(392 days)
Extentrac consists of rotating patient platform and two separate traction force generators. It is designed to exert a therapeutic distractive force on the patient's spine through 'gravitational' or 'motorized' means as required to relieve pressure on anatomical structures that may be causing pain. It produces the forces and positions required to cause decompression of the intervertrebral discs, that is, unloading due to distraction and positioning.
Conditions that may be treated include localized low back pain or peripheral radiation / sciatica due to:
- Protruding or herniated intervertebral discs .
- Acute facet problems .
- . Degenerative disc disease
The Extentrac Elite is a multifunctional traction table that incorporates two traction force generators to supply 'powered' traction during horizontal patient positioning while offering 'gravitational' traction and selective patient positioning during treatment into flexion, axial, extension, and lateral flexion.
The device consists of two main assemblies:
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- A rectangular base platform, which provides the support for the rotating patient upper support platform.
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- A rotating cushioned patient platform (upper top section) consisting of three separate support cushions attached to the sub-support frame. It is pivotally connected at its approximate center of gravity with the top end of the rectangular base platform. This provides the rotational capability to effect vertical gravity treatment protocols and positions the rotating patient platform assembly in the horizontal plane for administrating decompression /distraction protocols utilizing the power features in the lumbar and leg assembly respectively.
The rotating patient platform assembly consists of 1. Underarm/supports with integral handgrips containing the patient controls, 2. Lumbar back support cushion assembly (convex shaped), 3. Leg Support Assembly, 4. Upper Torso Support Cushion Assembly, 5. Overhead Rear Gripping Bar.
This patient platform and the attached assemblies measures 80 inches long with the power traction leg assembly un-extended and 89 inches fully extended. The manual leg assembly range is 12 inches. The total vertical retracted height of the device is 84 inches and the height extended is 92 inches. The width of the rectangular base is 35 inches.
Two hydraulic cylinders internal to the right and left side telescoping columns on the rectangular base platform raise and lower the height of the moving assembly by 12 inches.
The leg assembly distractive range is 9 inches (power) The lumbar assembly distractive range is 6 inches (power)
Maximum weight capacity is 300 lbs.
All of the devices movements are powered by hydraulic actuators. The actuators position the device and all assemblies with the use of positioning sensing potentiometers for exact input of data to the PLC to coordinate and sequence all of the devices movements. The traction/distractive forces applied are through hydraulic driven assemblies with load cells to accurately monitor pounds of force applied throughout the treatment cycle.
The device is controlled by the practitioner with following:
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- Remote Control Keypad
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- Computer Flat Screen Monitor and Mouse
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- Control Bar Switches on Leg Assembly
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- Lumbar Side Control Panel
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- Power Control Panel
Patients may control gravity traction vertical procedures by utilizing handgrip switches or overhead rear gripping bar switches. These switches control the patient platform rotation and the lumbar extension of the lumbar cushion.
Patients do not have the ability to utilize any of the power traction features of either the lumbar or leg assemblies. Operation of the patient switches may be deactivated by the practitioner at any time.
The level of device risk has been evaluated to be minimum, as numerous safety features have effectively mitigated any hazards.
The provided 510(k) summary for the ABT Advanced Back Technologies, Inc. Extentrac Elite is for a medical device that performs mechanical traction. The document does not describe an AI/ML powered device, nor does it contain any information about acceptance criteria or a study that proves the device meets such criteria in the context of AI/ML performance.
Instead, the document focuses on regulatory compliance for a physical medical device. It mentions:
- Substantial Equivalence: The device is deemed substantially equivalent to several predicate devices, meaning its safety and effectiveness are comparable to legally marketed devices. This is the primary method for clearance for many Class II medical devices.
- Safety and Electrical Compliance: The device was tested and certified to be in compliance with IEC 601-1-1 (Electrical Medical Equipment. General Requirements for Safety) and IEC 601-1-2 (Electromagnetic Compatibility) by Underwriters Laboratories (UL). This indicates that the device meets general safety and EMC standards for medical equipment.
Since this device is not an AI/ML product, the information requested regarding acceptance criteria and studies related to AI/ML performance (such as sample size, data provenance, expert ground truth, MRMC studies, standalone performance, and training set details) is not applicable to this 510(k) submission.
Therefore, I cannot populate the table or answer the specific questions related to AI/ML performance, as the provided document does not contain that type of information.
§ 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).