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SAGICO IBF System - ARIA Lumbar implants are interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).

SAGICO IBF System - ARIA Lumbar are to be filled with autogenous bone graft material. The SAGICO IBF System -ARIA Lumbar implant is intended to be used with supplemental fixation cleared by the FDA to properly utilize this device.

The SAGICO IBF System - ARION Cervical implant is interbody fusion device intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from (C2-T1). DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and at least six (6) weeks of non-operative treatment.

The SAGICO IBF System - ARION Cervical implant is to be filled with autogenous bone graft material and placed via open anterior approach. The SAGICO IBF System – ARION Cervical implant must be used with additional internal fixation (e.g. anterior plate or cervical pedicle screws) cleared by the FDA to properly utilize this device.

SAGICO IBF System - ARIA Lumbar implants are interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. SAGICO IBF System - ARIA Lumbar implants are provided in different shapes to accommodate various surgical approaches to the lumbar spine (posterior, transforaminal [posterolateral] or lateral and can expand to the desired height. The SAGICO IBF System - ARIA Lumbar implants are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. The SAGICO IBF System - ARIA Lumbar implants are to be filled with autogenous bone graft material. Protrusions are located on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion.

SAGICO IBF System - ARION Cervical implants are interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. SAGICO IBF System - ARION Cervical implant is intended to be used between two contiguous levels from C2 to T1 and placed via an open anterior surgical approach. The implants are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. SAGICO IBF System - ARION Cervical implants are comprised of PEEK Optima LT1 and include large central hollow window to be filled with autogenous bone graft material. SAGICO IBF System - ARION Cervical implants features protrusions located on the top and bottom surfaces of PEEK spacers to engage with superior and inferior endplates of the adjacent vertebrae to resist rotational and expulsion. SAGICO IBF System - ARION Cervical includes internal titanium spin blade offering internal fixation and expansion of 1mm in height allowing low profile insertion. SAGICO IBF System - ARION Cervical implant is intended to be used with FDA cleared supplemental fixation to properly utilize the device.

The SAGICO IBF System ARIA Lumbar and ARION Cervical implants are manufactured from medical Grade PEEK (Polyetheretherketone) OPTIMAT LT I (Invibio"") per ISO 10993-1 USP Class VI, and ASTM F2026, Titanium Alloy per ASTM F136 and Tantalum beads /rods to be Grade IINS R05200, IINS R05400 according to ASTM F560.

The SAGICO IBF System ARIA Lumbar and ARION Cervical implants are intervertebral body fusion devices to help restore integrity to the spine in the cervical and lumbar regions.

Here's a breakdown of the acceptance criteria and study information for the SAGICO IBF System - ARIA Lumbar and ARION Cervical devices, based on the provided document:

This document describes a 510(k) premarket notification for intervertebral body fusion devices, which means the approval process focuses on demonstrating substantial equivalence to already legally marketed devices, rather than establishing a completely new safety and effectiveness profile through extensive clinical trials. Therefore, the "study" referred to is a non-clinical performance study comparing the device to predicates, not a clinical trial with human subjects.

1. Table of Acceptance Criteria and Reported Device Performance

Note on Acceptance Criteria: For a 510(k), explicit numerical acceptance criteria for each test are often not provided in the summary document but are implicitly understood to be meeting or exceeding the performance of the chosen predicate devices according to recognized standards. The "reported device performance" is essentially that the device performed substantially equivalently to the predicates in these tests.

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

• Sample Size: The document does not specify exact sample sizes for the non-clinical tests (e.g., how many devices were tested for compression, shear, etc.). It refers to "non-clinical performance data testing."
• Data Provenance: This is a non-clinical, in-vitro study. Therefore, there is no country of origin for patient data. The data is generated from laboratory testing of the devices.

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. "Ground truth" usually refers to clinical diagnoses or outcomes established by medical experts for a diagnostic or AI-driven system. Here, the "truth" is established by adherence to engineering and biocompatibility standards.

4. Adjudication Method for the Test Set

• Not applicable. This is a non-clinical engineering study, not a clinical study requiring adjudication of expert opinions.

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 intervertebral body fusion device, not a diagnostic or AI-driven imaging interpretation system. MRMC studies are not relevant here.

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

• Not applicable. This is a physical implant device, not an algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for these types of devices is established by engineering standards and material specifications. The device's performance is compared against the requirements outlined in standards like ASTM F2077, F2267-04, F04.25.02.02, and material standards (ISO 10993-1, ASTM F2026, F136, F560). The "truth" is that the device meets these established performance and material safety benchmarks, demonstrating substantial equivalence to predicate devices that also meet these benchmarks.

8. The Sample Size for the Training Set

• Not applicable. There is no concept of a "training set" for a physical medical implant device in this context. This is not an AI/machine learning application.

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

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

Summary of the Study:

The study described is a non-clinical performance evaluation focusing on the mechanical and material characteristics of the SAGICO IBF System - ARIA Lumbar and ARION Cervical devices. The goal was to demonstrate substantial equivalence to legally marketed predicate devices, a requirement for 510(k) clearance by the FDA. The testing included:

• Mechanical Testing: According to ASTM F2077 (Static and Dynamic Compression, Compression Shear, Torsion) and ASTM F2267-04 (Subsidence), and ASTM F04.25.02.02 (Static Push-out Test).
• Material Biocompatibility: Assessed by the use of medical-grade materials (PEEK Optima LT1, Titanium Alloy, Tantalum beads/rods) that comply with established international and ASTM standards (ISO 10993-1 USP Class VI, ASTM F2026, ASTM F136, ASTM F560).

The conclusion of this non-clinical testing was that the SAGICO IBF System devices demonstrated performance substantially equivalent to legally marketed predicate devices, thus supporting their clearance for market.

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The Leva® Anterior Expandable Spacer System is indicated for intervertebral body fission procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis at the involved level(s). The Leva® Anterior Expandable Spacer System is to be used with autogenous bone graft and with supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral body fusion device.

The Leva® Anterior Expandable Spacer is an expandable lumbar intervertebral body fusion device manufactured from unalloyed commercially pure titanium per ASTM F67. The Leva® Anterior Expandable Inserter, a reusable surgical instrument, expands the spacer (which is provided in a collapsed form) in situ to a predefined height. To accommodate the anatomical needs of a variety of patients, the spacer is available in a range of sizes. The superior and inferior surfaces of the spacer are convex with a lordotic angle to conform to the vertebral endplates, and ridges on both surfaces help resist expulsion. The spacer is designed to accommodate autogenous bone graft material.

I am sorry, but the provided text describes a 510(k) premarket notification for a medical device (Leva® Anterior Expandable Spacer System), which is an intervertebral body fusion device. This documentation focuses on demonstrating substantial equivalence to predicate devices based on mechanical testing and material properties, rather than the performance of an AI or diagnostic device that would involve an AI algorithm.

Therefore, the document does not contain the information requested regarding acceptance criteria related to AI device performance, sample sizes for test/training sets, expert adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment for such studies.

The acceptance criteria in this document relate to the physical and mechanical properties of the implant, such as:

• Static and dynamic axial compression (per ASTM F2077)
• Static and dynamic compression shear (per ASTM F2077)
• Subsidence (per ASTM F2267)
• Cadaveric validation

Since the input doesn't provide data for an AI-related medical device study, I cannot generate the requested table and information.

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The Leva™ Spacer System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radios. These DDD patients may have up to Grade I spondylolisthesis at the involved level(s). The Leva™ Spacer System is to be used with autogenous bone graft and with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral body fusion device.

The Leva™ Spacer System is a lumbar intervertebral body fusion device fabricated from unalloyed commercially pure (Class II) titanium per ASTM F67. The device is available in both expandable and fixed configurations. The expandable device is provided in a collapsed form and is expanded to a predefined height in-situ using the Leva™ Inserter Instrument. Both the fixed and expandable implants are provided in different heights to accommodate the anatomical needs for a range of patients. The implants are designed to accommodate autogenous bone graft material. The implants have curved endplates to conform to the bony endplates of the patient and ridges on the endplates to resist expulsion.

I am sorry, but based on the provided text, I cannot extract any information about acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) premarket notification for a medical device called the Leva™ Spacer System. It describes the device, its intended use, and states that performance testing was conducted to demonstrate substantial equivalence to predicate devices, but it does not specify any acceptance criteria or detail the results of those tests in a way that would allow me to fill out the requested table or provide the other information.

Specifically:

• There is no table of acceptance criteria or reported device performance.
• There is no mention of sample sizes for test sets, data provenance, number or qualifications of experts, or adjudication methods for establishing ground truth.
• There is no information about multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
• The type of ground truth for any testing isn't specified (e.g., pathology, outcomes data).
• There is no information about the sample size for a training set or how ground truth for a training set was established, as this document pertains to a physical medical device, not an AI/ML algorithm.

The performance data section only lists the types of tests performed (e.g., Static and dynamic axial compression per ASTM F2077) but does not provide any results, acceptance criteria, or details regarding the studies themselves.

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The X-spine Calix Lumbar Spinal Implant System is intended for spinal fusion procedures at one or two contiguous levels (L2 - S1 inclusive) in skeletally mature patients with degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the lumbosacral spine. DDD patients may also have up to a Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved level(s). These implants are to be packed with autogenous bone graft and implanted via an anterior, posterior, and/or transforaminal approach. Patients should receive at least six (6) months of non-operative treatment prior to treatment with a lumbosacral intervertebral fusion device.

This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems).

The X-spine Calix Lumbar Spinal Implant System is a generally box or oval shaped device manufactured from Invibio PEEK-Optima LT1 per ASTM F2026 with an array of holes located throughout its geometry as well as teeth on the superior and inferior surfaces. The device is supplied in several widths and heights to accommodate variations in patient anatomy. The devices contain radiographic markers made from tantalum per ASTM F560.

The hollow center of the implant allows the device to be packed with bone graft.

The provided text describes a 510(k) summary for the Calix™ Lumbar Spinal Implant System. This document focuses on the administrative and technical details of a medical device submission, specifically detailing its equivalence to previously marketed products and the performance testing conducted.

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail manner. Instead, it describes a series of standardized tests performed to demonstrate the device's biomechanical equivalence to predicate devices. The "reported device performance" is implied by the successful completion of these tests, signifying that the device performs "at least as safely and effectively as the cited predicate devices."

Note: The document states "biomechanical testing results indicate that the Calix Lumbar Spinal Implant System is substantially equivalent to predicate device performance and is as effective, and performs at least as safely and effectively as the cited predicate devices." This is the general statement of performance, rather than specific quantitative results against discrete acceptance values.

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

The document does not provide a "test set" in the context you would typically find for an AI/software device (e.g., a set of medical images for diagnostic accuracy assessment). Instead, the "performance data" refers to biomechanical testing of the device itself.

• Sample Size for Test Set: Not specified in terms of number of devices or specific load cycles, but refers to "full device constructs" undergoing standardized tests. For biomechanical testing, sample size would typically refer to the number of physical devices tested under various conditions.
• Data Provenance: The tests are standard ASTM (American Society for Testing and Materials) and FDA guidance-driven tests, which implies an engineering/laboratory setting rather than clinical data from a specific country or retrospective/prospective study.

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

This question is not applicable to the provided document. The "ground truth" here is established by the specifications and pass/fail criteria of the ASTM and FDA-recommended biomechanical tests themselves, not by human expert assessment of device performance in a clinical or diagnostic setting.

4. Adjudication Method for the Test Set

This question is not applicable to the provided document as it does not involve expert review or consensus for establishing ground truth. The 'adjudication' in biomechanical testing is typically determined by whether the physical device meets the mechanical performance requirements defined by the test standard.

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

No. The document describes biomechanical testing of a spinal implant, not a diagnostic or AI-powered medical imaging device that would involve human readers. Therefore, an MRMC study is not relevant to this content.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No. This question is relevant for AI/software devices. The provided document concerns a physical spinal implant and its mechanical performance testing.

7. The Type of Ground Truth Used

The "ground truth" for the performance data in this context is the established physical and mechanical properties of the predicate devices and the requirements set forth in the ASTM standards (F2077, F2267) and FDA guidance for intervertebral body fusion devices. The device's performance is compared against these engineering standards and the known performance characteristics of already cleared devices to establish "substantial equivalence."

8. The Sample Size for the Training Set

This question is not applicable. The device is a physical implant, not an AI algorithm requiring a training set.

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

This question is not applicable, as there is no training set for a physical implant.

In summary: The provided 510(k) summary for the Calix Lumbar Spinal Implant System focuses on demonstrating substantial equivalence to predicate devices through biomechanical performance testing. It does not contain information related to AI/software device performance, clinical studies with human readers, or image-based diagnostic accuracy. The "acceptance criteria" are implied by the successful completion of standardized engineering tests, and the "ground truth" is based on these objective engineering standards and predicate device performance.

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PATRIOT® TransContinental™ Spacers are interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with deqeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).

The PATRIOT® TransContinental® Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation, such as the PROTEX® or REVERE® Stabilization System.

The PATRIOT® TransContinental® Spacers are lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. The spacers are inserted using an anterior or lateral approach to the lumbar spine. The devices are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. These spacers are to be filled with autogenous bone graft material. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion.

PATRIOT® Spacers are made from radiolucent polymer, with titanium alloy or tantalum markers, as specified in F2026, F136, F1295, and F560.

This document is a 510(k) premarket notification for the PATRIOT® TransContinental® Spacer, an intervertebral body fusion device. It describes the device and its intended use, but it does NOT contain a study or data proving the device meets acceptance criteria.

The 510(k) process is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device. It does not typically require new clinical studies with acceptance criteria in the same way a PMA (Premarket Approval) submission would.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them because this document does not contain that information. It primarily focuses on demonstrating substantial equivalence to predicate devices, which is a different regulatory pathway.

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The VERTEBRON Interbody Fusion System is indicated for use with autogenous bone graft in skeletally mature patients with degenerative disc disease ("DDD") at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have had a previous non-fusion spinal surgery at the involved spinal level(s), and may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).

The VERTEBRON Interbody Fusion System is implanted via an anterior or posterior approach and is to be combined with cleared supplemental fixation systems, such as the VERTEBRON PSS Pedicle Screw System.

The VERTEBRON Interbody Fusion System consists of various heights, angles and configurations (i.e., square, rectangular D-shaped, etc.). The device is use singly or in pairs to better approximate the anatomical variations observed in different vertebral levels and/or patient anatomy.

The VERTEBRON Interbody Fusion System is comprised of a variety of components fabricated and manufactured from Polyetheretherketone (PEEK) as described by ASTM 2026. This material is utilized due to its radiolucent properties, which aid the surgeon in determining if fusion in the operative site has occurred.

The VERTEBRON Interbody Fusion System has a hollow chamber to permit packing with autogenous bone graft to facilitate fusion, but is of sufficient strength to provide column support even in the absence of fusion for prolonged periods. The superior and inferior surfaces of the construct have a pattern of teeth to provide increased stability and to help prevent movement of the device. Tantalum wire markers (ASTM F560) are inserted into the components to give surgeons a visual aid in determining the location of the implant, both inter and post-operatively.

The material used is PEEK ASTM F2026-07e1 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications or titanium alloy (TI-6AI-4V) that conforms to ASTM F136 Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401) and ASTM F560 Standard Specification for Unalloyed Tantalum for Surgical Implant Applications.

The VERTEBRON Interbody Fusion System is an intervertebral body fusion device. The acceptance criteria and the study performed for this device are described below, based on the provided 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

The provided 510(k) summary does not contain information about a test set with human subject data for efficacy or safety comparisons. The studies mentioned are primarily bench testing for mechanical properties.

• Sample Size: Not applicable for human data. For mechanical testing, the sample size would be determined by the ASTM standards (e.g., number of devices tested). This specific detail is not provided.
• Data Provenance: Not applicable for human data. For mechanical testing, the data would be generated from laboratory tests.

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

Not applicable. The studies referenced are mechanical bench tests against established ASTM standards, not clinical studies requiring expert consensus for ground truth.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical test set requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This 510(k) pertains to a medical implant (interbody fusion system), not an AI or imaging diagnostic device where MRMC studies are typically performed.

6. Standalone Performance Study

Yes, a standalone study in the context of mechanical performance was conducted. The device's mechanical properties were evaluated in a standalone manner (i.e., the device itself, without human interaction influencing performance in the test) against the specified ASTM standards. This is a "standalone" evaluation of the device's physical and mechanical characteristics.

7. Type of Ground Truth Used

The "ground truth" for the performance evaluation of this device was based on widely accepted engineering and material standards (ASTM F2077-03 and ASTM F2267 for mechanical properties; ASTM F2026-07e1, ASTM F136, and ASTM F560 for material specifications). The device was evaluated against these predefined, objective standards for mechanical strength and material composition.

8. Sample Size for the Training Set

Not applicable. This device is an implanted medical device, not an AI or machine learning algorithm that requires a training set. The performance evaluation relies on engineering principles and bench testing.

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

Not applicable. As there is no AI/ML component, there is no training set or ground truth required to be established for one.

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