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Extentrac provides traction, for the relief of a variety of conditions involving anatomical dysfunctions of the lumbar spine including: localized low back pain, peripheral radiation (radicular pain), protruding or herniated intervertebral discs, acute facet problems, degenerative disc disease.

Extentrac falls under the classification of a multipurpose physical therapy table whose components are constructed of welded, bolted, tubular (solid and hollow), or flat plate heavy gauge steel and high strength aluminum), plywood, vinyl, hydraulic cylinders, pump, motor, wires, solenoid valves, relays, and switches. EXTENTRAC has two major sections connected to each other through a pivot shaft arrangement: 1. A rectangular base platform (Bottom Section): - Its function is to support and provide the pivot means for the rotating top section. Extentrac's stationary patient foot platform, is integral with this base platform, and therefore does not rotate with the patient. It also provides the telescoping means enabling elevation of the top patient platform section (rotating/tilting assembly), to effect height accommodations and different treatment protocols. 2. Rotating/tilting patient platform (Top Section): - It consists of three individual, separated patient support cushions, mounted to a metal support sub-frame, through a pivot connection with the top end of the weighted base platform. The patient support sub-frame (immediately below patient cushions) has the upper 2/3th. of its length angled in a backwards direction. and at 30 degrees in relation to its lower 1/3th. This arrangement allows the upper torso support cushion to move downward 30 degrees. Extentrac's patient platform is designed to rotate about this pivot point.

The provided text does not contain information about acceptance criteria or a study proving the device meets them. The document is a 510(k) summary for a physical therapy table called "Extentrac," primarily focused on establishing substantial equivalence to a predicate device (AUTO-TRAC TABLE K844233) for its intended use of traction.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC study results, standalone performance, ground truth details, or training set information.

The document primarily describes:

• Intended Use: Traction for conditions involving anatomical dysfunctions of the lumbar spine, such as localized low back pain, peripheral radiation, protruding or herniated intervertebral discs, acute facet problems, and degenerative disc disease.
• Device Description: A multipurpose physical therapy table with two major sections (base platform and rotating/tilting patient platform) and various functional elements like underarm/shoulder supports, an upper torso cushion, lumbar support, calf/ankle support, and lift unit.
• Operation: Practitioner-controlled via a handheld keypad with switches for individual and combined table movements (lift, rotation, arm movement, lumbar support, leg/calf support).
• Substantial Equivalence: Claimed equivalence to the AUTO-TRAC TABLE based on intended use and similar design characteristics that enable active or passive traction.

No performance data, clinical study, or specific acceptance criteria for device efficacy or safety are presented in this document beyond the general statement of substantial equivalence to a legally marketed predicate device.

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