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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 Firebird Spinal Fixation System and Phoenix MIS Spinal Fixation System are intended for posterior, non-cervical pedicle, and non-pedicle fixation (T1-S2/Ilium). Pedicle screw fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion using autograft. The device is indicated for all of the following indications:

a) degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
b) spondylolisthesis,
c) trauma (i.e., fracture or dislocation),
d) spinal stenosis,
e) deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
f) tumor,
g) pseudoarthrosis, and
h) failed previous fusion

When used for fixation to the illum, 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 non-cervical pedicle screw fixation in pediatic patients, the Firebird Spinal Fixation System implants are indicated as an adjunct to freat adolescent idiopathic scoliosis. The Firebird Spinal Fixation System for pediatric use is intended to be used with autograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System (K151488, K130932) 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, hooks, 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.

Here's an analysis of the provided text regarding the Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System, focusing on acceptance criteria and supporting studies.

Based on the provided FDA 510(k) summary, the device is a spinal fixation system, and the submission is for modifications to previously cleared versions. The type of acceptance criteria and studies described are primarily focused on mechanical performance to demonstrate substantial equivalence to predicate devices, rather than clinical performance (e.g., diagnostic accuracy, treatment outcomes).

It's important to note that the provided documents are regulatory submissions for a Class III medical device (pedicle screw spinal system). For such devices, "acceptance criteria" and "study that proves the device meets the acceptance criteria" are typically related to:

1. Benchtop Mechanical Testing: To ensure the device new modifications meet established standards (e.g., ASTM standards for mechanical strength, fatigue, etc.) or are at least as good as the predicate device.
2. Biocompatibility Testing: To ensure the materials are safe for implantation.
3. Sterilization Validation: To ensure the device can be properly sterilized.

The provided text focuses only on the mechanical testing aspects. Clinical studies involving human subjects with endpoints like "accuracy" or "effect size improvement" are not generally required for 510(k) submissions unless demonstrating a new intended use or significant change that impacts clinical performance in a way not covered by substantial equivalence. This submission is for modifications to existing cleared devices, asserting substantial equivalence.

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Note on "Acceptance Criteria" and "Reported Device Performance": In this 510(k) summary, the specific numerical acceptance criteria (e.g., minimum load to failure, fatigue life cycles) and the exact numerical results obtained from the tests are not provided. The summary states that testing was "conducted" per the standards and that these tests form the "basis of substantial equivalence." This implies that the devices met the performance targets (typically, at least matching or exceeding the predicate device's performance as per the relevant ASTM standards). For a detailed understanding, one would need to review the full testing reports submitted to the FDA.

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

• Sample Size: The document does not specify the exact sample sizes (number of screws, bodies, constructs tested) used for the mechanical benchtop tests. Specific sample sizes are typically detailed in the full mechanical test reports.
• Data Provenance: The data comes from benchtop mechanical testing performed by the manufacturer, Orthofix Inc. This is prospective data generated specifically for the 510(k) submission. It is not clinical or patient data and therefore has no country of origin in that sense.

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

This question is not applicable to this type of submission. This 510(k) is for a physical medical device (spinal fixation system) and relies on mechanical engineering principles and testing, not on interpretation of data by human experts to establish "ground truth" in the way an AI diagnostic device would. The "ground truth" here is the physical performance data against established engineering standards or predicate device performance.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods (like 2+1, 3+1) are for human-interpreted data (e.g., radiology reads, clinical outcomes) to establish a consensus ground truth. For mechanical benchtop testing, the "adjudication" is typically the comparison of test results against predefined (often standard-based) acceptance criteria by qualified engineers and statisticians.

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

This question is not applicable. An MRMC study is relevant for AI-powered diagnostic or interpretive devices that assist human readers. This submission is for a physical implantable device, not an AI diagnostic tool.

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

This question is not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the mechanical performance tests is established by:

• Mechanical Engineering Standards: Specifically, ASTM F1798-13 (Flexion-Bending) and ASTM F1717-14 (Static and Dynamic Compression Bending, and Static Torsion). These standards define the test methodologies and often provide guidelines for performance expectations.
• Predicate Device Performance: To establish substantial equivalence, the performance of the modified components is compared to the performance of the legally marketed predicate device (Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System, K130932) on which the modifications are based. The implicit ground truth is that the new device's performance must be at least equivalent or better than the predicate.

8. The Sample Size for the Training Set

This question is not applicable. This is not an AI or machine learning device; therefore, there is no "training set."

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

This question is not applicable as there is no training set for an AI/ML model.

In summary, the provided document describes a 510(k) submission for modifications to a spinal fixation system. The "acceptance criteria" and "studies" are primarily focused on benchtop mechanical performance testing to ensure the modified components continue to meet established engineering standards and are substantially equivalent to their predicate devices, thereby assuring their safety and effectiveness. The nature of the device means that many of the questions related to AI/ML or clinical ground truth are not relevant.

Ask a specific question about this device

The Firebird Spinal Fixation System and Phoenix MIS Spinal Fixation System are intended for posterior, non-cervical pedicle, and non-pedicle fixation (T1-S2/Ilium). Pedicle screw fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion using autograft. The device is indicated for all of the following indications:

a) degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
b) spondylolisthesis,
c) trauma (i.e., fracture or dislocation),
d) spinal stenosis,
e) deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
f) tumor,
g) pseudoarthrosis, and
h) failed previous fusion

When used for fixation to the illum, 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 Spinal Fixation 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 non-cervical pedicle screw fixation in pediatric patients, the Firebird Spinal Fixation System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Firebird System for pediatric use is intended to be used with autograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The Firebird Spinal Fixation System and Phoenix MIS Spinal Fixation System are temporary, multiple component systems comprised of a variety of non-sterile and sterile, single use components, made of titanium alloy or cobalt chrome alloy, that allow a 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 and 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, hooks, iliac connectors and STERILE packed HA Coated bone screws. A subset of the Firebird Spinal Fixation System and 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.

Here's a breakdown of the acceptance criteria and study information based on the provided document:

This document is a 510(k) premarket notification for a medical device (Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System) and primarily focuses on proving substantial equivalence to a predicate device, not on presenting novel clinical study results for acceptance criteria in the typical sense of a new AI/diagnostic device.

The "acceptance criteria" here are mechanical performance standards for the spinal fixation system components and are met by demonstrating the new component (HA Coated Bone Screws) performs equivalently or better than the predicate device. The "study" is a series of non-clinical mechanical tests.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify a numerical sample size for the mechanical tests. It refers to "the subject Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System HA (Hydroxyapatite) Coated Bone Screws" and "predicate Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System Self-Tapping Cannulated Bone Screws." In mechanical testing, samples are typically specific numbers of manufactured devices.
• Data Provenance: The data comes from non-clinical performance testing conducted by the manufacturer, Orthofix, Incorporated. It is not patient or clinical data, so country of origin or retrospective/prospective does not apply in the typical sense. It's laboratory test data.

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

• This information is not applicable. For mechanical tests, the "ground truth" is defined by the physical properties and performance characteristics measured against industry standards (ASTM). The determination of "substantial equivalence" is made by the FDA based on the submitted test results and comparison to predicate devices, not by clinical experts establishing ground truth on a test set.

4. Adjudication method for the test set

• This is not applicable. Mechanical testing does not involve adjudication of expert opinions. The test results are quantitative measurements compared against predefined standards or predicate device performance.

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

• This is not applicable. This submission is for a spinal fixation system, not an AI or diagnostic imaging device. No MRMC study was conducted.

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

• This is not applicable. This is not an algorithm or AI device.

7. The type of ground truth used

• The "ground truth" for the mechanical tests is defined by the industry standard specifications (ASTM F1717-12, ASTM F1798-97(2008)) for spinal implant systems and the measured performance characteristics of the predicate device (K130932). The goal was to show that the new HA-coated screws perform at least as well as the established, FDA-cleared predicate device against these objective mechanical benchmarks.

8. The sample size for the training set

• This is not applicable. No training set was used as this is not an AI/machine learning device.

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

• This is not applicable. No training set was used.

Ask a specific question about this device

The Firebird Spinal Fixation System is intended for posterior, non-cervical pedicle fixation. Pedicle screw fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion using autograft or allograft. The device is indicated for all of the following indications:

• 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),
• spinal stenosis,
• deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
• tumor,
• pseudoarthrosis, and
• failed previous fusion.

The Firebird Spinal Fixation System components are used with certain components of the Blackstone SFS system, including rods, rod connectors and cross-connectors.

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

The Firebird Spinal Fixation System is a temporary, titanium alloy, multiple component system comprised of a variety of non-sterile, single use components that allow the surgeon to build a spinal implant construct. The components include rods, screws, screw bodies, offset head, lateral offsets, and connectors. The system is attached to the vertebral body by means of screws to the non-cervical spine. The spinal construct is completed by connecting the screws with titanium alloy or cobalt chrome rods.

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

This document is a 510(k) summary for the Orthofix Firebird Spinal Fixation System and Phoenix MIS Spinal Fixation System. It describes the device, its intended use, and its substantial equivalence to previously cleared devices. It does not contain information about acceptance criteria or a study proving that a device meets those criteria in the context of an AI/ML-driven medical device.

Therefore, I cannot provide the requested information because the provided text does not describe an AI/ML-driven device or its performance studies. It describes a spinal fixation system, which is a physical implant.

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