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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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Elite™ Expandable implants are intervertebral body fusion devices indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.

Elite™ Expandable implants are designed for use with autograft comprised of cancellous and/or corticocancellous bone graft as an adjunct to fusion and are intended for use with supplemental fixation systems cleared by the FDA for use in the lumbar spine.

The Elite™ Expandable Interbody Fusion System is designed for use as a lumbar intervertebral body fusion device and consists of medical grade titanium alloy (Ti-6AL-4V, ELI) cages and implantation instrumentation. The cages are available in various geometries and sizes to accommodate patient anatomy. The cages have ridges or teeth that resist rotation and migration and have cavities to accept packing of bone graft. Components of the Elite™ IBF Expandable Lumbar Fusion System should not be used with components of any other system or manufacturer.

This document does not contain information about acceptance criteria, device performance metrics, or a study specifically designed to establish acceptance criteria for the Elite™ Expandable Interbody Fusion Device.

The document is an FDA 510(k) clearance letter and a 510(k) summary for the Elite™ Expandable Interbody Fusion Device. It primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices, not on proving that the device meets specific performance acceptance criteria through a clinical study or detailed non-clinical performance report.

Here's what can be extracted from the document:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not provided in the document. The document lists mechanical tests performed (ASTM F2077, F2267) and bacterial endotoxin testing, but it does not specify quantitative acceptance criteria for these tests nor does it report specific numeric results against those criteria. It only states that these tests were "conducted in accordance with FDA's Class II Special Controls Guidance Document... and applicable American Society for Testing and Materials (ASTM) standards." This implies the tests were performed to demonstrate mechanical integrity and biocompatibility, but the specific performance values and acceptable ranges are not disclosed.

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

• Test Set Sample Size: Not applicable as no specific clinical or performance test set (in the context of real-world patient data or detailed device performance metrics) is described in terms of a sample size. The "test set" here refers to the physical devices subjected to mechanical testing.
• Data Provenance: The document refers to non-clinical mechanical testing and bacterial endotoxin testing. This is laboratory-based testing, not clinical data from patients.

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

Not applicable. The document describes mechanical and biocompatibility testing of the device, not a study evaluating human interpretation or diagnosis. Therefore, there's no "ground truth" established by experts in the context of diagnostic performance.

4. Adjudication Method:

Not applicable. There's no adjudication method mentioned as this document does not describe a study involving expert review or interpretation.

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

No. An MRMC comparative effectiveness study was not done. This type of study typically assesses the performance of human readers (e.g., radiologists) with and without AI assistance, which is not relevant to this mechanical device submission.

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

Not applicable. This is a physical intervertebral body fusion device, not an algorithm or AI software. Therefore, "standalone performance" in the context of an algorithm is not relevant.

7. Type of Ground Truth Used:

Not applicable in the context of diagnostic or interpretive performance. For the mechanical and biocompatibility testing, the "ground truth" would be established by the physical properties of the materials and the manufacturing process, verified by standardized laboratory tests.

8. Sample Size for the Training Set:

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

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

Not applicable for the same reason as point 8.

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The ELSA™ Spacer is an interbody fusion device 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 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 ELSA™ Spacer is to be filled with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone, may be used with two bone screws, and is to be used with supplemental fixation. Hyperlordotic (≥20°) implants must be used with the two bone screws and supplemental fixation in addition to the bone screws.

ELSA™ Spacers are expandable lateral lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. The devices are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to aid in expulsion resistance.

ELSA™ Spacers are manufactured from titanium alloy, as specified in ASTM F136 and F1295, and include an internal component manufactured from radiolucent PEEK polymer, as specified in ASTM F2026. The screws used with ELSA™ are manufactured from titanium allov, as specified in ASTM F136 and F1295, and are available with hydroxyapatite (HA) coating, as specified in ASTM F1185.

The provided text describes a medical device, the ELSA™ Spacer, which is an intervertebral body fusion device. The document is a 510(k) premarket notification summary submitted to the FDA. The submission seeks to demonstrate substantial equivalence to legally marketed predicate devices.

However, the provided text does not include information about acceptance criteria for a device's performance (such as a diagnostic algorithm or AI system) or a study that specifically proves the device meets such criteria in terms of clinical accuracy or effectiveness. Instead, it describes mechanical and material performance testing for the physical implant itself, aimed at demonstrating functional equivalence to existing devices.

Therefore, many of the requested categories about acceptance criteria, clinical study design, ground truth establishment, and AI performance metrics cannot be answered from the provided document.

Here's a breakdown of what can be extracted and what is missing:

1. Table of acceptance criteria and the reported device performance

The document lists performance tests conducted for the physical device, not for a diagnostic algorithm's accuracy. The "acceptance criteria" here relate to the mechanical integrity and safety of the implant itself, aligning with established ASTM standards for intervertebral fusion devices.

2. 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 document describes mechanical and material testing of a physical implant, not a clinical study involving a test set of patient data or images. The "samples" would refer to the number of devices subjected to various mechanical stress tests, which is not specified in this summary.

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)

• Not applicable. Ground truth establishment by clinical experts is relevant for diagnostic or AI devices, not for the mechanical testing of an interbody fusion device.

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

• Not applicable. This pertains to clinical studies for diagnostic accuracy, not mechanical testing.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This is for AI-assisted diagnostic devices. The ELSA™ Spacer is a physical implant.

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

• Not applicable. There is no algorithm or AI component described for the ELSA™ Spacer.

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

• Not applicable. For mechanical testing, the "ground truth" is adherence to established engineering standards (ASTM and FDA guidance) for device strength, durability, and biocompatibility.

8. The sample size for the training set

• Not applicable. There is no AI training set mentioned for this physical device.

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

• Not applicable. No training set or ground truth in the AI context are relevant to this document.

Summary of Device and Study Type:

The ELSA™ Spacer is an interbody fusion device, a physical implant used in spinal surgery. The "study" described in this document is a series of mechanical and material performance tests (e.g., static and dynamic compression, subsidence, expulsion, bacterial endotoxin) conducted in accordance with established ASTM standards and FDA guidance. The purpose of these tests is to demonstrate the substantial equivalence of the ELSA™ Spacer to legally marketed predicate devices in terms of safety, function, and mechanical integrity, rather than clinical diagnostic performance or AI accuracy.

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The Integra® Expandable Intervertebral Body Fusion Device (IBD) System is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). These patients should have had six months of non-operative treatment. The device is intended to be used with autogenous bone graft and supplemental fixation.

The Integra Expandable IBD System consists of lumbar interbody fusion devices manufactured from PEEK-OPTIMA® LT1 (ASTM F2026), titanium (Ti-6Al-4V ELI per ASTM F136) and cobalt chromium (Co-28Cr-6Mo per ASTM F1537) materials, with radiographic tantalum markers (ASTM F560). These implants are generally box shaped with surface teeth and a central channel to be filled with autogenous bone graft. They are available in a range of sizes, and their heights can be intra-operatively expanded to the desired height to accommodate variations in surgical approach and patient anatomy. Non-expandable implants are manufactured from PEEK-OPTIMA® LT1 only with radiopaque markers. The system also includes instruments to assist with the surgical procedure/ implantation, as well as trays and caddies for organization.

This is a medical device application for an intervertebral body fusion device, not an AI/ML device. Therefore, the requested information about acceptance criteria, study data, expert involvement, and ground truth establishment, which are typical for studies validating AI/ML performance, is not applicable in this context.

Here's a breakdown of why the requested information cannot be provided given the input:

• Device Type: The Integra Expandable IBD System is a physical medical implant (intervertebral body fusion device) made of PEEK, titanium, and cobalt chromium. It is not a software algorithm or an AI/ML diagnostic tool.
• Regulatory Pathway: This is a 510(k) premarket notification, which demonstrates substantial equivalence to legally marketed predicate devices. This pathway typically relies on non-clinical (bench) testing and comparison to existing devices, rather than large-scale clinical trials or AI/ML performance studies with specific acceptance criteria like sensitivity, specificity, etc.
• Non-Clinical Testing: The submission explicitly states "Non-clinical Testing: The Integra Expandable IBD System demonstrated equivalent performance to the predicate systems through static and dynamic axial compression shear testing per ASTM F2077, with wear evaluation per ASTM F1877, subsidence testing per ASTM F2267, and expulsion testing per ASTM Draft F04.25.0202. In addition, a cadaver implantation study was conducted to demonstrate usability and graft containment/volume of the subject device."
• Clinical Testing: The submission explicitly states "Clinical Testing: No clinical testing was required to demonstrate equivalence."

Therefore, I cannot populate the table or answer the questions as they pertain to AI/ML device validation. The provided document concerns a traditional medical device demonstrating substantial equivalence through non-clinical performance standards and a cadaver study, not through a study involving AI performance metrics, readers, or ground truth as defined in an AI context.

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