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The LAGUNA™ Spinal System is intended to be used as an adjunct to fusion using autograft or allograft in posterior, non-cervical pedicle 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™ Size 8 Pedicle Screws are intended to help provide correction, immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral space in conjunction with the Allez Spine LAGUNA™ Polyaxial Pedicle Screw System. 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. The Allez Spine LAGUNA™ Polyaxial Pedicle Screw System (K050060) was cleared for marketing on May 4, 2005. The LAGUNA™ Size 8 Pedicle Screws are available in eleven sizes ranging from 30 mm to 100 mm are fabricated from medical grade titanium alloy described by such standards as ASTM F136 or ISO 5832-3 or 5832-2.

The provided text describes a medical device, the LAGUNA™ Size 8 Pedicle Screw, and its clearance through the FDA 510(k) process. However, it does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the way typically associated with AI/ML device evaluations.

The document primarily focuses on:

• Identifying the device and its manufacturer.
• Classifying the device and specifying its product codes.
• Describing the device and its intended use as an adjunct to fusion for various spinal conditions.
• Declaring substantial equivalence to a previously cleared device (LAGUNA™ Pedicle Screw System K050060).
• Mentioning that "Biomechanical tests have been performed. The test results were equivalent to other similar implants and are sufficient for in vivo loading."

This is a regulatory filing for a physical medical implant (a pedicle screw), not an AI/ML-based diagnostic or therapeutic software device. Therefore, the questions related to AI/ML device performance, such as sample sizes for test/training sets, ground truth establishment, expert adjudication, MRMC studies, and standalone algorithm performance, are not applicable to this document.

Therefore, many of your requested fields will be filled with "Not Applicable" or similar, as the provided document pertains to a physical medical device and not an AI/ML-based system.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not specified. The document refers to "biomechanical tests" without detailing the number of units tested.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The tests are described generally as "biomechanical tests."

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

• Not Applicable. This is a physical device, not an AI/ML system requiring expert ground truth for classification/detection. Performance is assessed through mechanical testing.

4. Adjudication method for the test set

• Not Applicable. Biomechanical tests typically involve laboratory measurements against engineering specifications, not expert adjudication.

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 device, not an AI/ML system for diagnostic assistance.

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

• Not Applicable. This is a physical device, not an AI/ML algorithm.

7. The type of ground truth used

• For biomechanical tests, the "ground truth" would implicitly be the established engineering standards and performance expectations for spinal fixation devices, as well as comparison to the predicate device's performance. There isn't a "ground truth" in the AI/ML sense (e.g., pathology, expert consensus).

8. The sample size for the training set

• Not Applicable. This is a physical device; there is no "training set" in the context of AI/ML.

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

• Not Applicable. This is a physical device; there is no "training set" or corresponding ground truth establishment process related to AI/ML.

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The ALLEZ SPINE Cross Connectors are intended to help provide correction, immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral space in conjunction with the Allez Spine Laguna Polyaxial Pedicle Screw System. The ALLEZ SPINE Cross Connectors are intended for posterior, non-cervical fixation in conjunction with the Allez Spine Laguna Pedicle Screw System 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 ALLEZ SPINE Cross Connectors are intended to help provide and Characteristics: correction, immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral space in conjunction with the Allez Spine Laguna Polyaxial Pedicle Screw System. 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. The Allez Spine Laguna Polyaxial Pedicle Screw System (K050060) was cleared for marketing on May 4, 2005. The ALLEZ SPINE Cross Connectors are available in three sizes: small (37 mm), medium (50 mm) and large (80 mm) and are fabricated from medical grade titanium alloy described by such standards as ASTM F136 or ISO 5832-3 or 5832-2.

The provided text describes a 510(k) submission for the ALLEZ SPINE Cross Connectors. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria through novel studies. Therefore, many of the requested elements are not applicable to a 510(k) summary focused on substantial equivalence.

Here's an analysis based on the provided text, highlighting where information is available and where it is not, or not relevant to this type of regulatory submission:

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

This information is not applicable in the context of a 510(k) summary that relies on substantial equivalence. A 510(k) submission primarily focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device, without necessarily establishing new, specific performance acceptance criteria beyond what is inherent in the predicate.

The document states: "Biomechanical tests have been performed. The test results were equivalent to other similar implants and are sufficient for in vivo loading." However, it does not provide specific numerical acceptance criteria or the detailed results of these biomechanical tests.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable for device performance testing in a 510(k) submission focused on substantial equivalence. The "test set" and "data provenance" as implied in the question are typically relevant for clinical studies, which are not detailed or required for this type of submission.

The biomechanical tests mentioned would have their own sample sizes for the laboratory setups, but these are not provided in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable. The concept of "ground truth" and expert consensus is typically associated with clinical studies, especially those involving image analysis or diagnostic accuracy, which are not the focus of this 510(k) submission for a spinal fixation device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable for the same reasons as point 3.

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

This information is not applicable. An MRMC study is relevant for evaluating the performance of AI-powered diagnostic or decision support systems. The ALLEZ SPINE Cross Connectors are mechanical implants, not AI-driven diagnostic tools.

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

This information is not applicable. This question is relevant for AI algorithms. The device in question is a mechanical implant.

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

This information is not applicable for the reasons mentioned in point 3. The primary "ground truth" in this context is the performance of the legally marketed predicate device, to which the new device is compared. For mechanical devices, performance is usually assessed through bench testing (e.g., fatigue, static loading) rather than clinical "ground truth" in the diagnostic sense.

8. The sample size for the training set

This information is not applicable. The concept of a "training set" is relevant for machine learning algorithms. The ALLEZ SPINE Cross Connectors are a physical medical device.

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

This information is not applicable for the same reasons as point 8.

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