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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.

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The ANAX™ 5.5 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
• -Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
• -Tumor
• -Pseudoarthrosis
• -Failed previous fusion

The ANAX™ 5.5 Spinal System is manufactured by U&I corporation. 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 provided text is a 510(k) summary for a spinal system, not an AI/ML device. Therefore, it does not contain the specific information requested in the prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies, as these are typically relevant for AI/ML device submissions.

The document discusses substantial equivalence to a predicate device based on design, materials, mechanical performance, and intended use. The "performance justification" section states that no new mechanical testing was conducted because no new worst-case scenario was introduced. Instead, the mechanical strength was evaluated theoretically by comparing data of the subject device to the predicate devices.

Therefore, I cannot extract the requested information because it is not present in the provided text.

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The ANAX™ 5.5 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:

Spondylolithesis (Grade 3 and 4) Degenerative spondylolisthesis with objective evidence of neurological impairment Trauma (i.e., fracture or dislocation) Spinal stenosis Defomities 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.

MIS Extended Screw, Set Screw for MIS, and Straight and Curved MIS Rod have newly added in the system and they are intended for use in minimally invasive surgery (MIS).

Specialized instruments made from surgical instrument grade stainless steel are available for the application and removal of ANAX™ 5.5 Spinal System implants.

The provided document is a 510(k) premarket notification from the FDA regarding a spinal system, not an AI/ML device. Therefore, it does not contain the information required to answer the specific questions about acceptance criteria for an AI/ML device's performance study.

The document discusses the substantial equivalence of the ANAX™ 5.5 Spinal System to previously cleared predicate devices based on design, material, mechanical performance, function, and intended use. It mentions that "mechanical performance of ANAX™ 5.5 Spinal System met the acceptance criteria which have been established from the predicate devices" and that "Additional mechanical testing (bench testing) was not conducted on the ANAX™ 5.5 Spinal System. However, the justification report was conducted to compare data of modified device to the ANAX™ 5.5 Spinal System (K132101, K143417) and determined no new worst case was introduced."

This statement refers to mechanical performance for a physical implant, not the diagnostic performance of an AI/ML algorithm. Consequently, I cannot extract details such as:

• A table of acceptance criteria and reported device performance for an AI/ML model.
• Sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or types of ground truth relevant to an AI/ML diagnostic study.
• Training set details for an AI/ML model.

The document focuses on the regulatory clearance for a medical device (a spinal implant system) based on substantial equivalence to existing devices, primarily through engineering and mechanical testing or justification, rather than a clinical performance study of an AI/ML algorithm.

Ask a specific question about this device

ANAX™ 5.5 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
• · Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
• · Tumor
• · Pseudoarthrosis
• · Failed previous fusion

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. ANAX M 5.5 Spinal System allows surgeons to build a spinal implant construct to stabilize and promote spinal fusion. ANAX™ 5.5 Spinal System components are supplied nonsterile, single use and are fabricated from medical grade titanium alloy (ASTM F136) and medical grade cobalt-chromium-molybdenum alloy (ASTM F1537). Specialized instruments made from surgical instrument grade stainless steel are available for the application and removal of ANAXTM 5.5 Spinal System implants.

This document is a 510(k) premarket notification for the ANAX™ 5.5 Spinal System, seeking FDA clearance for marketing. It does not describe a study involving an AI/Machine Learning device or any clinical performance studies that would involve acceptance criteria and device performance as typically understood for software/AI.

Therefore, I cannot extract the information required concerning acceptance criteria and a study proving a device meets them, because this document pertains to a traditional medical device (pedicle screw spinal system) and its substantial equivalence to previously cleared predicate devices through bench testing, not a digital health product with AI/ML components.

The "Performance Testing" section explicitly states: "ANAX™ 5.5 Spinal System was tested in a non clinical setting (bench testing) to assess mechanical performance of this device. Static mechanical tests (axial gripping capacity test, torque gripping capacity test) were performed according to ASTM F1798. The testing verifies that performance of the ANAX™ 5.5 Spinal System is substantially equivalent to the predicate devices."

This type of testing focuses on the physical properties and mechanical strength of the hardware, not on diagnostic accuracy, sensitivity, specificity, or other metrics typically associated with AI/ML performance. There is no mention of a test set, ground truth established by experts, multi-reader multi-case studies, or training data for an algorithm.

Ask a specific question about this device

The ANAX™ 5.5 Spinal System is a posterior, noncervical pedicle fixation system intended to provide immobilization and stabilization of spinal segments in skeletallymature 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 manufactured by U&I corporation. 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 cobait-chromium-molybdenum alloy (ASTM F1537).

The provided text describes a medical device, the ANAX™ 5.5 Spinal System, and its substantial equivalence to predicate devices, focusing on mechanical performance. This document pertains to a 510(k) submission to the FDA, which is primarily concerned with establishing substantial equivalence for medical devices based on predicate devices. It does not contain information about studies involving AI, human readers, or image-based diagnostics.

Therefore, many of the requested categories are not applicable to the provided text.

Here's a breakdown of the information that can be extracted or inferred from the provided text, and where the requested information is not present:

ANAX™ 5.5 Spinal System - Acceptance Criteria and Performance

The ANAX™ 5.5 Spinal System is a mechanical spinal fixation system designed to provide immobilization and stabilization of spinal segments. The provided document details its substantial equivalence to predicate devices based on mechanical performance.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated. The testing was "bench testing" on the device itself.
• Data Provenance: Not applicable in the context of clinical data/patient data. The testing was non-clinical bench testing.

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

• This is not applicable. The ground truth for mechanical performance testing is based on established engineering standards (ASTM F1717) and comparison to predicate devices, not expert human interpretation for diagnostics.

4. Adjudication Method for the Test Set

• This is not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus on diagnostic interpretations, not for mechanical bench testing.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size of how much Human Readers Improve with AI vs without AI Assistance

• This is not applicable. The device is a mechanical spinal fixation system, not an AI-assisted diagnostic tool or system designed to be read by human readers. Therefore, an MRMC study and AI improvement effect size is irrelevant to this submission.

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

• This is not applicable. The device is a mechanical system, not an algorithm.

7. The Type of Ground Truth Used

• Ground Truth: Established engineering standards (ASTM F1717 for mechanical testing) and the performance characteristics of legally marketed predicate devices.

8. The Sample Size for the Training Set

• This is not applicable. There is no "training set" in the context of a mechanical device's 510(k) submission. This term applies to machine learning models.

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

• This is not applicable. There is no training set for this type of device.

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