(53 days)
The OrthoPediatrics Orthex External Fixation System is intended for external fixation with the following indications:
- Stabilization of Fractures & Osteotomy
- Rear and Mid-foot Foot Arthrodesis
- Adult and Pediatric Leg Lengthening
- Correction of Bone Deformity in Upper & Lower Extremities
The P&C Software is intended to be used as a component of multilateral external fixations listed above.
The OrthoPediatrics Orthex External Fixation System is an external fixator which includes typical components such as rings, partial rings, footplates, monolateral rails, and numerous hardware necessary for the construction of a frame to which tensioned wires and half pins are attached to the bone and to the frame itself. The system has an optional software to assist the user in adjusting the hexapod.
The components included in external fixation systems are made from various types of metal and plastic materials. Half pins and wires are manufactured from implant grade materials and are non-pyrogenic. External fixation components and implants are for single use only and not designed or sold for any use except as indicated.
The web-based Orthex Point and Click (P&C) Software aids the surgeon in the use of the Orthex External Fixation System. The software is optional to use. The Orthex Point and Click (P&C) Software does not control any hardware (such as rings, struts, wires, half pins) directly. The Point and Click (P&C) Software is only compatible with the Orthex External Fixation System. It can be accessed at www.orthex.net. The Pre-Operative planning function of the software aids the surgeon in pre-operative deformity analysis which includes determining where an osteotomy will be made, visualizing corrections, and planning for hexapod construction by positioning rings and calculating the initial strut lengths in preparation for frame application. The Post-Operative planning function of the software aids the surgeon in producing a strut length schedule to achieve the desired correction. The patient or caregiver manually adjusts the struts according to the strut length schedule.
This document is a 510(k) Premarket Notification from the FDA regarding the OrthoPediatrics Orthex External Fixation System. It grants clearance for the device based on its substantial equivalence to a predicate device.
The prompt requires information about acceptance criteria and a study that proves the device meets them, specifically for a software component ("P&C Software"). However, this document primarily discusses the hardware aspects and the software's role as an optional component. It states that the key updates to the software relate to adding a pre-operative planning function, changing schedule output formatting, and improving X-ray page functionality. The most significant software-related change mentioned is the re-addition of the "Rear and Mid-foot Foot Arthrodesis" indication to the software, as the software now includes the necessary modules and icons.
Crucially, this document does not describe any specific clinical study demonstrating accuracy or clinical effectiveness for the software. Instead, it relies on:
- Substantial Equivalence: The primary argument is that the device (hardware and updated software) is substantially equivalent to a previously cleared predicate device.
- Verification and Validation (V&V) Testing: It broadly states, "The safety and effectiveness of all the updates made to the software since its initial clearance have been successfully verified and validated. The software documentation including the verification and validation testing support that the subject software has met applicable design requirements established based on their intended use."
Given this, I cannot provide detailed answers to many of the sub-questions as they pertain to clinical or performance studies that are not described in this document. The V&V testing mentioned is typically internal engineering testing, not a comparative effectiveness study with human readers or standalone performance data in the way implied by the questions.
Therefore, the following table and explanations reflect what can be inferred or directly stated from the provided text, and where information is not present.
Acceptance Criteria and Device Performance (Based on available information)
| Acceptance Criteria | Reported Device Performance (Summary from Document) |
|---|---|
| Software Functional Performance (Implicitly, that the software performs its intended functions correctly) | "The safety and effectiveness of all the updates made to the software since its initial clearance have been successfully verified and validated. The software documentation including the verification and validation testing support that the subject software has met applicable design requirements established based on their intended use." This includes: |
- Pre-operative planning function
- Changing schedule outputs formatting
- Improved X-Ray pages' functionality
- Inclusion of foot and ankle modules/icons to support "Rear and Mid-foot Foot Arthrodesis" indication. |
| Safety (Hardware, MR Environment) (Explicitly for hardware) | "The Orthex External Fixation System is MR unsafe" due to ferromagnetic materials. |
| Substantial Equivalence (Overall regulatory criterion) | "The Orthex External Fixation System is as safe and effective as the predicate device." |
Study Details (As much as can be gleaned from the document):
-
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not specified. The document mentions "verification and validation testing" but does not detail a test set in terms of patient data or clinical cases. This testing is likely internal engineering and functional testing of the software itself and its algorithms, rather than a clinical study with a patient data test set.
-
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 specified. Ground truth establishment, if any, for software function would likely be based on engineering specifications or perhaps orthopedic surgical principles, not necessarily expert adjudication of clinical cases as would be done for an AI diagnostic device.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified. This pertains to clinical studies often involving AI, which is not detailed here.
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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:
- No such study is described. The document indicates the software "aids the surgeon" and "is optional to use." It explicitly states, "The P&C Software is intended to be used as a component of multilateral external fixations listed above," implying an assistive role. However, no MRMC study or data on human reader improvement with or without AI assistance is provided.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No standalone performance study is explicitly described in terms of clinical accuracy. The "verification and validation testing" would represent internal standalone performance assessments against design requirements, but not typically a stated accuracy metric like AUC or sensitivity/specificity for a diagnostic AI. The software's role is assistive, not a standalone diagnostic.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not explicitly stated for a clinical ground truth. For the software's functionality, ground truth would be based on engineering specifications, mathematical models for hexapod adjustments, and established orthopedic principles for deformity correction and planning.
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The sample size for the training set:
- Not applicable / Not specified. This device's software is described as tool-based (calculating strut lengths, pre-operative planning) rather than a machine learning model that requires a "training set" in the conventional sense of deep learning or AI. It seems to be based on deterministic algorithms.
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How the ground truth for the training set was established:
- Not applicable / Not specified. As it does not appear to be an AI/ML model with a "training set," this question is not relevant based on the information provided. Its "ground truth" would be the mathematical correctness of its calculations and the accurate representation of orthopedic planning principles.
§ 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.