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When used as a pedicle screw fixation system, the NuVasive Armada Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the posterior thoracic, lumbar, and sacral spine:

1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
2. Degenerative spondylolisthesis with objective evidence of neurologic impairment
3. Fracture
4. Dislocation
5. Scoliosis
6. Kyphosis
7. Spinal tumor and/or
8. Failed previous fusion (pseudoarthrosis)

The NuVasive Armada Spinal System is also indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebral joint in skeletally mature patients receiving fusion by autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (L3 to sacrum), with removal of the implants after attainment of a solid fusion.

When used as an anterolateral non-pedicle screw system in the thoracic and lumbar spine, the NuVasive Armada Spinal System is also intended for the following indications:

1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
2. Spinal stenosis
3. Spondylolisthesis
4. Spinal deformities
5. Fracture
6. Pseudoarthosis
7. Tumor resection and/or
8. Failed previous fusion

When used as a pedicle screw fixation system, the NuVasive Precept Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the posterior thoracic, lumbar, and sacral spine:

1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
2. Degenerative spondylolisthesis with objective evidence of neurologic impairment
3. Fracture
4. Dislocation
5. Scoliosis
6. Kyphosis
7. Spinal tumor and/or
8. Failed previous fusion (pseudoarthrosis)

The NuVasive Precept Spinal System is also indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebral joint in skeletally mature patients receiving fusion by autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (L3 to sacrum), with removal of the implants after attainment of a solid fusion.

When used as an anterolateral non-pedicle screw system in the thoracic and lumbar spine, the NuVasive Precept Spinal System is also intended for the following indications:

1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
2. Spinal stenosis
3. Spondylolisthesis
4. Spinal deformities
5. Fracture
6. Pseudoarthosis
7. Tumor resection and/or
8. Failed previous fusion

When used as a pedicle screw fixation system, the NuVasive SpheRx Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the posterior thoracic, lumbar, and sacral spine:

1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
2. Degenerative spondylolisthesis with objective evidence of neurologic impairment
3. Fracture
4. Dislocation
5. Scoliosis
6. Kyphosis
7. Spinal tumor and/or
8. Failed previous fusion (pseudoarthrosis)

The NuVasive SoheRx Spinal System is also indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebral joint in skeletally mature patients receiving fusion by autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (L3 to sacrum), with removal of the implants after attainment of a solid fusion.

When used as an anterolateral non-pedicle screw system in the thoracic and lumbar spine, the NuVasive SpheRx Spinal System is also intended for the following indications:

1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
2. Spinal stenosis
3. Spondylolisthesis
4. Spinal deformities
5. Fracture
6. Pseudoarthosis
7. Tumor resection and/or
8. Failed previous fusion

The NuVasive Polyaxial Screws are part of the following NuVasive systems: Precept (K102514), Armada (K092287), and SpheRx PPS (K090981) that consist of a variety of polyaxial screws, reduction screws, offset connectors, rods, locking nuts, and transverse connectors. Implant components can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the patient. This 510(k) is for the modification to a component used in the assembly of tulip to screw shanks of polyaxial screws.

The provided text is a 510(k) Summary for NuVasive Polyaxial Spinal Screws. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than establishing de novo acceptance criteria for a new type of device or conducting studies to prove a device meets specific clinical performance metrics. Therefore, many of the requested elements for an acceptance criteria study (e.g., sample size, number of experts for ground truth, MRMC studies) are not applicable to this type of regulatory submission.

The device being described is a medical implant (polyaxial spinal screws), not a software or AI-based diagnostic/detection device. The "performance data" section refers to mechanical testing of the physical hardware, not clinical performance or diagnostic accuracy.

Here's an attempt to answer the questions based on the provided text, highlighting where the information is not applicable due to the nature of the submission:

NuVasive Polyaxial Spinal Screws 510(k) Summary Analysis

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

For this medical implant, "acceptance criteria" are equivalent to demonstrating that the device meets or exceeds the mechanical performance of predicate devices as per specific ASTM standards and internal tests.

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

The document does not specify the exact sample sizes (number of screws or test repetitions) used for each mechanical test. The data provenance is internal laboratory testing and comparisons to predicate device data, rather than clinical patient data. Therefore, country of origin or retrospective/prospective classification is not applicable.

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

Not applicable. "Ground truth" in the context of mechanical testing refers to the physical properties and performance measured against engineering standards, not expert clinical interpretation of data.

4. Adjudication method for the test set

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies where expert consensus is needed to establish ground truth from subjective interpretations. For mechanical testing, the results are quantitative and directly measured.

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 is a physical medical device (spinal screws), not an AI-assisted diagnostic or interpretation tool. Therefore, MRMC studies and "human readers" are irrelevant.

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

Not applicable. This is a physical medical device, not an algorithm.

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

The "ground truth" for the performance of this device is established by engineering standards and mechanical test results. The performance is compared against the known performance of predicate devices. There is no expert consensus, pathology, or outcomes data involved in this specific performance assessment for a 510(k) submission focused on substantial equivalence through mechanical testing.

8. The sample size for the training set

Not applicable. There is no concept of a "training set" for physical device mechanical testing. The tests are designed to evaluate the physical properties and performance of the manufactured device.

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

Not applicable. As there is no training set, there is no ground truth to establish for it.

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