(51 days)
The Decompression' of Choice (DOC) and AAAR 2K10 is a non invasive method of applying distractive forces to the spine through controlled tensions. It is designed to apply decompression (decompression is unloading due to distraction and positioning and/or as non-surgical in nature) forces to intervertebral discs. The Decompression' of Choice (DOC) and AAAR 2K10 may be used for back pain, neck pain, hemiated discs, protruding discs, degenerative disc disease, sciatica and posterior facet syndromes.
The Devices are a non surgical traction or also called decompression' systems. It accurately controls tensions designed to relax Para spinal musculature and to allow distractive- traction forces to decompress inter vertebral spinal disk space. The Devices do this by creating a negative pressure in the disc due to the distractive forces and treatment protocols. Bulges or herniation are reduced back into the center or annular part of the disc. Fibroblasts then form a matrix over the protryded area to form a "seal" over the previously injured area. The load cell constantly updates the user interface provided which controls a gear-motor/linear actuator to immediately and safely apply forces as determined by qualified healthcare personnel. The load cell feedback is also used to further verify and adjust traction forces allowing for variations in patient postures and outside influencing forces. This method of operation allows safe, continuous and smooth operation of the unit and proper comfortable and safe appliance of said forces to the patient. An extensive manual of suggested treatment protocols and safety warnings is furnished to the end user.
The provided text describes a medical device called "Decompression of Choice (DOC) and AAAR 2K10" (referred to as "Devices") which is a power traction equipment for spinal decompression. The study described focuses on proving equivalence to predicate devices rather than establishing specific performance metrics against pre-defined acceptance criteria for a novel functionality.
Here's a breakdown of the information requested, based only on the provided text:
Acceptance Criteria and Device Performance
The document does not explicitly list quantitative "acceptance criteria" for the device itself in terms of clinical efficacy or diagnostic accuracy (as would be common for AI/imaging devices). Instead, the performance testing described is focused on demonstrating the device's ability to deliver and measure specific forces accurately, which is a functional requirement for this type of equipment. The primary "acceptance" is based on substantial equivalence to predicate devices and compliance with safety standards.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Accuracy of Applied Force | Demonstrated accurate force delivery and measurement on cervical and lumbar sections using a calibrated scale. |
| Safety Standards Compliance | In compliance with IEC 60601-1, IEC 60601-2-46, IEC 60601-1-4, UL 60601-1, and IEC 60601-1-2. |
| Equivalence of Traction Pulls | Performs similar static, intermittent, and cyclic ramp up, treatment, and ramp down traction pulls as predicate K053223. |
| Maximum Traction Force | Lumbar section maximum traction: 200 lbs (matches predicate K053223). Cervical section maximum traction: 50 lbs (for patient safety). |
| Biocompatibility | Materials in contact with patient (table top, cervical capture) are commonly used and have no known adverse effects (biocompatibility testing not warranted). |
Study Details
The provided text describes a functional and safety performance test, not a clinical study to assess diagnostic or therapeutic efficacy in patients.
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable in the traditional sense of patient data. The "test set" involved the device itself being tested with a calibrated scale. No specific number of "tests" or "measurements" is provided, but it implies a series of measurements to confirm force accuracy across different settings.
- Data Provenance: The testing was likely conducted in a controlled laboratory environment by the manufacturer or a testing facility during device development/validation. Country of origin not specified, but the applicant is from the USA (Watertown, SD). This is prospective testing of the device's physical function.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for the force measurements would be the readings from the calibrated scale, which is an objective instrument. No human experts were involved in establishing this ground truth.
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Adjudication method for the test set: Not applicable. The test involved physical measurements against a calibrated instrument.
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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 therapeutic power traction equipment, not an AI-assisted diagnostic or imaging device. No human reader studies were conducted or described.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is mechanical/electronic equipment, not an algorithm. Its operation inherently involves a human operator (qualified healthcare personnel) who sets the parameters.
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The type of ground truth used: For the force measurement performance, the ground truth was objective measurements from a calibrated scale. For safety, compliance with listed safety standards served as the "ground truth." For substantial equivalence, the characteristics and performance of the predicate devices served as the comparative ground truth.
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The sample size for the training set: Not applicable. This device does not use machine learning or AI, so there is no "training set."
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How the ground truth for the training set was established: Not applicable. There is no training set for this device.
§ 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).