available in the provided text.)

8. The sample size for the training set:
(No information available in the provided text.)

9. How the ground truth for the training set was established:
(No information available in the provided text.)

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