(88 days)
The DRX5000 provides a program of treatments for relief from pain for those patients suffering with low back pain and neck pain. Each treatment consists of a physician prescribed treatment period on the DRX5000 and is designed to provide static, intermittent, and cycling distraction forces to relieve pressures on structures that may be causing low back or neck pain. Conditions that may be treated include neck pain and back 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.
The DRX5000 is a powered traction equipment device. The bed is a stand on/stand off tilt type bed that allows the fully clothed patient to step onto a footrest while it is in near vertical position. The bed and patient can then be slowly lowered to the horizontal treatment position using a remote controller hand held by the practitioner. The bed is split into two cushions, each slide able in the horizontal plane only on low friction runners and each being able to be locked independently. Distraction tensions are applied to the patient via a pelvic harness while the upper body of the patient is anchored to the locked upper cushion via a chest harness. The lower cushion, which is unlocked and on which the patient's lower trunk is rested, is able to slide easily thus reducing almost completely any frictional movement between patient and bed cushion when distraction tensions are applied, this concentrates virtually all the forces to the affected part of the lumbar spine. The traction unit is mounted to the foot of the tower and the belt pulley system is attached to a vertical movable platform incorporated into the tower at the foot end of the bed. This enables the distraction tensions to be applied at differing angles to the patient (between 0 and 30 degrees). The traction unit is programmed and controlled from a control panel fitted into the tower to give static or intermittent distraction. The minimum and maximum distraction settings are 0-200 lbs. Treatment parameters i.e. tensions and time are continuously monitored and shown by LCD readout at the time of treatment set up and during treatment. At the conclusion of treatment time, tension always returns to zero. A DVD player, which is incorporated in a separate section of the control panel, and headphones provide comfort and relaxation to the patient and provides and opportunity for patient education via clinical tapes. There is instantaneous release of all tensions if the patient pushes the button on the hand held Patient Safety Switch, or the Stop Button, or Emergency Stop on the control panel has been pushed by the practitioner. The DRX5000 will not operate if the Patient Safety Switch is not working properly or has not been tested prior to each treatment. The treatment cannot be restarted when a patient activates the Patient Safety Switch or the Stop Button has been pushed during treatment unless all treatment parameters are manually re-entered into the controller.
The provided text describes the DRX5000 Traction Equipment and its 510(k) submission, primarily focusing on its equivalence to predicate devices and safety features. However, it does not include a study proving the device meets specific acceptance criteria related to its performance in relieving pain or decompressing intervertebral discs.
Instead, it relies on:
- Predicate Device Equivalence: Stating that the DRX5000 "incorporates various principles and working characteristics of the predicate devices" (3-D Active Trac and Tru-Trac 401 Traction Device).
- Reference to Existing Clinical Trials: It mentions, "Clinical trials carried out by VAX-D (K951622) endorse the principle of decompression and similar studies using similar technology have reported the same results." It then directs the reader to appendices, which are not provided in the input text.
Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment cannot be extracted from the given document.
Here's a breakdown of what can be inferred or stated based on the provided text, and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Inferred from intended use) | Reported Device Performance (as stated in the document) |
|---|---|
| Relief from low back and neck pain | Not directly reported for the DRX5000 itself. The document states that "Clinical trials carried out by VAX-D (K951622) endorse the principle of decompression and similar studies using similar technology have reported the same results." This implies that the principle of decompression is effective, and since the DRX5000 uses similar technology, it is expected to achieve similar results. |
| Provide static, intermittent, and cycling distraction forces to relieve pressures on structures | The DRX5000 is designed to "provide static, intermittent, and cycling distraction forces" and "achieves these effects through decompression of intervertebral discs, that is, unloading due to distraction and positioning." |
| Treat conditions like herniated discs, protruding discs, degenerative disc disease, posterior facet syndrome, and sciatica | The device is intended to treat these conditions by relieving pressures and decompressing intervertebral discs. No direct performance data for the DRX5000 is reported. |
2. Sample size used for the test set and the data provenance:
- Not provided. The text only references clinical trials performed by VAX-D (K951622) and "similar studies," but no details about their sample sizes or data provenance are given for these external studies, nor for any specific test set for the DRX5000 itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not provided.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not provided.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is traction equipment, not an AI software or imaging interpretation tool that involves human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is traction equipment.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not explicitly stated for the DRX5000. For the referenced VAX-D studies, it can be inferred that the "principle of decompression" led to positive "results," which likely implies patient outcomes data (e.g., pain relief, improved function).
8. The sample size for the training set:
- Not applicable/Not provided. This is physical medical equipment, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable/Not provided.
In summary, the document serves as a 510(k) submission focusing on the equivalence of the DRX5000 to existing devices and its safety features. It references clinical evidence for the underlying principle of decompression therapy in general (citing VAX-D studies), but it does not present a specific study validating the DRX5000 against detailed acceptance criteria with statistical performance metrics, sample sizes, or ground truth methodologies directly related to the DRX5000's efficacy.
§ 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).