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510(k) Data Aggregation
(48 days)
The system is intended for use in adult and pediatric (subpopulation: transitional adolescent B (18 years to
The 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 medical grade titanium alloy (Ti6Al4V-ELI) and silicone elastomer in the subject device. 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 a silicone elastomer sheath that is bonded to both the plate and 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.
The provided text describes a 510(k) premarket notification for the G3™ Active Plate® Large Fragment System, a medical device for bone fixation. However, it does not contain the specific detailed information typically found in a study proving the device meets particular acceptance criteria, especially for AI/ML device performance.
The document primarily focuses on establishing substantial equivalence to predicate devices based on intended use, material, geometry, and mechanical testing (stiffness, fatigue, pullout, torsion, torque, construct fatigue, and wear) according to ASTM F543 and ASTM F382. It also notes biocompatibility evaluation per ISO 10993-1.
Therefore, many of the requested elements for an AI/ML device's acceptance criteria and study cannot be extracted from this document, as it outlines a submission for a traditional mechanical medical device, not an AI/ML product.
I will fill in the table and address the questions to the best of my ability based on the provided text, indicating where information is not present.
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document describes mechanical performance testing to demonstrate substantial equivalence, rather than traditional "acceptance criteria" with specific thresholds for sensitivity, specificity, or other AI/ML metrics. The performance is assessed against predicate devices.
| Acceptance Criterion (implicitly by substantial equivalence) | Reported Device Performance |
|---|---|
| Mechanical Performance: | |
| Stiffness (per ASTM F543 & F382) | "demonstrated to be substantially equivalent in terms of construct stiffness performance when compared to the previously cleared Zimmer MotionLoc™ Screws for NCB® Locking Plate System" |
| Fatigue (per ASTM F543 & F382) | "G3™ Active Plate® Large Fragment System has demonstrated to be substantially equivalent to the Synthes LCP Plate (K05186; S.E. 9/8/2005) in construct fatigue testing." |
| Pullout (per ASTM F543) | "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 and the results have shown them to be substantially equivalent to the predicate plate and screw systems." (Specific quantitative equivalence not provided, only statement of substantial equivalence). |
| Torsion (per ASTM F543) | "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 and the results have shown them to be substantially equivalent to the predicate plate and screw systems." (Specific quantitative equivalence not provided, only statement of substantial equivalence). |
| Torque (per ASTM F543) | "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 and the results have shown them to be substantially equivalent to the predicate plate and screw systems." (Specific quantitative equivalence not provided, only statement of substantial equivalence). |
| Construct Fatigue (per ASTM F382) | Covered under "Fatigue" above. |
| Wear (per applicable standards) | "Mechanical testing, including... wear have been performed... and the results have shown them to be substantially equivalent to the predicate plate and screw systems." (Specific quantitative equivalence not provided, only statement of substantial equivalence). |
| Biocompatibility (per ISO 10993-1) | "Biocompatibility of the G3™ Active Plate® Large Fragment System was evaluated per ISO 10993-1." (No specific results or acceptance criteria are detailed, only that it was evaluated). |
| Locking Screw Performance | "The subject G3™ Locking Screws have also demonstrated to be substantially equivalent to those in the previously cleared Zimmer Periarticular Locking Plate System (K040593; S.E. 04/12/2004) in terms of performance." |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The document mentions "mechanical testing" and "construct fatigue testing" per ASTM standards, but does not provide details on the number of samples or specimens used for these tests.
- Data Provenance: Not applicable in the context of clinical data. The tests are in vitro mechanical tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This device is a mechanical implant, not an AI/ML diagnostic or image analysis device that would require expert-established ground truth from clinical data. The "ground truth" for mechanical testing is derived from standardized test methods and measurement equipment.
4. Adjudication method for the test set
- Not applicable. Adjudication methods are relevant for expert review of clinical data, not for in vitro mechanical testing.
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 study was not done. This is a mechanical device, not an AI/ML diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a mechanical device, not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for the performance testing is based on standardized mechanical testing methodologies (e.g., ASTM F543, ASTM F382) which provide quantitative measurements of properties like stiffness, fatigue life, pullout strength, etc. The performance is then compared against established predicate devices.
8. The sample size for the training set
- Not applicable. This document is for a mechanical device, not an AI/ML device that requires a training set of data.
9. How the ground truth for the training set was established
- Not applicable. This document is for a mechanical device, not an AI/ML device.
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