(127 days)
Lo-Bak TRAX is intended for single person use by adults to provide portable, nonpowered traction force to the lumbar spine and to stretch and relax the para-spinal muscles and soft tissues.
Use of Lo-Bak TRAX is indicated for the following conditions: low back pain, degenerative disc disease, spinal degenerative joint disease, spinal stenosis, herniated disc, spinal curvature due to tight muscles, sciatica and muscle spasm.
Lo-Bak TRAX is a non-powered, portable spinal traction device which is designed to simplify spinal traction of the lumbar spine and stretch the para-spinal soft tissues. It is light-weight (weighs less than 5 pounds) and compact, yet very strong and durable. Much like bicycle handlebars, there is a right and left handle. Correspondingly, there is a right and left thigh contact. The two thigh contacts are designed to align with the inguinal/thigh crease formed where the upper-most thigh attaches to the trunk when the hips are flexed 90 degrees. It has foam handle grips and ¼" SCE foam leg contact pads which both, provide comfort and function to prevent slippage while using the device. It is powder-coated with high gloss paint to make clean up easy with a warm, soapy cloth or disinfective wipe.
There are no moving parts and no assembly required. It is ready to use from the moment you take it out of the box.
This device is designed to traction the lumbar spine by utilizing the upper thighs as the contact point and the bilateral upper extremities as the traction force source. The device will accomplish this by having the user lie in a supine posture with the lower extremities flexed at both the hips and knees bilaterally with the heels positioned as close as comfortable to the corresponding buttock area. This posture flattens the lumbar lordosis, creating more of a straight line force vector which results in unweighting of the discs and facet joints while simultaneously relaxing the surrounding para-spinal musculature. This posture makes the spine more amenable to distraction with less force required than a device which attempts to traction the lumbar spine with the lumbar lordosis maintained.
Here's a breakdown of the acceptance criteria and related study information for the Lo-Bak TRAX device, based on the provided 510(k) summary:
This 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed clinical study for novel performance metrics with specific acceptance criteria in the manner typical for AI/ML devices. Therefore, a direct table of "acceptance criteria and reported device performance" as might be found for quantitative diagnostic or prognostic devices is not explicitly stated. The acceptance criteria here are implicitly met if the device demonstrates comparable safety and effectiveness to the predicate.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance (Summary of Safety and Effectiveness Claim) |
|---|---|
| Safety: Device does not adversely affect user safety compared to the predicate device. | "Lo-Bak TRAX's new approach to lumbar spine traction does not adversely affect safety or effectiveness as compared to the predicate device." |
Key safety attributes cited: User-controlled force source with no reliance on mechanical involvement; biomechanical postural approach to maximize comfort while minimizing force; intermittent traction; one-piece design with no moving parts. |
| Effectiveness: Device maintains effectiveness for its intended use and indications compared to the predicate device. | "Lo-Bak TRAX's new approach to lumbar spine traction does not adversely affect safety or effectiveness as compared to the predicate device."
The device is designed to "simplify spinal traction of the lumbar spine and stretch the para-spinal soft tissues."
Effectiveness is tied to the ability to provide "significant traction to the lumbar spine area without the need for any cables, pulleys, restraints or weights," and "unweighting of the discs and facet joints while simultaneously relaxing the surrounding para-spinal musculature." |
| Indications for Use: Lo-Bak TRAX is suitable for the stated conditions (low back pain, degenerative disc disease, etc.). | The device is indicated for a range of conditions, similar to those that might benefit from the predicate device's function. The submission implicitly argues that the mechanism of action (traction, unweighting, muscle relaxation) is comparable and thus effective for these indications. |
| Technological Characteristics: Key differences from the predicate device do not raise new questions of safety or effectiveness. | The submission highlights differences (lightweight, portable, supine posture, user-generated intermittent traction, no moving parts, no assembly) and argues that these "do not adversely affect safety or effectiveness." These differences are presented as improvements or alternative approaches that maintain the core functionality without introducing new risks. |
Study Information Details
The provided document is a 510(k) Summary, which primarily focuses on demonstrating substantial equivalence to a predicate device. It does not describe a formal clinical study with a test set, ground truth establishment, or sample sizes in the manner typically associated with AI/ML device performance evaluation. Instead, the "proof" is through comparison of technological characteristics and intended use with a legally marketed predicate.
Therefore, many of the requested details are not applicable (N/A) in the context of this 510(k) submission.
- Sample size used for the test set and the data provenance:
- N/A: The submission does not describe a formal test set for evaluating specific performance metrics. Substantial equivalence is argued based on the design, intended use, and comparison to the predicate device.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A: No ground truth establishment study involving experts is described.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- N/A: No adjudication method is described as there is no specific test set requiring ground truth establishment through expert consensus.
- 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:
- N/A: This device is a physical, non-powered orthopedic traction apparatus, not an AI/ML diagnostic or assistive technology. Therefore, an MRMC study or evaluation of human reader improvement with AI assistance is not relevant.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- N/A: This is a physical device, not an algorithm.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- N/A: The safety and effectiveness argument relies on the well-understood principles of spinal traction and comparison to a predicate, not on a new ground truth established through a study.
- The sample size for the training set:
- N/A: The device is not an AI/ML product that requires a training set.
- How the ground truth for the training set was established:
- N/A: Not applicable, as there is no training set for this type of device.
In summary, this 510(k) document demonstrates substantial equivalence by comparing the Lo-Bak TRAX to a predicate device (Teeter Hang Up's Inversion Table) based on:
- Similarities in intended use and fundamental mechanism of action (spinal traction, unweighting discs/facets, relaxing muscles).
- Differences in physical attributes and method of force generation that are argued not to raise new questions of safety or effectiveness.
- The argument that the device's design (user-controlled, intermittent traction, specific posture) maintains effectiveness while potentially enhancing safety and ease of use.
§ 888.5850 Nonpowered orthopedic traction apparatus and accessories.
(a)
Identification. A nonpowered orthopedic traction apparatus is a device that consists of a rigid frame with nonpowered traction accessories, such as cords, pulleys, or weights, and that is intended to apply a therapeutic pulling force to the skeletal system.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, regarding general requirements concerning records, and § 820.198, regarding complaint files.