(98 days)
AutoStrut is indicated for the following treatments in adults, and in both children (3-12) and adolescents (12-21) in which growth plates have fused and will not be crossed with hardware:
- · fracture fixation (open and closed)
- · pseudoarthrosis of long bones
- · limb lengthening (epiphyseal or metaphyseal distraction)
- · joint arthrodesis
- · infected fractures or nonunions
- · correction of bony or soft tissue deformities
- · correction of segmental defects.
AutoStrut is comprised of six length-adiustable struts powered by a motor, a control system and software. The device is used in conjunction with the predicate DePuy Synthes MAXFRAME multi axial correction system (K161417), including all its parts and software but the MAXFRAME struts are substituted with the AutoStrut motorized struts.
The provided text is a 510(k) summary for the OrthoSpin AutoStrut device. It describes the device, its intended use, and its technological characteristics. Crucially, this document is a regulatory submission focused on demonstrating substantial equivalence to a predicate device, not on presenting a clinical study or detailed performance acceptance criteria in the manner typically seen for diagnostic AI/ML devices.
Therefore, many of the requested categories (such as sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or not available in this document, as the submission does not describe a study involving human or image-based diagnostic performance.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
Since this is a mechanical device rather than a diagnostic AI, the acceptance criteria relate to mechanical and electrical performance, biocompatibility, and sterilization, not diagnostic accuracy. The document mentions performance testing, but it does not provide specific acceptance criteria (e.g., "tensile strength must be >X Newtons") or detailed reported performance values in a tabular format. Instead, it makes general comparative statements.
| Acceptance Criteria Category | Reported Device Performance (as described in the document) |
|---|---|
| Sterilization Validation | Performed per ISO 11135 |
| Cytotoxicity Testing | Performed per ISO 10993-5 |
| Software Characterization and Validation | Performed |
| Electrical Safety Testing | Performed per IEC 60601-1 |
| EMC Testing | Performed per IEC 60601-1-2 |
| Static Compression, Torsion, Cantilever Bending | Performed per ASTM F1541; "performs at least as well as the MAXFRAME multi axial correction system." |
| Dynamic Compression/Tension Testing | Performed per ASTM F1541; "performs at least as well as the MAXFRAME multi axial correction system." |
| Extension Speed and Resolution | Performed; "accuracy and speed of adjustment is similar or better than the MAXFRAME strut." |
| Weight | Additional motors and components add 540g to the entire fixation system. |
2. Sample size used for the test set and the data provenance
Not applicable. This is not a study involving a test set of data (e.g., medical images, patient records). The performance data relates to mechanical and electrical testing of the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No ground truth based on expert consensus for a diagnostic output is involved.
4. Adjudication method for the test set
Not applicable. No diagnostic test set or adjudication process is described.
5. 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 device is an external fixation system, not a diagnostic AI tool, and thus no MRMC study was conducted or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm for diagnosis. Its "standalone" performance refers to its mechanical and electrical function. The document states that the AutoStrut's motorized adjustment "simply carries out the treatment plan generated by the same software as the predicate device," implying it functions as an automated executor of a plan, rather than a standalone diagnostic tool.
7. The type of ground truth used
For the mechanical and electrical tests conducted (e.g., static compression), the "ground truth" would be established by the physical properties and performance metrics defined in the ASTM and ISO standards themselves. It's objective, quantitative measurement, not expert consensus, pathology, or outcomes data in the clinical diagnostic sense.
8. The sample size for the training set
Not applicable. This is a mechanical device, not an AI/ML algorithm requiring a training set for model development.
9. How the ground truth for the training set was established
Not applicable. There is no AI/ML training set.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.