(116 days)
Use of the TM-400 powered traction device is indicated for the following:
- Providing standard therapeutic and custom user-defined treatments in static, intermittent, . progressive, regressive, cyclical and combination distraction forces to relieve pressures on structures that may be causing pain of skeletal or muscular origin (cervical, thoracic, lumbar, hip, wrist, shoulder).
- Providing traction and mobilization of skeletal structures and skeletal muscles. .
- . Relieving peripheral radiation / sciatica and pain associated with:
Discs:
- A Protruding, bulging, herniated and prolapsed discs
- A Degenerative disc disease
- A Discogenic pain
Facets:
- A Facet syndrome
- A Posterior facet syndrome
- Acute facet problem A
Muscles & Joints:
- Muscle pain and spasms A
- Degenerative joint disease A
Spinal Structures:
- Spinal root impingement A
- a Pinched nerves
- A Compression fractures
Pain:
-
Back, lower back, neck, joint, sciatic and radicular pain A
Mobility & Flexibility: -
Hypomobility
-
Limited spinal and joint flexibility
The TM-400 is a simple to use powered traction unit that offers static, intermittent, and cycle traction with user-definable hold, rest and treatment times. The unit consists of a software-controlled electro-mechanical traction system. The physical characteristics of the TM-400 are substantially equivalent to the predicate traction devices including size, weight, materials of construction, and user interface. In addition, the unit has incorporated similar features as the predicate devices such as:
- ア Automatic calibration of traction force
-
An internal memory that stores up to 30 treatment patterns
- A Traction speed selectable from five preset values
- 公 Eight traction modes
- A Remote patient-controlled treatment shutoff switch
- ﺮ Large and high-visibility LCD screen
The TM-400 traction device operates by attaching the cable hook to a harness accessory, which is in turn attached to the patient treatment area, for traction and mobilization of skeletal muscles according to the detailed indications of use.
The provided text describes the TM-400 powered traction device and its intended use, but it does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.
The document is a 510(k) summary for a medical device submitted to the FDA, which primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance study results against acceptance criteria.
Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and performance study results based solely on the provided text.
Here's why and what information would typically be expected for such a request:
- Acceptance Criteria and Reported Device Performance: This would require a table outlining quantitative or qualitative performance targets (e.g., accuracy of traction force, speed consistency) and the actual validated performance values from testing. The document states "Testing was carried out to assure compliance to FDA recognized electrical safety standards," and "Non-clinical verification and validation testing was conducted on final TM-400 production units, and the results of such testing appear in Section 12 and Section 14 of this submission." However, these sections are not provided in the input, so the specific acceptance criteria and performance data are missing.
- Sample size, data provenance, number of experts, adjudication method, MRMC study, standalone study, ground truth type, training set size, and training set ground truth establishment: These are all elements typically found in detailed clinical or non-clinical performance studies, often in sections beyond a 510(k) summary. The provided text only mentions "non-clinical verification and validation testing." For a powered traction device, these studies would likely focus on mechanical performance, safety, and potentially effectiveness if a clinical study were performed (though typically not required for substantial equivalence).
In summary, the provided document focuses on:
- Device description and features.
- Intended use and indications for use.
- Comparison to predicate devices (K992545 and K053223).
- Compliance with electrical safety (UL60601-1) and electromagnetic compatibility (IEC60601-1-2) standards.
- The FDA's decision of substantial equivalence.
It does not disclose the detailed results of non-clinical verification and validation testing or any clinical studies that would address the acceptance criteria and performance metrics you've requested.
§ 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).