(488 days)
The VAX-D® Therapeutic Table is designed to relieve pressure on structures that may be causing low back pain. It relieves the pain associated with herniated discs, degenerative disc disease, posterior facet syndrome and radicular pain. It achieves these effects through decompression of intervertebral discs, that is, unloading, due to distraction and positioning.
This therapy provides a primary treatment modality for the management of pain and disability for patients presenting with incapacitating low back pain. It has been found to provide relief in a variety of conditions involving anatomical dysfunctions of the lumbar spine that generate localized low back pain as well as peripheral radiation, including patients with protruding or herniated intervertebral discs, degenerative discs as well as those with acute facet problems.
The VAX-D® Therapeutic Table is designed to apply distraction tensions to the patient's lumbar spine. The patient lies on the table in a prone position; the upper body is on the stationary portion of the table and is restrained by the patient holding on to adjustable hand grips. The table is a split-table design, whereby distraction tensions are applied to the patient through a pelvic harness attached to a tensionometer and by the separation of the movable part of the table. The VAX-D® Therapeutic Table provides automated or varied timed distraction cycles. For safety, the patient holds on to the handgrip which can be released at any time to end the session and restore full relaxation. Distraction tensions and rates are continuously monitored and measured by the tensionometer attached to the pelvic belt, and the output is shown on a digital gauge and captured on a pen-writer printout, or optionally through direct connection to a computer terminal. The chart recording forms a permanent record of the treatment parameters, which becomes part of the patient's chart.
This document is a 510(k) summary for the VAX-D® Therapeutic Table, a medical device intended to relieve low back pain. The document describes the device, its intended use, and its safety and effectiveness.
Here’s a breakdown of the information requested, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" for device performance in a quantitative or statistical sense, as one might find for a diagnostic or AI-driven device. Instead, it focuses on the safety and effectiveness from a predicate device comparison and clinical use history.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety equivalent to predicate device | No MDR reports filed in seven years of clinical use. Patient can release tensions at will for safety. |
| Effectiveness equivalent to predicate device | "Operating principles… permit application of effective distraction tensions." "Has been in clinical use since 1989." |
| Relief of low back pain | "Designed to relieve pressure on structures that may be causing low back pain." |
| Decompression of intervertebral discs | Achieves effects through "decompression of intervertebral discs, that is, unloading, due to distraction and positioning." |
| Applicable across various conditions | "Found to provide relief in a variety of conditions involving anatomical dysfunctions of the lumbar spine… including patients with protruding or herniated intervertebral discs, degenerative discs as well as those with acute facet problems." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a formal "test set" sample size for a specific study. The information provided heavily relies on the device's history of clinical use and its substantial equivalence to a predicate device.
- Data Provenance: The device has been in "clinical use since 1989." VAT-TECH, INC. "maintains contact with the clinics administering the therapy." This suggests real-world clinical data, likely prospective in terms of ongoing monitoring, but the 510(k) summary itself retrospectively reports on this history. The country of origin for the data is not specified, but the sponsor is based in Florida, USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This information is not provided in the document. The document describes the device's mechanism of action and its reported clinical efficacy based on its use since 1989. There is no mention of a specific ground truth establishment process involving experts in the context of a controlled study for this 510(k) submission.
4. Adjudication Method for the Test Set
This information is not provided as there is no described formal test set with adjudicated ground truth.
5. 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
This document describes a therapeutic table for physical traction, not an AI-driven or diagnostic imaging device. Therefore, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study focusing on human readers improving with AI assistance is not applicable and was not performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is a physical medical device, not an algorithm. Therefore, a standalone algorithm-only performance study is not applicable and was not performed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The primary "ground truth" or evidence of effectiveness appears to be:
- Clinical outcomes data from the device's seven years of clinical use (implied by "has been in clinical use since 1989" and "found to provide relief").
- Safety data (absence of MDR reports).
- Substantial equivalence to a predicate device (VAX-T® Therapeutic Table).
- The mechanistic understanding of how distraction tensions relieve pressure on the lumbar spine.
8. The Sample Size for the Training Set
This information is not applicable as this describes a physical medical device and not a machine learning model. There is no concept of a "training set" in the context of this 510(k) submission.
9. How the Ground Truth for the Training Set was Established
This information is not applicable for the reasons stated above.
§ 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).