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The icotec Pedicle System is intended to provide immobilization of the posterior, noncervical spine in skeletally mature patients as an adjunct to the following indications: degenerative disc disease (DDD) (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, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The icotec Pedicle System is a posterior pedicle screw system manufactured from titanium alloy (Ti6Al4V ELI per ASTM F136) designed for fixation of the non-cervical spine. The icotec Pedicle System is comprised of monoaxial and polyaxial pedicle screws and curved and straight rods. The icotec Pedicle System can be used for single or multiple level fixations.

This document is a 510(k) premarket notification for the icotec Pedicle System, a medical device. It describes the device, its intended use, and its substantial equivalence to previously marketed predicate devices.

Here's an analysis of the provided text in the context of the requested information about acceptance criteria and evidence of meeting them:

Critically, this document is a 510(k) submission for a pedicle screw spinal system, a physical medical device (implant). It is not a document describing an AI/ML medical device submission. Therefore, the concepts of "acceptance criteria" and "study proving the device meets the acceptance criteria" as they apply to software performance (e.g., sensitivity, specificity, AUC) are not directly applicable in the way your prompt expects for an AI/ML device.

This 510(k) demonstrates substantial equivalence primarily through:

• Intended Use, Material, Geometry, Method of Fixation, and Mechanical Properties comparison with predicate devices.
• Mechanical Testing (non-clinical) to show that the device performs equivalently to previously cleared devices under simulated physiological conditions.

Given this, I will interpret your questions in the context of a physical medical device's submission dossier.

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

For a physical device like a pedicle screw system, acceptance criteria are generally related to mechanical performance, material properties, and design specifications. The document states that the device meets these through comparison to predicates and non-clinical testing.

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

For physical device mechanical testing (preclinical testing), "sample size" refers to the number of devices or test specimens used in the mechanical tests (e.g., number of screws tested for bending strength). This information is not provided in this summary. Such details would typically be in the full test reports submitted to the FDA, not in the 510(k) summary.

Data provenance: The mechanical tests were performed by "the company" (icotec AG). The tests are "non-clinical," implying laboratory-based testing rather than patient data.

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

This concept is not directly applicable to a physical device's mechanical or material testing. There isn't "ground truth" derived from expert consensus for device mechanical properties in the way there is for image interpretation in an AI/ML study. The "ground truth" for mechanical testing is established by engineering standards (e.g., ASTM F1717) and the physical measurements themselves.

4. Adjudication method for the test set

Not applicable for mechanical testing of a physical 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. This is a 510(k) for a physical implant, not an AI/ML diagnostic or assistive device.

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

Not applicable. This is a 510(k) for a physical implant, not an AI/ML algorithm.

7. The type of ground truth used

The "ground truth" for this device's performance is based on engineering standards (ASTM F1717) and the measured mechanical properties of the device components, demonstrating equivalence to the predicate devices. There is no biological/clinical "ground truth" from patients or pathology in this specific context of demonstrating substantial equivalence via preclinical testing.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of a traditional 510(k) for a physical medical device. The device design and manufacturing process are established, and then the product is tested against established standards and predicates.

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

Not applicable. See point 8.

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The TIGER" Spine System is intended to provide immobilization 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 thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

When used as a pedicle screw system, the TIGER™ Spine System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

The TIGER™ Spine System is comprised of polyaxial pedicle screws, rods and crosslinks. The TIGER™ Spine System can be used for single or multiple level fixations. The pedicle screws are available in various lengths and diameters. The rods are available in straight and pre-iordosed (curved) configurations. The system has variable length cross connectors.

The provided text describes the TIGER™ Spine System, a pedicle screw system, and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets specific acceptance criteria in the context of the requested AI/medical device performance evaluation framework.

The document is a 510(k) summary for a medical device (TIGER™ Spine System), which is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed predicate device. This process typically relies on demonstrating substantial equivalence rather than meeting pre-defined performance acceptance criteria in the way an AI algorithm might have.

Here's a breakdown of why many of your requested points cannot be answered from the provided text:

• Acceptance Criteria & Device Performance: The document outlines the device's characteristics and compares them to predicate devices to establish substantial equivalence. It does not define performance metrics, thresholds, or acceptance criteria in the sense of accuracy, sensitivity, specificity, or other performance measures that would be relevant for an AI device.
  • The "performance" described is in terms of the device's physical properties, materials, and intended function, not diagnostic or predictive performance.
• Study Details (Sample Size, Data Provenance, Ground Truth, Experts, Adjudication, MRMC, Standalone): The document explicitly states: "No clinical studies were performed." This means there are no details about a test set, training set, experts, ground truth, or any other elements related to performance evaluation studies for an AI/diagnostic device.
• Training Set Sample Size & Ground Truth: Since no clinical studies were performed, there is no mention of a training set or how ground truth for such a set would have been established.

Summary based on the provided document:

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

   • Acceptance Criteria: Not explicitly defined in terms of measurable performance thresholds for a diagnostic device. The acceptance criteria for its 510(k) approval are based on demonstrating "substantial equivalence" to predicate devices in terms of intended use, design, materials, and function.
   • Reported Device Performance: No quantitative performance metrics (e.g., accuracy, sensitivity) are reported. The performance described is its function as a posterior pedicle screw system for temporary stabilization.

2. Sample sized used for the test set and the data provenance: None, as no clinical studies were performed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: None, as no clinical studies were performed.

4. Adjudication method for the test set: None, as no clinical studies were performed.

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, as this is a physical spinal implant system, not an AI diagnostic device, and no clinical studies were performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical spinal implant system.

7. The type of ground truth used: Not applicable, as no clinical studies requiring ground truth for performance evaluation were performed.

8. The sample size for the training set: Not applicable, as no clinical studies were performed.

9. How the ground truth for the training set was established: Not applicable, as no clinical studies were performed.

What the document does provide regarding "performance" and "studies":

• Non-clinical Test Summary: Mentions "Static and dynamic compression and static torsion per ASTM F1717." These are mechanical tests to ensure the physical integrity and strength of the implant, not performance as a diagnostic or AI device. The results of these tests (e.g., meeting ASTM F1717 standards) would be the "performance" data, but specific numerical outcomes are not detailed in this summary.
• Conclusion: States that the TIGER™ Spine System is "substantially equivalent to the predicate devices in terms of indications for use, design, material, and function." This "substantial equivalence" is the primary basis for its acceptance (510(k) clearance).

In essence, the provided document is for a traditional medical device (implant) and not an AI-powered diagnostic tool, therefore the requested information fields related to AI performance evaluation are not relevant or present in this context.

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