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The OrthoScan mobile c-arm is designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to, surgical orthopedic procedures and critical and emergency care procedures.

The OrthoScan is a mini C-arm mobile imaging system. The OrthoScan is used for processing and capturing live fluoroscopic images. Interfaces are provided for external peripheral devices such as controls, thermal printers, video cassette recorders and DICOM. The device is compatible with NTSC video outputs and 100 Base T Ethernet.

The provided text is a 510(k) summary for the OrthoScan and OrthoScan-HD devices, which are image-intensified fluoroscopic x-ray systems. This type of regulatory document focuses on establishing substantial equivalence to existing legally marketed devices, rather than proving the device meets acceptance criteria through a traditional clinical study with defined performance metrics.

Therefore, the document does not contain information about acceptance criteria or a study designed to prove the device meets specific performance criteria in the way new, non-substantially-equivalent devices might.

Instead, it relies on demonstrating that the OrthoScan devices are as safe and effective as predicate devices already on the market.

Here's a breakdown of what can be inferred or directly stated from the document, acknowledging the absence of a traditional "acceptance criteria study":

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

This information is not present in the provided 510(k) summary. The document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study against specific acceptance criteria.

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 present in the provided 510(k) summary. A test set as commonly understood in a clinical performance study (e.g., a set of patient images to be evaluated) is not described.

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 present in the provided 510(k) summary. Ground truth establishment for a test set is not described, as there is no mention of a traditional test set being used for performance evaluation.

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

This information is not present in the provided 510(k) summary. Adjudication methods are typically relevant for studies involving human interpretation and ground truth, which are not described here.

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 present in the provided 510(k) summary. The device described is an X-ray imaging system, not an AI-assisted diagnostic tool. No MRMC study is mentioned.

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

This information is not present in the provided 510(k) summary. The device itself is an imaging system, not a standalone algorithm. While it states that "A number of algorithms are used in the image processing functions," it does not describe a standalone performance evaluation of these algorithms separate from the integrated system.

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

This information is not present in the provided 510(k) summary. As there's no described performance study or test set for evaluation, there's no mention of how ground truth would have been established.

8. The sample size for the training set

This information is not present in the provided 510(k) summary. The document mentions algorithms for image processing but does not describe a machine learning model that would require a "training set" in the modern sense. The "training" mentioned refers to training for human users of the equipment.

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

This information is not present in the provided 510(k) summary, for the same reasons as item 8.

Summary of Device and Regulatory Context (Based on Provided Text):

• Device: OrthoScan, OrthoScan-HD (Image-intensified fluoroscopic x-ray system)
• Intended Use: General fluoroscopic visualization for physicians, including surgical orthopedic procedures and critical/emergency care procedures.
• Predicate Devices: GE/OEC Medical Systems series 6800 mini view digital mobile imaging device and Hologic/FluoroScan Imaging System Premier Encore mobile imaging device.
• Regulatory Approach: 510(k) Premarket Notification based on substantial equivalence to legally marketed predicate devices. This means the manufacturer is asserting their device is as safe and effective as the predicate devices, not necessarily that it meets specific, predefined performance metrics from a new, independent study.
• Technical Information (instead of performance criteria): The document provides details on physical characteristics (e.g., components, power ratings, kVp, uA ranges, Automatic Exposure Rate Control), major system components, and adherence to various electrical and radiation safety standards (e.g., 21 CFR Part 1020.30-32, NFPA, UL, CSA, IEC standards). It also references image processing algorithms but does not detail their performance.

In essence, a 510(k) is often a "paper exercise" demonstrating similarity to existing devices, and typically does not include the detailed performance study information requested in your prompt.

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