(180 days)
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
| Acceptance Criteria (from predicate devices) | Reported Device Performance |
|---|---|
| Mechanical Performance: Comparability in Static and Fatigue four-point bending tests based on ASTM F1264. | Comparable Mechanical Performance: The device demonstrated "comparable mechanical performances" to the predicate device in direct side-by-side testing for Static and Fatigue four-point bending tests (ASTM F1264). |
| Torsional Strength: Exceed predicate device. | Exceeds Predicate (with margin): Engineering analysis demonstrated "strengths that exceed those of the predicate device with a significant margin of safety." |
| Screw Pullout Strength: Exceed predicate device. | Exceeds Predicate (with margin): Engineering analysis further demonstrated "strengths that exceed those of the predicate device with a significant margin of safety." |
| Functional Equivalence: Similar in design and function to predicate devices. | Functionally Equivalent: Stated that "The technological characteristics of the Free Gliding SCFE Screw System are equivalent or similar to those of the predicate devices." |
| Safety and Effectiveness: Demonstrated through testing. | Safety and Effectiveness: "These tests demonstrated comparable mechanical performances...in order to establish safety and effectiveness." |
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.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.