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The indication for use of the APOLLO is: radiology and fluoroscopy investigations when installed in conjunction with adequate image intensifier, image acquisition systems, X-ray generators and X-ray tubes.

Remote controlled radiology table, collimator and spot film device

I'm sorry, but the provided text does not contain the detailed information necessary to describe acceptance criteria and a study proving device performance as requested.

The document is a 510(k) summary for the APOLLO remote-controlled radiology table. It focuses on establishing substantial equivalence to a predicate device by comparing technical specifications and intended use.

Specifically, the document does NOT contain information on:

• Acceptance Criteria for performance: It lists specifications of the device but not criteria against which its performance was measured to demonstrate safety and effectiveness.
• A "study that proves the device meets the acceptance criteria": There is no description of a clinical trial, performance testing study, or any other formal study conducted to "prove" the device's performance against specific metrics.
• Sample size or data provenance for a test set.
• Number or qualifications of experts for ground truth.
• Adjudication method.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
• Standalone algorithm performance.
• Type of ground truth used.
• Sample size for a training set.
• How ground truth for a training set was established.

The document is primarily a comparison table of features between the APOLLO and its predicate device (Philips Omnidiagnost Eleva) to demonstrate substantial equivalence, a regulatory pathway that doesn't typically require extensive performance studies as might be seen for novel devices or AI solutions.

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