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The OrthoNext™ Platform System is indicated for assisting healthcare professionals in preoperative planning of orthopedic surgery and post-operative planning of orthopedic treatment. The device allows for overlaying of Orthofix Product templates on radiological images, and includes tools for performing measurements on the image and for positioning the template. Clinical judgments and experience are required to properly use the software.

The subject OrthoNext™ Platform System is a web-based modular software system, indicated for assisting healthcare professionals in planning of orthopedic surgery and treatment both preoperatively and postoperatively, including deformity analysis and correction with several Orthofix products.
The subject software system is intended for use by Healthcare Professionals (HCP), with full awareness of the appropriate orthopedic procedures, in the operating theatre only.
The subject software functions are intended to inform the HCP on orthopedic procedure treatment planning when the Orthofix external or internal fixation systems are used. These functions are evidence-based tools that support HCP when considering treatment digital planning options for a patient. The software functions do not treat a patient or determine a patient's treatment.
The software enables the HCP to import radiological images, display 2D views (frontal and lateral) of the radiological images, overlay the positioning of the template and simulate the treatment plan option, and to generate parameters and/or measurements to be verified or adjusted by the HCP based on their clinical judgment.

Here's a breakdown of the acceptance criteria and the study details for the OrthoNext Platform System, based on the provided document:

Acceptance Criteria and Device Performance

The OrthoNext Platform System was evaluated for measurement accuracy and an AI/ML algorithm's performance for automatic marker detection.

Table of Acceptance Criteria and Reported Device Performance

• Mean error: 0.1 mm for linear measurements, 0.05 degrees for angular measurements.
• Mean percentage error: 0.24% (threshold 0.27% within 95th percentile) for linear measurements, 0.08% (threshold 1% within 95th percentile) for angular measurements.

For measurements made using mechanical axes:

• Mean error: 0.4 mm for linear measurements, 0.06 degrees for angular measurements.
• Mean percentage error: 1.73% (threshold 16.67% within 95th percentile) for linear measurements, 0.28% (threshold 1.27% within 95th percentile) for angular measurements. |
  | Sensitivity of Measurements | Not explicitly stated as a separate acceptance criterion, but device performance reported. | 1 mm for linear measurements, 1 degree for angular measurements. |
  | Specificity of Measurements | Not explicitly applicable as a direct acceptance criterion due to manual nature. | The device requires active user involvement for each measurement, relying on user expertise. |
  | AI/ML Algorithm Accuracy | Not explicitly stated as an isolated acceptance criterion, but reported. | 0.8 |
  | AI/ML Algorithm Specificity | Goal: zero false positives in the test set, resulting in a precision of 1. | 1 (Precision) |
  | AI/ML Algorithm Sensitivity | Not explicitly stated as an isolated acceptance criterion, but reported. | 0.75 (TPR/Recall) |
  | AI/ML Algorithm FPR | Not explicitly stated as an isolated acceptance criterion, but reported. | 0 |
  | AI/ML Algorithm F1 Score | Not explicitly stated as an isolated acceptance criterion, but reported. | 0.86 |
  | AI/ML Algorithm Intersection over Union (IoU) | Not explicitly stated as a direct acceptance criterion, but reported. | 79% |
  | AI/ML Algorithm Center MAE | Not explicitly stated as a direct acceptance criterion, but reported. | 4.83 px |
  | AI/ML Algorithm Center MAPE | Not explicitly stated as a direct acceptance criterion, but reported. | 0.38% |
  | AI/ML Algorithm Radius MAE | Not explicitly stated as a direct acceptance criterion, but reported. | 1.29 px |
  | AI/ML Algorithm Radius MAPE | Satisfying 3% Radius MAPE. | 3% Radius MAPE, contributing to an error of less than 1 mm. |

Study Details: Magnification Marker Detection Algorithm

The document focuses on the performance testing for the magnification marker detection algorithm, which is an AI/ML component of the OrthoNext Platform System.

1. Sample size used for the test set and the data provenance:

   • Sample Size: 1000 X-ray images. Of these, 800 images depicted a magnification marker, and 200 images did not.
   • Data Provenance: The test set consisted of real X-ray images. The document does not specify the country of origin of the data or whether it was retrospective or prospective. It only states that these images were "not used during training, ensuring independence."

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Number of Experts: Not explicitly stated. The document mentions "qualified personnel" were used for the truthing process.
   • Qualifications of Experts: "Qualified personnel" are mentioned, but specific qualifications (e.g., radiologist with X years of experience) are not provided.

3. Adjudication method for the test set:

   • The document describes a "review and discard process" implemented to ensure the quality of the annotations, but it does not specify an adjudication method like "2+1" or "3+1". This suggests a quality control step for annotations rather than a formal consensus process among multiple readers for ground truth establishment.

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:

   • No MRMC comparative effectiveness study was done or reported in this document. The study evaluates the standalone performance of the AI/ML algorithm for magnification marker detection, not its impact on human reader performance.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Yes, a standalone performance evaluation of the AI/ML algorithm for magnification marker detection was explicitly done and reported. The performance metrics (Precision, Accuracy, TPR/Recall, FPR, F1 Score, IoU, MAE, MAPE) are all indicative of standalone algorithm performance.

6. The type of ground truth used:

   • Expert Consensus (Annotation): The ground truth was established through a "truthing process... conducted by qualified personnel, who carefully overlaid a circular shape on each magnification marker using annotation software."

7. The sample size for the training set:

   • Training Set Composition: 1500 X-ray images with random areas depicting magnification markers.
   • These 1500 magnification markers were randomly overlaid on top of 4000 X-ray images.
   • Image augmentation techniques (random rotations, brightness adjustments) generated 24,000 unique X-ray images for training.

8. How the ground truth for the training set was established:

   • The training set involved synthetic images. Specifically, "1500 X-ray images with random areas depicting magnification markers" were created, and these markers were "randomly overlaid on top of 4000 X-ray images." Image augmentation was then applied. This suggests that the ground truth for the training set markers was generated as part of the synthetic image creation process (i.e., the location and characteristics of the overlaid markers were known by design). A "hash check" was used to ensure the uniqueness of these synthetic images.

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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)

• 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):

1. 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.

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 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.

3. 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.

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:

   • 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.

5. 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.

6. 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.

7. 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.

8. 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.

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The Sequel Ring Fixation System is indicated for both adults and pediatric patients for:

1. Open and closed fracture fixation
2. Pseudoarthrosis or non-union of long bones
3. Limb lengthening by epiphyseal or metaphyseal distraction
4. Correction of bony or soft tissue deformities
5. Correction of segmental or nonsegmental bony or soft tissue defects
6. Post-Traumatic joint contracture which has resulted in loss of range of motion

The Sequel® External Fixation System is a single-use modular external fixator consisting of implantable half pins and fixation wires and non-patient contact rings, struts, telescoping rods, threaded rods, posts, hinges, connection plates, twisted plates, threaded sockets, bolts, washers and nuts that are combined by the health care professional to construct different frame configurations based on patient anatomy and indicated use. The frame forms the support metalwork for the torsion wire used in fracture fixation and several other indications for long bone fixation procedures. The Subject device includes additional components (tabbed rings and struts) compared to the primary predicate. The tabbed rings and struts are substantially equivalent to the tabbed rings and struts in the secondary predicates. Special wrenches and accessories are included for the proper assembly of the components. The components of the frame are manufactured from titanium, stainless steel, and aluminum.

The provided FDA 510(k) summary for the Sequel External Fixation Device (K202833) does not describe acceptance criteria for an AI/CADe device or a study demonstrating such criteria.

This document pertains to a medical device (external fixation system), not an AI or CADe product. The information included in the summary focuses on demonstrating substantial equivalence to predicate devices through comparisons of:

• Intended Use and Indications for Use
• Technological Characteristics (materials, operating principle, components)
• Performance Testing (biocompatibility and bench testing in accordance with ASTM F1541-17, sterilization validation in accordance with ISO 17665-1:2006 and ISO/TS 17665-2:2009).

Since this is a filing for a physical medical device and not an AI/CADe system, the requested information regarding AI/CADe acceptance criteria, study details, ground truth, sample sizes for test/training sets, experts, and MRMC studies is not applicable and therefore not present in the provided text.

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