Search Results

The Kodiak Spinal Fixation System is intended for posterior, non-cervical fixation in skeletally mature patients as an adjunct to fusion for the following indications; degenerative discase (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, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.

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

The Kodiak Spinal Fixation System is intended to be used with autograft and/or allograft.

The Kodiak Spinal Fixation System is a thoracolumbosacral pedicle screw system designed to be implanted through a posterior surgical approach. The implants are manufactured from titanium alloy (Ti-6AI-4V ELI) per ASTM F136, commercially pure titanium (CP Ti Grade 2) per ASTM F67 and cobalt chromium (Co-28Cr-6Mo) alloy per ASTM F1537. The Kodiak System consists of a variety of shapes and sizes of screws, hooks, rods, connectors, and cross-connectors to create a rigid construct as an adjunct to fusion for temporary internal fixation and stabilization of the thoracic, lumbar and sacral spine.

The provided text is a 510(k) summary for the Kodiak Spinal Fixation System, a medical device for orthopedic surgery. It details the device's intended use, regulatory classification, and a comparison to predicate devices, focusing on non-clinical testing.

However, the document explicitly states: "Clinical Information: Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data."

This means that the 510(k) submission for the Kodiak Spinal Fixation System does not include a study proving the device meets acceptance criteria based on clinical performance or human-in-the-loop AI assistance. The "performance data" section only describes non-clinical mechanical testing (e.g., static and dynamic axial compression testing per ASTM F1717).

Therefore, I cannot provide the requested information regarding acceptance criteria and a study that proves the device meets those criteria, as no such clinical study data is presented or summarized in this 510(k) document. The device's substantial equivalence determination was based on non-clinical performance and a comparison of technological features to predicate devices.

Ask a specific question about this device

The DPZ Pedicular 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 spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, deformities or curvatures (i.e., scoliosis, and/or lordosis), spinal tumor, pseudarthrosis and failed previous fusion.

The DPZ Pedicular Fixation System is also intended for non-cervical pedicle screw fixation for the following indications: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. It is also intended for the following indications: trauma (i.e., fracture or dislocation); spinal stenosis, deformities or curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudarthrosis and failed previous fusion.

The DPZ Pedicular Fixation System is a top loading, multiple component, posterior spinal fixation system which consists of pedicle screws, rods and cross links. All of the components are available in a variety of sizes to more closely match the patient's anatomy.

The provided text describes the DPZ Pedicular Fixation System, its intended use, and the non-clinical tests conducted to demonstrate its equivalence to predicate devices. However, it explicitly states: "No clinical studies were performed."

Therefore, I cannot provide information on acceptance criteria based on human performance or studies involving human readers/experts, as no such clinical data is presented in this document.

Here's the information that can be extracted from the provided text regarding the device's acceptance criteria and the study that proves it meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified for the non-clinical tests. The document only mentions "The following analyses were conducted."
• Data Provenance: Not explicitly stated, but it refers to "non-clinical tests" which typically involve laboratory or bench testing of the device hardware.

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

• Not applicable. The "ground truth" for non-clinical mechanical testing is based on the specifications within the ASTM F1717 standard and the measured performance of the device compared to predicate devices. Human experts are not involved in establishing this ground truth for a mechanical test.

4. Adjudication method for the test set:

• Not applicable, as this refers to human reader review and consensus, which was not 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 MRMC study was done, as "No clinical studies were performed."

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

• Not applicable. This is a medical device (pedicle fixation system), not an algorithm or AI. The standalone performance refers to the device's mechanical integrity under specified ASTM standards.

7. The type of ground truth used:

• The ground truth for the non-clinical tests was based on the performance requirements and methodologies outlined in the ASTM F1717 standard for spinal implant constructs. The device's performance was then compared to that of predicate devices to establish substantial equivalence.

8. The sample size for the training set:

• Not applicable. This is a non-AI/algorithm medical device. "Training set" refers to data used to train an AI model.

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

• Not applicable for the same reason as above.

Ask a specific question about this device

The CosmoLock Pedicle Screw 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 spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, and/or lordosis), spinal tumor, pseudarthrosis and failed previous fusion.

The CosmoLock Pedicle Screw System is also intended for non-cervical pedicle screw fixation for the following indications: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. It is also intended for the following indications: trauma (i.e. fracture or dislocation); spinal stenosis; deformities or curvatures (i.e. scoliosis, and/or lordosis), tumor; pseudoarthrosis; and failed previous fusion.

The CosmoLock Pedicle Screw System is a top loading, multiple component, posterior spinal fixation system which consists of pedicle screws, rods and cross links. All of the components are available in a variety of sizes to match more closely the patient's anatomy.

Materials:

Ti-6Al-4V per ASTM F136 CoCr per ASTM F1537

This document is a 510(k) Summary for the CosmoLock Pedicle Screw System. It describes the device and its intended use and claims substantial equivalence to predicate devices. However, it does not contain the detailed information needed to answer many of your questions, as it explicitly states that no clinical studies were performed.

Here's an analysis based on the provided text:

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

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

This information is not provided in the document. The studies mentioned are non-clinical (mechanical tests), and details about sample sizes for these tests are 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)

This information is not applicable/provided. No clinical studies were performed, and therefore no ground truth established by experts is relevant to the data presented.

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

This information is not applicable/provided. No clinical studies 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. This document states, "No clinical studies were performed."

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

This information is not applicable. The device is a mechanical pedicle screw system, not an AI or algorithm-based device. No standalone performance study in this context was performed.

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

The ground truth for the non-clinical tests would be the established mechanical testing standards (ASTM F1717) and the performance of the predicate devices. There is no biological or expert-defined "ground truth" in the typical medical imaging/diagnosis sense, as this is a mechanical implant.

8. The sample size for the training set

This information is not applicable/provided. No clinical studies were performed, and there is no mention of an algorithm or AI requiring a training set.

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

This information is not applicable/provided. No training set or associated ground truth was established, as no clinical studies or AI development are described. The focus is on demonstrating mechanical equivalence to predicate devices.

Ask a specific question about this device

The XENON Pedicle Screw System is intended for posterior, non-cervical pedicle fixation in skeletally mature patients as an adjunct to fusion 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. It is intended to provide stabilization during the development of fusion utilizing autograft or allograft bone graft.

The system is comprised of XENON standard polyaxial screws, hightop polyaxial screws, set screws, rods. The XENON polyaxial screw features a dual lead thread, 3 prong drive instrument interface and is self tapping. The polyaxial screws are offered in various diameters ranging from 4.5mm to 8.0mm and lengths ranging from 25mm and 80mm. The polyaxial screws range of motion is 50 degrees Medial/Lateral and 50 degrees Inferior/superior. The 5.5mm diameter rods are offered in lengths 35mm to 600mm. The rods are also offered in two profiles, straight and precontoured. The adjustable bridges are offered in 4 different sizes. The implants are manufactured from surgical grade titanium alloy (Ti6AI-4V).

Here's a breakdown of the acceptance criteria and the study that proves the XENON™ Pedicle Screw System meets them, based on the provided document:

This document is a 510(k) summary for a medical device (XENON™ Pedicle Screw System), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study results against predefined acceptance criteria for a novel device. Therefore, much of the requested information regarding sample sizes, expert involvement, and ground truth establishment, which are typical for clinical performance studies of AI/diagnostic devices, is not present in this type of submission.

The "acceptance criteria" here are implicitly the performance standards set by recognized consensus standards for spinal implant mechanical testing, and the "proof" is that the device met these standards and was substantially equivalent to the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that the testing "demonstrated that XENON Pedicle Screw System is substantially equivalent to the predicate Zodiac Polyaxial Spinal Fixation System device." This implies that the XENON system met or exceeded the performance of the predicate device when tested against ASTM F1717. Specific numerical thresholds for these tests are not provided in this summary but would be part of the full test reports.

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

• Test Set Sample Size: Not applicable/not specified in this 510(k) summary. The "test set" here refers to the device specimens used for mechanical testing, not patient data. The number of physical units tested to satisfy ASTM F1717 standards is not disclosed in this summary.
• Data Provenance: Not applicable. This study involves mechanical testing of physical device components, not human data.

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

• Number of Experts: Not applicable. Ground truth as typically defined for AI or diagnostic devices (e.g., expert consensus on medical images) is not relevant here. The "ground truth" for mechanical testing is established by the specifications and outcomes of the standardized tests (ASTM F1717) and the performance of the predicate device.
• Qualifications of Experts: Not applicable. Material scientists, engineers, and technicians would be involved in conducting and interpreting the mechanical tests according to industry standards.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Mechanical testing results are typically objective measurements, not subject to human adjudication in the same way clinical diagnoses or image interpretations are. Calibration and adherence to test protocols ensure consistency.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a pedicle screw system, not an AI or diagnostic tool that requires human interpretation of medical cases. The study was mechanical testing of physical hardware.

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

• Standalone Study: Yes, in a broad sense. The "standalone" performance here refers to the mechanical performance of the device itself, without human intervention once the tests begin. However, this terminology typically applies to AI algorithms. For this device, it implies that the mechanical tests measured the intrinsic properties and performance of the pedicle screws and system components independent of surgical implantation technique (which would involve human-in-the-loop aspects).

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth for this submission is established by recognized consensus standards (ASTM F1717) for mechanical testing of spinal implants and the demonstrated performance of the predicate device when subjected to these same standards. The "truth" is that the XENON system's mechanical capabilities are equivalent to a device already deemed safe and effective.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This submission describes mechanical testing, not a machine learning model. There is no "training set" in this context.

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

• Ground Truth for Training Set: Not applicable, as there is no training set for this type of submission.

Ask a specific question about this device

The Zodiac® Polyaxial Spinal Fixation System is intended for use as a posterior spinal fixation device to aid in the surgical correction of various spinal deformities and pathologies of the spine. It is intended to provide stabilization during the development of fusion utilizing a bone graft. Specific indications for the Zodiac® Polyaxial Spinal Fixation System are dependent in part on the configuration of the assembled device and the method of attachment to the spine.

It is intended that this device, in any system configuration, be removed after development of solid fusion mass. Hook component indications are limited to T7-L5. Sacral-iliac screw indications are limited to the sacrum-iliac crest only.

1. The Zodiac® Polyaxial Spinal Fixation System when used as a hook and sacral iliac screw fixation system (nonpedicle screw) is intended for:

a. Patients having fractures of the thoracic and lumbar spine,

b. Patients having deformity (i.e. idioscoliosis, neuromuscular scoliosis or kyphoscoliosis with associated paralysis or spasticity),

c. Patients having spondylolisthesis (i.e. isthmic spondylolisthesis, degenerative spondylolisthesis, and acute pars fracture allowing spondylolisthesis).

2. The Zodiac® Polyaxial Spinal Fixation System, when used a pedicle screw system in the thoraco-lumbo-sacral iliac region of the spine is intended for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal turnor and failed previous fusion (pseudoarthrosis).

3. In addition, the Zodiac® Polyaxial Spinal Fixation System, when used as a pedicle screw system is intended for:

a. Patients receiving only autogenous bone graft

b. Patient having the device fixed or attached to the lumbar and sacral iliac spine and having severe spondylolisthesis grade 3 or 4 at the fifth lumbar-first sacral (L5-S1) vertebral joint.

4. The Zodiac® Polyaxial Spinal Fixation System, when used as a laminar hook and bone screw system is intended for:

a. Patients having fractures of thoracic and lumbar spine.

b. Patients having thoracolumbar deformity (i.e. idioscoliosis, neuromuscular scoliosis, kyphoscoliosis or kyphoscoliosis with associated paralysis or spasticity),

c. Patients having spondylolisthesis (i.e. Isthmic spondylolisthesis, degenerative spondylolisthesis and acute pars fracture allowing spondylolisthesis).

The Zodiac® Polyaxial Spinal Fixation System is intended for use as a posterior spinal fixation device to aid in the surgical correction of various spinal deformities and pathologies in the thoracolumbo-sacral iliac portion of the spine. It is intended to provide stabilization during the development of fusion utilizing a bone graft. Specific indications for the Zodiac® Polyaxial Spinal Fixation System are dependent in part on the configuration of the assembled device and the method of attachment to the spine.

This document describes a 510(k) submission for the Zodiac® Polyaxial Spinal Fixation System, which is a medical device. As such, the "acceptance criteria" and "device performance" are not related to diagnostic accuracy or clinical outcomes as would be the case for AI/ML devices. Instead, they refer to the device's mechanical properties and its substantial equivalence to previously approved devices. The "study" refers to mechanical testing.

Here's a breakdown of the requested information based on the provided text:

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)

This information is not applicable as this is a mechanical device, not an AI/ML diagnostic or prognostic device that uses data for testing. The "test set" would refer to the physical samples of the device undergoing mechanical testing. The document states "Mechanical and dynamic testing was performed," implying laboratory testing of device components.

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 information is not applicable. For mechanical devices, "ground truth" is established by engineering specifications, material properties, and standardized testing protocols, not by expert consensus on clinical data.

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

This information is not applicable. Adjudication methods are used for resolving discrepancies in expert interpretations of data, which is not relevant for mechanical testing of a spinal fixation system.

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 information is not applicable. This is a physical spinal fixation device, not an AI/ML diagnostic tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant.

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

This information is not applicable. This is a physical spinal fixation device, not an algorithm.

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

For mechanical devices, the "ground truth" is typically derived from engineering specifications, material science principles, and established international and national consensus standards (e.g., ASTM, ISO standards for spinal implants) that define performance requirements for strength, fatigue life, and other mechanical properties. The document explicitly states, "Performance testing was performed per the recognized consensus standards and per the guidance document, Spinal System 510(k)s - Guidance for Industry and FDA Staff," indicating adherence to these established engineering "ground truths."

8. The sample size for the training set

This information is not applicable. This is a physical medical device. "Training set" refers to data used to train AI/ML models, which is not relevant here.

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

This information is not applicable. As no training set is used for a mechanical device.

Summary of the Study:

The study described is a series of mechanical and dynamic performance tests conducted on the Zodiac® Polyaxial Spinal Fixation System and its additional components.

• Objective: To provide reasonable assurance of the safety and effectiveness of the device for its intended use and to demonstrate substantial equivalence to predicate devices.
• Methodology: Testing was performed according to "recognized consensus standards and per the guidance document, Spinal System 510(k)s - Guidance for Industry and FDA Staff." This involved evaluating both "static and fatigue performance characteristics."
• Results: The testing "clearly demonstrated that the performance characteristics satisfy the requirements of posterior lumbar fixation." Furthermore, the "mechanical performance of the Zodiac® Polyaxial Spinal Fixation System additional components is substantially equivalent to the predicate Zodiac® Polyaxial Spinal Fixation System device."
• Conclusion: The tests confirmed that the device's mechanical properties were comparable to previously approved predicate devices, supporting its substantial equivalence claim to the FDA.

Ask a specific question about this device