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510(k) Data Aggregation
(106 days)
G3¿ Active Plate**®** Large Fragment System
The G3™ Active Plate® Large Fragment system is intended for use in adult and pediatric (subpopulation: transitional adolescent B (18 years to
The subject G3™ Active Plate® Large Fragment System is a straight plate and locking screw system comprised of a variety of sizes to accommodate various patient anatomy and pathology. The plates and screws are intended to be used for long bone fracture fixation. All implantable components are manufactured from stainless steel (316L) and medical grade titanium alloy (Ti-6Al-4V-ELI). The screws are 5.0 mm diameter and come in lengths ranging from 14 to 145 mm. The plates range in size from 6 holes to 14 holes. The plates incorporate sliding elements, which are constrained within the plate and embedded in an elastomer sheath made from silicone that is bonded to the sliding element. Once locking screws are inserted, the active elements allow for independent controlled axial translation of the screws. All instruments are made from stainless steel.
Here's an analysis of the provided text, focusing on acceptance criteria and supporting studies for the G3™ Active Plate® Large Fragment System.
It's important to note that this document is a 510(k) summary for a medical device (bone fixation system), not an AI/software as a medical device (SaMD) submission. Therefore, many of the requested fields related to AI performance, ground truth, and expert evaluation are not applicable to this type of device and submission. The "device" in this context is a physical orthopedic implant.
Acceptance Criteria and Study Details for G3™ Active Plate® Large Fragment System
1. Table of Acceptance Criteria and Reported Device Performance
For a physical orthopedic implant like the G3™ Active Plate® Large Fragment System, performance is measured against established mechanical standards rather than typical statistical metrics like sensitivity/specificity for AI. The acceptance criteria are implicit in meeting or exceeding the performance of predicate devices or established ASTM standards.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Mechanical Performance: | |
| Stiffness (per ASTM F382 & F543 or equivalent) | "Mechanical testing, including stiffness... have been performed per ASTM F543 and ASTM F382 on the subject G3™ Active Plate® Large Fragment System... [and] have shown them to be substantially equivalent to the predicate plate and screw systems." Also, "the subject G3™ Active Plate® Large Fragment System has also demonstrated to be substantially equivalent in terms of construct stiffness performance when compared to the previously cleared reference devices K955848 and K962808." |
| Fatigue (per ASTM F382 & F543 or equivalent) | "Mechanical testing, including... fatigue... have been performed per ASTM F543 and ASTM F382 on the subject G3™ Active Plate® Large Fragment System... [and] have shown them to be substantially equivalent to the predicate plate and screw systems." Also, "the G3™ Active Plate® Large Fragment System has demonstrated to be substantially equivalent to the G3™ Active Plate Fragment System (K142938; S.E. 11/26/2014) in both fatigue and construct fatigue testing." |
| Pullout Strength (per ASTM F543 or equivalent, for screws) | "Mechanical testing, including... pullout... have been performed per ASTM F543 and ASTM F382 on the subject G3™ Active Plate® Large Fragment System, as well as the G3™ locking screws used within the system, have shown them to be substantially equivalent to the predicate plate and screw systems." |
| Torsion (for screws) | "Mechanical testing, including... torsion... have been performed per ASTM F543 and ASTM F382 on the subject G3™ Active Plate® Large Fragment System, as well as the G3™ locking screws used within the system, have shown them to be substantially equivalent to the predicate plate and screw systems." |
| Torque (for screws) | "Mechanical testing, including... torque... have been performed per ASTM F543 and ASTM F382 on the subject G3™ Active Plate® Large Fragment System, as well as the G3™ locking screws used within the system, have shown them to be substantially equivalent to the predicate plate and screw systems." |
| Wear (for elastomer sheath) | "Mechanical testing, including... wear have been performed per ASTM F543 and ASTM F382 on the subject G3™ Active Plate® Large Fragment System, as well as the G3™ locking screws used within the system, have shown them to be substantially equivalent to the predicate plate and screw systems." (Assuming 'wear' refers to the elastomer sheath's durability). |
| Biocompatibility | "In addition, a biocompatibility evaluation was conducted to demonstrate substantial equivalence to the predicate device." |
| Material Equivalence | The device uses "Titanium Alloy or Stainless Steel," which is "Identical" to the primary predicate material. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set): The document does not specify exact "sample sizes" in terms of number of devices tested. For mechanical testing, samples are typically a set number of devices (e.g., 6 or 12 per test condition) to allow for statistical comparison to failure criteria or predicate performance. This information is usually detailed in the full test report, not the 510(k) summary.
- Data Provenance: The studies are mechanical laboratory tests performed on physical devices, not human subject data. Therefore, concepts like "country of origin of the data" or "retrospective/prospective" do not apply.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
- Not Applicable. This is a physical device submission undergoing mechanical testing, not a diagnostic or AI device requiring expert-established ground truth from clinical images or data. Performance is measured against engineering standards and against predicate device performance.
4. Adjudication Method for the Test Set
- Not Applicable. As this is mechanical testing of a physical device, there is no expert adjudication process for the test set. Results are quantitative measurements interpreted against established standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- No. An MRMC study is relevant for diagnostic performance, typically for imaging or other interpretation tasks performed by human readers. This is a physical orthopedic implant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No. This refers to AI/software performance. This device is a physical bone fixation system.
7. The Type of Ground Truth Used
- Engineering Standards and Predicate Device Performance: For mechanical testing, the "ground truth" is typically defined by:
- ASTM Standards: Established specifications for mechanical properties (e.g., minimum fatigue strength, stiffness range).
- Predicate Device Data: Performance data from an already legally marketed, substantially equivalent device that the new device aims to match or exceed.
- Not Applicable to pathology, outcomes data, or expert consensus in the human health context.
8. The Sample Size for the Training Set
- Not Applicable. This concept is for AI/machine learning models. For a physical device, there isn't a "training set" in the same sense. Design and material selection are based on engineering principles and prior knowledge, not iterative training.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no "training set" for this physical device, this question is irrelevant.
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