(19 days)
The Autogenesis™ Automator™, in conjunction with standard, commercially available circular and unilateral fixation devices, may be used to perform compression or distraction on long bones. The Automator™ may replace Automator™ 2000 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.
Distraction osteogenesis is the process by which our bodies are able to "grow" bone and soft tissues at a fracture site if the bone fragments are gradually separated at a rate approximating 1 mm per day. The Automator 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.
Adjustment of external frames for bone positioning is presently performed with Automator 2000 or manual adjustment techniques. The Automator is a modified version of the Automator 2000. The device is physically smaller in size and weight while retaining the same basic design and safety features of Automator 2000. Additionally, the Automator's user interface has been enhanced to include an LCD and two control buttons. The upgraded interface makes additional rate settings available to the user. A programming option of cyclic motion was added to aid with pseudoarthrosis (non-union) healing.
Modifications to the predicate device include the devices housing, gearing, circuitry, software, and battery supply. The mechanical design of the Automator is very similar to the design of Automator 2000. The design modifications mostly involve miniaturization of Automator 2000.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Power Consumption | The Automator requires less power than Automator 2000, running equally long on 1/2AA lithium cells as its predecessor does on AA lithium cells. Expected battery life in the most common distraction mode is 6 months. |
| Precision | The Automator maintains accuracy within 1/64th mm for the telescoping rod adjustment. Its predecessor, Automator 2000, had an accuracy of 1/72mm, and an even earlier variant, CF Automator, had an accuracy of 1/32mm. The Automator can make adjustments in 1/384 mm increments for motor timing. |
| Motor Control | Uses the same DC Motor with a gear reduction ratio of 5752:1 as Automator 2000, resulting in high torque and slow RPM output. Motor timing allows for adjustments in 1/384mm increments. |
| Housing & Enclosure | More compact and lightweight than Automator 2000. Machined from aluminum, providing robust design for axial force and impact loads. Does not require a cap for switches, featuring an LCD and two control buttons for programming. |
| Circuitry & Software/Safety Features | Smaller circuit board than Automator 2000. Software modified for component changes, user interface, and additional programming selections. Retains the same self-diagnostic and circuitry controls as Automator 2000. Uses the final drive gear as an encoder to verify rod position, enters error mode with alarms if accuracy is not met. Checks current on motor circuit to verify motor runs only when intended and current is not higher than expected. Switches remain open between motor pulses. Incorporates a watchdog circuit for continuous software operation confirmation. Redundant audio and visual alarms. |
| Programmable Settings | Features 13 rate settings (compared to 7 for Automator 2000). Allows programming of total distraction with audible/visual alarm. Includes cyclical motion functionality for pseudoarthrosis healing. |
| Load on Telescoping Rod | Designed to handle the same axial load, alarming when resistance approximates 250 lbs. Accommodates impact loads of 50 lbs on the telescoping rod. |
Study Proving Device Meets Acceptance Criteria:
The document describes non-clinical performance testing and design validation activities to demonstrate that the Autogenesis Automator meets its acceptance criteria and is safe and effective, and substantially equivalent to the Automator 2000.
Details of the Study:
The Automator was designed in accordance with the design control guidance for medical device manufacturers published March 17, 1997. Multiple tests were conducted as part of the verification exercises during the product modification and design process.
- Sample size used for the test set and the data provenance: Not explicitly stated. The document refers to "multiple tests" and "design validation performed through dynamic testing of the device under variable loads, temperatures, and battery voltages." It doesn't specify the number of units tested or the origin of the test data (e.g., country). It is a retrospective summary of performed tests.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. This is a mechanical/electrical device performance study, not one requiring expert interpretation of human data.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. As above, this is not a study requiring human adjudication of results. The performance was confirmed through direct measurement and internal verification procedures.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not a study involving human readers or AI in an assistive capacity.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Yes, the described non-clinical performance testing and design validation were conducted on the device itself, representing its standalone performance. The software algorithm's accuracy (1/64th mm) and control over the motor were specifically tested.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth for the performance criteria was established through engineering specifications, design input requirements, and direct physical measurement of the device's output (e.g., motor torque, adjustment accuracy, load capacity, battery life). For software functionality, it was based on the intended logical operation and self-diagnostic capabilities.
- The sample size for the training set: Not applicable. This is not a machine learning or AI-driven system that requires a "training set" in the conventional sense. The development involved traditional engineering design, prototyping, and iterative testing.
- How the ground truth for the training set was established: Not applicable, as there was no training set. The design input requirements and specifications served as the baseline for the device's intended performance.
Specific Tests Performed (as outlined in the document):
The testing verified the following:
- Motor selection for sufficient torque.
- Motor power consumption efficiency.
- Motor output speed suitability for processor control and energy efficiency.
- Adequacy of two 1/2 AA lithium batteries for power.
- Reliability of the software algorithm to assure accuracy to 1/64th mm.
- Adequacy of all mechanical components for specified axial and impact loading.
- Integration and verification of all functions, error modes, and self-diagnostic procedures in the product's software and hardware.
Additionally, "traceability matrix was maintained to assure that all design input has been accomplished by the design of the device."
Design Validation:
Further design validation included dynamic testing of the device under variable loads, temperatures, and battery voltages. Life testing confirmed battery life expectancy and documented continuous error-free operation.
In conclusion, the study involved comprehensive non-clinical engineering and performance testing, as well as design validation, to ensure that the Autogenesis Automator met its specified design inputs and performed safely and effectively, demonstrating substantial equivalence to its predicate device, the Automator 2000.
§ 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.