(57 days)
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.
§ 892.1980 Radiologic table.
(a)
Identification. A radiologic table is a device intended for medical purposes to support a patient during radiologic procedures. The table may be fixed or tilting and may be electrically powered.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.