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The Free-Gliding SCFE Screw System is indicated as a temporary implant for stabilization of pediatric femoral neck fractures and slipped capital femoral epiphysis (SCFE) in all pediatric patients (less than or equal to 21 years old) with the exclusion of newborn and infants under 2 years of age.

The Free Glidinq SCFE Screw is a self-extending cannulated screw for use in fixation of slipped capital femoral epiphysis and femoral neck fractures. The design of the screw includes a male component (which is attached to the lateral cortex) and a female component (which is attached at the proximal epiphysis). Anchorage of the components is achieved through screw-type fixation. The screw has a built-in feature that allows for free extension of its length as the slipped capital physeal plate heals and normal patient growth continues. Stable fixation and rotational stability is created at the fracture (slip) site while avoiding compression forces thus avoiding premature closure of the physeal plate.

Here's an analysis of the provided text regarding the acceptance criteria and study for "The Free-Gliding SCFE Screw System":

1. Table of Acceptance Criteria and Reported Device Performance

Important Note: The document explicitly states "No clinical testing is provided as a basis for substantial equivalence." This means that acceptance criteria for clinical outcomes (e.g., success rates, complication rates in patients) were not established or met through a clinical study for this device's 510(k) clearance. The substantial equivalence was based solely on non-clinical (biomechanical) testing and comparison to predicate devices.

Here's the breakdown of the other requested information, based on the provided document:

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size (Test Set): Not specified for the biomechanical tests. The document refers to "tests" but does not detail the number of samples tested for each biomechanical assessment (e.g., number of screws for four-point bending, torsional strength, or pullout strength).
• Data Provenance: The biomechanical testing was performed in Canada by Pega Medical Inc. (the applicant). This is an in-vitro (laboratory) study, not a human retrospective or prospective study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Not Applicable. Since this was a biomechanical (engineering) study, the "ground truth" was established by objective physical measurements according to specified ASTM standards and engineering analyses, not by expert consensus on clinical data.

4. Adjudication Method for the Test Set

• Not Applicable. No human-based adjudication was involved, as it was a biomechanical study.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. No MRMC study was conducted. The device is a physical implant, not a diagnostic imaging or AI-assisted system that would involve human readers.

6. Standalone (Algorithm Only Without Human-in-the Loop Performance) Study

• Not Applicable. This is a physical medical device (screw system), not an algorithm or AI system.

7. The Type of Ground Truth Used

• Objective Mechanical Measurements: The ground truth for the biomechanical tests was based on objective measurements of physical properties (e.g., force, displacement, torque) as prescribed by ASTM F1264 and standard engineering principles. The comparison was made against the measurements obtained from predicate devices.

8. Sample Size for the Training Set

• Not Applicable. This is a physical medical device. There is no concept of a "training set" as understood in machine learning or AI.

9. How the Ground Truth for the Training Set Was Established

• Not Applicable. As there is no training set, this question is not applicable.

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The Hansson™ Pin System is intended for use in the temporary stabilization of types of fractures of the proximal femur. The subject device is indicated for fixation of proximal femoral fractures including but not limited to:

• Intracapsular fractures of the femoral neck such as Transcervical and Subcapital Neck . Fractures
• Basal Neck Fractures .
• Slipped Capital Femoral Epiphysis (in pediatric patients) .

The Hansson" Pin is a hip fracture system designed to treat various types of fractures of the proximal femur. This premarket notification is a line extension to modify the existing Hansson™ Pin System, which was cleared via K964893. The indications for use are being expanded to include additional types of proximal femoral fractures. Also, several dimension changes have been made to the predicate device's outer sleeve to improve the deployment and removal of the inner pin. In addition, the Hansson" Pin will also be fabricated from Titanium Alloy and an end cap will be added to the product line.

This document is a 510(k) premarket notification for the Hansson™ Pin System, a hip fracture fixation device. The notification describes a line extension to modify the existing system, expanding its indications for use and making minor design changes.

Here's an analysis of the provided text in relation to your questions:

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

The provided 510(k) summary does not contain acceptance criteria or performance data from a study. 510(k) submissions typically demonstrate substantial equivalence to a predicate device, meaning they show the new device is as safe and effective as a legally marketed device, often through
comparison of technological characteristics or non-clinical performance data (e.g., mechanical testing). This particular document focuses on expanding indications and design changes, and relies on the substantial equivalence to the previously cleared Hansson Pin System (K964893) and the ASNIS II & III Cannulated Bone Screws.

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

There is no information provided in this document regarding a test set sample size or data provenance for a study.

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)

There is no information provided about experts, ground truth, or a test set in this document.

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

There is no information provided about an adjudication method or a test set in this document.

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

This document describes a medical device (a pin system for hip fracture fixation), not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and not mentioned.

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

This document describes a medical device, not an algorithm. Therefore, a standalone algorithm performance study is not applicable and not mentioned.

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

Since no study with a "test set" is described, there is no information provided regarding the type of ground truth used. The 510(k) process for devices like this typically relies on established engineering principles, biocompatibility testing, mechanical testing (e.g., fatigue, tensile strength), and comparison to predicate devices, rather than clinical ground truth from human data in the way an AI diagnostic would.

8. The sample size for the training set

There is no information provided about a training set sample size, as this document does not describe the development or validation of an algorithm or AI model.

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

There is no information provided about how ground truth for a training set was established, as this document does not describe the development or validation of an algorithm or AI model.

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