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The QV-9000 Universal System is a stationary radiographic imaging system used for acquiring radiographic images of various anatomical regions of the human body.

The QV-9000 Universal System is a stationary, general purpose, X-ray imaging system used for acquiring radiographic exposures of various parts of the body including the skull, spinal column, chest, thorax, abdomen and extremities. The QV-9000 Universal System incorporates a floor-mounted vertical support column, with an attached rotating 'C' arm, an image receptor, an X-ray tube and collimator. The QV-9000 Universal System is compatible for use with either a digital or non-digital (film type) image receptor cabinet

The provided text does not contain detailed information about acceptance criteria for device performance, nor does it describe a specific study proving the device meets particular acceptance criteria.

The document is a 510(k) summary for a Special 510(k): Device Modification for the QV-9000 Universal System, an X-ray imaging system. The key information provided focuses on the device description, indications for use, and a general statement about safety and performance based on compliance with design control requirements, risk analysis, and verification/validation testing.

Here's why the requested information cannot be extracted from the given text:

• No specific performance metrics are listed: The document states "A description and summary of the verification and validation testing methods and results utilized to qualify the device modifications is also included in this submission," but these details are not present in the provided text.
• No detailed study description: There is no mention of a clinical study, reader study, or any specific test protocol with sample sizes, ground truth establishment, or expert involvement. The submission appears to rely on compliance with regulations and internal testing rather than a comparative effectiveness study or standalone performance study.

Therefore, I cannot populate the table or answer the subsequent questions about sample sizes, experts, adjudication, MRMC studies, standalone performance, or ground truth establishment based on the provided text.

The document primarily focuses on regulatory compliance (510(k) process, substantial equivalence to a predicate device K023008, and general controls) rather than detailed performance reporting as typically found in clinical study summaries.

Summary of available information regarding acceptance criteria and studies:

• Acceptance Criteria & Reported Device Performance: Not specified in the provided text. The document refers to "verification and validation testing methods and results" as being included in the submission, but these details are not provided here.
• Sample size for test set and data provenance: Not specified.
• Number of experts and qualifications: Not specified.
• Adjudication method: Not specified.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned.
• Standalone performance study: Not mentioned. The device's approval is based on substantial equivalence to a predicate and compliance with design controls and internal testing.
• Type of ground truth used: Not specified.
• Sample size for the training set: Not applicable, as this is an X-ray imaging system, not an AI/CAD system, and no "training set" for an algorithm is mentioned.
• How the ground truth for the training set was established: Not applicable.

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