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The Invictus Robotic Navigation Instruments are indicated for use during the placement of Invictus Spinal Fixation System screws in either open or minimally invasive procedures. The Invictus Robotic Navigation Instruments are specifically designed for use with Globus Medical's Excelsius GPS® Robotic Navigation Platform, which is intended for use as an aid for precisely locating anatomical structures and for the spationing and orientation of an instrument holder or guide tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous procedures, provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy.

The Invictus Robotic Navigation Instruments are surgical instruments that is designed to be compatible with Globus Medical's Excelsius GPS® Robotic Navigation Platform. The subject device is intended to facilitate the placement of screws during spinal surgery. The subject device are reusable instruments and offered non-sterile to be cleaned and steam sterilized by the end user.

The provided text is a 510(k) summary for the Invictus Robotic Navigation Instruments. It explains that the determination of substantial equivalence (SE) is not based on an assessment of clinical performance data. Instead, it states that the device was evaluated through dimensional analysis and geometric comparison to the predicate devices to establish safety and effectiveness for accuracy performance.

Therefore, the document does not contain the information requested concerning acceptance criteria, device performance, test set sample sizes, data provenance, expert involvement for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth details for training sets.

The relevant section states:
"Clinical Information
Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data.

VII. PERFORMANCE DATA
The Invictus Robotic Navigation Instruments have been evaluated through a dimensional analysis and geometric comparison to the predicate devices to establish the safety and effectiveness for accuracy performance."

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The QUARTEX® Occipito-Cervico-Thoracic Spinal System implants are intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (CI-C7) and the thoracic spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radior myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. These implants are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion. In order to achieve additional levels of fixation, rods may be connected to occipital cervical thoracic or thoracolumbar stabilization systems ranging in diameter from 3.2mm to 6.5mm, using corresponding connectors.

The ExcelsiusGPS® is intended for use as an aid for precisely locating anatomical structures and for spatial positioning and orientation of an instrument holder or guide to be used by surgeons for navigating compatible surgical instruments in open or percutaneous provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. The system is indicated for the placement of spinal and orthopedic bone screws and interbody spacers.

The ExcelsiusHub™ is intended for use as an aid for precisely locating anatomical structures to be used by surgeons for navigating compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. The system is indicated for the placement of spinal and orthopedic bone screws and interbody fusion devices.

QUARTEX® additional implants include monoaxial, polyaxial, and dual lead polyaxial screws manufactured from titanium alloy; MIS rods manufactured from titanium alloy, stainless steel, and/or cobalt chromium molybdenum; and, associated manual and navigated surgical instruments.

ExcelsiusGPS® Instruments are nonsterile, reusable instruments that can be used with ExcelsiusGPS® or ExcelsiusHub® and may be used for a navigated surgical procedure. No changes were made to the ExcelsiusGPS® or ExcelsiusHub® systems with the addition of the subject ExcelsiusGPS® instruments.

The provided text is a US FDA 510(k) K231850 clearance letter for the QUARTEX® Occipito-Cervico-Thoracic Spinal System and ExcelsiusGPS® Instruments. This document primarily focuses on regulatory approval based on demonstrating substantial equivalence to predicate devices, rather than presenting a detailed study proving performance against acceptance criteria in the context of an AI/medical device standalone or comparative effectiveness study.

Therefore, the requested information regarding acceptance criteria, study details (sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, training set details) is not available within the provided text.

The document mentions "Verification and validation testing were conducted to confirm implant placement accuracy with ExcelsiusGPS®" under the "Performance Data" section. However, it does not provide any specifics about these tests, methodologies, acceptance criteria, or the results of these tests.

In summary, the provided document does not contain the information needed to fill out the requested table or answer the detailed questions about the study proving the device meets acceptance criteria.

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The HILINE™ Fixation System consists of temporary implants for use in orthopedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications:

· Spinal trauma surgery, used in sublaminar, interspinous, or facet wiring techniques;

· Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age and older, adult scoliosis, and spondylolisthesis;

· Spinal degenerative surgery, as an adjunct to spinal fusions;

· Use with a posterior spinal instrumentation construct when ligament augmentation is needed.

The HILINE™ Fixation System may also be used in conjunction with other medical implants made of similar metals whenever "wiring" may help secure the attachment of other implants.

The HILINE™ Fixation System is a sublaminar fixation system consisting of bands and clamps to mate with 3.5-6.5mm diameter rods, and associated manual surgical instruments. The bands have a titanium anchor attachment on one end that is detached after insertion and is not intended to be implanted. HILINE™ implants are manufactured from polyethylene terephthalate (PET), titanium alloy, commercially pure titanium, stainless steel, or cobalt chromium molybdenum alloy.

The provided text is a 510(k) summary for the HILINE™ Fixation System, which is a medical device. It focuses on demonstrating substantial equivalence to predicate devices based on mechanical testing and material characteristics. The summary explicitly states:

"Performance data demonstrate substantial equivalence to the predicate devices."

However, the provided text does not contain the detailed information required to fill out the table regarding acceptance criteria, specific device performance metrics, or study design details for clinical or AI-related performance evaluations. The "Performance Data" section solely mentions mechanical testing in accordance with ASTM F1798. There is no indication of a study involving human readers, ground truth establishment by experts, or any AI component.

Therefore, several sections of your request cannot be fulfilled based on the given information.

Here's what can be extracted and what cannot:

1. Table of acceptance criteria and the reported device performance:

The document states that mechanical testing (static and dynamic tension, band pull-through, rod push-through, and static component torsion) was conducted in accordance with ASTM F1798, and that the performance data demonstrated substantial equivalence to the predicate devices. However, it does not specify the numerical acceptance criteria or the specific numerical results of these tests.

2. Sample size used for the test set and the data provenance: Not applicable. No clinical or human-involved test set is described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment by experts for a test set is described.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No test set requiring expert adjudication is described.

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: No, an MRMC study was not done. The device description and performance data section do not mention any AI component or human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, a standalone algorithm study was not done. The device description and performance data section do not mention any AI component.

7. The type of ground truth used: Not applicable. No ground truth for an AI algorithm or diagnostic performance study is mentioned. The "ground truth" relevant here pertains to the physical properties and performance of the device under mechanical stress, which are assessed through standardized mechanical testing (ASTM F1798).

8. The sample size for the training set: Not applicable. No training set for an AI algorithm is mentioned.

9. How the ground truth for the training set was established: Not applicable. No training set for an AI algorithm is mentioned.

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The QUARTEX™ Occipito-Cervico-Thoracic Spinal System implants are intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1-C7) and the thoracic spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. These implants are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion. In order to achieve additional levels of fixation, rods may be connected to occipital cervical thoracic or thoracolumbar stabilization systems ranging in diameter from 3.2mm to 6.5mm, using corresponding connectors.

Globus Navigation Instruments are intended to be used during the preparation and placement of Globus screws (QUARTEX™, CREO®, REVERE®, REVOLVE®, ELLIPSE®, PROTEX® CT, and SI-LOK®) during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation® System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

The QUARTEX™ Occipito-Cervico-Thoracic Spinal System includes 3.5mm-4.0mm jointed, straight and pre-bent rods, tapered rods, polyaxial screws, hooks, locking caps, t-connectors, lateral connectors, parallel connectors, in-line connectors, rod-to-rod connectors, rod extension clamps, QUARTEX™ H-LINK™ integrated rod, and occipital plates and screws. The implants are composed of titanium alloy, stainless steel, or cobalt chromium molybdenum (CoCr) alloy.

QUARTEX™ constructs may be connected to stabilization systems including ELLIPSE®, PROTEX® CT, PROTEX®, CREO®, REVERE®, or BEACON® Systems using corresponding connectors. The QUARTEX™ System includes manual surgical instruments.

Globus Navigation Instruments are intended to be used during the preparation and placement of Globus screws (QUARTEX™, CREO®, REVERE®, REVOLVE®, ELLIPSE®, PROTEX® CT, and SI-LOK®) during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation® System.

The provided text does not contain information about the acceptance criteria and study proving a device meets these criteria in the context of an Artificial Intelligence (AI) or machine learning device. The document is an FDA 510(k) clearance letter for a QUARTEX™ Occipito-Cervico-Thoracic Spinal System and Globus Navigation Instruments.

This document focuses on the mechanical and material equivalence of a surgical spinal system to previously cleared predicate devices. It discusses:

• Device Name: QUARTEXTM Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments
• Regulation Number: 21 CFR 888.3075 (Posterior Cervical Screw System)
• Regulatory Class: Class II
• Product Code: NKG, KWP, OLO
• Indications for Use: Stabilization of spinal segments, assistance in locating anatomical structures during spinal surgery.
• Performance Data: Mechanical testing (static and dynamic compression bending, static interconnection testing) in accordance with ASTM F1717, ASTM F1798, and FDA guidance. Bacterial endotoxin testing (BET) per ANSI/AAMI ST-72:2011.
• Basis of Substantial Equivalence: Similar technical characteristics, performance, material composition, function, and intended use to predicate devices.

Therefore, I cannot extract the requested information regarding AI device acceptance criteria and study details (such as sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance) because this information is not present in the provided document.

The document describes material and mechanical testing for a physical surgical implant and navigation instruments, not an AI/ML diagnostic or prognostic device.

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The Adena-Zina System is intended for posterior, non-cervical fixation as an adjunct to fusion for skeletally mature patients for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.

In addition, when used as a pedicle screw fixation system, the Adena-Zina System is intended for skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral, L5-S1 vertebra, who are receiving fusion by autogenous bone graft only, who are having the device attached to the lumbar and sacral spine (levels may be from L3 to the sacrum/ilium), who are having the device removed after the attainment of a solid fusion.

The Adena-Zina System consists of a variety of shapes and sizes of screws, 5.5mm and 6.35mm rods, and other connecting components that can be rigidly locked in a variety of configurations, with each construct being tailor-made for the individual case. Fixation is provided via a posterior approach. All implant components are made from medical grade titanium alloy (Ti6Al4V-ELI) per ASTM F-136/ISO 5832-3 or cobalt chrome alloy per ASTM F1537-11/ISO 5832-12.

The purpose of this submission is to add the Duetto dual headed Screws and connectors, along with associated set screws to the Adena-Zina Spinal System.

The provided text pertains to an FDA 510(k) premarket notification for the "Adena-Zina System," a thoracolumbosacral pedicle screw system. This document outlines the regulatory clearance process for a medical device and describes its intended use, materials, and a declaration of substantial equivalence to predicate devices.

However, the provided text does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria related to an AI/ML algorithm or software functionality. The "Performance Testing" section only mentions bench testing for mechanical properties (static compression, static torsion, and dynamic axial compression) of the screws, as per ASTM F1717-18, which is standard for spinal implants, not for software performance or diagnostic accuracy.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them concerning AI/ML performance, because the provided input does not contain this information. The document focuses on the physical device and its mechanical properties.

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The KHEIRON Spinal Fixation System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), spinal stenosis, spinal tumor, pseudarthrosis and failed previous fusion.

When used for posterior, non-cervical, pedicle screw fixation in pediatric patients, the KHEIRON System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the KHEIRON Spinal Fixation System is intended to treat pediatic patients diagnosed with spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion.

This system is intended to be used with autograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The KHEIRON® Spinal Fixation System may be used for a variety of conditions that affect the thoracic and lumbar spine. In cases in which the posterior elements are fractured, the pedicle screw offers an excellent means of stabilizing a specific spinal segment. KHEIRON Spinal Fixation System includes screws and connecting components in a wide variety of sizes and shapes, which can be locked in various configurations, each assembly being tailor-made. KHEIRON pedicular screws must be used with Ø 5.5mm and Ø 6mm rods.

The KHEIRON® Spinal Fixation System is a medical device and the provided document is a 510(k) summary for its premarket notification to the FDA. This summary focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific performance criteria through a standalone study of its capabilities in a clinical setting.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not directly available in the provided text. The document states "No clinical studies were performed."

However, the document does provide information on non-clinical testing to demonstrate the physical performance and safety of the device:

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

Since no specific numerical acceptance criteria (e.g., minimum strength values) are given, and only a comparative statement is made regarding performance against predicates, a direct table of acceptance criteria and the reported device performance as typically expected for an AI/diagnostic device is not applicable here.

Instead, the non-clinical test summary states:

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

• Test Set Sample Size: Not specified as clinical studies were not performed. For non-clinical tests (mechanical tests), the sample sizes for the devices tested were not provided.
• Data Provenance: Not applicable as no clinical data was used. Mechanical testing is typically done in a laboratory setting. No country of origin for the mechanical test data is mentioned.

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, as no clinical studies requiring expert consensus for ground truth were performed.

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

• Not applicable, as no clinical studies requiring ground truth adjudication were performed.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states, "No clinical studies were performed." This device is a mechanical spinal fixation system, not an AI or diagnostic tool that would typically involve human "readers."

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

• Not applicable. This device is a mechanical implant, not an algorithm.

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

• For the non-clinical mechanical tests, the "ground truth" would be the engineering standards (e.g., ASTM F1717 and ASTM F1798) and the performance characteristics of the predicate devices. The device's strength was directly measured against these established benchmarks.

8. The sample size for the training set:

• Not applicable, as this is a mechanical spinal fixation system and not an AI/machine learning device that requires a training set.

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

• Not applicable, as this is a mechanical spinal fixation system and not an AI/machine learning device.

Summary of Non-Clinical Testing:

The KHEIRON® Spinal Fixation System underwent the following non-clinical mechanical tests:

• Static and dynamic compression bending (according to ASTM F1717)
• Static torsion (according to ASTM F1717)
• Torsional and axial gripping capacity (according to ASTM F1798)

The results of these evaluations indicated that the KHEIRON Spinal Fixation System is "substantially equivalent to legally marketed predicate devices" and specifically noted that its "strength values" were "greater or equivalent" compared to other cleared devices for thoracolumbosacral spine use.

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The PASS LP Spinal System is a pedicle screw fixation system intended for immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, tracture or dislocation), deformity or curvature (e.g., scoliosis, and/or lordosis), tumor, spinal stenosis, pseudarthrosis, or failed previous fusion.

Except for rod plates and caps for sacral plates, when used for posterior non-cervical pediatric patients, the PASS LP Spinal System implants are indicated as an adjunct to treat adolescent idiopathic scollosis. Additionally, the system is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/ spondylolysis and fracture caused by tumor and/or trauma. The PASS LP Spinal System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The PASS LP is designed to contribute to correction and surgical stabilization of the thoracic, lumbar and sacral spine.

The system consists of pedicle screws, hooks, sacral plates, iliac screws, clamps, rods, nuts, rod plates and crosslink components. It can be used for single or multiple level fixations. Components are manufactured from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136 and ISO 5832-3.

A subset of PASS LP components may be used for posterior pedicle screw fixation in pediatrics cases. These constructs may be comprised of a variety of shapes and sizes of rods, hooks, sacral plates, iliac screws, clamps, nuts and crosslink components. The PASS LP components can be rigidly locked into a variety of configurations, with each construct being tailored made for the individual case.

The purpose of this submission is to extend to the PASS LP range, with the addition of those new components:

• TULIP GENESIS Non-cannulated Pedicle Screws
• TULIP GENESIS Non-cannulated Iliac Screws
• TULIP GENESIS Cannulated Pedicle Screws
• TULIP GENESIS Cannulated Iliac Screws
• TULIP GENESIS Breakable Setscrew

This document is a 510(k) Pre-Market Notification from the FDA for the PASS LP Spinal System. It is an approval letter and a summary of the device and its intended use, not a study evaluating its performance against acceptance criteria in the context of an AI/ML medical device.

Therefore, I cannot provide the requested information as the document does not contain details about:

1. Acceptance criteria and reported device performance related to an AI/ML model. This document is for a medical implant (spinal fixation system), not a software device that relies on performance metrics like accuracy, sensitivity, or specificity.
2. Sample size and data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
6. Stand-alone algorithm performance.
7. Type of ground truth used (e.g., pathology, outcomes data) for an AI/ML model.
8. Sample size for a training set.
9. How ground truth for the training set was established.

The "Performance Data" section (g) only mentions mechanical testing according to ASTM F1717-18 for static compression bending, static torsion, and dynamic compression bending tests, concluding that the products are "as mechanically sound as other devices commercially available." This refers to the physical properties of the spinal implants, not the performance of an AI or Machine Learning algorithm.

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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 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.

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