Search Results

The ANAX™ 5.5 SPINAL SYSTEM is a posterior, non cervical pedicle fixation system intended to provide immobilization and stabilization of spinal segments in skeletally-mature patients as an adjunct to fusion by autogenous bone graft in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar and sacral spine:

• · Spondylolisthesis (Grade 3 and 4)
• · Degenerative spondylolisthesis with objective evidence of neurological impairment
• · Trauma (i.e., fracture or dislocation)
• · Spinal stenosis
• · Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
• Tumor
• · Pseudoarthrosis
• · Failed previous fusion

The ANAX™ 5.5 Spinal System is a top-loading multiple component, posterior spinal fixation system and minimally invasive surgery system which consist of pedicle screws, rods, set screws, connectors and a transverse (cross) linking mechanism. The ANAX™ 5.5 Spinal System allows surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The ANAX™ 5.5 Spinal System components are supplied non-sterile, single use and are fabricated from medical grade titanium alloy (ASTM F136) and medical grade cobalt-chromium-molybdenum alloy (ASTM F1537). All pedicle screws have self-tapping function in ANAX™ 5.5 Spinal System The double lead thread is applied to the all pedicle screws to shorten the operation time. ANAX™ 5.5 Spinal System with CoCr rods may be used to provide immobilization and stabilization of spinal segment when the rigid system is need. (Recommendation: trauma or deformities) The product life time of ANAX™ 5.5 Spinal System is 2 years based on mechanical test result. The purpose of this submission is to add uniplanar screws and connectors to the ANAX™ 5.5 Spinal System.

The FDA 510(k) summary for the ANAX™ 5.5 Spinal System (K231737) indicates that the device's performance was evaluated through mechanical testing to demonstrate substantial equivalence to its predicate devices. Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the mechanical performance of the ANAX™ 5.5 Spinal System "met the acceptance criteria which have been established from the predicate device." However, the specific quantitative acceptance criteria values (e.g., specific load values, deflection limits, or number of cycles) are not explicitly provided in the excerpt. Similarly, the reported quantitative device performance data is also not presented in the document. The summary only states that the device "met all acceptance criteria."

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

The document does not specify the sample size (number of devices, components) used for each mechanical test. Mechanical tests typically involve multiple samples to ensure repeatability and statistical significance, but the exact numbers are not mentioned in this summary.

Data Provenance: The tests are described as "mechanical strength evaluation" and "performance testing" conducted to compare the proposed device with predicate devices. This is not clinical data, but rather laboratory-based engineering test data. The document does not specify the country of origin for the testing itself, but the manufacturer is based in Korea (Innosys Co., Ltd., Uijeongbu-si, Gyeonggi-do, Korea). These are not retrospective or prospective studies in the clinical sense, but rather benchtop studies.

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

This question is not applicable in the context of this 510(k) submission. The "ground truth" for mechanical performance is established by validated international standards (ASTM F1717, ASTM F1798) and comparison to previously cleared predicate devices, not by human expert consensus on clinical findings. Therefore, no experts were used to establish a "ground truth" in the way clinical diagnostic studies would.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among human readers or evaluators in clinical studies. Mechanical testing involves objective measurements against predefined criteria, not subjective interpretation requiring adjudication among experts.

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 ANAX™ 5.5 Spinal System is a physical medical device (spinal fixation system), not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or evaluation of human reader improvement with AI assistance was performed.

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 physical implant, not an algorithm.

7. The Type of Ground Truth Used

For the mechanical tests, the "ground truth" is defined by the specifications and performance characteristics of the predicate devices and the requirements outlined in the relevant ASTM standards (ASTM F1717 and ASTM F1798). The goal was to demonstrate that the proposed device performs equivalently to the predicate devices and meets established engineering standards 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 physical implant. Training sets are typically used for machine learning algorithms.

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.

Ask a specific question about this device

The Inertia® Pedicle Screw and Deformity Correxxion™ System is intended for pedicle and non-pedicle immobilization and stabilization of the posterior non-cervical spine (T1-S2/Ilium) 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, cyphosis, kyphosis, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.

When used for posterior non-cervical pediatic patients, the Inertia® Pedicle Screw and Deformity Correxxion™ System implants are indicated as an adjunct to treat adolescent idiopathic scoliosis. The Inettia® Pedicle Screw and Deformity Correxxion™ System is to be used with autograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The Inertia® Pedicle Screw and Deformity Correxxion™ System consists of longitudinal members (rods), anchors (screws and hooks), interconnections (offset, rod-rod and crosslink) and fasteners in a variety of sizes to accommodate differing anatomic requirements. The Inertia® Pedicle Screw and Deformity Correxxion™ System implants are sold sterile and non-sterile.

The provided text describes a 510(k) premarket notification for the "Inertia® Pedicle Screw and Deformity Correxxion™ System," a medical device for spinal stabilization and immobilization. However, the document does not contain information regarding an AI/Machine Learning-enabled device or a study proving its performance against specific acceptance criteria for such a device.

The acceptance criteria described in the document, and the study conducted, pertain to the mechanical performance of the pedicle screw system itself, not to the performance of an AI algorithm.

Therefore, I cannot provide the details requested in your prompt regarding AI/ML device performance, such as:

• A table of acceptance criteria and reported device performance for an AI/ML device.
• Sample size for the test set and data provenance for an AI/ML device.
• Number of experts and their qualifications for establishing ground truth for an AI/ML device.
• Adjudication method for an AI/ML device.
• MRMC comparative effectiveness study results or effect size for AI assistance.
• Standalone performance for an AI/ML device.
• Type of ground truth used for an AI/ML device.
• Sample size for the training set for an AI/ML device.
• How ground truth for the training set was established for an AI/ML device.

What the document does describe (related to mechanical device performance):

The document implicitly defines acceptance criteria by stating that the device's performance needs to be "substantially equivalent" to predicate devices.

1. A table of acceptance criteria and the reported device performance (for the mechanical device):

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

• Sample Size: Not explicitly stated as a number of devices, but refers to "worst case Inertia® Pedicle Screw and Deformity Correxxion™ System constructs."
• Data Provenance: The tests are described as mechanical testing, implying in-vitro lab testing rather than human patient data.

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

• This is not applicable as the "ground truth" here refers to established engineering standards (ASTM F1717) for mechanical performance, not expert clinical interpretation.

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

• This is not applicable, as it refers to a clinical or AI-based assessment, not mechanical 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, this type of study was not done, as the document concerns a mechanical spinal implant, not an AI-assisted diagnostic or therapeutic tool.

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

• Not applicable; this is not an AI device.

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

• The "ground truth" for the mechanical device's performance is established by ASTM F1717 standards for static and dynamic compression bending and static torsion.

8. The sample size for the training set:

• Not applicable; mechanical testing doesn't involve a "training set" in the context of AI/ML.

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

• Not applicable.

Ask a specific question about this device

The Perfix™ Spinal System is a posterior, noncervical pedicle fixation system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion by autogenous bone graft in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar and sacral spine:

• Spondylolisthesis (Grade 3 and 4) .
• Degenerative spondylolisthesis with objective evidence of neurological impairment
• Trauma (i.e., fracture or dislocation)
• Spinal stenosis .
• Spinal deformities (Scoliosis, Kyphosis, Lordosis) .
• Pelvic obliquity ●
• Spinal tumor
• Pseudarthrosis
• Failed previous fusion

The Perfix™ Iliac Screw System includes the following four components; iliac screw, iliac connector, iliac cap, and a set screw. These components are only to be used in conjunction with the Perfix™ Spinal System's 6.0mm diameter rods.

Perfix™ Iliac Screw System consists of a variety of shapes and size of iliac screws, iliac connectors, iliac screw cap and set screw. All implant components are made from a titanium alloy (Ti-6Al-4V ELI) in accordance with ASTM F136. Perfix" Iliac Screw System is intended to provide spinal stability related to the lumbosacral fixation or spinopelvic fixation is provided by iliac screws inserted into the vertebral body of the lumbar spine and sacrum regions using a posterior approach.

The U&I Corporation's Perfix™ Iliac Screw System underwent non-clinical (bench) testing to demonstrate its performance and establish substantial equivalence to predicate devices. The study aimed to show that the device met established acceptance criteria, indicating no new safety or efficiency issues compared to existing, legally marketed spinal fixation systems.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document states that the mechanical performance of the Perfix™ Iliac Screw System met the acceptance criteria which have been established from the predicate devices. However, the exact numerical acceptance criteria for each test and the specific reported performance values for the Perfix™ system are not detailed in the provided text. The document generally confirms that the tests were performed and the device met the criteria.

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

• Sample Size: The document does not specify the exact number of devices or constructs tested for the "test set" in the performance testing.
• Data Provenance: The study was a non-clinical setting (bench testing). Data provenance is not geographical in this context, but rather refers to the type of experimental setup. It is retrospective in the sense that the acceptance criteria were established from existing predicate devices.

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 study. The "ground truth" for this type of mechanical performance testing is defined by established engineering standards (ASTM F1717) and the performance of predicate devices, not by expert medical opinion on individual cases.

4. Adjudication Method for the Test Set

This question is not applicable to this study. Adjudication methods are typically used in clinical studies involving interpretation of medical data by multiple observers. This study involved mechanical testing against predefined criteria.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study focused on the mechanical performance of a medical device, not on the interpretative performance of human readers, with or without AI assistance.

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

N/A. This device is a physical spinal implant system, not a software algorithm. Therefore, "standalone" algorithm performance is not relevant. The performance testing was for the physical device itself.

7. The Type of Ground Truth Used

The "ground truth" for the performance testing was based on:

• Established industry standards: Specifically, ASTM F1717 (Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model).
• Performance of predicate devices: The Perfix™ Iliac Screw System was compared directly against the mechanical performance of the Synergy™ Spinal System - Synergy VLS Screws (K011437), OPTIMA™ Spinal System (K024096), and Global Spinal Fixation System™ (K001668). The acceptance criteria were derived from these predicate devices.

8. The Sample Size for the Training Set

This question is not applicable to this study. There is no concept of a "training set" in a mechanical bench testing study for a physical device.

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

This question is not applicable as there was no training set.

Ask a specific question about this device

When used as a pedicle screw fixation system, the NuVasive GSB Global Spinal Balance System is 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 posterior thoracic, lumbar, and sacral spine:

• I. Degenerative disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
• 2. Degenerative spondylolisthesis with objective evidence of neurologic impairment
• 3. Fracture
• 4. Dislocation
• 5. Scoliosis
• 6. Kyphosis
• 7. Spinal tumor and/or
• 8. Failed previous fusion (pseudoarthrosis)

The NuVasive GSB Global Spinal Balance System is also indivated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebral joint in skeletally mature patients receiving fusion by autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (L3 to sacrum). with removal of the implants after attainment of a solid fusion.

When used as an anterolateral non-pedicle screw system in the thoracic and lumbar spine. the NuVasive GSB Global Spinal Balance System is also intended for the following indications:

• 1.Degenerative disease (as defined by back pain of discogenic origin with deveneration of the disc confirmed by patient history and radiographic studies)
• 2. Spinal stenosis
• 3. Spondvlolisthesis
• 4. Spinal deformities
• 5.Fracture
• 6. Pseudoarthosis
• 7. Tumor resection and/or
• 8. Failed previous fusion

The NuVasive GSB Global Spinal Balance System (hereto referenced as the GSB System) is a pedicle screw system that consists of a variety screws, hooks, rods, lock screws, transverse connectors, rod-to-rod connectors, iliac connectors and associated general instruments. Implant components are available in a variety sizes and can be rigidly locked into a variety of different contigurations to suit the individual pathology and anatomical conditions of the patient.

The provided 510(k) summary for the NuVasive® GSB Global Spinal Balance System ([K132014](https://510k.innolitics.com/search/K132014)) describes a medical device with mechanical performance requirements, not an AI/ML powered device. As such, the typical acceptance criteria and study designs found in AI/ML performance evaluations (e.g., sample size for test/training sets, ground truth by expert consensus, MRMC studies) are not applicable here.

Instead, the acceptance criteria and study details provided relate to non-clinical mechanical and material testing to demonstrate substantial equivalence to predicate devices.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Study that proves the device meets the acceptance criteria:

The study performed was nonclinical testing described in section G. "Performance Data." The objective was to demonstrate substantial equivalence to predicate devices by comparing the mechanical properties of the NuVasive GSB Global Balance System to established performance benchmarks for such devices, as defined by ASTM F1717 and a "Tulip pull-off" test. The summary states that "The results demonstrate that the subject NuVasive GSB Global Balance System is substantially equivalent to the predicate."

Regarding the AI/ML-specific questions (2-9), this information is NOT applicable or available for this type of medical device submission:

2. Sample sized used for the test set and the data provenance: Not applicable. The tests are mechanical, not data-driven for AI/ML.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is based on engineered specifications and test results against established standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Mechanical test results are objective measurements.
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 implant system, not an AI diagnostic or assistance tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. "Ground truth" for this device refers to physical properties meeting mechanical specifications and safety standards.
8. The sample size for the training set: Not applicable. There is no training set for an AI/ML algorithm.
9. How the ground truth for the training set was established: Not applicable. There is no training set for an AI/ML algorithm.

Ask a specific question about this device