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Teeter Decompression Devices are multiple user, reusable devices for home use, intended to provide traction to the spine while stretching the para-spinal muscles and soft tissues. The devices provide non-powered traction and are meant for use by adults.

Use of the Teeter Decompression Devices is indicated for the following conditions: back pain, muscle tension, degenerative disc disease, spinal degenerative joint disease, spinal stenosis, herniated disc, spinal curvature due to tight muscles, sciatica, muscle spasm, and facet syndrome.

Teeter's decompression devices are designed to decompress the spine and stretch paraspinal soft tissues. The devices are non-powered, external (non-invasive) and usercontrolled. Decompression is accomplished in various ways depending on the model within the Teeter product family.

The provided document is a 510(k) premarket notification for "Teeter Decompression Devices" and their accessories. It primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device (Lo-Bak TRAX) and does not contain the type of acceptance criteria and rigorous scientific study details typically associated with advanced AI/ML medical devices.

Therefore, an answer fulfilling all the requested information about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be generated from the given text.

The document describes non-powered mechanical devices (inversion tables, gravity boots, and other manual traction devices) and their intended use. The "performance data" section only mentions "Safety evaluations (Inversion table and gravity boots only)" and "Risk analysis," which are general assessments for mechanical devices rather than the detailed clinical or validation studies for AI/ML algorithms that your request implies.

Here's a breakdown of why the requested information is absent:

1. Acceptance Criteria and Reported Device Performance: While the document outlines the "Indications for Use" and compares technological characteristics to a predicate, it does not present a table of specific, quantifiable acceptance criteria (e.g., sensitivity, specificity, AUC for an AI device) or detailed performance metrics against those criteria.
2. Sample Size and Data Provenance (Test Set): No information about a test set, its sample size, or data provenance (country, retrospective/prospective) is provided. The document focuses on mechanical design and functional equivalence.
3. Number of Experts and Qualifications (Ground Truth): Since there's no mention of a test set or AI algorithm requiring ground truth, there's no information on experts or their qualifications for establishing ground truth.
4. Adjudication Method: Not applicable as there's no test set requiring ground truth adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No MRMC study is mentioned. The devices are mechanical and do not involve human readers interpreting output from an AI.
6. Standalone Performance: No mention of standalone algorithm performance, as there is no algorithm.
7. Type of Ground Truth: Not applicable, as no AI algorithm is involved that would require a ground truth.
8. Sample Size for Training Set: No training set is mentioned, as there is no AI/ML component.
9. Ground Truth for Training Set: Not applicable.

In conclusion, the input document describes a Class I medical device (Nonpowered Orthopedic Traction Apparatus and Accessories) which is a physical, mechanical device. The substantial equivalence determination for such devices typically relies on engineering and safety testing, comparison of design and materials with existing devices, and a demonstration that the new device does not raise new questions of safety or effectiveness. It does not involve the elaborate clinical validation studies and AI/ML specific performance metrics asked in your prompt.

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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

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.

1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. The sample size for the training set:
   • N/A: The device is not an AI/ML product that requires a training set.
8. 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.

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The BACK - ON - TRAC is intended for the treatment of acute and chronic low back pain of disc origin or due to malalignments of the apophyseal joints.

Not Found

This document is a 510(k) clearance letter from the FDA for a device called "BACK-ON-TRAC". It states that the device is substantially equivalent to legally marketed predicate devices. However, this letter does not contain any information about acceptance criteria, device performance, or specific studies conducted.

Therefore, I cannot provide the requested information. The letter only confirms that the device can be marketed based on its substantial equivalence to pre-existing devices, but it does not detail the technical performance or the studies used to demonstrate that performance.

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