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The Firebird Spinal Fixation System and Phoenix MIS Spinal Fixation System are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion as a pedicle screw fixation system (T1-S2/Ilium), or as an anterolateral fixation system (T8-L5), in the treatment of the following acute and chronic instabilities or deformities:

1. degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
2. spondylolisthesis,
3. trauma (i.e., fracture or dislocation),
4. spinal stenosis,
5. deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
6. tumor,
7. pseudoarthrosis, and
8. failed previous fusion

When used for fixation to the illium, the offset connectors of the Firebird Spinal Fixation System must be used in conjunction with pedicle screws placed at the S1 or S2 spinal level.

The Phoenix MIS Fixation System when used with the Firebird System is indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery.

The Firebird Spinal Fixation System and Phoenix MIS Spinal Fixation System components are used with certain components of the Orthofix Spinal Fixation System, including rods, rod connectors and cross-connectors.

When used for posterior pedicle screw fixation in pediatric patients, the Firebird Spinal Fixation System and Phoenix MIS Spinal Fixation System are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Pediatric pedicle screw fixation is limited to a posterior approach. The Firebird Spinal Fixation System and Phoenix MIS Spinal Fixation System are intended to be used with autograft or allograft.

The Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System (K153428) are temporary, multiple component systems comprised of a variety of non-sterile, single use components, made of titanium alloy or cobalt chrome alloy, that allow the surgeon to build a spinal implant construct. The systems are attached to the vertebral body and ilium by means of screw or hook fixation to the non-cervical spine. The Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System consist of an assortment of rods, multi-axial and mono-axial pedicle screws, set screws, lateral offsets, bone screws, screw bodies, iliac connectors and STERILE packed HA Coated bone screws. A subset of the Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System components may be used in pediatric patients. These components consist of a variety of screws ranging in diameters from 4.0mm to 7.5mm and lengths ranging from 25mm to 60mm.

This FDA 510(k) premarket notification describes the Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline Fixation Screw, Phoenix CDX MIS Spinal Fixation System, and Firebird NXG Spinal Fixation System by Orthofix Inc. The submission is a Special 510(k) for additions and modifications to an already cleared system (K153428).

Here's an analysis based on the provided document:

Acceptance Criteria and Reported Device Performance

The document states that the additions and modifications to the device "do not change the previously cleared Firebird Spinal Fixation System (K153428) indications for use, contraindications, warnings or precautions." This implies that the acceptance criteria for the modified devices are the same as those established for the predicate device K153428. The primary performance metric mentioned is mechanical integrity under dynamic compression bending.

The acceptance criteria appear to be meeting or exceeding the performance of the predicate device (K153428) and compliance with the ASTM F1717-15 standard for spinal implant constructs.

Study Details

The document describes non-clinical mechanical testing, not a clinical study involving human patients or ground truth established by experts in a diagnostic context.

1. Sample size used for the test set and the data provenance: The document does not specify a numerical sample size for the mechanical tests. It lists the types of components tested (Reduction Body, Low Profile Offset, Mono-Axial Lateral Offset, Front Loading, Top Loading & Axial Rod Connectors, Anodized Straight and Pre-Lordosed titanium alloy Lined Rods). The data provenance is internal testing performed by Orthofix Inc. on manufactured device components. It is not prospective or retrospective patient data.

2. 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): Not applicable. This was a mechanical engineering study, not a study requiring expert clinical assessment for ground truth. The "ground truth" here is the physical performance under specified ASTM mechanical testing standards.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This was a mechanical engineering study, not a study requiring clinical adjudication.

4. 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 device is a spinal fixation system, not an AI-powered diagnostic tool.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a spinal fixation system, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this engineering study is defined by established mechanical testing standards (ASTM F1717-15) and comparison to the performance of the predicate device.

7. The sample size for the training set: Not applicable. There is no training set mentioned, as this is a mechanical engineering study for a physical medical device, not an AI/machine learning product.

8. How the ground truth for the training set was established: Not applicable. There is no training set.

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The SKYHAWK Lateral Plate System is intended to be used as a non-pedicle lateral or anterolateral fixation system in skeletally mature patients and 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 of the thoracic and lumbar spine. It may be used from levels T1 to L5 with the following indications:

• Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies);
• Spondylolisthesis;
• Spinal stenosis;
• Spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis);
• Tumor;
• Pseudoarthrosis;
• Failed previous fusion; and
• Trauma (i.e., fracture or dislocation).

The SKYHAWK Lateral Plate System consists of an assortment of non-sterile, single use, titanium alloy (Ti6Al4V ELI per ASTM F136) rigid plates, bone screws, and set screws. The.plates attach by means of screws to the anterolateral or lateral portion of the vertebral body of the thoracolumbar spine (T1-L5). The system includes instrumentation which assists in the surgical implantation of the devices. The SKYHAWK Lateral Plate System implants and instruments are provided non-sterile. They require sterilization prior to use.

The SKYHAWK Lateral Plate System is a medical device for spinal fixation. The provided document details its mechanical testing results but lacks information on performance metrics typically associated with AI/ML-driven devices (like sensitivity, specificity, etc.) or specific acceptance criteria beyond meeting performance benchmarks of predicate devices. Therefore, some sections of your request cannot be fully addressed.

Here's an analysis based on the provided text, focusing on what is available:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document describes non-clinical mechanical testing of the device itself, not a test set of data reflecting patient outcomes or imaging. Therefore, concepts like "sample size for the test set" and "data provenance (e.g., country of origin of the data, retrospective or prospective)" as they relate to AI/ML studies are not applicable here. The "sample" in this context refers to the physical devices subjected to mechanical stress tests. The number of devices tested is not specified, but it would align with the requirements of ASTM F1717-13.

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

This is not applicable as the study involves mechanical testing of a physical device, not an AI/ML diagnostic or prognostic system requiring expert review of data for ground truth establishment. The "ground truth" here is the physical performance of the device under specific, standardized mechanical loads, as measured by testing equipment.

4. Adjudication Method for the Test Set

Not applicable. The "test set" is the physical device and its components, and performance is determined by mechanical measurements against established ASTM standards and predicate device performance, not by 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 510(k) submission for a physical medical device (spinal plate system) based on mechanical equivalency, not an AI/ML device involving human readers or comparative effectiveness studies of human performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this study is the physical performance of the SKYHAWK Lateral Plate System as measured through standardized mechanical testing (static and dynamic axial compression bending, and static torsion testing), compared against the established performance of legally marketed predicate devices and the requirements of ASTM F1717-13.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

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