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510(k) Data Aggregation
(156 days)
RxG Distraction System
The RxG Distraction System includes devices intended for use in bone stabilization and elongation (lengthening) in the correction of congenital or developmental defects in cranial reconstruction for the pediatric and adult populations.
The RxG Distraction System consists of implantable devices used to lengthen or increase the dimension of cranial 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 40 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.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Performance Bench | The RxG distractor should exhibit less deformation than the LactoSorb distractor. | The RxG Distraction System exhibited less deformation and achieved greater distraction distance than the LactoSorb distractor. The results showed substantial equivalence to the primary predicate. |
| Biocompatibility | Biocompatibility requirements met as per FDA Blue Book Memorandum #G95-1. | The RxG Distraction System patient-contacting materials are previously cleared, have the same chemical composition, manufacturing processes, body contact, and sterilization methods as the reference device. The biocompatibility requirements have been met. |
| Sterility | Achieve a Sterility Assurance Level (SAL) of 10⁻⁶. | The subject device undergoes the same sterilization methods as the reference devices and achieved an SAL of 10⁻⁶. |
| Packaging & Shelf-Life | Packaging suitable for sterilization and capable of maintaining sterility for shelf life. | The packaging & shelf-life for the subject device is identical to a reference device. The packaging is suitable for the intended sterilization process and can maintain sterility during the intended shelf life period of 5 years. |
2. Sample Size Used for the Test Set and Data Provenance
The document only describes non-clinical testing.
- Performance Bench: The test involved comparing the RxG distractor to the LactoSorb distractor. The sample size for this comparative mechanical testing is not specified in the provided text.
- Data Provenance: The tests are described as non-clinical (bench testing), so there's no patient data or country of origin to report.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. The tests are non-clinical (bench testing) and do not involve human expert interpretation for ground truth.
4. Adjudication Method for the Test Set
Not applicable. The tests are non-clinical (bench testing) and do not involve human adjudication.
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
Not applicable. This device is a medical implant system, not an AI-powered diagnostic tool. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a medical implant system, not an algorithm. No standalone performance study (in the context of AI) was done.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the non-clinical tests was based on:
- Performance Bench: Direct measurements of deformation and distraction distance during simulated osteotomy in a controlled laboratory setting.
- Biocompatibility: Adherence to FDA-recognized international standards (ISO 10993).
- Sterility: Adherence to international standards for sterilization validation (ISO 11137, ISO 11737).
- Packaging & Shelf-Life: Adherence to international standards for packaging integrity (ISO 11607) and real-time stability testing.
8. The Sample Size for the Training Set
Not applicable. This device is a medical implant system, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This device is a medical implant system, not an AI model.
Summary of the Study that Proves the Device Meets the Acceptance Criteria:
The KLS-Martin RxG Distraction System demonstrated substantial equivalence through a series of non-clinical laboratory tests. These tests compared the subject device to its primary predicate (LactoSorb Distraction, K002083) and referenced other cleared devices (RxG Distraction System, K133304; Resorb-X G, K121606) to demonstrate that the new device does not raise new issues of safety or effectiveness.
The key studies and their findings were:
- Performance Bench Testing: Comparative mechanical testing was conducted between the RxG distractor and the LactoSorb distractor. The devices were affixed to sawbone blocks, simulating an osteotomy, and placed in a Ringer's solution waterbath. After a 48-hour latency period, distraction and consolidation were simulated over 52 days, with deformation measurements taken at regular intervals. The RxG Distraction System met the acceptance criterion by exhibiting less deformation and achieving greater distraction distance than the predicate device.
- Biocompatibility Testing: The biocompatibility of the materials (Resorb xG, Ti-6Al-4V, and Stainless Steel) was assessed according to FDA Blue Book Memorandum #G95-1, encompassing toxicology, cytotoxicity, and chemical analysis. The materials in the subject device were deemed to have met biocompatibility requirements as they are identical to those previously cleared in reference devices, with the same chemical composition, manufacturing processes, body contact, and sterilization methods.
- Sterility Testing: Validation of the gamma sterilization process was performed in accordance with ISO 11137-1, -2, and ISO 11737-1, -2. The tests included bioburden assessment and dose verification. The sterilization methods achieved an SAL of 10⁻⁶, meeting the acceptance criteria.
- Packaging & Shelf-Life Testing: Validation of package integrity was conducted per ISO 11607-1, -2, and real-time stability testing was performed for the Resorb xG implants. The packaging and shelf-life were found to be identical to a reference device, confirming its suitability for sterilization and maintenance of sterility for a 5-year shelf life.
Clinical testing was explicitly stated as "not necessary for the determination of substantial equivalence." This indicates that the non-clinical data was considered sufficient by the FDA to demonstrate that the RxG Distraction System is as safe and effective as existing legally marketed devices.
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(199 days)
RXG DISTRACTION SYSTEM
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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