(106 days)
The W-Tracker is a bi-axial wrist-joint movement assessment device mounted on a forearm and hand. Specifically, it measures angular range of motion and velocity in two planes. The Clinical Analysis protocol requires the subject to perform a series of wrist movements, including wrist flexion/extension and ulnar/radial deviation, each to be performed by the subject at his/her preferred speed. The data obtained during the Clinical Analysis protocol is real-time data, and is immediately transferred from the W-Tracker to the computer via an A/D conversion device to a serial port.
The goals of the device when performing the Clinical Analysis protocol is to compile information related to tests devised by the AMA to measure impairment of wrist joints, and to compare performance profiles of normal and injured populations.
The W-Tracker is a bi-axial wrist-joint movement assessment device mounted on a forearm and hand. Specifically, it measures angular range of motion and velocity in two planes. The data obtained during the Clinical Analysis protocol is real-time data, and is immediately transferred from the W-Tracker to the computer via an A/D conversion device to a serial port. The W-Tracker does not initiate or control any movement during a test and it does not induce any forces on the subject. It is, therefore, a passive device. The only forces acting on the subject are the negligible inertial forces of the W-Tracker generated by the subject's wrist movements. The device is fail-safe in design to obviate safety concerns for the subject.
I am sorry, but the provided text from K971079 does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria. This document is a 510(k) clearance letter from the FDA for the Interlogics W-Tracker and Wristworks Software, indicating that the device is substantially equivalent to legally marketed predicate devices.
The letter explicitly states:
"We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act)."
The purpose of a 510(k) submission is to demonstrate substantial equivalence, not necessarily to provide detailed performance studies with acceptance criteria in the manner that might be required for a PMA (Premarket Approval) device or a more recent device with novel intended uses.
Therefore, I cannot provide the requested information, which includes:
- A table of acceptance criteria and the reported device performance
- Sample sized used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Adjudication method for the test set
- If a multi reader multi case (MRMC) comparative effectiveness study was done
- If a standalone performance (i.e. algorithm only without human-in-the-loop performance) was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
The document focuses on the regulatory clearance for marketing based on substantial equivalence, and describes the device's function and indications for use.
§ 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.