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Small Cannulated Screws (2.5mm - 4.0mm diameter) are intended for fixation of fractures and non-unions of small bones and small bone arthrodeses. Examples include, but are not limited to scaphoid and other carpal and phalangeal fusions, osteotomies, and bunionectomies.

Large Cannulated Screws (4.5mm – 7.5 mm diameter) are intended for fracture fixation of large bones and large bone fragments. Diameters 6.5 mm and larger are intended for large bone fragments such as slipped capital femoral epiphyses; pediatric femoral neck fractures; tibial plateau fractures; SI joint disruptions; intercondylar femur fractures; subtalar arthrodesis and fixation of pelvis and iliosacral joint.

Device Description

The OrthoPediatrics Cannulated Screw System is a cancellous screw system intended for the use in the fixation of bone fragments. The subject Cannulated Screw System is composed of cannulated screws offered in a variety of sizes and options to accommodate patient anatomy, as well as washers and associated instrumentation to facilitate or aid in placement of the subject screws. The cannulated design of these screws allows them to be used in combination with a guide wire, also included in this system, for precise placement into bone. The included Bone Screw Washers provide optional increased stabilization between the screw head and cortical bone. All subject screws and washers are manufactured from medical grade stainless steel per ASTM F138. All instruments are manufactured from stainless steel per ASTM F899, with the exception of the guide wires, which are manufactured from cobalt chrome per ASTM F562.

AI/ML Overview

This document does not describe an AI/ML powered device, therefore, the requested information elements related to AI/ML device performance and testing are not applicable.

The document describes the OrthoPediatrics Cannulated Screw System, a medical device for bone fixation. The provided text outlines the regulatory submission, intended use, device description, and a summary of technological characteristics compared to predicate devices to establish substantial equivalence.

Here's a breakdown of the requested information based on the provided text, indicating where information is not available due to the nature of the device (not an AI/ML product) or the submission type (510(k)):

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Non-Clinical Tests (Mechanical Properties)	The subject device was tested for mechanical properties relevant to bone screws. The specific acceptance criteria (e.g., minimum torque values, maximum pullout forces) are not explicitly stated in the summary. However, the reported performance indicates that: "Testing demonstrated the subject device to be substantially equivalent to predicate Synthes Cannulated Screws (K963172 and K012945) devices." This implies that the device met the performance levels expected to be equivalent to the predicate devices. Testing included: - Torque to Failure per ASTM F543 - Driving Torque per ASTM F543 - Axial Pullout per ASTM F543
MR Environment Compatibility	"The OrthoPediatrics Cannulated Screw System was evaluated for use in an MR Environment and were determined to be MR Conditional." (This indicates it met the criteria for MR Conditional labeling, though the specific criteria are not detailed in this summary.)

Acceptance Criteria

Reported Device Performance

Non-Clinical Tests (Mechanical Properties)

The subject device was tested for mechanical properties relevant to bone screws. The specific acceptance criteria (e.g., minimum torque values, maximum pullout forces) are not explicitly stated in the summary. However, the reported performance indicates that: "Testing demonstrated the subject device to be substantially equivalent to predicate Synthes Cannulated Screws (K963172 and K012945) devices." This implies that the device met the performance levels expected to be equivalent to the predicate devices. Testing included: - Torque to Failure per ASTM F543 - Driving Torque per ASTM F543 - Axial Pullout per ASTM F543

MR Environment Compatibility

"The OrthoPediatrics Cannulated Screw System was evaluated for use in an MR Environment and were determined to be MR Conditional." (This indicates it met the criteria for MR Conditional labeling, though the specific criteria are not detailed in this summary.)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: The document does not specify the sample size for the non-clinical mechanical tests. It only mentions the types of tests performed.
Data Provenance: The mechanical testing data would typically be generated in a lab setting, likely in the country of manufacture or a designated testing facility. The specific country or whether the data is retrospective/prospective is not mentioned. Given it's pre-market testing for a physical device, it would be considered prospective testing for the device's design.

3. 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)

This is not applicable as the device is a physical bone screw system, not an AI/ML diagnostic or predictive tool that requires expert-established ground truth for its performance evaluation in the context of this 510(k) submission. Mechanical testing relies on standardized test methods (e.g., ASTM standards) rather than expert consensus on data interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable for a physical device undergoing mechanical performance testing. Adjudication methods are relevant for studies involving human interpretation of data, such as in imaging or clinical trials.

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 is a physical medical device (cannulated screw system), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies are not relevant.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the mechanical performance data, the "ground truth" is established by adherence to standardized testing methods (e.g., ASTM F543) and quantifiable physical properties. There is no expert consensus, pathology, or outcomes data used as "ground truth" for the performance evaluation of the device itself in this submission. The "ground truth" for substantial equivalence lies in demonstrating that the mechanical properties are comparable to legally marketed predicate devices.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable. There is no training set for this type of device.

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