(47 days)
THE TILTMASTER KIT DESIGN IS INTENDED FOR USE ON A POWER AND MANUAL WHEELCHAIR TO PROVIDE PATIENTS WITH POSTERIOR TILT FOR POSITIONING AND SEATING PRESSURE RELIEF.
THE TILT MASTER CG SYSTEMS (CENTER OF GRAVITY), IS AN AFTERMARKET KIT CONSISTING OF A LINEAR ACTUATOR WITH 900 POUNDS CAPACITY, ALUMINUM AND STEEL BRACKETS, WIRING HARNESS TO SUPPLY VOLTAGE TO THE ACTUATOR, AND A MERCURY SWITCH DRIVER LOCKOUT WHICH RENDERS THE WHEELCHAIR INOPERABLE WHEN TILTED BEYOND 15 DEGREES. THE CG SYSTEM KIT IS DESIGNED TO CONVERT A POWERED OR MANUAL STANDARD WHEELCHAIR TO A POWER RECLINE. THE TILT MASTER CG SYSTEM USES A CENTER OF GRAVITY DESIGN TO MOVE THE PATIENTS CENTER OF GRAVITY FORWARD 6" AS THE SYSTEM TILTS. THIS PROVIDES ADDED SECURITY WHEN IN THE TILTED POSITION. THE TILT MASTER CG SYSTEM ALLOWS THE USER TO HAVE 5 TO 55 DEGREE RANGE OF TILT. THE TILT MASTER CG SYSTEM IS DESIGNED SO IF ANY CATASTROPHIC FAILURE OCCURS WHILE THE SEAT IS IN THE TILT POSITION, THE SAFETY NUT ON THE ACTUATOR WILL ALLOW THE DRIVER TO PUT THE SEAT BACK ON THE DRIVE POSITION AND WILL DISABLE THE TILT MECHANISM. THE DRIVER WILL BE UNABLE TO PUT THE SYSTEM IN THE TILT POSITION ONCE THIS OCCURS.
The provided document is a 510(k) premarket notification for the "TILT MASTER CG SYSTEMS (CENTER OF GRAVITY)" and primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study demonstrating performance against those criteria.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies is not available in the provided text.
The document states "NON CLINICAL TESTING: PLEASE REFER TO THE FOLLOWING ATTACHMENT," indicating that the actual performance study details were provided in a separate attachment, which is not included in the provided text. The text only mentions the device's technical characteristics and intended use.
Based on the provided text, the following information can be extracted/inferred:
- Device Name: TILT MASTER CG SYSTEMS (CENTER OF GRAVITY)
- Intended Use: To provide power recline for posterior tilt for positioning and seating pressure relief on power or manual standard wheelchairs.
- Technological Characteristics Comparison (to E&J System - a predicate device):
- TILT MASTER CG SYSTEM has a 6" linear motion (vs. 3" for E&J).
- TILT MASTER CG SYSTEM uses an oil light bearing roller through a trough means (vs. rolls on cam means for E&J).
- TILT MASTER CG SYSTEM uses a "higher quality made actuator by LINAK which also has an extra 2 year warranty" (vs. actuator by Motion for E&J).
- TILT MASTER CG SYSTEM includes a padded contoured back and headrest.
- Safety Feature: A mercury switch driver lockout renders the wheelchair inoperable when tilted beyond 15 degrees. If a catastrophic failure occurs while tilted, a safety nut on the actuator allows the seat to be put back on the drive position and disables the tilt mechanism.
- Tilt Range: 5 to 55 degrees.
Therefore, a table of acceptance criteria and reported device performance, and details about the study proving it, cannot be generated from the given text. The document focuses on the description of the device and its intended use for regulatory clearance.
§ 890.3860 Powered wheelchair.
(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).