(379 days)
The LOADPRO™ Intraoperative Rod Strain Sensor is an intraoperative surgical tool that allows surgeons to measure unidirectional rod microstrain on posterior rods in the sagittal plane when performing spine surgery. This device is an adjunct to surgeon tactile feedback and is not intended to replace a surgeon's clinical judgment.
The LOADPRO™ Intraoperative Rod Strain Sensor is a single use, disposable tool to be used in conjunction with X-Spine Systems Fortex Pedicle Screw System for 5.5mm diameter titanium (ASTM F136) or cobalt chrome (ASTM F1537) rod configurations.
The LOADPRO™ Intraoperative Rod Strain Sensor includes a titanium/zirconia ceramic, single use strain sensing device, which includes radio-frequency identification (RFID) technology (13.56MHz), intended to enable access to strain measurement values, incorporating a passive transponder, inserter, and scanner (Figure 1 and 2). The transponder attaches to X-Spine Systems Fortex Pedicle Screw System using 5.5mm titanium alloy or cobalt chrome rods in corrective spinal surgeries (Figure 3). The transponder is used only to acquire rod microstrain values and a unique device identification code, which is read by the scanner, during the surgical correction.
The LOADPRO™ Intraoperative Rod Strain Sensor is a titanium/zirconia ceramic, ethylene oxide (EtO) sterilized, single use device designed to provide objective readings of the change of mechanical unidirectional strain on a pedicle screw rod. The LOADPRO™ Intraoperative Rod Strain Sensor consists of the following primary components, described in the proceeding sections:
- LOADPROTM Intraoperative Rod Strain Sensor ●
- . Hand Held Reader (scanner)
- . Manual Orthopaedic Surgical Instrumentation
Here's a breakdown of the acceptance criteria and the study information for the LOADPRO™ Intraoperative Rod Strain Sensor, based on the provided text:
Acceptance Criteria and Reported Device Performance
Note: The provided document does not explicitly present a "table of acceptance criteria and the reported device performance" in the format of a direct comparison for all performance metrics. Instead, it describes various tests and their successful outcomes against implied or stated criteria. The table below synthesizes the information available.
| Acceptance Criteria Category | Specific Acceptance Criteria (Implied/Stated) | Reported Device Performance |
|---|---|---|
| Rod Durability | Non-abrasive clamping, does not impact mechanical integrity of the rod or rod/screw construct fatigue life. | Dynamic Compression Bend Testing: No change between sensored and non-sensored rods after 15 installations/removals (runout to 5M cycles, equivalent to Fortex 510(k)). |
| Static Cantilever Bend Testing: No meaningful difference in strength and stiffness. | ||
| Sensor Limit Testing | Rod strain value > yield strain for each material (Ti > b strain, CoCr > b strain) when bridge sees 2000 u strain on the bridge. | Passed (implied by "The acceptance criterion requires the rod strain value..."). |
| Sensor Variability Testing | Measure strain linearly and are not load dependent; acceptable sensor-to-sensor resistance variability. | Resistance Variability: -50N: 9.9%, -100N: 6.2%, -150N: 5.8%, -200N: 5.2%. |
| Linearity: Graph "Sensor Sensitivity ASTM F1717 Testing Micro Strain Vs. Load" shows linear behavior (Average Slope y = 9.9569x, R^2 = 1). | ||
| Sensor Longevity Test | Accuracy of sensor when seated on the rod construct for 8 hours with strain readings recorded every hour. | Passed (implied by this being a "Test"). |
| Sensor Temperature Variability Test | Sensors will not dramatically change in strain value as the environmental temperature fluctuates within typical OR limits (65°F, 70°F, 75°F). | Passed (implied by this being a "Test"). |
| Reader Duration Test | Reader can function without battery change for the entire duration of a typical surgery (5 minute intervals up to 120 minutes of total scanning time). | Passed (implied by this being a "Test"). |
| Accuracy and Repeatability Testing | Accurately and repeatably measure load on a cantilevered rod (e.g., when the mounted strain gage recorded 1400 u-strain in Titanium and Cobalt/Chrome rods); microstrain reading errors |
§ 888.3090 Intraoperative orthopedic strain sensor.
(a)
Identification. A strain sensor device is an adjunct tool intended to measure strain on an orthopedic implant in the intraoperative setting only. The device is not intended to provide diagnostic information or influence clinical decision making.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance testing must be conducted:
(i) Mechanical testing to evaluate the effect of the device on the mechanical performance of the implant and to characterize the mechanical limits of the components used with the implant; and
(ii) Accuracy and repeatability testing of strain measurements.
(2) Usability testing must evaluate the effect of the device on the performance of the surgical procedure.
(3) The patient-contacting components of the device must be demonstrated to be biocompatible.
(4) Performance testing must support the sterility and shelf life of the patient-contacting components of the device.
(5) Software verification, validation, and hazard analysis must be performed.
(6) Performance data must validate the reprocessing instructions for reusable components of the device.
(7) Performance data must be provided to demonstrate the electromagnetic compatibility (EMC) and electrical safety of the device.
(8) Labeling must include the following:
(i) A shelf life;
(ii) Instructions for use;
(iii) Reprocessing instructions for any reusable components; and
(iv) A statement that the device is not intended to provide diagnostic information or influence clinical decision making.