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510(k) Data Aggregation
(199 days)
The RxG Distraction System includes devices intended for use in bone stabilization and elongation (lengthening) in the correction of congenital or developmental defects of the midface and alveolar ridge.
The RxG Distraction System also includes devices intended for use in bone stabilization and elongation (lengthening) in the correction of congenital or developmental defects of the mandible in patients 2 years old or younger.
The RxG Distraction System is not intended for load-bearing applications in adult or adolescent populations.
The RxG Distraction System consists of implantable devices used to lengthen or increase the dimension of maxillary and mandibular bones through distraction osteogenesis. It is composed of multiple sizes and shapes of RxG footplates and a threaded drive screw connected to an activation arm. The device is positioned internally with the connected activation arm extending through the soft tissue for external activation. The RxG footplates are secured to the bone on either side of the osteotomy with SonicPins RxG. Distraction is achieved by turning the activation arm with the patient activation driver, causing the plates to separate. Various lengths of drive screws are available to achieve up to 30 mm of distraction. Upon completion of distraction and consolidation of the bone, the drive screw is detached from the RxG footplates and removed, while the RxG footplates and SonicPins RxG remain implanted and are resorbed in 12-14 months.
The provided documentation describes the KLS Martin L.P. RxG Distraction System and outlines the performance testing conducted to demonstrate its substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and the study, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" with numerical thresholds for performance. Instead, it relies on demonstrating substantial equivalence to a predicate device (LactoSorb Distraction System) through comparative mechanical testing. The implicit acceptance criterion is that the RxG Distraction System performs comparably to the predicate device in simulated use.
| Characteristic / Test | Acceptance Criteria (Implicit: Substantial Equivalence to Predicate) | Reported Device Performance (RxG Distraction System vs. LactoSorb Distraction) |
|---|---|---|
| Mechanical Testing: Deformation measurements over simulated distraction and consolidation (52 days) | Performance comparable to the LactoSorb Distractor | "The results of the mechanical testing showed that the RxG Distractor is substantially equivalent to the predicate." |
| Pyrogenicity | No claim of "pyrogen free" is made | No claim of "pyrogen free" is made |
| Intended Use | Same intended use as the LactoSorb Distractor | "The RxG Distraction System has the same intended use as the predicate, the LactoSorb Distractor." |
| Technological Characteristics (Material, Sterility, Resorption Time, Max. Distraction Distance, Plate Thickness, Pin/Screw Diameter/Length etc.) | Similar to the LactoSorb Distractor (or other predicates for specific aspects) | Detailed comparison provided in the table, demonstrating similarities. For example, both use PLLA/PGA, have similar resorption times (12-14 months vs. 12 months), and comparable maximum distraction distances. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify a numerical sample size (e.g., number of devices or iterations) for the comparative mechanical testing. It mentions "The devices were affixed to abutted sawbone blocks..." suggesting multiple instances, but no quantity is given.
- Data Provenance: The study appears to be retrospective in the sense that it's a pre-market notification relying on comparison to already marketed devices. It is an in-vitro (benchtop) study using "sawbone blocks" rather than human or animal data. The country of origin for the data generation is not explicitly stated, but the submission is from a US company to the US FDA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this type of performance study for a medical device seeking 510(k) clearance. The "ground truth" for mechanical testing is established by physical measurement against engineering standards or direct comparison to a predicate device's measured performance, not by expert consensus on clinical findings.
4. Adjudication Method for the Test Set
This information is not applicable as there is no expert review or human interpretation of clinical data in this comparative mechanical test. The assessment is based on physical deformation measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This study is focused on the mechanical performance of a device, not on the interpretative performance of human readers, with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not done. This is a physical medical device, not an algorithm or AI system.
7. The Type of Ground Truth Used
For the mechanical performance testing, the "ground truth" is established through physical measurements of deformation under simulated conditions, directly compared to the measured performance of the predicate device. It is a benchtop (in-vitro) ground truth, not pathology, outcomes data, or expert consensus on clinical cases.
8. The Sample Size for the Training Set
This information is not applicable. This is a physical device, and its development does not involve machine learning algorithms that require a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as above (no training set for a physical device).
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