(144 days)
The VAX-D Genesis G2 Dynamic Logarithmic Spinal Decompression System is designed to relieve pressure on structures that may be causing low back pain, sciatica and neck pain. It relieves the pain associated with herniated discs, degenerative disc disease, posterior facet syndrome and radio. This is achieved non-surgically through the application of logarithmic distraction tensions applied to the patient according to the VAX-D protocol.
This therapy provides a primary treatment modality for the management of pain and disability for patients suffering with spinal pain. It has been found to provide relief in a variety of conditions involving anatomical dysfunctions of the spine that generate localized pain as well as peripheral radiation, including patients with protruding or herniated intervertebral discs as well as those with acute facet problems and sciatica.
The VAX-D Genesis G2 is designed to apply distraction tensions to the patient's lumbar and cervical spine in order to non-surgically decompress the spine and intervertebral disc. Disc decompression is defined as unloading due to distraction and positioning. For lumbar treatment the patient is fitted with pelvic harness and lies on the table; the upper body is positioned on the stationary partion of the table and is restrained by the patient holding on to adjustable handgrips, or by the vise of possive shoulder restraint. The table is a split table design, whereby distraction tensions are applied to the patient through a harness attached to a tensionometer and by the separation of the movable part of the movable The tensionometer can be programmed to move synchronously in a horizontal rand vertical plane in order to apply tension in a logarithmic time/force progression that is designed to follow the curvature of the spine.
The system is designed to apply tensions to the spine in a smooth logarithmic time/force curve that allows trunk and paraspinal muscles to relax. The system provides automated or variable e ined distraction-relaxation cycles. For safety the patient holds on to handgrips which can be released at any time to end the session and restore full relaxation. The patient may choose to use a passive shoulder restraint that utilizes a patient 'quick release' buckle, or they may use the handheld patient safety witch to stop the treatment. For cervical treatment the tensionometer applies tension to the cervical spine through a cervical harness. Distraction tensions and rates are continuously monitored and measured hy the tensionometer, and the output is monitored by a computer system which continuously processes the data and adjusts the tension to produce a patented 'logarithmic' curve. The chart recording produced is a permanent record of the treatment parameters which becomes part of the patient's chart.
The provided text is a 510(k) summary for the VAX-D Genesis G2 device. It describes the device, its intended use, indications for use, and technological characteristics, and references predicate devices. However, this document is a premarket notification for a medical device and does not contain a study that proves the device meets acceptance criteria in the way you've outlined for performance studies (e.g., specific metrics like sensitivity, specificity, or reader improvement).
Instead, the document asserts the safety and effectiveness of the VAX-D Genesis G2 by demonstrating substantial equivalence to legally marketed predicate devices. The "acceptance criteria" in this context are not quantitative performance metrics from a controlled study, but rather the FDA's regulatory requirements for substantial equivalence, which primarily relate to intended use, technological characteristics, and safety and effectiveness.
Here's a breakdown of why I cannot fill out your requested table and information, followed by what the document does provide:
Why the requested information cannot be provided from this document:
- No acceptance criteria table or reported device performance metrics: The document does not define specific, quantifiable acceptance criteria (e.g., minimum sensitivity, AUC, or reader improvement percentages) for the device's clinical performance. It also does not report specific performance outcomes from a study against such criteria.
- No sample size for test set, data provenance, ground truth experts, or adjudication method: These details are characteristic of clinical studies, particularly performance studies for diagnostic or AI-powered devices. This document is a regulatory submission focused on equivalence, not a detailed clinical trial report.
- No Multi-Reader Multi-Case (MRMC) comparative effectiveness study: The document doesn't describe any study comparing human readers with and without AI assistance. The device itself is a spinal decompression system, not a diagnostic imaging AI.
- No standalone algorithm performance study: The VAX-D Genesis G2 is a physical medical device (a spinal decompression system), not a software algorithm, so a "standalone" algorithm performance study is not applicable.
- No type of ground truth, training set sample size, or training set ground truth establishment: These are concepts related to the development and validation of machine learning or AI models. This device is a physical therapeutic device.
What the document does provide regarding "acceptance" and "proof":
The "proof" in this 510(k) submission is the demonstration of substantial equivalence to predicate devices. The FDA's "acceptance" is represented by their letter stating that the device is substantially equivalent and thus can be marketed.
1. Acceptance Criteria (implicit for 510(k) Substantial Equivalence):
The implicit "acceptance criteria" for a 510(k) clearance are that the new device shares the same intended use and/or indications for use as a legally marketed predicate device, and it is as safe and effective as the predicate device(s). If there are technological differences, they must not raise different questions of safety and effectiveness, or if they do, adequate scientific evidence must demonstrate that the device is as safe and effective as the predicate.
| Acceptance Criterion | Reported Device Performance (as per 510(k) argument) |
|---|---|
| Intended Use | To relieve pressure on structures that may be causing low back pain, sciatica and neck pain, through non-surgical distraction tensions. (Same as predicate) |
| Indications for Use | Management of pain and disability for patients suffering with spinal pain, including herniated discs, degenerative disc disease, posterior facet syndrome, and sciatica. (Same as predicate) |
| Technological Characteristics | Incorporates principles and working characteristics of predicate devices (VAX-D Genesis System K053503, VAX-D Therapeutic Table K951622, 3D Activetrac K001712, Henley Tru-Trac 401 K844385). Modifications (control arm, more accurate tension application, patient data storage) were evaluated and found not to impact safety and effectiveness. |
| Safety | Patients can immediately release tensions; "not a single MDR report of injury has been filed" over fourteen years for VAX-D therapy in clinical use, reflecting inherent safety. (Based on predicate/therapy history) |
| Effectiveness | Operating principles allow accurately controlled distraction tensions to decompress discs, which is the mechanism of action for efficacy. (Based on predicate/therapy principles) |
2. Study that proves the device meets acceptance criteria:
The document leverages the history and established safety/effectiveness of the predicate devices and the VAX-D therapy concept itself. It doesn't present a novel, prospective clinical study designed to meet specific quantitative performance endpoints for the G2 model.
- Sample size used for the test set and the data provenance: Not applicable in the context of a de novo performance study for the G2. However, the document states: "VAX-D therapy has been in clinical use since 1989 and has been the subject of multiple clinical studies examining its effectiveness and mechanisms of action." It also notes that "VAX-D Medical Technologies maintains contact with the clinics administering the therapy, and over the past fourteen years, not a single MDR report of injury has been filed..." This refers to a broad history of clinical use and post-market surveillance rather than a specific test set for the G2.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: No.
- Standalone algorithm performance study: No, as it's a physical device.
- Type of ground truth used: For the claim of safety and effectiveness, the "ground truth" relies on the established body of evidence and clinical history of the predicate devices and the general VAX-D therapy principles, including the absence of reported adverse events (MDRs).
- Sample size for the training set: Not applicable (not an AI/ML device).
- How the ground truth for the training set was established: Not applicable.
In summary, the VAX-D Genesis G2 obtained FDA clearance through the 510(k) pathway by demonstrating substantial equivalence to existing predicate devices. The "proof" of meeting acceptance criteria is rooted in the known characteristics, intended use, safety record, and effectiveness of these established devices and the VAX-D therapy approach, rather than a new, detailed clinical performance study for the G2 model itself.
§ 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).