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The Sintea Posterior Lumbar System is a posterior, nonpedicle screw system of the noncervical spine indicated for degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, tumor, pseudarthrosis, and failed previous fusion.

The Sintea Biotech Posterior Lumbar System is a pedicle screw system 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 thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The Sintea Biotech Posterior Lumbar System is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-SI vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

PLS recovery screws and screws for ring are available with the same material, shape, fillet, diameters and length of PLS standard screws. They have the same characteristics as PLS standard screws with the exception of a locking ring adopted in place of a locking cap.

The PLS Multi-axial screws are made of the same material as the PLS standard (monoaxial) screws. The somatic thread is the same as the thread of the PLS standard screws. The lengths and diameters of the multi-axial screws are the lengths and diameters of the PLS standard screws. The design of this screw allows for up to 25 degrees of angulation in any direction to accommodate different anatomic conditions.

The provided document is a 510(k) summary for a medical device (Sintea Biotech Posterior Lumbar System Multi-axial Screw and Recovery Screw with Ring). It focuses on demonstrating substantial equivalence to a predicate device through mechanical testing and comparison of design, materials, and intended use.

Therefore, it does not describe a clinical study in the traditional sense that would involve patient data, ground truth established by experts, or human reader performance. The "acceptance criteria" here refer to the performance of the device in biomechanical tests compared to a predicate device, as required for 510(k) clearance rather than clinical efficacy/diagnostic accuracy.

However, based on the information provided, I can infer and extrapolate the relevant parts that would correspond to your requested sections, focusing on the device performance within a biomechanical study context.

Here's a breakdown of the information that can be extracted or inferred:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size (Test Set): Not explicitly stated, as this was a biomechanical (material/engineering) study, not a clinical study involving patients. "Test set" in this context would refer to the number of device constructs tested. This detail is typically found in the full biomechanical report, not the 510(k) summary.
• Data Provenance: Not applicable in the context of geographical origin or retrospective/prospective for a biomechanical study. The studies were "conducted on the Sintea Biotech Posterior Lumbar System multi-axial screw, recovery screw, screw for ring and ring implant constructs," implying testing in a lab setting.

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

• This is not applicable to this type of submission. "Ground truth" established by experts (e.g., radiologists) is relevant for diagnostic devices or those involving interpretation of medical images/patient data. For a biomechanical study, the "ground truth" would be established by validated engineering test standards and measurements, interpreted by engineers or scientists.

4. Adjudication Method for the Test Set

• Not applicable for this type of biomechanical study. Adjudication typically refers to resolving discrepancies between human readers or experts, which is not relevant here.

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

• No, an MRMC study was not done. This is a submission for a spinal implant, not an AI/diagnostic device.

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

• No, this is not applicable. This is a hardware device (spinal implant), not an algorithm or software.

7. The Type of Ground Truth Used

• For the biomechanical studies, the "ground truth" would be the physical measurements and performance under established mechanical testing standards (e.g., ASTM, ISO standards mentioned, though specific test numbers are not listed in the summary). This would be based on empirically measured properties and engineering specifications.

8. The Sample Size for the Training Set

• Not applicable. This submission describes a physical medical device, not a machine learning model, so there is no "training set."

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

• Not applicable, as there is no training set for this type of device submission.

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