(30 days)
The Autogenesis™ Automator™2000, in conjunction with standard, commercially available circular and unilateral fixation devices, may be used to perform compression or distraction on long bones. The Automator™2000 may replace the CF Automator™ or manual distraction and compression devices where they are traditionally applied. Indications for such use include the following:
- the correction of bony or soft tissue deformities,
- limb lengthening by epiphayseal and metaphyseal distraction,
- bone thickening and/or lengthening of amputated stumps,
- fracture fixation (open or closed),
- pseudoarthrosis or non-union of long bones,
- correction of segmental bony or soft tissue defects.
Automator 2000 is a simple battery powered, motorized device used to accomplish precision distraction for the purpose of bone and soft tissue (re)generation. The programmable device is used as a component on commonly available external fixation frames. Specifically, the device accomplishes micro-adjustments of a telescoping rod, which, in turn, positions the external frames, and bone segments to which the frames are attached.
Autogenesis, Inc .: Automator 2000 - Acceptance Criteria and Study Details
The provided document describes the Autogenesis™ Automator 2000, a motorized device for precision distraction in bone and soft tissue regeneration, which is a modified version of the predicate device, the CF Automator. The submission focuses on demonstrating substantial equivalence to the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Predicate Device (CF Automator) Performance | Automator 2000 Performance | Compliance / Improvement |
|---|---|---|---|---|
| Power | Less power required than predicate device | Custom lithium pack (21V/14V), 3 weeks life | 9V battery (lithium/alkaline), 3.5 months/3.5 weeks life | Improved (Reduced power, longer life) |
| Precision | Maintain accuracy | 1/32 mm | 1/72 mm | Improved (Higher precision) |
| Motor Control | Provide precise micro-motion; higher torque, lower RPM | Stepper motor (0.36 deg step) | DC motor (5752:1 gear reduction) | Improved (Higher torque, better size, less power) |
| Housing & Enclosure | Compact, self-contained, robust, preclude RFI | Separately enclosed components (Delrin) | Single housing (machined aluminum) | Improved (Simplified installation, better protection) |
| Circuitry & Software Safety | Redundant self-diagnostic, circuitry controls, encoder verification, current monitoring, watchdog circuit, alarms | Existing for predicate device; complex for multiple units; IR communication for programming | Retained, simplified for single unit, switch-based programming | Retained/Simplified |
| Programming | Simplified programming | 14 rate settings, 7 rhythm settings | 7 rate settings, constant 1/360mm increment | Simplified |
| Axial Load Capacity | Handle increased axial load | 125 lbs | 250 lbs (175 lbs axial + 75 lbs side) | Improved (Increased capacity) |
| Impact Load Capacity | Accommodate impact loads on telescoping rod | Not specified | 50 lbs | Improved (Capacity added) |
| Electromagnetic Compatibility | Confirm compliance with standard IEC 60601-1-2 | Not specified | Complies (Confirmed by testing) | Complies |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" sample size or data provenance in the context of clinical studies for performance metrics. The testing described is primarily non-clinical performance testing to verify design requirements. The device is a "device modification" to an already cleared predicate, and the focus is on demonstrating that the modifications do not negatively impact safety or effectiveness.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable as the document does not describe a clinical study involving human assessment of device performance or the establishment of ground truth by human experts. The verification and validation activities are focused on engineering and performance parameters.
4. Adjudication Method for the Test Set
This is not applicable as there is no human-based assessment or diagnostic ground truth to adjudicate.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not performed. The submission describes non-clinical performance testing and technical comparisons to the predicate device, not a study evaluating human reader performance with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
A standalone algorithm performance study was performed indirectly through the non-clinical performance testing. The entire device, which includes the software algorithm for motor control, was tested to verify its performance against specified parameters like precision, torque, and power requirements. For example, "The motor chosen for Automator 2000 provides higher torque," and "The software algorithm for controlling the motor adjustments may demand a high level of precision for the telescoping rod adjustment. Automator 2000 maintains accuracy within 1/72 mm." This demonstrates standalone performance of the engineered system.
7. Type of Ground Truth Used
The ground truth used for the verification and validation (testing) described is based on engineering specifications and established performance standards. For example:
- Precision: Measured against a specified accuracy of 1/72 mm.
- Load capacity: Measured against specified axial loads (250 lbs) and impact loads (50 lbs).
- Power consumption: Measured against expected battery life.
- Compatibility: Compliance with standard IEC 60601-1-2 for EMC.
Essentially, the "ground truth" is the predefined design input requirements and benchmark performance of the predicate device.
8. Sample Size for the Training Set
This is not applicable. The Automator 2000 is a mechanical and electronic device with embedded software for control, not a machine learning or AI system that requires a "training set" in the conventional sense of data-driven model training. The software is designed based on engineering principles and tested for functionality.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the reasons stated in point 8. The "ground truth" for the device's operational parameters (e.g., motor control steps, error conditions) would have been established through engineering design, mathematical modeling, and previous experience with the predicate device, rather than through labeled data training.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.