(148 days)
Modpod cervical traction provides mobilization of skeletal structures and muscles in static, intermittent, progressive, and regressive distraction forces to relieve pressures that may be causing pain of skeletal or muscular origin. These effects are achieved through decompression of intervertebral discs, that is, unloading due to distraction and positioning, and may be used to relieve peripheral radiation/sciatica and pain associated with:
• Protruding discs
• Bulging discs
• Herniated discs
• Degenerative disc disease
• Posterior facet syndrome
• Acute facet problems
• Radicular pain
• Prolapsed discs
• Spinal root impingement
• Hypomobility
• Degenerative joint disease
• Facet syndrome
• Compressions fracture
• Joint pain
• Discogenic pain
The Modpod™ Cervical Traction Device provides static and intermittent distraction forces to the cervical spine to relieve pressures on structures that may be causing pain of skeletal or muscular origin. Therapeutic distraction can be applied in a variety of programmable patterns and functions.
The device design allows a clinician access to a patients head and neck when hands-on interaction and positioning is needed. Use of the device reduces the level of exertion experienced by the clinician when compared to manual traction therapy techniques. Additionally, hands-on interaction and positioning by the clinician may occur before or after treatment.
Painted sheet metal and ABS plastic encasement housing electronic circuitry; software and electronics engage a gear driven motor with load sensors; slide mechanism, and patient head harness to apply cervical traction.
I am sorry, but I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria from the provided text. The document is a 510(k) premarket notification letter from the FDA to Hollywog, LLC, regarding their device called "Modpod".
This document primarily focuses on establishing substantial equivalence to previously marketed predicate devices (K051938 and K053223). It details:
- Indications for Use: The medical conditions the device is intended to treat.
- Technical Specifications: Information about the device's design, power supply, components, and operational characteristics.
- Comparison to Predicate Devices: A comprehensive table comparing the Modpod to the predicate devices across various parameters like regulation, product class, intended use, anatomical site, maximum traction force, electrical standards, etc.
However, the document does not contain information about specific acceptance criteria (performance metrics) or a study report with associated data and statistical analysis that proves the device meets such criteria. It states that "The Modpod cervical traction device is as safe and effective, and performs as well or better than the claimed predicate devices," which is a conclusion based on the comparison provided, but not a detailed study report with results against predefined acceptance criteria.
Therefore, I cannot extract the requested information regarding:
- A table of acceptance criteria and reported device performance.
- Sample size and data provenance for a test set.
- Number and qualifications of experts for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study results.
- Standalone algorithm performance.
- Type of ground truth used.
- Training set sample size.
- How training set ground truth was established.
§ 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).