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The Leva® Anterior Interbody System is a stand-alone system 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 radiographic studies. These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Leva® Anterior Interbody System is intended to be filled with autogenous bone graft material and used with the bone screws provided. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral body fusion device.

The Leva® Anterior Interbody System is family of stand-alone lumbar intervertebral body fusion devices fabricated from Ti-6A1-4V per ASTM F1472 and Ti-6A1-4V ELI per ASTM F136. The device includes integrated plate/screw fixation available in two configurations. In both device configurations, the surgeon inserts the bone screws through the anterior plate screw holes to provide fixation to the vertebral bodies. The device is intended to be filled with autogenous bone graft material. Both implant configurations are provided in various dimensions to accommodate the anatomical needs for a range of patients. The implants have convex endplates to conform to the bony endplates of the patient and ridges on the endplates to resist expulsion.

The provided text describes a medical device, the Leva® Anterior Interbody System, and its clearance process with the FDA. However, it does not contain information regarding acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML model.

The text is a 510(k) premarket notification for a traditional medical device (an intervertebral body fusion device) and focuses on demonstrating substantial equivalence to predicate devices, primarily through mechanical performance testing and material composition.

Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details, or training set information) because the provided document is not about an AI/ML device or its performance evaluation.

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The Camber Spine Technologies ENZA Zero-Profile Anterior Interbody Fusion is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. 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 six months of non-operative treatment. Patients with previous non-fusion spinal surgery at the treated level may be treated. These implants may be implanted via a laparoscopic or an open anterior approach.

The Camber Spine Technologies ENZA Zero-Profile Anterior Interbody Fusion is intended to be used with additional FDA-cleared supplementary fixation systems.

The Camber Spine Technologies ENZA Zero-Profile Anterior Interbody Fusion system must be used with bone grafting material (autograft only).

The Camber Spine Technologies ENZA Zero-Profile Anterior Interbody Fusion is an Interbody Fusion Device that has a hollow chamber to permit packing with bone graft to facilitate fusion. The superior and inferior surfaces of the device have a pattern of teeth to provide increased stability and to help prevent movement of the device has a built-in fixation mechanism that is manually deployed into the vertebral bodies by the operating surgeon.

The provided text describes the Camber Spine Technologies ENZA Zero-Profile Anterior Interbody Fusion device and its clearance by the FDA. It includes a 510(k) summary and non-clinical performance testing information.

Here's an analysis of the acceptance criteria and study that proves the device meets them, based solely on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that the device was tested against acceptance criteria defined by predicate device performance. However, it does not explicitly list the quantitative acceptance criteria for each test. Instead, it makes a general statement about meeting them.

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

The document does not specify the sample size for any of the non-clinical tests (e.g., how many devices were tested for static compression). It also does not mention the data provenance (e.g., country of origin, retrospective or prospective) as these are non-clinical engineering tests, not clinical studies involving patient data.

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

This information is not applicable as the evaluation involved non-clinical performance testing of a physical device, not interpretation of clinical data requiring expert human assessment for ground truth establishment.

4. Adjudication Method for the Test Set:

This information is not applicable as the evaluation involved non-clinical performance testing of a physical device, not interpretation of clinical data requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improvement with AI vs. Without AI Assistance:

This information is not applicable. The document describes the clearance of an intervertebral body fusion device, which is a physical implant, not an AI or imaging diagnostic device.

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

This information is not applicable. See point 5.

7. The Type of Ground Truth Used:

The "ground truth" for the non-clinical performance tests was the performance of legally marketed predicate devices as defined by the relevant ASTM standards (ASTM F2077-14 and F2267-04). This implies that "ground truth" was established based on established engineering benchmarks and typical performance of similar, already-cleared devices.

8. The Sample Size for the Training Set:

This information is not applicable. There is no "training set" in the context of non-clinical mechanical testing of a medical device. This term is relevant for machine learning algorithms.

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

This information is not applicable. See point 8.

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The stand-alone intersomatic IMPIX ALIF S/A implants are indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s).

This device is to be used with autogenous bone graft.

Patients should have a satisfactory course of conservative treatment (usually at least six (6) months of non-operative treatment) prior to treatment with an IMPIX-ALIF-S/A stand-alone cage.

The IMPIX ALIF S/A devices should be used with the three (3) bone screws (Small Footprint) or four (4) bone screws (Medium. Large Footprints) accompanying the device. Otherwise, an additional fixation system (e.g., pedicle screw system) should be implanted.

The MEDICREA® IMPIX ALIF S/A is an intervertebral fusion device with integrated fixation use as an adjunct to fusion. The implant is composed of:

• one PEEK cage with tantalum markers
• either 3 or 4 IMPIX ALIF S/A screws , depending on the footprint of cage considered.

The IMPIX ALIF S/A screw is manufactured from titanium alloy (Ti-6Al-4V) meeting ASTM F136 and ISO 5832-3 standards, and the PEEK cage is manufactured from PEEK OPTIMA® LT1 meeting the ASTM F 2026.The tantalum markers are manufactured from tantalum meeting the ASTMF560 and ISO 13782 standards.

Materials: Titanium alloy (Ti-6Al-4V) and PEEK OPTIMA® LT1 and tantalum

The provided document is a 510(k) premarket notification for a medical device (IMPIX ALIF S/A), primarily focusing on demonstrating substantial equivalence to predicate devices for regulatory clearance. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way typically expected for an AI/ML powered device, or a clinical trial showing efficacy.

The "performance data" section in the document refers to biocompatibility and mechanical testing, which are standard for implantable medical devices, not for assessing the performance of an AI model against specific acceptance criteria.

Therefore, for the requested information regarding acceptance criteria and a study proving the device meets those criteria, most of the fields cannot be filled from the provided text as they are not applicable to the type of regulatory submission presented.

Here's a breakdown of what can be extracted and why other parts cannot be:

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

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. The "performance data" refers to engineering and laboratory tests of the physical device, not performance on a dataset of patient data.

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 information is irrelevant for the mechanical and biocompatibility testing of a physical implant.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.

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. The device is an intervertebral fusion device, not an AI-powered diagnostic or assistive tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical implant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For biocompatibility: Adherence to established ISO and ASTM standards for materials and biological reaction.
For mechanical testing: Adherence to established ASTM standards for mechanical properties.
No clinical ground truth (like pathology or outcomes data) was used or provided as no clinical studies were performed.

8. The sample size for the training set
Not applicable. This document describes a physical medical device, not an AI/ML algorithm that would have a "training set."

9. How the ground truth for the training set was established
Not applicable.

Summary of what the document confirms regarding performance:

• No clinical studies were performed.
• No animal studies were performed.
• The device's performance was assessed through biocompatibility testing and mechanical testing against relevant ISO and ASTM standards, demonstrating compliance and substantial equivalence to predicate devices.
• The biocompatibility testing included cytotoxicity, sensitization, irritation, systemic toxicity, and pyrogen testing.
• The mechanical testing included FEA, static and dynamic axial compression, static and dynamic compression shear, subsidence, expulsion, and screw clip-out evaluation, all performed in compliance with FDA guidance and ASTM standards for intervertebral body fusion devices.

This document specifically highlights that the "performance data" provided was sufficient to establish "substantial equivalence" for regulatory approval without human or animal clinical studies, or any data-driven AI/ML performance evaluation.

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The Irix-A Lumbar Integrated Fusion System is a stand-alone intervertebral body fusion device intended for use in patients with degenerative disc disease (DDD) at one (1) or two (2) contiguous levels of the lumbosacral spine (L2-S1 inclusive). DDD is defined as back pain of discogenic origin 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 had a previous non-fusion spinal surgery at the involved level(s) and may have had up to a Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Irix-A System is intended to be used with autogenous bone graft material, and is to be used with three titanium alloy bone screws included as part of the system.

The Irix-A Lumbar Integrated Fusion System is a stand-alone intervertebral fusion device to restore biomechanical height and act as an aid in fusion of the lumbar spine in anterior discectomy procedures. The device is generally box-shaped with teeth on the superior and inferior faces of the drix-A implant is manufactured from both titanium alloy (Ti6Al4V) in accordance with ASTM F136 and Invibio PEEK-Optima LT1 in accordance with ASTM F2026, or from Ti6AMV titanium alloy alone. The device will be supplied with the option of having the superior and inferior surfaces of the device plasma coated with medical-grade commercially pure titanium (CP Ti) per ASTM F1580. The device is secured in location through the use of bone screws, also manufactured from titanium alloy (Ti6Al4V) per ASTM F136. The devices are provided in various sizes and screws are offered in multiple lengths to adjust for variations in patient anatomy.

The CP-Ti coated devices will be sterile packed with the balance of system components being provided clean and non-sterile. The non-sterile components are to be sterilized by a healthcare professional using a steam autoclave in accordance with the instructions for use provided by X-spine Systems Inc., as well as the instructions provided by the manufacturer of the autoclave.

The information provided describes the Irix-A™ Lumbar Integrated Fusion System, which is an intervertebral body fusion device, not a device that relies on AI algorithms or machine learning. Therefore, many of the requested categories related to acceptance criteria for AI/ML performance, such as sample sizes for test/training sets, ground truth establishment by experts, adjudication methods, and MRMC studies, are not applicable.

The acceptance criteria and supporting study for this device are based on mechanical performance testing to demonstrate substantial equivalence to existing predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance
This is a medical device (spinal implant) and not an AI/ML device relying on a test set of data in the common sense. The "test set" refers to the physical devices and materials tested. The summary does not specify the exact number of units or samples tested for each mechanical test, but implies sufficient testing was conducted to meet the ASTM standards and satisfy FDA requirements for substantial equivalence.
Data provenance: The testing was conducted by X-spine Systems, Inc. in Miamisburg, OH, USA.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The "ground truth" for this type of device is established by meeting engineering and mechanical standards, not by expert consensus on data interpretation. Performance is objectively measured against specified limits in the ASTM standards.

4. Adjudication method for the test set
Not applicable. Mechanical testing results are objective measurements against pre-defined engineering standards, not subjective interpretations requiring adjudication.

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 not an AI/ML device, and thus no MRMC study involving human readers and AI assistance was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical spinal implant, not an algorithm.

7. The type of ground truth used
The "ground truth" in this context is based on established engineering principles, materials science, and biomechanical performance standards (e.g., ASTM F2077, ASTM F2267). The device's performance is objectively measured against the requirements of these standards and compared to the performance of predicate devices.

8. The sample size for the training set
Not applicable. This is not an AI/ML device requiring a training set.

9. How the ground truth for the training set was established
Not applicable.

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The STALIF MIDLINE™ is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. 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 six months of non-operative treatment. Patients with previous non-fusion spinal surgery at the treated level may be treated. These implants may be implanted via a laparoscopic or an open anterior approach.

The STALIF MIDLINE™ is a stand-alone system intended to be used with the bone screws provided and requires no additional supplementary fixation systems.

The STALIF MIDLINE™ system must be used with bone grafting material (autograft only).

The STALIF MIDLINE™ is a radiolucent intervertebral body fusion device and unicortical cancellous bone screws intended to be used without supplemental fixation. The purpose of this 510(k) is to modify the STALIFTM TT (K073109) to include a modified anti-back out feature and additional sizes.

The provided text describes the STALIF MIDLINE™ intervertebral body fusion device and its substantial equivalence to a predicate device (STALIF™ TT, K073109). The information primarily focuses on the device's indications for use, description, and mechanical performance testing.

Here's an analysis of the requested information based on the provided text:

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

The study that proves the device meets the acceptance criteria is the mechanical testing performed in accordance with ASTM F2077 and ASTM F2267. This testing indicated that the STALIF MIDLINE™ is "mechanically equivalent to predicate devices."

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

The document does not provide details on the sample size used for the mechanical tests, the type of data (human or animal), or its provenance. It only states that "Testing performed in accordance with ASTM F2077... and ASTM F2267... indicates the STALIF MIDLINE™ is mechanically equivalent to predicate devices." These ASTM standards refer to in-vitro mechanical testing of intervertebral body fusion devices, not clinical trials with patient data.

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 is not applicable as the study involves mechanical testing of a medical device, not a performance study that requires expert review of diagnostic images or clinical outcomes.

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

This is not applicable, as there is no human interpretation of data described in the 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

This is not applicable. The provided document concerns the regulatory clearance of a physical medical implant (intervertebral body fusion device) based on mechanical equivalence, not an AI-assisted diagnostic tool. Therefore, no MRMC study or AI-related effectiveness is discussed.

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

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

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

The "ground truth" for the mechanical performance of the STALIF MIDLINE™ device is established by the specifications and performance characteristics defined in the ASTM F2077 and ASTM F2267 standards, and by comparison to the established mechanical performance of the predicate device (STALIF™ TT, K073109).

8. The sample size for the training set

This is not applicable. The device is a physical implant assessed through mechanical testing; there is no "training set" in the context of an algorithm.

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

This is not applicable, as there is no training set for an algorithm. The "ground truth" for the mechanical testing is based on established engineering standards for medical devices and the predicate device's performance.

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