(77 days)
The Ortelius 800 is a prescriptive device intended to measure the angle of spinal deformity as an aiding tool for the diagnosis and monitoring of spinal deformities such as scoliosis and kyphosis.
The Ortelius 800 may be used in medical clinics/institutes.
The Ortelius 800 is a device designed for the measuring and monitoring spine deformities.
The Ortelius 800 enables the following features:
- · Spine curve reconstruction based on the points sampled by the Sensor.
- · Automatically calculated spine deformity angles of the primary curve.
- · Indication of the extreme vertebra from which the spine deformity angle was calculated.
The provided text describes the Ortelius 800, a goniometer intended to measure spinal deformity angles. However, it does not include detailed information regarding acceptance criteria, a specific study proving device performance against those criteria, or the methodology for such a study.
Therefore, I cannot populate the table or answer the specific questions requested, as the necessary information is not present in the provided document.
The document primarily focuses on:
- The device's general description and intended use.
- Its classification and regulatory aspects (510(k) submission, substantial equivalence to predicate devices).
- Compliance with general performance standards (IEC 60601-1, etc.) which are related to electrical safety and electromagnetic compatibility, not clinical performance for angle measurement accuracy.
To provide the requested information, a document detailing the clinical or performance validation study would be required.
§ 888.1500 Goniometer.
(a)
Identification. A goniometer is an AC-powered or battery powered device intended to evaluate joint function by measuring and recording ranges of motion, acceleration, or forces exerted by a joint.(b)
Classification. (1) Class I (general controls) for a goniometer that does not use electrode lead wires and patient cables. This device is exempt from the premarket notification procedures of subpart E of part 807 of this chapter subject to § 888.9.(2) Class II (special controls) for a goniometer that uses electrode lead wires and patient cables. The special controls consist of:
(i) The performance standard under part 898 of this chapter, and
(ii) The guidance entitled “Guidance on the Performance Standard for Electrode Lead Wires and Patient Cables.” This device is exempt from the premarket notification procedures of subpart E of part 807 of this chapter subject to § 888.9.