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The GenerOs SB is an implantable device for distraction osteogenesis techniques in the small bone of the extremities. GenerOs SB is used to treat conditions where small bones of the extremities are deficient. The types of deformities that fall into this category include, but are not limited to:

• Congenital deficiencies of the bones of the forearms, wrists, ankles, hands and feet;
• Post-traumatic deficiencies of the bones of the forearms, wrists, ankles, hands and feet:
• Deficiencies of the bones of the forearms, wrists, ankles, hands and feet due to tumor resection.
  Each GenerOs SB is intended for single use only. The device is to be removed after distraction and bone stabilization are complete. It is to be used with other commercially-available accessory devices, such as bone screws for fixation to the bone surface. The device is not intended to be fixed to the bone with bone cement. However, it is possible that commercially-available bone cement may be used on the undersurface of the device to level or stabilize it on a curved surface.

GenerOs SB is an implantable device made of surgical grade stainless steel for deficiencies of small bones of the extremities. It features two telescoping component bone plates that are distracted apart by a threaded drive shaft. The activation pin and the drive shaft are articulated using an internal gear. The device has a fixation plates on the activation and sliding block, and if not used for fixation of the device, may be easily removed. Activation of the drive shaft occurs through a transcutaneous pin. which is removed once the distraction phase is complete. The GenerOs SB implant is removed after distraction and consolidation are complete. The GenerOs SB includes reusable instruments such as activation, insertion / removal tools and other surgical instruments.
GenerOs SB is a single-use device, sold non-sterile, and requires sterilization prior to use. It is. Sterilization instructions are included in the labeling.

The provided text describes a 510(k) premarket notification for the GenerOs SB Small Bone Distraction Implant. This document focuses on establishing substantial equivalence to existing predicate devices rather than presenting a study demonstrating performance against specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and a study proving their fulfillment cannot be extracted directly from this submission.

Here's a breakdown of what can be inferred or stated based on the provided text:

1. A table of acceptance criteria and the reported device performance

The submission does not provide a table of acceptance criteria with corresponding performance results. Instead, it states that "Performance of the GenerOs SB has been substantiated by biocompatibility, sterilization, packaging validation, and mechanical tests in conformance to standard testing quidelines for bone plate implant devices." However, specific quantitative acceptance criteria or detailed performance data from these tests are not provided.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The submission focuses on substantial equivalence based on design, materials, function, and intended use, rather than clinical efficacy studies requiring specific test set sizes or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided because there is no clinical study mentioned that would require establishing a ground truth by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided as there is no mention of a clinical study that would involve expert 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

There is no mention of an MRMC study, AI assistance, or human readers in this document. The device is a physical, implantable medical device, not an AI-powered diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable as the device is a physical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Since no clinical study with a test set is described, there is no mention of the type of ground truth used. The submission relies on substantial equivalence to predicate devices, implying that the safety and effectiveness are supported by the established performance of those predicates and general performance testing (biocompatibility, mechanical, etc.).

8. The sample size for the training set

This information is not applicable as the device is a physical implant, not a machine learning model requiring a training set.

9. How the ground truth for the training set was established

This information is not applicable as the device is a physical implant, not a machine learning model.

Summary of what is present:

The document serves as a 510(k) premarket notification declaring that the GenerOs™ SB Small Bone Distraction Implant is substantially equivalent to legally marketed predicate devices. The basis for this claim is:

• Identical features and technology to K993869 (GenerOs CF Craniofacial Bone Generator), with the only difference being the indication for use.
• Comparison of features and indications for use to K031875 (OrthoNetx' Limb Lengthener).
• Comparison of indications for use to K040907 (Arthrex Small Fragment Plates and Screws), K992961 (Lorenz Small Fragment System), and K050110 (LCP Modular Foot Plates).
• Performance substantiated by:
  • Biocompatibility tests
  • Sterilization validation
  • Packaging validation
  • Mechanical tests

These tests were performed "in conformance to standard testing guidelines for bone plate implant devices," which implies that the device met industry-standard acceptance criteria for those specific performance areas, even if those criteria are not explicitly detailed in this document. The core argument for acceptance is substantial equivalence to already cleared devices, meaning the FDA did not require new clinical effectiveness studies for this particular submission.

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