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The LAGUNA® Size 8 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); tumor pseudarthrosis; and/or failed previous fusion.

The LAGUNA® Size 8 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® Size 8 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 35 mm to 100 mm and 8mm diameter sizes. All sizes are able to receive 5.5mm connecting rods only. The LAGUNA® Size 8 Pedicle Screw System implant components are fabricated from medical grade titanium alloy per ASTM F136.

The provided text describes a medical device, the Allez Spine LAGUNA® Size 8 Pedicle Screw System, and its 510(k) premarket notification (K091995) to the FDA. The document focuses on the regulatory clearance process and includes information about the device's indications for use and equivalence to a previously marketed device.

However, the provided text does not contain any information regarding acceptance criteria or a study that proves the device meets specific acceptance criteria.

The section "Performance data" states: "Biomechanical tests have been performed. The test results were equivalent to other similar implants and are sufficient for in vivo loading." This is a general statement and does not provide numerical acceptance criteria or detailed study results.

Therefore, I cannot populate the requested table or answer the specific questions about sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details as this information is not present in the provided document.

To summarize the requested categories:

1. Table of acceptance criteria and reported device performance: Not provided in the text. The text only vaguely states "test results were equivalent to other similar implants and are sufficient for in vivo loading."
2. Sample size used for the test set and data provenance: Not provided in the text.
3. Number of experts used to establish the ground truth for the test set and qualifications: Not applicable, as no clinical study with expert ground truth is described.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not applicable, as this device is a physical spinal fixation system, not an AI or imaging diagnostic device. The concept of "human readers improve with AI vs without AI assistance" does not apply here.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this is a physical medical device.
7. The type of ground truth used: Not explicitly stated for performance testing beyond "biomechanical tests."
8. The sample size for the training set: Not applicable, as this is not an AI/ML device with a training set.
9. How the ground truth for the training set was established: Not applicable.

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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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