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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 Synthes 7.3 mm Cannulated Slipped Capital Femoral Epiphysis Screws are intended for fracture fixation of large bones and large bone fragments including femoral necla fractures; slipped capital femoral epiphyses; tibial plateau fractures; ankle arthrodeses; pediatric femoral neck fractures; intercondylar femur fractures; SI joint disruptions; and subtalar arthrodeses.

The Synthes 7.3 mm Cannulated Slipped Capital Femoral Epiphysis Screws (SCFE) have a cannulated shaft, are self-tapping with a cancellous thread that can be guided into position via a 2.8 mm guide wire, and range in overall lengths from 45 mm - 130 mm, and have 10 mm and 20 mm thread lengths. Oval washers of 1 mm and 2 mm are also available to use with the screws for precise depth placement in bone. The screws and washers are available in stainless steel.

I am sorry, but the provided text is a 510(k) summary and associated FDA correspondence for a medical device (Synthes 7.3 mm Cannulated Slipped Capital Femoral Epiphysis Screws). This type of document focuses on establishing substantial equivalence to a predicate device based on similar design, materials, and intended use, rather than presenting a performance study with acceptance criteria and detailed quantitative results as would be typical for an AI/algorithm-based device.

Therefore, the requested information for acceptance criteria, device performance, sample sizes, expert qualifications, ground truth, and comparative effectiveness studies is not present in this document. This document does not describe a study that uses AI or an algorithm.

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The I.T.S. Epiphysis Screw is a titanium implant fracture fixation screw system for a slipped femoral capital epiphysis and alternative cancellous bone screw fixation where accurate screw placement is required such as in the pelvis, ankle, knee, etc.,

Indications for Use include fracture fixation of large bone fragments, such as femoral neck fractures; slipped capital femoral epiphysis; tibial plateau fractures; pediatric femoral neck fractures; intercondylar femur fractures; and subtalar arthrodeses.

The system is not intended for spinal use.

The I.T.S. Epiphysis Screw is a self-tapping and self-drilling screw with a cancellous thread that can be guided into a position via a guidewire pin. Screws are available partially threaded in lengths from 50mm to 120mm in 5mm increments. A full complement of instrumentation is available to assist in placement. The screws are manufactured from 6-4 ELI Titanium alloy with a Tiodize, Type II surface.

Here's an analysis of the provided text regarding the acceptance criteria and study for the I.T.S. Epiphysis Screw:

Missing Information:

It's important to note that the provided documents are a 510(k) summary and an FDA clearance letter. These documents primarily focus on demonstrating substantial equivalence to a predicate device rather than detailing specific performance studies with acceptance criteria in the manner you've requested for a clinical trial or AI device validation. Most of the information you've asked for (such as MRMC studies, sample sizes, ground truth establishment, expert qualifications, and detailed performance metrics beyond basic equivalence) is not present in these regulatory documents.

The 510(k) process for this type of device (a bone screw) relies heavily on comparing the new device's design, materials, and intended use to existing, legally marketed predicate devices to show that it is "substantially equivalent" and thus as safe and effective. It does not typically involve the kind of rigorous, quantitative human-in-the-loop or standalone performance studies with detailed acceptance criteria that are characteristic of, for example, diagnostic imaging AI.

Here's a breakdown of what can be extracted or inferred, and what is explicitly unobtainable from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided documents, explicit acceptance criteria and corresponding reported device performance as numerical metrics (e.g., sensitivity, specificity, accuracy) are NOT available.

For a device like a bone screw, "acceptance criteria" in the context of a 510(k) are typically met by demonstrating:

• Substantial Equivalence: The device is as safe and effective as a legally marketed predicate device. This is the primary "acceptance criterion" for 510(k) clearance.
• Biocompatibility: The materials used are biologically safe.
• Mechanical Performance: The device meets certain strength, fatigue, and other engineering specifications (often tested in-vitro).
• Sterility: The device can be sterilized and maintained as sterile.
• Labeling: Clear instructions for use and warnings are provided.

The provided text focuses on the conclusion of substantial equivalence, not the detailed test results against specific criteria.

Study Details (Based on the provided documents)

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: Not applicable/not provided. This type of 510(k) submission for a bone screw does not typically involve a patient "test set" in the way a diagnostic AI device would. Performance is demonstrated through engineering tests (which are not detailed here) and comparison to predicate devices.
• Data Provenance: Not applicable/not provided.

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)

• Not applicable/not provided. Ground truth establishment with experts is not part of this type of 510(k) submission.

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

• Not applicable/not provided.

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

• No. An MRMC comparative effectiveness study is not relevant or performed for a bone screw. This type of study is typically for diagnostic devices or AI applications where human interpretation is a factor.

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

• No. This is a physical bone screw, not an algorithm. Standalone performance studies are not applicable.

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

• Not applicable in the context of a "ground truth" for a patient test set. The "ground truth" for this device's safety and effectiveness relies on established engineering principles, material science, clinical consensus for predicate devices, and in-vitro testing for mechanical properties (not detailed here).

8. The sample size for the training set

• Not applicable/not provided. This device is not an AI algorithm requiring a training set.

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

• Not applicable/not provided.

Summary of what the documents do provide:

• Device Name: Epiphysis Screw
• Manufacturer: I.T.S. Implantat-Technologie-Systeme GmbH. (AUSTRIA)
• Device Description: Self-tapping, self-drilling, cannulated bone screw from 6-4 ELI Titanium alloy with Tiodize, Type II surface. Available in lengths 50mm-120mm.
• Intended Use: Stabilize slipped capital femoral epiphysis and fracture fixation in the pelvis of large bones and large bone fragments. Specific indications include: femoral neck fractures; slipped capital femoral epiphysis; tibial plateau fractures; pediatric femoral neck fractures; intercondylar femur fractures; and subtalar arthrodeses. Not intended for spinal use.
• Predicate Devices: Synthes 6.5mm Cannulated Screw (K021932), Howmedica Osteonics ASNIS III Cannulated Screw (K000080), Orthomet/Wright Medical Cannulated Screw (K862157), Ace/Depuy Cannulated Self Tapping Cancellous Bone Screw (K903810), Zimmer MAGNA-Fx Cannulated Screw Fixation system, Richards/Smith Nephew Universal Cannulated Screw, DePuyAce ACE SCFE Screw.
• Regulatory Conclusion: FDA found the device "substantially equivalent" to the predicate devices and cleared it for marketing.

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