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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

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.

1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. 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.
8. 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.

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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

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.

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