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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

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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