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The LAGUNA® Pedicle Screw System is intended to be used as an adjunct to fusion in skeletally mature patients using autograft or allograft in posterior, non-cervical fixation for the following conditions: degenerative disc disease (defined as back pain of discogenic origin 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 and/or lordosis); tumors; pseudarthrosis; and/or failed previous fusion.

The LAGUNA® Pedicle Screw System is intended to help provide correction, immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral space. The LAGUNA® Pedicle Screw System consists of a variety of rods and screws, which can be rigidly locked into a variety of configurations, with each construct being tailor made for the individual case. Polyaxial screws are supplied in winged and non-winged configurations, in a variety of different length, ranging from 30 mm to 100 mm and 5 mm, 6 mm, 7 mm and 8mm diameter sizes. All sizes are able to receive 5.5mm connecting rods only. The LAGUNA® Pedicle Screw System implant components are fabricated from medical grade titanium alloy per ASTM F136.

The provided text describes a spinal fixation system, not an AI/ML device. Therefore, many of the requested criteria, such as those related to AI algorithm performance (standalone performance, MRMC studies, training/test set details, ground truth establishment for AI), are not applicable.

However, I can extract information related to the device's performance testing based on the provided text.

The device is the "LAGUNA® Pedicle Screw System," a spinal fixation system.

Acceptance Criteria and Device Performance:

The provided text states that the device was evaluated through biomechanical tests. The acceptance criteria are implicitly that the device performs equivalently to other similar implants.

Study Details (Non-AI/ML specific):

• Sample size used for the test set and the data provenance: Not explicitly stated in terms of number of devices tested, but the tests were "Biomechanical tests per ASTM F1717-10". These are laboratory tests on device components, not human or clinical data.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for biomechanical testing is defined by the ASTM F1717-10 standard, which specifies test methodologies and performance characteristics. It does not involve human expert consensus for "ground truth" in the way an AI assessment would.
• Adjudication method for the test set: Not applicable for biomechanical testing. The results are quantitative measurements against a standard.
• 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 not an AI/ML device.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
• The type of ground truth used: The ground truth is defined by the performance requirements and methodologies outlined in the ASTM F1717-10 standard for biomechanical testing.
• The sample size for the training set: Not applicable. This is not an AI/ML device.
• How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

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The Laguna Spinal System is intended for posterior, non-cervical fixation for the following conditions: degenerative disc disease (defined as back pain of discogenic origin 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 and/or lordosis); tumor pseudarthrosis; and/or failed previous fusion.

The Laguna TM Pedicle Screw System is intended to help provide correction, immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral space. The Laguna Spinal System consists of a variety of rods and screws, which can be rigidly locked into a variety of configurations, with each construct being tailor made for the individual case. Multi axial implant screws are supplied in 5mm, 6mm, 7mm and 8mm diameter sizes. All sizes are able to receive 5.5mm connecting rods only. The Laguna Spinal System implant components are fabricated from medical grade titanium alloy described by such standards as ASTM F136 or ISO 5832-3 or 5832-2.

The provided text is a 510(k) summary for the Allez Spine Laguna™ Pedicle Screw System and a determination letter from the FDA. This document is for a medical device and therefore, the acceptance criteria and study information typically associated with AI/ML-based software (like those related to diagnostic performance or multi-reader studies) are not applicable.

Instead, the "performance data" section in this submission refers to biomechanical tests for the pedicle screw system, comparing its physical properties and mechanical strength to similar, already-approved implants. This is a common practice for hardware-based medical devices seeking 510(k) clearance via substantial equivalence.

Here's how to interpret the provided information in the context of a medical device submission, focusing on the available "performance data" section:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation:
For a 510(k) submission based on substantial equivalence for a pedicle screw system, the "acceptance criteria" are not explicitly stated in numerical terms like sensitivity/specificity for AI, but are implied by the requirement to demonstrate that the new device performs as safely and effectively as a legally marketed predicate device. This is typically shown through comparative biomechanical testing. The performance data states that the Laguna™ system's biomechanical test results were equivalent to other similar implants and sufficient for in vivo loading, thus meeting the implicit acceptance criteria for substantial equivalence.

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

• Sample Size for Test Set: This information is not provided in the document. Biomechanical testing typically involves a specific number of samples of the device components (e.g., screws, rods, constructs) tested under various loading conditions, but the exact number of components tested is not detailed here.
• Data Provenance: Not applicable in the human data sense. Biomechanical tests are laboratory-based studies performed on the device itself.

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

• Number of Experts: Not applicable. Ground truth for biomechanical tests is established by engineering standards and measurements, not expert clinical interpretation.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Biomechanical tests are analytical measurements, not subjective evaluations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or image-interpretation software where human readers' performance with and without AI assistance is evaluated. This device is a surgical implant.
• Effect Size of Human Readers Improvement: Not applicable.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Standalone Performance Study: No, a standalone algorithm performance study was not done. This concept applies to AI/ML software; the device described is a physical implant.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth for biomechanical testing is based on engineering principles, material science standards (e.g., ASTM F136 or ISO 5832-3 or 5832-2 for materials), and established mechanical testing protocols. "Equivalence" is determined by comparing measured properties (e.g., strength, stiffness, fatigue resistance) against the predicate device's known performance or against accepted industry standards for spinal implants deemed sufficient for in vivo loading.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This concept applies to machine learning models, not physical medical devices undergoing biomechanical testing.

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

• Ground Truth for Training Set: Not applicable.

Summary in Context of the Device:

The Allez Spine Laguna™ Pedicle Screw System is a physical implant, not an AI/ML-based software. The "performance data" refers to biomechanical tests conducted to demonstrate that its physical properties and mechanical performance are equivalent to predicate devices already on the market, ensuring its safety and effectiveness for its intended use as an adjunct to spinal fusion. The acceptance criteria are therefore implicit in proving substantial equivalence through these physical tests as opposed to clinical or diagnostic performance criteria.

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