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The EBI Omega21 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 EBI® Omega21 Spinal Fixation System is a spinal fixation device that utilizes rods, screws, couplers and hooks. This submission is for the modification to the Indications for Use.

The provided document is a 510(k) summary for a spinal fixation system, not a study evaluating an AI/ML device. Therefore, it does not contain information related to acceptance criteria, device performance, sample sizes, ground truth establishment, or clinical study methodologies typically associated with AI/ML device evaluations.

The document is primarily focused on demonstrating substantial equivalence of the EBI® Omega21™ Spinal Fixation System to previously marketed predicate devices, as required for FDA clearance. It describes the device, its intended use, materials, and compares its technological characteristics to existing devices.

Therefore, I cannot extract the requested information as it is not present in the provided text.

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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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When used as a pedicle screw fixation system, Aesculap's Spine System® Evolution is 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 tumor, and failed previous fusion (pseudarthrosis).

It is also intended for the treatment of severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra in skelatally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine with removal of the implants after the attainment of a solid fusion. Levels of pedicle screw fixation for this indication are from L3-S1.

When used as a non-pedicle screw system, Aesculap's Spine System® Evolution is indicated for use in patients with degenerative disc disease (defined as back pain of discongenic origin with degeneration of the disc confirmed by history and radiographic studies), kyphosis, spondylolisthesis, neurological scoliosis, spine tumors and fractures. It is intended for posterior fixation from levels T1 through S1.

Spine System® Evolution is a multiple component system comprised of a variety of single use devices that allow the surgeon to build a spinal implant construct in order to stabilize the thoracic and lumbar vertebrae and promote spinal fusion. The additional components presented in this submission are pedicle, laminar, thoracic and counter hooks. The spinal implants are manufactured from titanium alloy (Ti6Al4V) in accordance to ISO 5832/III. The specialized instrumentation used to implant and explant the Spine System® Evolution implants are made from surgical grade stainless steel in accordance to ISO 7153/1.

The provided document is a 510(k) summary for the Aesculap Spine System® Evolution Additional Components, submitted in 1998. It primarily focuses on demonstrating substantial equivalence to pre-existing spinal fixation systems rather than proving device performance against specific acceptance criteria through a clinical study or even extensive standalone performance testing as would be expected for an AI/ML device.

Therefore, many of the requested elements for an AI/ML device's acceptance criteria and study proving performance are not applicable or not present in this type of regulatory submission for a medical device from that era.

Here's an attempt to answer based on the provided document, highlighting what is (and isn't) present:

Acceptance Criteria and Study to Prove Device Performance (Aesculap Spine System® Evolution Additional Components)

This submission demonstrates substantial equivalence of the Aesculap Spine System® Evolution Additional Components to previously marketed spinal implant systems. The "performance data" presented is primarily mechanical testing, typical for hardware medical devices, rather than a study proving performance against acceptance criteria as might be expected for an AI/ML device.

1. Table of Acceptance Criteria and Reported Device Performance

Note: For a traditional hardware device like this, "acceptance criteria" are often met by demonstrating adherence to recognized standards (like ISO for materials, or ASTM for mechanical testing) and by showing substantial equivalence to devices already legally on the market that have demonstrated safe and effective performance. Specific quantitative performance metrics for clinical outcomes against predefined thresholds are not typically part of a 510(k) summary for such devices.

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

• Sample Size for Test Set: Not applicable in the context of an AI/ML device's test set. For mechanical testing, the "sample size" would refer to the number of components or constructs tested in a lab setting. This information (specific number of samples tested for ASTM F 1717-96) is not provided in the summary.
• Data Provenance: Not applicable in the context of clinical data provenance for an AI/ML device. The "performance data" refers to in vitro mechanical testing.

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

Not applicable. This device is a physical spinal implant system, not a diagnostic AI/ML device requiring expert-established ground truth for a test set.

4. Adjudication Method for the Test Set

Not applicable. No expert adjudication process is described for this type of mechanical device.

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

No. An MRMC study is relevant for AI/ML diagnostic tools that impact human reader performance. This is a spinal implant, so such a study was not performed or described.

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

Not applicable. This device is a physical implant, not an algorithm. The "standalone performance" is related to its mechanical integrity, which was assessed via in vitro ASTM F 1717-96 testing. The results of this testing are not detailed in the summary, simply that it was performed.

7. Type of Ground Truth Used

Not applicable in the context of typical AI/ML ground truth.
For this device, "ground truth" would be established by:

• Adherence to material standards (ISO 5832/III).
• Results of mechanical testing (ASTM F 1717-96) demonstrating structural integrity and fatigue life, often compared against specified limits or predicate device performance.
• The established safety and effectiveness track record of the predicate devices to which it claims substantial equivalence.

8. Sample Size for the Training Set

Not applicable. This is a physical device, not an AI/ML algorithm requiring a training set.

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

Not applicable. As above, no training set for an AI/ML algorithm.

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