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FIDJI type 5 is a vertebral body replacement device that is intended for use in the thoracic and/or thoracolumbar spine (T1-L5) to replace a collapsed, damaged or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to turnor or trauma (i.e., fracture). The device is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period. This device is intended to be used with bone graft and supplemental fixation, such as the Spinal Concepts, Inc. InCompass System. Additionally, FIDJI type 5 is intended to be used in a paired configuration.

The Spine Next FIDJI Vetebral Body Replacement Type 5 devices are hollow blocks that are machined from extruded Polyetheretherketone (PEEK); the blocks are tapered to aid in maintaining lordosis of the spine following implantation. The devices have angled teeth on the cephalad and caudal surfaces. The devices include tantalum inserts that serve as a location and orientation markers for radiographs.

The provided text describes a 510(k) premarket notification for a medical device, the Spine Next FIDJI Vertebral Body Replacement Type 5. This type of submission relies on demonstrating substantial equivalence to a predicate device rather than conducting new clinical studies with specific acceptance criteria as you might see for a PMA (Premarket Approval) application for a novel device.

Therefore, the information you're asking for regarding acceptance criteria, specific study details (sample sizes, experts, adjudication methods, MRMC studies, standalone performance), and ground truth establishment, is generally not applicable to a 510(k) submission like this one. 510(k)s focus on demonstrating that the new device is as safe and effective as a legally marketed predicate device, often through engineering and performance testing that shows the new device performs similarly within established standards, rather than generating new clinical data against specific performance targets.

However, I can extract the relevant information from the provided text that aligns with what is typically done for a 510(k) in terms of "comparison to predicate" which serves as the "proof" of meeting the implicit acceptance criteria of substantial equivalence.

Acceptance Criteria and Device Performance (Implicit through Predicate Comparison)

For a 510(k) submission, the "acceptance criteria" are implicitly met by demonstrating "substantial equivalence" to a legally marketed predicate device. This is primarily done by showing similar technical characteristics, indications for use, and performance. When comparing to a predicate, the "performance" often refers to engineering and bench testing rather than clinical study outcomes.

Study Details Not Applicable to This 510(k) Submission

As this is a 510(k) submission, the device did not undergo a clinical study in the traditional sense that would generate new clinical performance data. Instead, it demonstrated equivalence to existing predicate devices based on design, materials, and mechanical performance testing (implied by "All devices meet mechanical performance requirements"). Therefore, the following information is not provided or required for this type of submission:

1. Sample size used for the test set and the data provenance: Not applicable for a 510(k) unless specific clinical data was used to demonstrate equivalence (which is not indicated here). The "test set" would primarily refer to engineering bench tests.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as clinical ground truth establishment is not typically part of a 510(k) for this type of implant.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
4. If a multi reader multi case (MRMC) comparative effectiveness study was done: No, this is not indicated and generally not a requirement for an orthopedic implant 510(k).
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical implant, not an algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to a 510(k) for an orthopedic implant. Ground truth for performance would come from validated mechanical testing methodologies against industry standards or predicate device performance.
7. The sample size for the training set: Not applicable, as this is not an AI/ML device requiring a training set.
8. How the ground truth for the training set was established: Not applicable.

In summary, the "study" demonstrating the device meets "acceptance criteria" for a 510(k) is the comparison to predicate devices, primarily focusing on technical characteristics, materials, and functional equivalence, often backed by bench testing to ensure mechanical performance is comparable. The FDA's decision to clear the device (K042713) signifies their acceptance that this comparison adequately demonstrates substantial equivalence to legally marketed predicate devices.

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FIDJI types 1, 2, 3, and 4 are vertebral body replacement devices that are intended for use in the thoracic and/or thoracolumbar spine (T1-L5) to replace a collapsed, damaged or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture). The device is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period. These devices are intended to be used with bone graft and supplemental fixation, such as the Spinal Concepts, Inc. InCompass System.

The FIDJI Vertebral Body Replacement Types 1, 2, 3, and 4 devices are hollow blocks that are machined from PEEK OPTIMA® (polyetheretherketone, ASTM F2026); the blocks are tapered to aid in maintaining lordosis of the spine following implantation. The devices have angled teeth on the cephalad and caudal surfaces. The devices include tantalum inserts that serve as a location and orientation markers for radiographs.

The provided text describes a 510(k) premarket notification for a medical device called "FIDJI Vertebral Body Replacement Types 1, 2, 3, and 4." This document primarily focuses on demonstrating substantial equivalence to predicate devices and detailing the device's design, intended use, and mechanical testing.

It does not contain information about a study proving the device meets acceptance criteria in the context of an AI/algorithm-based diagnostic or assistive system.

Therefore, I cannot provide the requested information in the format of the table and points because the document is not about an AI-powered device or a study involving human readers or ground truth for an AI system.

The document's "Mechanical Testing" section states: "Mechanical testing demonstrated that FIDJI types 1,2,3, and 4 exhibit the functional requirements to support their use as vertebral body replacements under normal physiologic loads in the spine." This indicates that physical, laboratory-based testing was conducted to ensure the device's structural integrity and performance, which is typical for implantable medical devices. However, this is not related to the type of AI/algorithm study information you've requested (e.g., sample size for test/training set, expert consensus, MRMC studies).

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When used as a pedicle screw fixation system, the SHIRAZ Systems are intended for treatment of severe spondylolisthesis (Grades 3 and 4) at the fifth lumbar - first sacral (L5-S1) vertebral joint in skeletally mature patients receiving fusion by autogenous bone grafting having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

When used as a pedicle screw fixation system, the SHIRAZ Systems are also intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or as an adjunct to fusion in the reading and sacral spine: degenerative spondylolisthesis with deformities of the thoracic, lumbar, and sacral spine, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).

When used as a posterior, noncervical hook, and/or sacral/iliac screws fixation system, or when used as a posterior, noncervical rod areas, we fixation system, the SHIRAZ Systems are as an bi-lateral anterior, and lordosis, fracture, loss of stability due to tumor, intended to treat scoliosis, kyphosis and lordosis, fracture, loss of stability due to tumor, Spinal Stenosis, Spondylolisthesis, a previously failed fusion surgery or degenerative disc disease (i.e., discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies).

The Spine Next SHIRAZ Anterior System is designed to treat scoliosis, kyphosis and lordosis, fracture, loss of stability due to tumor, spinal stenosis, spondylolisthesis, a previously failed fusion surgery or degenerative disc disease (i.e., discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies).

All implants are manufactured from Titanium Alloy (Ti6A14V) meeting the requirements of ASTM F136/ISO 5832 or commercially pure Titanium (cpTi, Grade 4) meeting requirements of ASTM F67/ISO 5832.

The provided text describes a 510(k) premarket notification for the Spine Next SHIRAZ Anterior System. This document focuses on the regulatory submission process and the determination of substantial equivalence to a predicate device, rather than a clinical study evaluating its performance against specific acceptance criteria.

Thus, based solely on the provided text, the following information cannot be extracted:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set or its provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for the test set.
• Information about a multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
• Information about a standalone (algorithm only) performance study.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for any clinical evaluation.
• Sample size for the training set.
• How the ground truth for the training set was established.

However, the document does contain information about performance data from biomechanical testing, which is a common method for demonstrating the safety and effectiveness of implantable devices like spinal fixation systems.

Here's what can be extracted regarding performance data:

Performance Data Mentioned:

The document states: "Biomechanical testing, including static and dynamic testing, was performed in accordance with ASTM F1717 and ASTM 1798."

This indicates that the device's mechanical integrity and stability were evaluated through a series of tests designed to simulate the stresses it would experience in the human body.

• ASTM F1717: This standard (ASTM F1717-96(2001) "Standard Test Methods for Spinal Implant Constructs in a Corpectomy Model") typically covers the in vitro static and dynamic characterization of spinal implant assemblies used for anterior corpectomy. It evaluates the mechanical performance of spinal implants, looking at properties like stiffness, fatigue strength, and resistance to permanent deformation.
• ASTM 1798: This standard likely refers to ASTM F1798 "Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants." This standard focuses on the connection mechanisms between different components of a spinal fixation system, ensuring they can withstand the forces without failure.

Limitations based on the provided text:

The provided 510(k) summary does not include the specific numerical acceptance criteria (e.g., minimum fatigue cycles, stiffness values) from these ASTM standards, nor does it present the actual test results of the SHIRAZ Anterior System against those criteria. It only states that the testing was performed in accordance with these standards. For a 510(k) submission, demonstrating adherence to established industry standards for mechanical performance is typically sufficient to show substantial equivalence for this type of device, as opposed to requiring clinical trial data found in PMAs.

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When used as a pedicle screw fixation system, the SHIRAZ Posterior System is intended for treatment of severe spondylolisthesis (Grades 3 and 4) at the fifth lumbar first sacral (L5-S1) vertebral joint in skeletally mature patients receiving fusion by mutogenous bone grafting having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

When used as a pedicle screw fixation system, the SHIRAZ Posterior System is also intended to provide immobilization and stabilization 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 the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).

The Spine Next Posterior System is designed to aid the surgical correction of several types of spinal conditions. This system is intended only to provide stabilization during the development of a solid fusion with the bone graft. These implanted are intended to be the avvelopment of a solid fusion mass. The system includes screws, rods, connectors and secondary sacral connectors.

All implants are manufactured from Titanium Alloy (Ti6Al4V) meeting the requirements of ASTM F136/ISO 5832 or commercially pure Titanium (cpTi, Grade 4) meeting requirements of ASTM F67/ISO 5832.

This document describes a 510(k) submission for the "Spine Next SHIRAZ Posterior System," a pedicle screw fixation system. The primary goal of the submission is to demonstrate substantial equivalence to a predicate device, not necessarily to prove predefined acceptance criteria through a standalone study in the same way a novel high-risk device might.

Here's an analysis based on the provided text, addressing your specific points:

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

• Comment: The document does not explicitly state "acceptance criteria" with numerical thresholds or specific performance metrics (e.g., "device must withstand X load for Y cycles"). Instead, for a Class II device like this, the "acceptance criteria" are generally implied to be meeting recognized international standards for materials and mechanical testing, and demonstrating substantial equivalence to a legally marketed predicate device. The performance data section confirms that testing according to relevant ASTM standards was performed, and the FDA's clearance letter confirms substantial equivalence.

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: Not applicable in the context of this 510(k) submission for mechanical testing. "Sample size" typically refers to the number of patients or cases in clinical studies. Here, it refers to the number of test articles (implants) tested in a laboratory setting. The document does not specify the number of individual screws, rods, or construct combinations tested.
• Data Provenance: Not applicable. The testing described (biomechanical) is laboratory-based, not clinical data from patients.

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. This submission focuses on the mechanical and material properties of an orthopedic implant, not on diagnostic accuracy or clinical judgment that would require expert-established ground truth.

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

• Not applicable. Adjudication methods are relevant for clinical studies where expert consensus is needed to establish ground truth (e.g., presence or absence of a disease). This is a biomechanical and materials-focused submission.

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 submission is for a physical orthopedic implant, not an AI/software device. Therefore, no MRMC study or AI assistance is relevant.

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

• Not applicable. As mentioned, this is not an AI/software device. Performance is assessed through mechanical testing of the physical implant components.

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

• The "ground truth" for this device's performance is material specifications (ASTM F136/ISO 5832, ASTM F67/ISO 5832 for Titanium alloys) and biomechanical performance standards (ASTM F1717, ASTM F1798). The implant is expected to meet or exceed the performance requirements defined by these standards, and to perform comparably to the predicate device.

8. The sample size for the training set

• Not applicable. There is no "training set" in the context of this type of device submission. Training sets are relevant for machine learning algorithms.

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

• Not applicable. As above, no training set.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" in this context refers to the biomechanical testing and materials characterization performed on the Spine Next SHIRAZ Posterior System.

• Testing Conducted: Biomechanical testing, including static and dynamic loading, was performed.
• Standards Used: This testing was conducted in accordance with recognized industry standards: ASTM F1717 (Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model) and ASTM F1798 (Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Post. Pedicle Screw Spinal Instrumentation). The materials used were also certified to meet ASTM F136/ISO 5832 (titanium alloy) and ASTM F67/ISO 5832 (commercially pure titanium).
• Proof of Meeting Criteria: By demonstrating that the device components are made from specified, compliant materials and that the assembled system can withstand the forces and cycles defined in the relevant ASTM standards, the manufacturer provides evidence that the device is safe and effective for its intended use and substantially equivalent to the predicate device. The FDA's clearance (K033947) confirms that based on this data, the device meets the regulatory requirements for market entry.

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When used as a pedicle screw fixation system, the SHIRAZ JAVA Spinal Fixation System is intended for treatment of severe spondylolisthesis (Grades 3 and 4) at the fifth lumbar - first sacral (L5-S1) vertebral joint in skeletally mature patients receiving fusion by autogenous bone grafting having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

When used as a pedicle screw fixation system, the SHIRAZ JAVA Spinal Fixation System is also intended to provide immobilization and stabilization 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 the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal turnor, and failed previous fusion (pseudarthrosis).

The Spine Next SHIRAZ JAVA Top Loading Spinal Fixation System is designed to aid the surgical correction of several types of spinal conditions. This system is intended only to provide stabilization during the development of a solid fusion with the bone graft. These implanted are intended to be removed after development of a solid fusion mass. The system includes screws, rods, connectors and transverse connectors.

All implants are manufactured from Titanium Alloy (Ti6A4V) meeting the requirements of ASTM F136.

The provided text describes a 510(k) premarket notification for the Spine Next SHIRAZ JAVA Spinal Fixation System. It details the device, its indications for use, and cites biomechanical testing according to specific ASTM standards. However, it does not provide information about acceptance criteria, reported device performance in a table, sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

Therefore, most of the requested information cannot be extracted from the provided text.

Here is what can be inferred and what is missing:

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

• Acceptance Criteria: Not explicitly stated in terms of quantitative values. The acceptance criteria for a 510(k) submission generally revolve around demonstrating substantial equivalence to a legally marketed predicate device, often through meeting industry standards.
• Reported Device Performance: Not reported in a table format. The document states that "Biomechanical testing, including static and dynamic testing, was performed in accordance with ASTM F1717 and ASTM 1798." These standards inherently define test methods and performance metrics (e.g., strength, durability, fatigue life), but the results of these tests (the actual performance data) and how they met specific acceptance thresholds are not provided in this summary.

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

• Sample Size: Not mentioned. For biomechanical testing, this would typically refer to the number of test specimens (e.g., screws, rods, constructs) tested.
• Data Provenance: Not mentioned. Biomechanical testing data would generally be generated in a lab setting, so "country of origin" is less relevant than for clinical data, but the specific lab or testing facility is not named. The studies are prospective in nature as they involve testing physical devices.

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 this is biomechanical testing, not a study involving human interpretation or clinical data where expert ground truth would be established. The "ground truth" for biomechanical testing is typically defined by the physical loads applied and the measured deformation/failure, evaluated against engineering standards.

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

• Not applicable for biomechanical testing.

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 MRMC study was mentioned. This type of study is relevant for imaging or diagnostic devices involving human interpretation, not for mechanical implants like spinal fixation systems.

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

• Not applicable. This is not an algorithm-based device.

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

• For biomechanical testing, the "ground truth" is defined by the objective physical measurements and engineering principles governed by the ASTM standards (F1717 and F1798). This involves applying defined loads and measuring mechanical responses (e.g., stiffness, yield strength, ultimate strength, fatigue cycles to failure).

8. The sample size for the training set

• Not applicable. This is not a machine learning device, so there is no training set.

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

• Not applicable.

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