(12 days)
This therapy provides a primary treatment modality for the management of pain and disability for patients suffering with 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 as well as those with acute facet problems and sciatica.
This therapy provides a primary treatment modality for the management of pain and disability for patients suffering with compressive and degenerative injuries of the spine. It has been found to provide relief of pain and symptoms associated with herniated discs, bulging discs, degenerative disc disease, posterior facet syndrome, and sciatica.
The VAX-D Genesis System is designed to apply distraction tensions to the patient's lumbar spine in order to non-surgically decompress the intervertebral discs. The patient's upper body is positioned on the stationary portion of the table and is restrained by the patient holding on to adjustable handgrips, or by the use of a passive shoulder restraint. The table is a split table design, whereby distraction tensions are applied to the patient first by a pelvic harness attached to a tensionometer and by the separation of the moveable part of the table. The system is designed to apply tensions to the lumbar spine in a patented logarithmic time/force curve that allows trunk and paraspinal muscles to relax. The system is managed on variable timed 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 simply raise their arms to release. Distraction tensions and rates are continuously monitored and measured by the tensionometer in the pelvic belt, and adjusts the tension to produce a patented logarithmic decompression curve. The chart recording produced is a permanent record of the treatment parameters which becomes part of the patient's chart.
This 510(k) submission (K053503) for the VAX-D Genesis System does not contain a study that establishes acceptance criteria or proves the device meets specific performance metrics. Instead, it focuses on demonstrating substantial equivalence to a predicate device (VAX-D Therapeutic Table, K951622).
Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document, nor can I answer questions about sample size, expert qualifications, adjudication methods, MRMC studies, or specific ground truth methodologies as these types of studies are not presented.
The device's safety and effectiveness are supported by its substantial equivalence to the predicate device and the claim that the VAX-D therapy has been the "subject of multiple clinical studies examining its effectiveness and mechanisms of action." However, these studies are not described or included within this 510(k) document.
Here's what can be extracted based on the provided text, focusing on how substantial equivalence is argued:
1. A table of acceptance criteria and the reported device performance:
Not applicable. This 510(k) does not present specific acceptance criteria or performance metrics in a study. The argument is based on substantial equivalence.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable. No new performance studies or test sets are described in this 510(k). The document mentions that the VAX-D therapy has been the "subject of multiple clinical studies," but these studies are not detailed here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. No ground truth establishment for a new test set is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No new test set or adjudication method is described.
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:
Not applicable. This device is not an AI-assisted diagnostic tool, and no MRMC studies are mentioned. It is a physical therapy device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a physical therapy system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable for this 510(k) submission, as it does not detail new clinical studies with defined ground truth. The primary ground for approval is demonstrated prior use and regulatory clearance of a substantially equivalent predicate device. The "intended use" and "indications for use" are based on clinical outcomes associated with the VAX-D therapy, which are presumably supported by the unreferenced "multiple clinical studies."
8. The sample size for the training set:
Not applicable. This 510(k) does not describe an AI model or a training set.
9. How the ground truth for the training set was established:
Not applicable. This 510(k) does not describe an AI model or a training set.
Summary of the K053503 approach to demonstrating safety and effectiveness:
The VAX-D Genesis System's acceptance into the market is based entirely on its substantial equivalence to a previously cleared device, the VAX-D Therapeutic Table (K951622).
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Basis for Equivalence:
- Technological Characteristics: The VAX-D Genesis System is described as "essentially the same product" as the predicate device.
- Modifications: VAX-D Medical Technologies "made some modifications to the appearance and components used in the storage of patient data to provide more accurate application of tension, and to provide for the storage of patient data."
- Evaluation of Changes: These changes were "evaluated by VAX-D Medical Technologies and found not to affect the safety or effectiveness of this device."
- Operating Principles: The operating principles (application of controlled distraction tensions to decompress intervertebral discs and spinal structures) are the same as the predicate.
- Safety Features: The "important safety factor is that patients can immediately release all the distraction tensions by simply releasing the hand-grips or by using the quick release buckle in the passive shoulder restraint." This feature is implied to be present and effective in both the predicate and the new device.
- Clinical History (of the therapy, not this specific device): The document states VAX-D therapy has been the "subject of multiple clinical studies examining its effectiveness and mechanisms of action" and that there have been no MDR (Medical Device Reporting) reports of injury over twelve years of contact with clinics administering the therapy. This broadly supports the safety of the underlying VAX-D therapeutic method, which the new device also executes.
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Conclusion: Because the new device is fundamentally similar in design, operating principle, and intended use, and its minor modifications do not affect safety or effectiveness, it is deemed substantially equivalent to the predicate, thus meeting the FDA's requirements for 510(k) clearance without requiring a new clinical performance study.
§ 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).