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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.

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 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 (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 or allograft. 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) Tumors: g) Pseudoarthrosis, and h) Failed previous fusion When used for fixation to the ilium, 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 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 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 is a temporary, titanium alloy, multiple component system 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 system is attached to the vertebral body and ilium by means of screw or hook fixation to the non-cervical spine. The Firebird Spinal Fixation System consists of an assortment of rods, multi-axial and mono-axial pedicle screws, set screws, lateral offsets, bone screws, screw bodies, hooks and iliac connectors.

The provided text describes a 510(k) premarket notification for the Firebird Spinal Fixation System. This type of submission is for medical devices and focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria through a clinical or performance study in the way an AI/ML device would.

Therefore, much of the requested information (e.g., sample size for test/training sets, ground truth establishment, MRMC studies, AI performance metrics) is not applicable to this document as it pertains to a mechanical spinal fixation system, not a software or AI/ML device.

However, I can extract the relevant information regarding performance data as presented in the document:

1. Table of Acceptance Criteria and Reported Device Performance

For this medical device (spinal fixation system), "acceptance criteria" are typically defined by the standard mechanical tests and their pass/fail requirements, demonstrating that the modified device's performance is equivalent to the predicate device.

Explanation of "Acceptance Criteria" for this device: The primary "acceptance criterion" for this 510(k) submission is that mechanical testing demonstrates that the modified device (Firebird Spinal Fixation System with lined rods) is substantially equivalent to the predicate device (Firebird Spinal Fixation System K130932) and the other predicate (LDR Spine USA SpineTune TL System K120760) per the specified ASTM standards. The specific quantitative results (e.g., load-to-failure values, cycles to failure) are not provided in this summary, but the conclusion that equivalence was demonstrated indicates the acceptance criteria were met.

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

• Sample size: The document does not specify the number of samples used for each mechanical test.
• Data provenance: The data provenance is from the mechanical testing performed on the device components themselves, adhering to specific ASTM standards in a laboratory setting. This is not clinical data (retrospective or prospective from a country of origin).

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

• Not Applicable. This is a mechanical device, and "ground truth" (in the context of expert consensus or pathology) is not established by human experts for mechanical performance testing. Ground truth for mechanical tests is the quantitative measurement of physical properties against engineering specifications and standards.

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

• Not Applicable. Adjudication methods like 2+1 or 3+1 are used for human expert review, typically in studies involving interpretation of medical images or clinical outcomes. Mechanical testing does not involve this type of 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. An MRMC study is relevant for diagnostic imaging devices involving human readers and AI. This document describes a spinal fixation system, which is a physical implant, not a diagnostic AI tool.

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

• Not Applicable. This refers to the performance of an AI algorithm without human involvement. This document describes a physical medical device.

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

• For mechanical performance testing, the "ground truth" is defined by the measured physical properties and performance characteristics (e.g., stiffness, strength, fatigue life) as determined by standardized laboratory tests (ASTM F1717-14, ASTM F1798-13) against the established performance of predicate devices.

8. The sample size for the training set:

• Not Applicable. This is a mechanical device, not an AI/ML system that requires a "training set."

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

• Not Applicable. As above, no training set is involved for this type of device submission.

Ask a specific question about this device

The Firebird Spinal Fixation System is intended for posterior, non-cervical pedicle, and nonpedicle 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 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)
• . spondy lolisthesis,
• . trauma (i.e., fracture or dislocation),
• . spinal stenosis,
• . deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
• . tumor;
• . pseudoarthrosis, and
• failed previous fusion .
  When used for fixation to the ilium, 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 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 Spinal Fixation System for pediatric use is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The Firebird Spinal Fixation System is a temporary, titanium alloy, multiple component system 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 system is attached to the vertebral body and ilium by means of screw or hook fixation to the non-cervical spine. The Firebird Spinal Fixation System consists of an assortment of rods, multi-axial and mono-axial pedicle screws, set screws, lateral offsets, bone screws, screw bodies, hooks and iliac connectors. The expansion of indications for the Firebird Spinal Fixation System is proposed for the inclusion of adolescent idiopathic scoliosis alone, and not other indications for a pediatric population.
A subset of the Firebird Spinal Fixation System and Phoenix MIS System components may be used in pediatric patients. These components consist of a variety of screws ranging in diameters from 4.5mm to 7.5mm and lengths ranging from 25mm to 60mm.

The provided document is a 510(k) summary for the Orthofix Firebird Spinal Fixation System. This type of regulatory submission (510(k)) is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria as you might see for a novel device or a PMA.

Therefore, the document does not contain information about acceptance criteria and a study proving a device meets them in the way a diagnostic AI device or a novel therapeutic device would. Instead, it focuses on demonstrating equivalence to existing devices based on design, materials, indications for use, and mechanical performance.

I will attempt to extract the closest equivalents to your requested information where possible, based on the context of a 510(k) submission.

Analysis of the Provided Document Regarding Acceptance Criteria and Device Performance

The Orthofix Firebird Spinal Fixation System is a Class III Preamendment Device (Pedicle screw spinal system) for which the manufacturer is seeking 510(k) clearance. A 510(k) clearance means the device is "substantially equivalent" to predicate devices. This type of submission generally relies on demonstrating that the new device has the same intended use, technological characteristics, and performs as safely and effectively as a legally marketed device. It typically does not involve traditional clinical studies with acceptance criteria for device classification as one would expect for a novel device or an AI/diagnostic product.

Therefore, many of the requested points below are not directly applicable or quantifiable from this document.

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

   Not applicable in the context of this 510(k) submission. The performance assessment is focused on "substantial equivalence" to predicate devices, primarily through mechanical testing and engineering analysis rather than specific clinical acceptance criteria.

   The document states:
   "Previous mechanical testing of the system included static and dynamic compression bending testing and static torsion testing per ASTM F1717-04 and finite element analysis."

   While these tests have criteria for compliance with the standard, the document does not present a table of these criteria alongside specific device performance data. The conclusion drawn is that the device is substantially equivalent based on these results.

2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

   Not explicitly stated for the mechanical testing mentioned. When mechanical testing is performed, the "sample size" refers to the number of physical devices or components tested. The data provenance is not specified.

3. 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. Mechanical testing does not involve "experts" establishing ground truth in the way a diagnostic study would. The standards for mechanical testing (e.g., ASTM F1717-04) define the methods and parameters.

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

   Not applicable. Mechanical testing does not involve 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 spinal fixation system, not a diagnostic or AI-powered device.

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

   Not applicable. This is a spinal fixation system, not an algorithm.

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

   For mechanical testing, the "ground truth" is defined by the physical properties and performance limits set by engineering standards (e.g., ASTM F1717-04). For the expansion of indications (specifically for adolescent idiopathic scoliosis), the document mentions: "Published clinical results and engineering analysis supported expansion of indications." This implies that existing clinical literature for similar predicate devices, combined with engineering analysis (which would include the mechanical testing), served as the basis for justifying the expanded indications. Outcomes data or expert consensus from previously published studies might have indirectly informed this, but no new study for this submission is detailed.

8. The sample size for the training set

   Not applicable. This is a spinal fixation system, not a machine learning model requiring a training set.

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

   Not applicable. This is a spinal fixation system, not a machine learning model.

Summary regarding the Firebird Spinal Fixation System and 510(k) process:

The K130932 submission for the Firebird Spinal Fixation System is a 510(k) premarket notification. The core of this submission is to demonstrate substantial equivalence to existing predicate devices. This is achieved by showing that the device:

• Has the same intended use.
• Has the same basic technological characteristics (design, materials: titanium alloy per ASTM F136 and cobalt chrome per ASTM F1537, as with predicates).
• Performs as safely and effectively as the predicate devices.

The "proof" the device meets acceptance criteria in this context relies on:

• Mechanical Testing: Static and dynamic compression bending, and static torsion testing per ASTM F1717-04.
• Finite Element Analysis (FEA).
• Comparison to existing predicate devices: K081684, K082797, K100044, K093926, K122901 (Orthofix Inc.), K113666 (Stryker Spine), K091445 (Medtronic Sofamor Danek USA), K994121 (Synthes Spine), K121630 (K2M, Inc.), K111492 (Medtronic Sofamor Danek USA).

The document states: "Previous testing performed on this device indicates that the Firebird Spinal Fixation System is substantially equivalent to predicate devices." and "Published clinical results and engineering analysis supported expansion of indications." This means the mechanical performance met relevant engineering standards, and the safety and efficacy for the expanded indications (specifically pediatric adolescent idiopathic scoliosis) were supported by existing clinical literature and the device's engineering characteristics being similar to already approved predicate devices.

Ask a specific question about this device

The Firebird Spinal Fixation System is intended for posterior, noncervical 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:
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
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 components are used with certain components of the Orthofix Spinal Fixation System, including rods, rod connectors and cross-connectors.

The Firebird Spinal Fixation System is a temporary, multiple component system 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 system is attached to the vertebral body bv means of screw . fixation to the non-cervical spine. The Firebird Spinal Fixation System consists of an assortment of pedicle screws, set screws, lateral offsets, bone screws and screw bodies. The Firebird Spinal Fixation System implants are not compatible with components or metal from any other manufacturer's system.
The Phoenix MIS Fixation System when used with the Firebird Spinal Fixation System as indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery.
The Firebird Spinal Fixation System components are used with certain components of the Orthofix Spinal Fixation System, including rods, rod connectors and cross-connectors.

The Orthofix Firebird Spinal Fixation System is a Class III preamendment device (Pedicle screw spinal system, 21 CFR 888.3070) designed for posterior, non-cervical pedicle fixation as an adjunct to fusion.

Here's an analysis of the acceptance criteria and supporting evidence:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided 510(k) summary does not specify sample sizes for mechanical testing or FEA simulations, nor does it indicate the provenance of any data beyond general material specifications. This submission is for a Special 510(k), which typically relies heavily on comparison to a predicate device and may not require extensive new testing if modifications are minor and proven equivalent.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This 510(k) summary is for a spinal fixation system, not an AI or imaging device that would typically involve human expert ground truth establishment for diagnostic accuracy. Therefore, this information is not applicable and not provided.

4. Adjudication Method for the Test Set

As this is not an AI or imaging device requiring human expert review for diagnostic accuracy, an adjudication method is not applicable and not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is typically for diagnostic imaging devices where human interpretation is a key component, often with and without AI assistance. This device is a surgical implant.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, a standalone performance study (algorithm only) was not done. This is not an AI-driven device. The "performance" assessment refers to the mechanical and material characteristics of the implant itself, not an algorithm's output.

7. The Type of Ground Truth Used

For this device, the "ground truth" is established through:

• Material Specifications: Adherence to established ASTM standards (ASTM F136 for titanium alloy and ASTM F1537 for cobalt-chrome).
• Mechanical Performance Standards: Verification against established industry standards or predicate device performance for axial grip and torque.
• Engineering Principles: Finite Element Analysis (FEA) simulation.

8. The Sample Size for the Training Set

This is not applicable. This submission concerns a physical medical device (spinal implant), not an AI algorithm that requires a training set.

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

This is not applicable as there is no AI training set for this device.

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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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The Firebird Spinal Fixation System is intended for posterior, non-cervical pedicle, and non-pedicle fixation (T1-S2/Ilium). The system is limited to use in 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:

• 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),
• spinal stenosis, 4)
• 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 ilium, 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 Firebird Spinal Fixation System components are used with certain components of the SFS system, including rod connectors and cross-connectors.

The additional, non-pedicle components presented in this premarket notification consist of Hooks and Iliac Connectors.

This document is a 510(k) Premarket Notification for the Blackstone Medical, Inc. Firebird Spinal Fixation System Expansion. It indicates that the submission is for an expansion of a previously cleared system, focusing on adding new non-pedicle components (Hooks and Iliac Connectors). Therefore, the "device" in question refers to these additional components for the existing Firebird Spinal Fixation System.

It's important to note that this is a 510(k) submission, which typically demonstrates substantial equivalence to a predicate device rather than independent proof of safety and effectiveness through a clinical trial with specific performance criteria for AI/software-as-a-medical-device. The "performance data" here refers to mechanical testing for the new components.

Here's an analysis based on the provided text, recognizing the context of a spinal implant device and not an AI/software device:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of "Acceptance Criteria" for this device:

For spinal fixation systems like this, acceptance criteria in a 510(k) context are typically demonstrated through:

• Mechanical Testing: Showing that the new components meet established standards for strength, durability, and resistance to wear, and perform comparably to legally marketed predicate devices. The document specifically mentions static compression bending, static torsion, and dynamic compression bending.
• Biocompatibility: (Though not explicitly detailed in this summary, it's an inherent requirement for implantable devices.)
• Design Rationale & Risk Analysis: Demonstrating that the design is appropriate for its intended use and that potential risks have been mitigated.
• Demonstration of Substantial Equivalence: The overarching goal of a 510(k) is to prove the device is as safe and effective as a legally marketed predicate device.

2. Sample Size for Test Set and Data Provenance

This document describes mechanical testing of physical implants, not a clinical study involving a "test set" of patients or data in the way an AI/software device would. Therefore, the concepts of "sample size for the test set" and "data provenance" (country of origin, retrospective/prospective) are not applicable in the context of this 510(k) submission. Mechanical tests would use a certain number of device components but this is not specified as a "sample size" in this document.

3. Number of Experts and Qualifications for Ground Truth

Again, this is a mechanical device submission, not an AI/software device. There were no experts used to establish "ground truth" in the clinical sense for a test set. The "ground truth" for mechanical testing is derived from established engineering standards and comparison to predicate device performance data (often from similar mechanical tests or published data).

4. Adjudication Method

Not applicable. There was no clinical test set requiring expert adjudication.

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

Not applicable. This submission is for a physical spinal implant, not an AI/software device that would assist human readers in diagnosis or analysis.

6. Standalone (Algorithm Only) Performance

Not applicable. This is a physical medical device; there is no algorithm or standalone software performance to evaluate.

7. Type of Ground Truth Used

The "ground truth" for this device's performance demonstration relies on:

• Engineering Standards: Established international and national standards for spinal implant mechanical testing.
• Predicate Device Performance Data: Mechanical test results from the identified predicate devices (e.g., Firebird Spinal Fixation System Cobalt-Chrome Rods, Blackstone Pedicle Screw System, Synthes Universal Spine System, DePuy Acromed systems). The performance of the new components must demonstrate equivalence to these established predicate devices.

8. Sample Size for the Training Set

Not applicable. As a physical device, there is no "training set" in the context of machine learning or AI.

9. How Ground Truth for the Training Set Was Established

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:

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

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 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 provided text is a 510(k) summary for a modification to the Firebird Spinal Fixation System, specifically the addition of a "Side-loading Body." This document describes a medical device and its regulatory submission, not a study involving AI or diagnostic performance metrics typically found in acceptance criteria for AI-powered devices.

Therefore, many of the requested categories (such as sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, and training set information) are not applicable to this document as it pertains to a mechanical medical device and its physical performance testing for substantial equivalence, not a diagnostic or AI-based system.

Here's an attempt to answer the applicable questions based on the provided text:

Acceptance Criteria and Device Performance

Study Details (Mechanical Device Context)

1. Sample size used for the test set and the data provenance: The document states "Mechanical testing... was conducted in accord with ASTM standards." ASTM standards for mechanical testing typically specify the number of samples required for each test (e.g., fatigue, static bending, axial pull-out). However, the specific sample sizes used for these tests are not provided in this 510(k) summary. Data provenance is implied to be from laboratory testing performed by or for Blackstone Medical, Inc. or its contract manufacturer. This is by nature prospective testing, as it's performed to evaluate the new component.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is not applicable. For mechanical performance testing of a spinal implant, "ground truth" is established by physical measurements and engineering analyses based on established ASTM standards, not by expert medical review.

3. Adjudication method: This is not applicable. Adjudication methods like 2+1 or 3+1 are used for clinical diagnostic studies where human disagreement needs resolution. Mechanical testing results are objective measurements.

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: This is not applicable. This document describes a mechanical medical device, not an AI or diagnostic tool.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This is not applicable. This refers to AI algorithm performance.

6. The type of ground truth used: For mechanical equivalence, the "ground truth" is defined by the performance specifications and physical characteristics of the legally marketed predicate devices and the established ASTM testing standards. The new device's performance is compared against these benchmarks to determine substantial equivalence.

7. The sample size for the training set: This is not applicable. There is no "training set" in the context of mechanical testing for substantial equivalence of a physical medical device.

8. How the ground truth for the training set was established: This is not applicable for the same reasons as above.

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:

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

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 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 document describes the K092624 premarket notification for the Blackstone Medical, Inc. Firebird Spinal Fixation System with the addition of a Cobalt Chrome Rod. This is a medical device submission, and as such, the concept of "acceptance criteria" and "device performance" as it might apply to software or AI algorithms is not directly applicable in the same way. Instead, the "acceptance criteria" for a medical device like this is typically demonstrating substantial equivalence to a predicate device, primarily through mechanical testing to ensure safety and effectiveness.

Here's a breakdown based on the provided text, adapted to the context of a medical hardware device:

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

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: The document does not specify the exact sample size for the mechanical testing. For medical devices, "sample size" in this context typically refers to the number of devices or components tested. ASTM standards for medical devices usually specify the required number of samples for each test type to achieve statistical significance.
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given that the submission is to the FDA (USA), it is reasonable to infer the testing was likely conducted in the US or by a lab adhering to US standards. Mechanical testing on medical devices is inherently prospective, as it involves newly produced components subjected to defined test protocols.

3. 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)

This question is not applicable. For mechanical testing of a medical device, "ground truth" is established by the specifications of the ASTM standards themselves and the objective measurements obtained from standardized testing equipment, not by a panel of human experts. Expert clinical opinion would be relevant in the initial design and indication definition, but not in validating the mechanical performance.

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

This question is not applicable. Mechanical testing of physical medical devices does not involve human adjudication in the way clinical studies or image analysis might. The results are based on objective physical measurements and adherence to pre-defined test protocols.

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. The device is a spinal fixation system (hardware), not an AI or imaging diagnostic tool. Therefore, MRMC studies or human reader improvement with AI assistance are irrelevant to this submission.

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

This question is not applicable. The device is a spinal fixation system, which is a physical implant, not an algorithm.

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

The "ground truth" for the mechanical testing of this device is established by objective physical measurements (e.g., force, displacement, cycles to failure) in accordance with recognized industry standards (ASTM standards). These standards define the criteria for acceptable performance (e.g., fatigue life, strength) for spinal fixation systems.

8. The sample size for the training set

This question is not applicable. There is no "training set" in the context of mechanical testing for a medical device like a spinal fixation system. The device's performance is evaluated against engineering standards and comparison to a predicate device.

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

This question is not applicable, as there is no training set for this type of device submission.

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