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The EBI® SpineLink® II Spinal Fixation System is a non-cervical spinal fixation device intended for use as a pedicle screw fixation system, a posterior hook and sacral/iliac screw fixation system, or as an anterolateral fixation system. Pedicle screw fixation is limited to skeletally mature patients. The device is indicated for all of the following indications regardless of the intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and or lordosis), tumor, stenosis, pseudoarthrosis, and failed previous fusion. The transverse connector is not intended for anterior/anterolateral fixation.

The EBT® SpineLink® II Spinal Fixation System is a spinal fixation device that utilizes interconnecting links, screws (fixed and polydirectional designs), transverse connectors, hooks, endcaps, locknuts, and link ties.

The provided text describes a 510(k) summary for a medical device called the EBI® SpineLink® - II Spinal Fixation System. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through clinical studies in the way an AI/ML device would. Therefore, most of the information requested in the prompt (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set sizes, and ground truth establishment for training) is not applicable to this type of device submission as described.

Here's an analysis based on the available information:

Description of the Device and its Assessment:

The EBI® SpineLink® - II Spinal Fixation System is a spinal fixation device used for various spinal conditions. Its 510(k) submission, K031355, asserts substantial equivalence to existing legally marketed predicate devices. This means the device's safety and effectiveness are established by showing it is as safe and effective as a device already on the market.

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria for Spinal Fixation Systems (Inferred from 510(k) principles): For a device like the EBI® SpineLink® - II Spinal Fixation System, the "acceptance criteria" are not typically expressed as specific performance metrics like sensitivity or specificity for diagnosis. Instead, they center around:

  • Substantial Equivalence: The primary criterion is demonstrating that the device is as safe and effective as legally marketed predicate devices. This is achieved by comparing its technological characteristics (intended use, materials, function) and through mechanical testing.
  • Compliance with Applicable Standards: The device must comply with relevant industry standards for spinal implants (e.g., ASTM F136 for materials).
  • Meeting Functional Requirements: The device must perform its intended mechanical functions reliably.

• Reported Device Performance (from the document):

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

• Not Applicable. This is a mechanical device, not an AI/ML diagnostic tool. Its performance is demonstrated through mechanical testing against predicate devices and adherence to material standards, not through analysis of data from a training/test set of patient images or other data. The "test set" in this context would refer to the physical devices undergoing mechanical tests, not a dataset. The document does not specify the number of devices tested.

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

• Not Applicable. Ground truth, in the sense of expert consensus on patient data or pathology, is not relevant for demonstrating the substantial equivalence of a mechanical spinal fixation system.

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

• Not Applicable. Adjudication methods are used to establish ground truth in studies involving human interpretation or uncertain outcomes, which is not the case for this type of device.

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. MRMC studies are specific to evaluating the impact of AI on human readers (e.g., radiologists interpreting images). This device is a surgical implant, not an AI diagnostic tool.

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

• Not Applicable. This device does not involve an algorithm or AI.

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

• Not Applicable (in the conventional sense). For this medical device, the "ground truth" for its safety and effectiveness is established by:
  • Mechanical Test Results: Demonstrating that its physical performance (strength, durability, etc.) is comparable to or better than predicate devices and meets relevant standards.
  • Material Specifications: Conformance to established material standards (e.g., ASTM F136 for titanium alloy).
  • Comparison to Predicate Devices: Showing that its design, intended use, and functional principles are substantially equivalent to devices already proven safe and effective.

8. The sample size for the training set:

• Not Applicable. There is no "training set" for a mechanical device like this.

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

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

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The EBI® SpineLink™ - II Spinal Fixation System is a spinal fixation device for pedicle screw fixation, and a non-pedicle hook and sacral/iliac screw fixation system of the non-cervical spine, and an anterior fixation system.

When used as a pedicle screw fixation system, in the non-cervical spine of skeletally mature patients, the System is intended to provide immobilization and stabilization of spinal segments, 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 neurologic impairment; fracture; dislocations; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system in skeletally mature patients, it is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (L5 - S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (d) who are having the device removed after the development of a solid fusion mass.

When used as a posterior hook and sacral/iliac screw fixation system, the levels of attachment are the lumbar and thoracic spine, and screw fixation is limited to the sacrum and ilium. The System is intended for the treatment of degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); pseudarthrosis; stenosis; scoliosis; spondylolisthesis; fracture; previous failed fusion; or tumor resection.

When used as an anterior fixation system, the levels of attachment are the anterolateral vertebral bodies of the lumbar and thoracic spine. The System is intended for the treatment of degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); pseudarthrosis; stenosis; scoliosis; spondylolisthesis; fracture; previous failed fusion; or tumor resection. The transverse connector is not intended for anterior fixation.

The EBI® SpineLink™ II Spinal Fixation System is a spinal fixation device that utilizes interconnecting links, screws (fixed and polydirectional designs), transverse connectors, hooks, endcaps, locknuts, and link ties.

This document is a 510(k) summary for a medical device called the EBI® SpineLink™ - II Spinal Fixation System. It is a premarket notification to the FDA to demonstrate substantial equivalence to legally marketed predicate devices. The document does not describe an AI/ML powered device, and therefore the request for acceptance criteria and study details related to an AI/ML device is not applicable.

The document focuses on demonstrating that the EBI® SpineLink™ - II Spinal Fixation System is substantially equivalent to predicate devices in regards to intended use, materials, and function. The only mention of "study" is for mechanical testing, which is a standard engineering evaluation, not an AI/ML performance study.

Therefore, I cannot provide the requested information regarding acceptance criteria and studies for an AI/ML device from this document.

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