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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 Zavation Spinal System is a pedicle screw system 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 neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The Zavation Spinal Systems is also indicated for pedicle screw fixation for the treatment of 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.

The Zavation Spinal Systems when used as anterior thoracic/lumbar screw fixation systems, is indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).

The Zavation Spinal System is comprised of polyaxial pedicle screws, rods, and cross connectors. The Zavation Spinal System can be used for single or multiple level fixations. The pedicle screws are available in various lengths and diameters. The rods are available in straight and pre-lordosed (curved) configurations. The system has variable length cross connectors.

The provided document is a 510(k) summary for the Zavation Spinal System, which is a medical device. This document does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of device performance as one would typically find for an AI/ML medical device.

Instead, this document describes the Zavation Spinal System, its intended use, materials, predicate devices, and the basis for its substantial equivalence to those predicate devices. The "Performance Data" section specifically states:

"Static compression bending and torsion, and dynamic compression bending were performed according to ASTM F1717 on a worst-case construct. The mechanical test results demonstrated that the Zavation Spinal System performs as well as or better than the predicate devices."

This indicates a mechanical performance study for a spinal implant, which is a different type of evaluation from what is typically done for AI/ML devices regarding diagnostic accuracy or clinical effectiveness.

Therefore, I cannot provide the requested information about acceptance criteria and device performance in the context of an AI/ML device from this document. The document primarily focuses on:

• Mechanical Safety/Performance: Comparing the mechanical strength of the Zavation Spinal System to predicate devices according to a specific ASTM standard (F1717). The acceptance criterion here is implicit: the device must perform "as well as or better than" the predicate devices in these mechanical tests.
• Substantial Equivalence: Arguing that the device is substantially equivalent to legally marketed predicate devices based on technological characteristics, performance, and intended use.

To answer your specific questions in the context of an AI/ML device, I would need a document detailing a clinical performance study or an AI algorithm validation study.

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The PSG 5.5mm Cannulated Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments 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 disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformity, or curvature (i.e., scoliosis, kyphosis, and lordosis), tumor, stenosis, pseudoarthrosis, and previous failed fusion.

The PSG 5.5mm Cannulated Pedicle Screw System is a non-cervical spinal fixation system. Pedicle screw fixation is limited to skeletally mature patients.

The PSG 5.5mm Cannulated Pedicle Screw System is a multiple component, posterior spinal fixation system which consists of pedicle screws, rods, cross-connectors, and locking cap set screws. All of the components are available in a variety of sizes to match more closely to the patient's anatomy. All components are made from titanium alloy described by such standards as ASTM F136.

The provided document is a 510(k) premarket notification for a medical device called the "PSG 5.5mm Cannulated Pedicle Screw System." This document focuses on demonstrating substantial equivalence to predicate devices based on design, materials, and mechanical performance rather than clinical efficacy studies in the context of AI/software-as-a-medical-device (SaMD). Therefore, many of the requested details about acceptance criteria, clinical study design, and AI performance metrics are not applicable or available in this submission.

However, I can extract the information relevant to the device's mechanical performance and what the submission provides in place of clinical study details.

1. Table of Acceptance Criteria and Reported Device Performance

For medical devices such as pedicle screw systems, "acceptance criteria" and "reported device performance" are typically defined by engineering standards to ensure mechanical integrity and safety. In this context, the device's performance is compared against these standards and to predicate devices.

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

The document does not specify the exact sample sizes (number of devices or test repetitions) used for the mechanical tests. It only states that the device "has been tested" according to the ASTM standards.

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 device is a mechanical implant, not an AI/SaMD that requires expert ground truth for image interpretation or diagnosis. The "ground truth" for mechanical testing is adherence to established engineering standards (ASTM F1717-13).

4. Adjudication method for the test set

Not applicable. Mechanical testing is objective and relies on measurements and adherence to specified test protocols, not human adjudication of results.

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 device is a pedicle screw system, not an AI/SaMD for diagnostic imaging or decision support. No MRMC study was performed.

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

The "ground truth" for this type of device is defined by engineering standards and established mechanical performance characteristics relevant to spinal implants. Specifically, the ASTM F1717-13 standard dictates the methodologies and expected performance metrics for static and dynamic mechanical integrity. Comparison to legally marketed predicate devices also serves as a benchmark for "ground truth" in terms of acceptable clinical performance and safety.

8. The sample size for the training set

Not applicable. There is no "training set" as this is a mechanical device, not a machine learning algorithm.

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

Not applicable.

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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.

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The CapLOX II 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 in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine including degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, pseudoarthrosis and failed previous fusion.

In addition, when used as a pedicle screw fixation system, the CapLOX II Spinal 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 Captiva Spine CapLOX II Spinal System is a top-loading spinal fixation system consisting of polyaxial pedicle screws, cannulated polyaxial pedicle screws set screws, rods, and cross connectors assembled to create a rigid spinal construct. It is intended to provide stabilization during the development of fusion utilizing a bone graft as well as aid in the surgical correction of various spinal deformities and pathologies in the thoracolumbo-sacral iliac portion of the spine. The titanium alloy, single-use components are provided clean and non-sterile. Various sizes of the implants (screws and rods) are available to accommodate individual patient anatomy. The purpose of this submission is to add additional screws to the pedicle screw system.

The provided 510(k) summary for the Captiva Spine CapLOX II Spinal System focuses on demonstrating substantial equivalence to predicate devices through technical comparisons rather than clinical performance studies with acceptance criteria based on metrics like sensitivity or specificity. Therefore, many of the requested data points related to clinical or AI/algorithm performance are not applicable to this submission.

Here's a breakdown of the information that is applicable and a note on what is not:

Acceptance Criteria and Device Performance:

Study Information:

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

   • Not applicable. This submission relies on engineering analysis (FEA) and comparison to predicate devices, not clinical performance data from a test set of patients or cases.

2. 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. No ground truth establishment by experts for a test set of clinical images/data is mentioned. The evaluation is based on engineering principles and comparison to existing devices.

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

   • Not applicable. No test set requiring adjudication is mentioned.

4. 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 not an AI/software device, and no MRMC study or assessment of human reader performance with or without AI assistance was conducted.

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

   • Not applicable. This is a spinal implant system, not an algorithm or AI device.

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

   • Not applicable. For this type of orthopedic implant, "ground truth" would typically relate to mechanical testing standards and successful clinical history of the predicate devices. The submission points to "Verification activities including FEA and engineering analysis" and "Documentation provided demonstrates that the Captiva Spine CapLOX II Conclusion: Spinal System is substantially equivalent to predicate devices." This implies that the 'truth' for evaluation is adherence to engineering principles and established performance characteristics of predicate devices, rather than clinical outcomes or diagnostic accuracy.

7. The sample size for the training set:

   • Not applicable. No training set is mentioned as this is not a machine learning or AI device.

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

   • Not applicable. No training set or associated ground truth establishment is mentioned.

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

The study that proves the Captiva Spine CapLOX II Spinal System meets acceptance criteria is a technical and engineering analysis comparing the subject device to legally marketed predicate devices. This is characteristic of a 510(k) submission for mechanical devices, where the primary goal is not to prove new clinical efficacy or diagnostic accuracy but to demonstrate "substantial equivalence" to a device already on the market.

The "study" involved:

• Verification activities: These included Finite Element Analysis (FEA) and general engineering analysis. These analyses would assess the mechanical properties, stress distribution, and overall design integrity of the new components (additional screws) to ensure they perform equivalently to the existing components and predicate devices.
• Comparison to predicate devices: The submission explicitly states the subject device is "substantially equivalent to the above listed predicate devices in terms of materials, design, indications for use and operational principles." This comparison forms the core of the "proof" for a 510(k) submission.

In essence, the "acceptance criteria" were met by demonstrating through engineering data and direct comparison that the CapLOX II Spinal System performs as safely and effectively as the predicate devices for its stated indications.

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The flamenco™ is a spinal fixation system intended to provide immobilization and stabilization of thoracic, lumbar, and sacral spinal segments as an adjunct to fusion.

When used as posterior, pedicle screw fixation, the system is intended for the treatment of severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients. In addition, when used as a pedicle screw fixation system in the non-cervical posterior spine (T1 to S2), the system is intended for the treatment of the following acute and chronic instabilities or deformities: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, spinal stenosis, scoliosis, kyphosis, lordosis, spinal tumor, pseudarthrosis and failed previous fusion in skeletally mature patients.

When used as a posterior, non-cervical, hook and/or sacral/iliac fixation system (i.e., nonpedicle screw), the flamenco™ is intended for the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (as conformed by patient history and radiographic studies), spondylolisthesis, fracture, dislocation, scoliosis, kyphosis, lordosis, spinal stenosis, spinal tumor, pseudarthrosis and failed previous fusion.

The flamenco™ consists of rods, monoaxial and polyaxial pedicle screws, hooks and transverse connectors with locking set screws. The components are available in various sizes to accommodate differing patient anatomy. Rods are available in one diameter and a variety of lengths. Monoaxial and polyaxial screws are available in a variety of diameter-length combinations. Hooks are offered in a variety shapes and sizes.

The provided text describes the "flamenco™ spinal fixation system," a Class II medical device. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a comprehensive study report for standalone performance or comparative effectiveness with AI.

Based on the provided information, the following can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The acceptance criteria are implied to be achieving performance at least on par with the predicate devices under the specified ASTM F1717 mechanical tests.

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

The document reports mechanical performance data, not clinical performance data from a test set of patient cases. Therefore, information regarding "sample size used for the test set" (referring to patient data) and "data provenance" (country of origin, retrospective/prospective) is not applicable in this context. The testing was laboratory-based mechanical testing of "worst case" device constructs.

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

As this is a mechanical testing study, there were no human experts involved in establishing "ground truth" in the clinical sense. The "ground truth" for the mechanical tests would be the physical properties and performance measured by standardized mechanical testing equipment.

4. Adjudication Method for the Test Set:

Not applicable, as this was a mechanical test, not a clinical study requiring adjudication of expert interpretations.

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

No, an MRMC comparative effectiveness study was not done. This device is a spinal fixation system, not an AI diagnostic or therapeutic software that would typically be evaluated with MRMC studies comparing human readers with and without AI assistance.

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

Yes, in spirit, a standalone performance was done for the device's mechanical properties. The mechanical tests were performed on the device "constructs" themselves, independent of human interaction during the test. This is not "standalone algorithm performance" in the context of AI, but rather standalone performance of the physical device.

7. The Type of Ground Truth Used:

The "ground truth" for the mechanical performance study was physical measurements and adherence to engineering standards (ASTM F1717). The performance was compared against the measured performance of predicate devices.

8. The Sample Size for the Training Set:

Not applicable. This device is a physical medical implant, not an AI algorithm that requires a "training set."

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

Not applicable, as there is no training set for a physical device.

Summary of Study:

The study described is a mechanical performance study conducted according to ASTM F1717. This standard specifies methods for static and dynamic testing of spinal implant constructs. The "flamenco™" system's "worst case" construct was subjected to static compression bending, torsion, and dynamic compression bending. The objective of the study was to demonstrate that the mechanical performance of the flamenco™ system is equivalent to or superior to that of legally marketed predicate devices. The study concluded that the "flamenco™ performs as well as or better than the predicate devices," thereby meeting the implied acceptance criteria for mechanical equivalence.

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The Perfix™ 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 Perfix™ Spinal System is manufactured by U&I corporation. The Perfix™ is a top-loading multiple component, posterior spinal fixation system which consists of pedicle screws, rods, set screws, connectors, and a transverse (cross) linking mechanism. The Perfix™ Spinal System allows surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The Penfix™ implant system components are supplied non-sterile, single use and are fabricated from titanium alloy (Ti-6Al-4V ELI) in accordance with ASTM F136.

This document describes a spinal fixation system, not an AI/ML powered device. As such, the requested information regarding acceptance criteria, study details, expert involvement, and ground truth establishment, which are typical for AI/ML device evaluations, are not applicable to the "Perfix™ Spinal System".

The provided text details the device's classification, intended use, and substantial equivalence to a predicate device, which are standard components of a 510(k) submission for a traditional medical device. It does not contain any information about software, algorithms, or AI/ML components.

Therefore, I cannot provide the requested information.

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When used as a pedicle screw fixation system in skeletally mature patients, the Dynesys® Spinal System is intended to provide immobilization and stabilization of spinal segments 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 and failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the Dynesys system is indicated for use in patients:

• Who are receiving fusions with autogenous graft only; ●
• Who are having the device fixed or attached to the lumbar or sacral spine; .
• Who are having the device removed after the development of a solid fusion . mass.

When the Dynesys Spinal System and the OPTIMA ZS Spinal System are used on contiguous levels, they must be used with the Zimmer® DTO™ Implant, rodacord combination implant, and the U & I Corporation OPTIMA ZS Transition Screw. The indications for use for each level is as specified for each system.

The Zimmer DTO Implant is a cord-rod combination implant that is assembled intraoperatively by the final tightening of the fastening pin that secures the connection of the cord and the rod. The U & I Corporation OPTIMA ZS Transition Screw is a pedicle screw that is part of the OPTIMA ZS Spinal System. When the Dynesys Spinal System and the OPTIMA ZS Spinal System are implanted on contiguous levels the Zimmer DTO Implant and the OPTIMA ZS Transition Screw are used at the interface of these two systems. The cord portion of the Zimmer DTO Implant interfaces with the Dynesys Spinal System. The rod portion of the Zimmer DTO Implant interfaces with the OPTIMA ZS Transition Screw and with the OPTIMA ZS Spinal System.

The provided text is a 510(k) summary for the Zimmer® DTO™ Implant, a spinal fixation system. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

The 510(k) summary focuses on demonstrating substantial equivalence to previously cleared devices based on design, materials, function, and intended use, rather than presenting a detailed clinical or performance study with defined acceptance criteria.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them using the provided text. The requested information is simply not present in this regulatory submission.

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The VERTEBRON PSS™ Pedicle Screw System is intended for noncervical, nonpedicle fixation 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, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients. The VERTEBRON PSS™ Pedicle Screw System is intended for non cervical pedicle fixation for the following indications: spondylolisthesis (Grade 3 and 4 at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment); trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

The VERTEBRON PSS™ Pedicle Screw System is comprised of non-sterile, single use, titanium alloy components. The VERTEBRON PSS™ Pedicle Screw System attaches to the vertebral body by means of screws to the non-cervical spinal and allows a surgeon to build a spinal implant construct. This system's design is intended to stabilize the spinal operative site during the fusion process of a bone graft in the disc space. The VERTEBRON PSS™ Pedicle Screw System is made up of rods, multi-axial and standard screws, hooks, locking caps and both adjustable and fixed cross connectors. This submission adds 4.5mm Standard and MA Screws.

The provided text describes a Special 510(k) Summary for a medical device called the VERTEBRON PSS™ Pedicle Screw System, specifically for the addition of 4.5mm Standard and MA Screws. The document asserts the substantial equivalence of these new components to previously cleared devices.

Based on the provided information, here's an analysis of the acceptance criteria and the study that proves the device meets them:

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)

The document does not specify a "test set" in the context of clinical data or patient samples. The testing referred to is mechanical testing according to ASTM F1717. The sample size for this mechanical testing is not explicitly stated. The data provenance is not mentioned, as it is a laboratory-based mechanical test, not clinical data from a specific country or patient population.

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 section is not applicable to the provided document. The "ground truth" for the device's acceptance is established through the demonstration of substantial equivalence to predicate devices, which is primarily based on mechanical testing and material conformity, not expert evaluation of a clinical "test set."

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

This section is not applicable to the provided document for the same reasons as #3. There is no mention of a human-reviewed "test set" or adjudication process.

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 section is not applicable to the provided document. The device is a pedicle screw system, not an AI-assisted diagnostic or treatment planning tool. Therefore, MRMC studies involving human readers and AI assistance are irrelevant in this context.

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

This section is not applicable to the provided document. The device is a mechanical medical implant, not an algorithm.

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

The "ground truth" for the acceptance of this device relies on demonstrated substantial equivalence to predicate devices. This is established through:

• Mechanical performance data (conformance to ASTM F1717).
• Material composition (conformance to ASTM F136).
• Design similarities to previously cleared devices.
• Intended use and indications being comparable to predicate devices.

8. The sample size for the training set

This section is not applicable to the provided document, as it concerns a mechanical medical device and not an AI/ML algorithm that requires a "training set."

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

This section is not applicable for the same reasons as #8.

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The VERTEBRON PSS™ Pedicle Screw System is intended for noncervical, nonpedicle fixation 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, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients. The VERTEBRON PSS™ Pedicle Screw System is intended for non cervical pedicle fixation for the following indications: spondylolisthesis (Grade 3 and 4 at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment); trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

The VERTEBRON PSS™ Pedicle Screw System is comprised of non-sterile, single use, titanium alloy components. The VERTEBRON PSS™ Pedicle Screw System attaches to the vertebral body by means of screws to the non-cervical spinal and allows a surgeon to build a spinal implant construct. This system's design is intended to stabilize the spinal operative site during the fusion process of a bone graft in the disc space. The VERTEBRON PSS™ Pedicle Screw System is made up of rods, multi-axial and standard screws, hooks and locking caps. This submission adds both adjustable and fixed cross connectors.

The provided text describes a 510(k) premarket notification for the VERTEBRON PSS™ Pedicle Screw System, specifically focusing on the addition of adjustable and fixed cross connectors. The submission primarily addresses substantial equivalence to predicate devices and describes the mechanical testing performed.

However, the provided text does not contain information related to a study proving the device meets acceptance criteria in terms of clinical performance, diagnostic accuracy, or human reader improvement, as typically seen in studies for AI/software as a medical device (SaMD). The acceptance criteria outlined are based on mechanical testing for substantial equivalence.

Therefore, I will extract the relevant information from the document regarding the acceptance criteria and the "study" (mechanical testing) that demonstrates equivalence. Many of the questions in your prompt are not applicable to this type of device submission (mechanical implant) and the information provided.

Here's the breakdown based on the provided text:

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

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

• Sample Size: Not explicitly stated in the provided text. Mechanical testing often involves a smaller number of physical samples compared to clinical trials or AI model evaluations.
• Data Provenance: The "study" was mechanical testing performed by VERTETEBRON Inc. It's not clinical data, so country of origin or retrospective/prospective does not apply in the typical sense.

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

• Not applicable. This was mechanical testing according to a standard (ASTM 1717), not an expert-driven ground truth establishment.

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

• Not applicable. Adjudication methods are relevant for expert-driven ground truth, not for standardized 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 is a mechanical implant device, not an AI or diagnostic device that would involve human readers or AI assistance for interpretation.

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

• Not applicable. This is a mechanical implant device.

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

• The "ground truth" here is compliance with the ASTM 1717 standard for mechanical testing, demonstrating substantial equivalence to predicate devices. It is not a clinical ground truth.

8. The sample size for the training set:

• Not applicable. This is a mechanical implant device, not an AI/ML algorithm that requires a training set.

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

• Not applicable. This is a mechanical implant device.

Summary of the Study (Mechanical Testing):

The study referenced is "Testing in accordance with ASTM 1717". This standard applies to the "Standard Test Method for Spinal Implant Constructs in a Corpectomy Model." The purpose of this testing was to demonstrate that the modified VERTEBRON PSS™ Pedicle Screw System (with cross connectors) is substantially equivalent in its mechanical performance to the previously cleared VERTEBRON PSS™ Pedicle Screw System (without cross connectors) and other predicate devices (Optima Spinal Fixation System; U&I America).

The acceptance criteria implicitly revolve around meeting the performance benchmarks or being within acceptable tolerance levels as compared to the predicate devices when tested under the ASTM 1717 protocol. The "reported device performance" is that it did demonstrate substantial equivalence.

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