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The NILE Alternative Fixation and NILE Proximal Fixation Spinal Systems are temporary implants for use in orthopedic surgery. The systems are intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures.

The indications for use include the following applications:

1. Spinal trauma surgery, used in sublaminar, interspinous, or facet wiring techniques;

2. Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age and older, adult scoliosis, and spondylolisthesis:

3. Spinal degenerative surgery, as an adjunct to spinal fusions.

The NILE Alternative Fixation and NILE Proximal Fixation Spinal Systems may also be used in conjunction with other medical implants made of similar metals whenever 'wiring' may help secure the attachment of other implants.

The NILE Proximal Fixation Spinal System is a multiple component spinal fixation system intended for application to the thoracic, lumbar and sacral spine. The band is manufactured from polyethylene terephthalate (PET) and the connectors are made from titanium alloy in accordance with ASTM F136.

Function: The NILE Proximal Fixation Spinal System is designed to be used in conjunction with spinal rod constructs for attachment to the posterior vertebral structures.

The purpose of this submission is to add bands and connectors to the Nile system.

This document (K161332) is a 510(k) premarket notification for the NILE Proximal Fixation Spinal System. It asserts substantial equivalence to a predicate device, the K2M NILE Alternative Fixation Spinal System (K143350). The FDA has reviewed and determined the device is substantially equivalent for its stated indications for use.

Here's an analysis of the provided text to answer your questions regarding acceptance criteria and performance studies:

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

The document does not explicitly state quantitative "acceptance criteria" for the NILE Proximal Fixation Spinal System in the traditional sense (e.g., minimum accuracy, sensitivity, or specificity values). Instead, the performance evaluation is based on a comparative study against predicate devices using recognized ASTM standards. The reported performance is a qualitative statement of equivalence or superiority.

2. Sample sized used for the test set and the data provenance

The document does not specify the sample sizes (number of devices or test repetitions) used for the mechanical performance testing conducted in accordance with ASTM F1717 and ASTM F1798. It also does not mention the data provenance (e.g., country of origin, retrospective or prospective) as the tests are non-clinical, mechanical device performance assessments.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable to the provided document. The "ground truth" for mechanical testing is established by the specified ASTM test methods and objective measurements of force, displacement, etc., not by expert clinical opinion or interpretation.

4. Adjudication method for the test set

This information is not applicable. Adjudication methods (like 2+1, 3+1) are typically used for clinical studies involving expert review of medical images or patient outcomes, not for non-clinical mechanical performance 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

There was no MRMC comparative effectiveness study described. This document pertains to a spinal fixation system, which is a physical implant, not an AI-assisted diagnostic or interpretative device. Therefore, the concept of "human readers improve with AI" is not relevant to this submission.

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

This information is not applicable. The device is a mechanical implant, not an algorithm, so standalone AI performance is not relevant.

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

For the non-clinical performance evaluation, the "ground truth" is based on objective, quantifiable physical measurements as defined by the ASTM standards (e.g., load-displacement curves, failure loads, pull-out forces). There is no "expert consensus," "pathology," or "outcomes data" ground truth utilized in this context.

8. The sample size for the training set

This information is not applicable. As the device is a mechanical implant and not an AI/machine learning system, there is no "training set."

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

This information is not applicable due to the reasons stated in point 8.

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