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The ASTRA System is intended to provide immobilization 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 thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; spinal tumor; and failed previous fusion (pseudo-arthrosis).

The ASTRA Spine System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3 to S1), and for whom the device is intended to be removed after solid fusion is attained.

The ASTRA System is also a sacral/iliac screw fixation system of the non-cervical spine indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudo-arthrosis).

When used in a percutaneous, posterior approach with AVANT Spine MIS instrumentation, the ASTRA Spine System is intended for non-cervical pedicle fixation for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis), tumor, pseudo-arthrosis, and failed previous fusion in skeletally mature patients . Levels of fixation are for the thoracic, lumbar and sacral spine.

The ASTRA Spine System is a top loading, multiple component, posterior spinal fixation system which consists of rods, cannulated and non-cannulated monoaxial, uniplanar and polyaxial screws, hooks, iliac connectors, rod connectors, and cross connectors. Most of the components are available in a variety of sizes to more closely match the patient's anatomy.

Materials:
Titanium alloy
CoCr alloy

Here's an analysis of the provided text regarding the ASTRA Spine System, focusing on acceptance criteria and study details.

Important Note: The provided document is a 510(k) summary for a medical device (Spine System), not an AI/ML device. Therefore, many of the requested fields related to AI/ML specific studies (like sample sizes for test/training sets, data provenance, expert ground truth, MRMC studies, standalone performance) are not applicable to this type of medical device submission. This document focuses on demonstrating substantial equivalence to predicate devices through non-clinical (mechanical) testing.

1. Table of Acceptance Criteria and Reported Device Performance

For this medical device, the "acceptance criteria" are implicitly defined by performance equivalence to predicate devices in standardized mechanical tests. The "reported device performance" is a statement of comparative equivalence.

2. Sample Size Used for the Test Set and the Data Provenance

This is a physical device, and the "test set" refers to the tested device components.

• Sample Size: Not explicitly stated in terms of number of components tested for each test, but standard engineering practices for medical device testing would involve a sufficient number (e.g., n=5 or n=10 per test) to ensure statistical significance, though the exact numbers are not provided in this summary.
• Data Provenance: The tests are non-clinical, meaning they were conducted in a laboratory setting. There is no patient data provenance (e.g., country of origin, retrospective/prospective) since no human data was used for these mechanical tests.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

• Not Applicable. For mechanical testing of a physical device, ground truth is established by standardized testing protocols (e.g., ASTM standards) and measured physical properties, not by expert consensus on clinical data. Engineers and lab technicians perform and analyze the tests according to these standards.

4. Adjudication Method for the Test Set

• Not Applicable. There is no adjudication in the sense of reconciling human expert opinions for clinical images or data. The results of mechanical tests are objective measurements against defined criteria.

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 spinal implant, not an AI/ML diagnostic or assistive device. No MRMC studies were performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not Applicable. This is a physical spinal implant; there is no algorithm or standalone performance.

7. The Type of Ground Truth Used

• Mechanical Test Standards and Predicate Device Performance: The "ground truth" for the non-clinical tests is based on the established performance characteristics and safety profiles of legally marketed predicate devices, as defined by FDA regulations for substantial equivalence, and adherence to relevant ASTM standards (ASTM F1717 and ASTM F1798).

8. The Sample Size for the Training Set

• Not Applicable. This is a physical device; there is no AI/ML model or "training set" in the context of machine learning. The device design and materials are based on engineering principles and knowledge of predicate devices.

9. How the Ground Truth for the Training Set Was Established

• Not Applicable. As there is no training set for an AI/ML model, this question is not relevant. The "ground truth" for developing the physical device is based on established biomechanical and medical understanding of spinal fixation and the performance of existing, cleared devices.

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