(170 days)
The DRX3000 provides a program of treatments for relief from pain for those patients suffering with low back pain. Each treatment consists of a physician prescribed treatment period on the DRX3000 and is designed to provide static, intermittent, and cycling distraction forces to relieve pressures on structures that may be causing low back pain. It relieves pain associated with herniated discs, protruding discs, degenerative disc disease, posterior facet syndrome, and sciatica. It achieves these effects through decompression of intervertebral discs, that is, unloading due to distraction and positioning.
Device Trade Name: DRX3000 Traction Equipment
Common Name: Power Traction Equipment
Classification Name: Power traction equipment
Class and Reference Product Code: Class II (21 CFR Section 890.5900) 89 ITH
The provided text does not contain information about acceptance criteria or a study proving that the DRX3000 meets such criteria. The document is a 510(k) summary for the DRX3000 Traction Equipment, outlining its description, predicate devices, and intended use for relief from low back pain. It states that the device is substantially equivalent to legally marketed predicate devices and mentions that "clinical trials carried out by VAX-D endorse the principle of decompression and similar studies using similar technology have reported the same results." However, it does not provide details about these studies, their methodologies, sample sizes, acceptance criteria, or specific performance metrics of the DRX3000 device itself.
Therefore, I cannot provide the requested information, including:
- A table of acceptance criteria and the reported device performance: No such criteria or performance data are presented for the DRX3000.
- Sample sized used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- Adjudication method: Not mentioned.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not relevant to this device, which is a traction equipment, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not relevant.
- The type of ground truth used: Not mentioned.
- The sample size for the training set: Not mentioned.
- How the ground truth for the training set was established: Not mentioned.
The document primarily focuses on establishing substantial equivalence to predicate devices based on technological characteristics and intended use, rather than on detailed clinical performance studies of the DRX3000 itself with specific acceptance criteria.
§ 890.5900 Power traction equipment.
(a)
Identification. Powered traction equipment consists of powered devices intended for medical purposes for use in conjunction with traction accessories, such as belts and harnesses, to exert therapeutic pulling forces on the patient's body.(b)
Classification. Class II (performance standards).