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The Posterior Lumber System Multi-Axial Screw DESCO 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, pseudoarthrosis, and failed previous fusion.

The 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 turnor, and failed previous fusion (pseudarthrosis).

The Posterior Lumbar System is a pedicle screw system indicated 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 having implants attached to the lumbar and sacral spine (L3 to Sacrum) with removal of the implants after the attainment of a solid fusion.

The crosslinks and rod-to-rod connectors are used to connect two rods in a pedicle screw construct. The purpose is to add further stability to the system. The components are made of medical grade, FDA recognized, titanium alloy (ASTM F316). The rigid crosslinks come in sizes ranging from 15mm to 48mm, in increments of 3mm, and the modular crosslinks come in 3 sizes (small 30-38mm, medium 37-52mm, and large 50-70mm), but can lock at any size in between the ranges. The variable flat crosslinks contain 2 components an SX (left) and DX (right). The two are connected by a nut that can lock the connector along any length: small 26.6-33.6mm, medium 36.6-53.6mm, and large 46.6-73.6mm. The cross-links are used to connect parallel constructs along the spinal column to stabilize the system. The rod-to-rod connectors come in domino form and longitudinal. The rod-to-rod connectors will connect two rods in series either along the same axis by utilizing the longitudinal connector or offset the rod laterally by approximately 5.5mm (the diameter of a rod) utilizing the domino connector. The crosslinks and rod-to-rod connectors utilize a nut which threads through the component and comes to contact with the rod to lock the component to the rod along the construct.

The provided document is a 510(k) summary for Sintea Plustek's Posterior Lumbar System, which describes a medical device, not a software device or an AI algorithm. Therefore, the questions related to AI/algorithm performance, ground truth establishment, expert consensus, and effects on human readers are not applicable.

The document primarily focuses on demonstrating the substantial equivalence of the modified device (adding cross-links and connectors) to its predicate device through mechanical testing.

Here's an analysis of the available information regarding acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Note on "Acceptance Criteria": The document doesn't explicitly state quantitative acceptance criteria (e.g., "must withstand X N of force"). Instead, the primary acceptance criterion is achieving "substantial equivalence" to the predicate device, which is demonstrated by meeting or exceeding the predicate's mechanical performance in the specified ASTM tests. The statement "the new version obtained results demonstrating greater stiffness, and higher yield and ultimate strength" for the cross-links strongly implies that the new device met or exceeded the performance of the predicate, thus satisfying the substantial equivalence requirement for mechanical properties.

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

• The document mentions "mechanical tests performed on the worst case crosslink construct" and "tests performed on the rod-to-rod connectors."
• Sample Size: The exact number of samples (e.g., how many cross-links or rod-to-rod connectors were tested for each configuration) is not specified in this 510(k) summary. For mechanical testing, sample sizes are typically small (e.g., 5-10 per test condition) but sufficient to demonstrate performance characteristics.
• Data Provenance: The tests are described as "mechanical tests," which are laboratory tests performed on physical medical device components. The data is generated from these controlled lab experiments, not from patient data or clinical studies. Therefore, there is no country of origin of patient data, nor is it retrospective or prospective in the clinical sense.

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

• Not Applicable. This is a physical medical device. Ground truth for its performance is established through standardized engineering mechanical tests (ASTM F1717, ASTM F1798), not through expert clinical consensus on patient data. The "ground truth" is the physical performance measured in a lab.

4. Adjudication Method for the Test Set

• Not Applicable. As this involves mechanical testing, there is no adjudication method in the human-reader sense. The test results are objective measurements from laboratory equipment.

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, not an AI or imaging diagnostic device. No human-in-the-loop performance or MRMC study was conducted.

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

• Not Applicable. This is a physical medical device. No algorithm or standalone software performance was evaluated.

7. The Type of Ground Truth Used

• The ground truth for this device's performance is established by objective measurements from standardized mechanical tests according to ASTM F1717 and ASTM F1798. These standards define the methodology for evaluating the mechanical properties (static compression, static torsion, dynamic compression/fatigue, stiffness, yield, ultimate strength) of spinal implant systems and intervertebral body fusion devices.

8. The Sample Size for the Training Set

• Not Applicable. There is no "training set" as this is not an AI/machine learning device. The design, development, and testing of this physical device are based on engineering principles and material science, not data training.

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

• Not Applicable. As there is no training set, this question is irrelevant.

Summary Conclusion:

The Sintea Plustek Posterior Lumbar System is a hardware medical device. Its acceptance criteria and performance are determined by demonstrating substantial equivalence to a predicate device through standardized biomechanical testing, not through clinical trials, expert interpretation of data, or AI algorithm performance metrics. The document clearly states that mechanical tests were performed according to ASTM F1717 and ASTM F1798, and that the new components (cross-links and rod-to-rod connectors) either performed better than the predicate's equivalent components or met the requirements for substantial equivalence.

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The DSC/ALF Spinal System is a vertebral body replacement system intended for use in the thoracolumbar spine (TI-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The DSC/ALF Spinal System is to be used with supplemental fixation. Specifically, the DSC/ALF spinal system is to be used with the anterior lateral plate that is included in the system, and may also be used with Sintea Biotech's PLS Spinal System. Additionally, the DSC/ALF spinal system is intended to be used with autograft.

This 510(k) consists on the submission to add additional lengths and cross-sections, an improved locking mechanism, cage body redesign, and end-plate charges to a previously cleared system. The DSC/ALF Spinal System provides two basic components: A VBR (DSC) and an anterior lateral fixation plate (ALF). The DSC has a hollow internal module that can slide in relation to an external module, which enables the former to be locked in the most suitable position by means of two screws. These screws are inserted into two tooth rails on the internal cage, on both the anterior and posterior part, and mechanically lock the two modules. Both modules have endplates that optimize the contact with the vertebral bodies between which the device is inserted, thus ensuring better primary stability. The cages present a symmetrical geometry in order to make device placement simpler for the surgeon. The ALF is composed of two plates that connect to the anterior side of a vertebra by two screws. The two plates are connected by a rod. All components of the DSC/ALF Spinal System are made of medical grade titanium alloy (Ti-6Al-4V) as described by ASTM Standard F136.

Here is an analysis of the acceptance criteria and study information for the Sintea Plustek DSC/ALF Spinal System:

The provided text describes a 510(k) submission for the Sintea Plustek DSC/ALF Spinal System, which is a vertebral body replacement system. The submission focuses on adding additional lengths and cross-sections, an improved locking mechanism, cage body redesign, and end-plate changes to a previously cleared system.

1. Table of Acceptance Criteria and Reported Device Performance:

The document outlines a series of performance tests conducted on the new device (referring to the modifications made to the previously cleared system) and compares their results to those of a predicate device. The specific numerical acceptance criteria for these tests are not explicitly stated in the provided text. Instead, the performance is reported comparatively.

The testing standards followed were ASTM F2077 and ASTM F2267.

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

The document describes mechanical testing rather than a clinical study involving human or animal subjects. Therefore, the concept of a "test set" in the context of human data or a specific provenance (country of origin, retrospective/prospective) is not applicable here. The "test set" would refer to the physical devices and components subjected to the mechanical tests. The sample size for these individual mechanical tests is not specified in the provided text.

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

This information is not applicable as the "ground truth" for mechanical performance tests is established by objective physical measurements based on engineering standards (ASTM F2077 and ASTM F2267), rather than expert opinion or clinical interpretation.

4. Adjudication Method for the Test Set:

This information is not applicable as the "test set" involves objective mechanical measurements, not subjective evaluations requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

An MRMC comparative effectiveness study was not performed as this is a mechanical device evaluation, not a study involving human readers interpreting medical images with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance):

This information is not applicable as the device is a physical spinal implant, not a software algorithm or AI-powered system.

7. Type of Ground Truth Used:

The ground truth for the performance claims ("better results" or "comparable results") is established through objective mechanical testing results, compared against the predicate device, following established ASTM standards (ASTM F2077 and ASTM F2267).

8. Sample Size for the Training Set:

This information is not applicable as this is a mechanical device evaluation, not a machine learning model.

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

This information is not applicable for the same reason as above; there is no "training set" in the context of a physical device's mechanical performance evaluation.

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