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The Reliance Lumbar IBF System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device systems are designed for use with autogenous bone graft to facilitate fusion. One device may be used per intervertebral space. The implants are intended to be used with legally cleared supplemental spinal fixation cleared for the implanted level. Additional supplemental fixation is not necessary for the Lumbar IBF-S if the integrated screws are implanted.

The Reliance Lumbar IBF System, when used as an Intervertebral Body Fusion device is also intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used in patients who have had six months of non-operative treatment.

The Reliance Lumbar IBF System is comprised of lumbar intervertebral body fusion devices and associated surgical instruments. This submission adds a line extension, the Reliance Lumbar IBF-S devices, which consist of spacers made of PEEK Optima LT1 with Tantalum markers, and integrated screws, faceplates, and locking plates manufactured from titanium alloy.

The provided text describes a medical device, the Reliance Lumbar IBF System, and its regulatory clearance process (510(k)). It does not include details about acceptance criteria, device performance metrics, or any clinical studies involving human readers or AI algorithms. The "Performance Data and Substantial Equivalence" section only mentions mechanical testing performed on the device to establish substantial equivalence to predicate devices, focusing on physical properties rather than diagnostic performance.

Therefore, I cannot extract the requested information from the provided text as it is not present. The document focuses on regulatory approval based on substantial equivalence to existing medical devices, not on the diagnostic performance or AI-assisted interpretation of medical images.

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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 NuVasive CoRoent XL-F System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous bone graft to facilitate fusion.

The CoRoent XL-F System is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to L5, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar devices are to be used in patients who have had at least six months of non-operative treatment. The system is intended to be used with supplemental internal spinal fixation systems (e.g., pedicle or facet screws) that are cleared by the FDA for use in the lumbar spine in addition to the integrated screws.

The NuVasive CoRoent XL-F System is manufactured from PEEK-Optima® LT-1 conforming to ASTM F2026, MP35N conforming to ASTM F562, and titanium alloy conforming to ASTM F136 and ISO 5832-3. The implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient.

The provided text describes a 510(k) premarket notification for the NuVasive CoRoent XL-F System, which is an intervertebral body fusion device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that the device meets specific acceptance criteria through a study with performance metrics in the typical sense of a novel medical AI/software device.

Therefore, the requested information elements related to performance criteria, sample sizes, ground truth establishment, expert involvement, and MRMC studies are not applicable to this document. The submission relies on non-clinical performance data (engineering analyses and cadaveric study) to demonstrate safety and effectiveness relative to existing devices.

Here's a breakdown of what can be extracted and why other elements are not applicable:

1. A table of acceptance criteria and the reported device performance

• Not Applicable in the traditional sense. For a 510(k) for an intervertebral body fusion device, "acceptance criteria" are typically related to meeting established performance standards for mechanical properties and biocompatibility, as demonstrated through engineering analyses and material testing, rather than clinical performance metrics (like sensitivity, specificity, accuracy) for an AI/software device. The document states that the objective was to demonstrate substantial equivalence to predicate devices.
• Reported Device Performance (based on non-clinical studies):
  • Axial Compression Finite Element Analysis: "Results demonstrate that the subject CoRoent XL-F System presents no new worst-case for performance testing."
  • Compression Shear Finite Element Analysis: "Results demonstrate that the subject CoRoent XL-F System presents no new worst-case for performance testing."
  • Wear Debris Analysis: No specific performance reported, but implied to be acceptable for substantial equivalence.
  • Subsidence Analysis: No specific performance reported, but implied to be acceptable for substantial equivalence.
  • Clinical Literature Analysis: Used for comparison, not direct performance measurement of the device itself.
  • Cadaveric Study: "Did not identify any new risks associated with the subject device."

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

• Not Applicable. No test set in the context of an AI/software device performance study was used. The studies conducted were engineering analyses (Finite Element Analysis) and a cadaveric study.
  • For the cadaveric study, the sample size is not specified in the provided text.
  • Data provenance for FEA is theoretical modeling; for the cadaveric study, the source/provenance is not detailed.

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. This device is a physical implant, not an AI/software device that requires human expert annotation for ground truth establishment. Engineering analyses and cadaveric studies are evaluated by engineers and medical professionals specialized in those fields, but not in the context of "ground truth" for a test set.

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

• Not Applicable. There was no "test set" in the context of a diagnostic or predictive performance study, and therefore no adjudication method as described.

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

• Not Applicable. This is a physical intervertebral body fusion device, not an AI or imaging diagnostic tool. Therefore, an MRMC study is irrelevant.

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

• Not Applicable. This device does not contain software or electrical equipment, as explicitly stated in section F. It is a physical implant.

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

• Not Applicable in the typical sense of AI/software device. For this physical device, the "ground truth" for its safety and effectiveness is established through adherence to engineering standards (e.g., ASTM F2026, F562, F136, ISO 5832-3 for material composition), and the findings of the finite element analyses and cadaveric study which confirm it performs similarly to predicate devices without introducing new risks. Clinical literature analysis also contributes to supporting the established safety and effectiveness of similar devices.

8. The sample size for the training set

• Not Applicable. This device does not involve a "training set" in the context of machine learning.

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

• Not Applicable. As there is no training set for machine learning involved with this device.

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The NuVasive CoRoent Single Tab System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous bone graft to facilitate fusion.

The CoRoent Single Tab System is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to L5, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The devices are to be used in patients who have had at least six months of non-operative treatment. The system is intended to be used with supplemental internal spinal fixation systems (e.g., pedicle or facet screws) that are cleared by the FDA for use in the lumbar spine in addition to the integrated screw.

The NuVasive CoRoent Single Tab System is manufactured from PEEK-Optima® LT-1 conforming to ASTM F2026, MP35N conforming to ASTM F562, and titanium alloy conforming to ASTM F136 and ISO 5832-3. The implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient.

The provided document is a 510(k) summary for the NuVasive CoRoent Single Tab System, which is an intervertebral body fusion device. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy through clinical studies or setting acceptance criteria for device performance based on a new study.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria, as well as details about sample sizes, ground truth establishment, expert adjudication, or MRMC comparative effectiveness studies.

Here's why and what information is available:

1. A table of acceptance criteria and the reported device performance:

• Not provided. The 510(k) pathway for this device relies on demonstrating substantial equivalence through bench testing, not on establishing and meeting new clinical performance acceptance criteria.
• The document states: "The results demonstrate that the subject CoRoent Single Tab System presents no new worst-case for performance testing, and the subject device was therefore found to be substantially equivalent to the predicate."

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/Not provided. No clinical test sets or patient data were used for this 510(k) submission. All testing was bench-based.

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

• Not applicable/Not provided. No human expert ground truth was established as there were no clinical studies.

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

• Not applicable/Not provided. No clinical test set.

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/Not provided. This is a physical medical device (intervertebral body fusion system) and does not involve AI, human readers, or image interpretation.

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

• Not applicable/Not provided. This device is a physical implant, not an algorithm. The document explicitly states: "This device does not contain software or electrical equipment."

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

• Not applicable/Not provided. Ground truth, in the clinical sense, was not established as there were no clinical studies. For bench testing, the "ground truth" is typically the established engineering and materials standards (e.g., ASTM standards).

8. The sample size for the training set:

• Not applicable/Not provided. No training set was used as this device does not involve machine learning or AI.

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

• Not applicable/Not provided. No training set was used.

Summary of available "Performance Data" from the document:

The device underwent bench testing to demonstrate substantial equivalence to predicate devices. The specific tests performed were:

• Static and dynamic axial compression and compression shear per ASTM F2077.
• Wear debris testing per ASTM F2077, ASTM F1714, and ASTM F1877.

The document explicitly states: "No animal or clinical studies were conducted."

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The INDEPENDENCE® Spacer is a stand-alone 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 nonoperative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The INDEPENDENCE® Spacer is to be filled with autogenous bone graft material, and is to be used with three titanium alloy screws, which accompany the implant.

The INDEPENDENCE® Spacer is a stand-alone anterior lumbar interbody fusion device used to provide structural stability in skeletally mature individuals following discectomy. The spacers 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. Screws are inserted through the anterior titanium portion of the implant into adjacent vertebral bodies for bony fixation. The spacer is to be filled with autogenous bone graft material.

The INDEPENDENCE® Spacer is made from radiolucent polymer, with titanium alloy or tantalum markers, as specified in ASTM F2026, F136, F1295, and F560. The anterior portion of the implant and the mating screws are manufactured from titanium alloy, as specified in ASTM F136 and F1295. The screws are available with or without hydroxyapatite (HA) coating, as specified in ASTM F1185.

Here's an analysis of the provided text regarding the acceptance criteria and study for the INDEPENDENCE® Spacer, structured as requested:

Acceptance Criteria and Study for INDEPENDENCE® Spacer

This 510(k) submission is for an enhancement to an existing device, the INDEPENDENCE® Spacer (K082252), specifically for the addition of hydroxyapatite (HA) coated screws. As such, the "acceptance criteria" and "study" are primarily focused on demonstrating substantial equivalence to the predicate device and ensuring the new component (HA coating) does not negatively impact performance.

Note: The provided document is a 510(k) summary and the FDA's clearance letter. It does not contain detailed study reports with raw data or comprehensive statistical analyses generally found in a full PMA (Premarket Approval) submission or a clinical trial report. Therefore, some information, particularly regarding specific performance metrics with numerical targets, sample sizes for specific tests, and details on expert ground truth, is limited or not explicitly stated in this summary.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated. The document refers to "mechanical testing (expulsion)" but does not provide the number of devices or iterations tested.
• Data Provenance: The testing was conducted internally by the manufacturer (Globus Medical Inc.) to support the 510(k) submission. It's a retrospective analysis in the sense that the testing was performed, and the results were compiled for submission. The location of the testing is not specified, but it's presumed to be in a lab setting rather than a clinical trial.

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

• Not applicable / Not specified. This submission focuses on engineering bench testing (mechanical performance, material specifications). It does not involve a clinical test set requiring expert consensus for ground truth for diagnostic accuracy or similar evaluations. The "ground truth" for this device's performance is derived from established engineering test methods and material standards.

4. Adjudication Method for the Test Set

• Not applicable. As the "test set" primarily refers to mechanical testing results against engineering standards and a predicate device, there is no need for expert adjudication. The compliance with standards and equivalence to the predicate is determined by the results of the mechanical tests performed.

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

• No. An MRMC study is typically performed for diagnostic imaging devices where human readers interpret medical images. This device is an intervertebral body fusion device, not a diagnostic device, and therefore such a study is not relevant or included.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

• Yes, effectively. The primary form of "performance" described is standalone. The device's mechanical properties and material composition are assessed independently against established engineering standards and compared to a predicate device. There is no "human-in-the-loop" component in evaluating the expulsion resistance or material characteristics of the spacer itself.

7. Type of Ground Truth Used

• Engineering Standards and Predicate Device Performance: The ground truth for this submission is established by:
  • Guidance Document: "Guidance for Industry and FDA Staff, Class II Special Controls Guidance Document: Intervertebral Body Fusion Device", June 12, 2007, which outlines the expectations for testing intervertebral fusion devices.
  • ASTM Standards: Material specifications (e.g., F2026, F136, F1295, F560, F1185) serve as the ground truth for material properties.
  • Predicate Device Data: The performance of the predicate device (InterContinental® Plate-Spacer, K103382) serves as the benchmark for substantial equivalence, particularly for mechanical properties like expulsion.

8. Sample Size for the Training Set

• Not applicable. This device is a physical implant, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.

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

• Not applicable. As there is no "training set" for an AI/ML algorithm, this question is not relevant.

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