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The Cogent Med-LIF 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. These devices are intended for intervertebral body fusion, and are intended to be used with supplemental fixation instrumentation which has been cleared by the FDA for use in the lumbar spine.

The Cogent Med-LIF is an interbody fusion device intended to stabilize the spinal segment to promote fusion. The Cogent Med-LIF consists of two PEEK spacers with axial voids to contain bone graft material, a titanium linkage that connects the PEEK spacers, angular anti-migration teeth, and tantalum x-ray markers. The Cogent Med-LIF is available in various sizes to accommodate varying patient anatomy. The implants come in two lordotic options, 0° (parallel) and 6° (lordotic). The parallel implants are available in heights ranging from 8mm to 16mm and the lordotic implants are available in heights ranging from 10mm to 16mm. All implants are 10mm wide and are available in three lengths; 20, 25 and 30mm. The Cogent Med-LIF implants may be inserted via an open or minimally invasive approach and may be placed as a single implant or as two units bilaterally in the same intervertebral space. The Cogent Med-LIF implants are non-sterile and are to be sterilized by the end user.

The provided document describes the Cogent Med-LIF, an intervertebral body fusion device, and its performance testing for a 510(k) submission. It does not describe a study involving AI, software or an analytical device. Therefore, it is impossible to answer the following sections, as they are not presented in the document:

• Acceptance criteria and reported device performance related to a diagnostic or analytical AI/software device.
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth for the test set and their qualifications.
• Adjudication method for the test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study, effect size.
• Standalone (algorithm only) performance.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for an AI/software device.
• Sample size for the training set.
• How ground truth for the training set was established.

However, I can extract information regarding the physical device's performance testing and its overall conclusion of substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

For the physical device, Cogent Med-LIF, the "acceptance criteria" are implied by compliance with ASTM standards and demonstrating performance comparable to legally marketed predicates. The "reported device performance" is a general statement that the device met these criteria.

Summary of the Study:

The document describes bench testing and a cadaveric implantation study for the Cogent Med-LIF device.

• Bench Tests: These tests focused on the mechanical properties of the device, adhering to established ASTM standards (F2077, F2267, and a draft expulsion standard). The specific acceptance criteria for these tests would be the performance benchmarks defined by these ASTM standards or comparative performance to the predicate devices.
• Cadaveric Implantation Study: This study's purpose was to confirm that autogenous bone graft could be adequately delivered using the Cogent Med-LIF, specifically when compared to a legally marketed predicate device.

Overall Conclusion:
The manufacturer concluded that "mechanical and non-clinical testing of the Cogent Med-LIF device indicated no new risks and demonstrated substantial equivalence in performance compared to a legally marketed predicate." This statement serves as the final "reported device performance" and meets the overarching "acceptance criteria" for a 510(k) submission, which is to demonstrate substantial equivalence to a predicate device.

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The K7 Lumbar Spacers are indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with supplemental fixation and with autograft to facilitate fusion.

The K7 Lumbar Spacers are a collection of radiolucent interbody devices having variously shaped cross-sections. The superior and inferior surfaces are open with parallel serrations to facilitate implant stability. The implants are available in an assortment of height, length, width and anteroposterior angulation combinations to accommodate a variety of anatomic requirements.

The provided text describes the K7 Lumbar Spacers, a medical device for intervertebral body fusion. The study presented focuses on demonstrating substantial equivalence to predicate devices through mechanical testing, rather than a clinical study evaluating the device's performance in a human population.

Therefore, many of the requested categories related to clinical performance metrics, ground truth establishment, expert involvement, and reader studies are not applicable or cannot be extracted from this document, as the FDA 510(k) submission for this device type typically relies on demonstrating engineering and material equivalence for clearance.

Here's a breakdown of the information that can be extracted, and where the requested information is not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

• Static Compression (according to ASTM F2077)
• Dynamic Compression (according to ASTM F2077) | Performance shown to be substantially equivalent to predicate devices. |
  | Subsidence Properties:
• Evaluated according to ASTM F2267 | Performance shown to be substantially equivalent to predicate devices. |
  | Technological Characteristics:
• Intended Use
• Basic Design (hollow column)
• Material (PEEK polymer and tantalum)
• Sizes (widths, lengths, heights within predicate range) | Same as predicate devices. |

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

• Sample Size: Not explicitly stated as a "test set" in the context of clinical data. The mechanical testing was likely performed on a representative sample of K7 Lumbar Spacers of the "worst case" configuration. The specific number of units tested for static, dynamic compression, and subsidence is not provided.
• Data Provenance: The data is from mechanical testing of the device itself (K7 Lumbar Spacers) in a laboratory setting, not from human subjects. Therefore, country of origin or retrospective/prospective clinical data is not applicable.

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

• This is not applicable. The "ground truth" for this device's regulatory clearance is established by engineering standards (ASTM F2077, ASTM F2267) and comparison to predicate device characteristics, not by expert clinical consensus on a "test set" of patient data.

4. Adjudication Method for the Test Set

• This is not applicable, as there was no clinical "test set" involving human interpretation or adjudication.

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

• No, an MRMC comparative effectiveness study was not done. This device is a spinal implant, and its regulatory clearance here is based on mechanical performance and material equivalence, not on the interpretative performance of a diagnostic algorithm or image analysis by human readers.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

• No, a standalone study in the context of AI algorithm performance was not done. This device is a physical implant, not an AI algorithm.

7. Type of Ground Truth Used

• For the mechanical performance, the "ground truth" is defined by engineering standards (ASTM F2077 for compression, ASTM F2267 for subsidence) and the established performance/characteristics of legally marketed predicate devices. The goal was to demonstrate that the K7 Lumbar Spacers met or were equivalent to these benchmarks.

8. Sample Size for the Training Set

• This is not applicable. There is no "training set" in the context of machine learning or AI as this is a physical medical device.

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

• This is not applicable. See point 8.

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When used as a cervical intervertebral body fusion device, the Lanx Intervertebral Body/VBR Fusion System ("Lanx Fusion System") is intended for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients with degenerative disc disease ("DDD") at one spinal level from the C2-C3 disc to the C7-T1 disc. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had at least of non-operative treatment. The Lanx Cervical Intervertebral Body Fusion is to be implanted via an anterior approach and is to be combined with supplemental fixation. Approved supplemental fixation systems include the Lanx Anterior Cervical Plate System.

When used as a lumbar intervertebral body fusion device, the Lanx Intervertebral Body/VBR Fusion System ("Lanx Fusion System") is intended for spinal fusion procedures to be used 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 nonoperative 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 The Lanx Fusion System is to be implanted via an anterior or posterior approach and is to be level(s). combined with supplemental fixation. Approved supplemental fixation systems include the Lanx Spinal Fixation System.

When used as vertebral body replacement, the Lanx Intervertebral Body/VBR Fusion ("Lanx Fusion System") is indicated for use to replace a vertebral body that has been resected or excised due to tumor or traumalfracture. The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from TI to LS) The Lanx Vertebral Body Replacement System may also be used in the thoracolumbar spine (i.e., T1- L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Lanx Vertebral Body Replacement System is also indicated for treating fractures of the thoracic and lumbar spine. The Lanx Vertebral Body Replacement System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column. For either indication the system must be used with supplemental internal fixation. Supplemental internal fixation is required to properly utilize this system

All devices in the Lanx Fusion System are made of PEEK (OPTIMA®) per ASTM F2026 and Titanium alloy (Ti-6Al-4V) per ASTM F136. The Fusion System has a hollowed out area to accommodate autogenous bone graft, and transverse grooves to improve fixation and stability. It is available in a variety of different sizes to accommodate anatomical variation in different vertebral levels and/or patient anatomy. The Lanx Fusion System is provided non-sterile.

The Lanx Fusion System, a medical device for spinal fusion and vertebral body replacement, obtained 510(k) clearance (K083815) based on mechanical performance testing.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document refers to mechanical performance testing per ASTM F2077 and ASTM F2267. These are standard test methods for evaluating medical devices. The document does not specify the exact sample size (number of devices tested) for these mechanical tests, nor does it provide information about data provenance (e.g., country of origin, retrospective/prospective) for clinical or patient data, as this device's clearance was based on demonstrating substantial equivalence through engineering and mechanical testing, not new clinical data.

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

Not applicable. This device's clearance was based on mechanical testing and comparison to predicate devices, not on expert-adjudicated ground truth derived from clinical cases or images.

4. Adjudication Method for the Test Set

Not applicable. See point 3.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission focuses on mechanical equivalence to predicate devices, not on comparing human reader performance with or without AI assistance.

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

No, a standalone algorithm performance study was not done. This device is a physical medical implant, not an AI or software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's acceptance was:

• Engineering Standards: Compliance with established ASTM standards (F2077, F2267 for mechanical properties; F2026, F136 for materials).
• Predicate Device Performance: The mechanical characteristics of the new device were compared and found "comparable" to existing cleared predicate devices.

8. The Sample Size for the Training Set

Not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI. The development process would involve iterative design and testing, but not in the sense of a data "training set."

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

Not applicable. See point 8.

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The Spinal USA Interbody Fusion Device is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion. One device is used per intervertebral space for the ALIF and TLIF system. Two devices are used per intervertebral space for the PLIF system.

The Spinal USA Interbody Fusion Device ALIF, PLIF, TLIF System are 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 I 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 with supplemental fixation and autogenuos bone graft. Patients should have at least six months of non-operative treatment prior to treatment with a lumbar intervertebral fusion device.

The Spinal USA Interbody Fusion Device consists of implants with various widths, heights and lengths to accommodate individual patient anatomy and graft material size. All components are manufactured from medical grade polyetheretherketone (Peek, LT1). The products are supplied clean and "NON-STERILE".

The provided text does not contain information about acceptance criteria or a study proving the device meets them. Instead, it describes a 510(k) summary for an Intervertebral Body Fusion Device, focusing on its intended use, device description, and substantial equivalence to predicate devices. There is no mention of specific performance metrics, test sets, ground truth establishment, or clinical studies involving AI or human readers.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or answer the questions regarding sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details based on the provided document.

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The Stryker Spine AVS® PL PEEK Spacers are intervertebral body fusion devices indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.

DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of non-operative therapy.

The AVS® PL PEEK Spacers are to be implanted via posterior approach.

The AVS® PL PEEK Spacers are 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).

The subject AVS PL PEEK Spacers and the predicates AVS PL PEEK Spacers and DePuy's Lumbar I/F Cage (i.e., Brantigan Cage) share similar design features:
• Hollow frame PEEK Implant
• Lateral fenestrations
• Serrations on the superior and inferior surfaces
• Comparable heights, widths, and angles
• Materials and mechanical testing results are similar between the subject device and the listed predicates.
This Special 510(k) premarket notification is intended to introduce the following line extensions to the AVS® PL PEEK Spacers approved under K073470: The addition of 20 and 25 mm lengths, 14, 15, 16 and 18 mm heights, 8 and 9 mm widths, and 8° angle. Additions to implants approved under K080758 include: Addition of a 14 mm length (4 implants).

All other attributes remain the same. Note that the AVS® PL PEEK Spacers may also be referred to as AVS Plus.

The provided text discusses a Special 510(k) Premarket Notification for a line extension to the AVS™ PL PEEK Spacer System. This document does not describe a study involving an artificial intelligence (AI) or machine learning device, nor does it involve the evaluation of a diagnostic or assistive technology where performance metrics like sensitivity, specificity, or reader improvement would be relevant.

Instead, this document is for a medical device (spinal implant) and focuses on demonstrating substantial equivalence to previously cleared predicate devices for regulatory approval. The "study" mentioned here refers to mechanical testing of the device, not a clinical study involving human readers or AI performance.

Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, and standalone performance for an AI device cannot be extracted from this document because it pertains to a different type of medical device and regulatory submission.

However, I can extract the information that is relevant to the document for the physical device:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "Testing in compliance with FDA's June 12, 2007 'Class II Special Controls Guidance Document: Intervertebral Body Fusion Device' was performed for the AVS PL PEEK Spacers and demonstrated substantially equivalent performance characteristics to the identified predicate device systems."

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

• Sample Size: Not specified in the provided text. The "test set" here refers to the number of physical devices or models subjected to mechanical testing.
• Data Provenance: Not applicable in the context of a retrospective/prospective study with human or AI data. The "provenance" refers to the results of internal mechanical testing performed by Stryker Spine.

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

Not applicable. This document is about the physical testing of a medical device, not a diagnostic or AI performance study requiring expert ground truth for interpretation.

4. Adjudication Method for the Test Set:

Not applicable. This concept pertains to resolving discrepancies in expert interpretations in diagnostic studies, which is not relevant here.

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

No. This is a special 510(k) for a physical medical device, not an AI or diagnostic tool.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-loop Performance):

No. This is a physical medical device.

7. Type of Ground Truth Used:

Mechanical properties and performance characteristics, as defined by FDA guidance for intervertebral body fusion devices, established through engineering testing.

8. Sample Size for the Training Set:

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

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The Stryker Spine AVS PL PEEK Spacers are intervertebral body fusion devices indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.

DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.

The AVS PL PEEK Spacers are to be implanted via posterior approach.

The AVS PL PEEK Spacers are 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).

This Special 510(k) premarket notification is intended to introduce the following design changes to the 0° AVSTM PL PEEK Spacers: The ogival shaped nose of the implant has been changed to a tapered design to facilitate insertion. The threaded hole on the front side of the implant has been omitted as it is not needed to remove the implant and field feedback confirms it would likely not be used. In the smaller heights, the back sided threaded hole has been adapted to remain consistent with the existing instruments (i.e., the two Inserters), and the back side of the spacer has been tapered in the frontal plane to match the geometry of the vertebral endplates and the two flat surfaces have been increased to improve connection with the Inserters. Note that the AVS PL PEEK Spacers are also referred to as AVS Plus.

I'm sorry, but based on the provided text, I cannot describe the acceptance criteria or a study proving the device meets them. The document is primarily a "Special 510(k) Summary of Safety and Effectiveness" for modifications to an existing spinal implant system, not a detailed study report with specific performance metrics and acceptance criteria.

Here's why the requested information cannot be extracted:

• Acceptance Criteria and Reported Device Performance: The document states that "Testing in compliance with FDA's June 12, 2007 'Class II Special Controls Guidance Document: Intervertebral Body Fusion Device' was performed for the AVS PL PEEK Spacers and demonstrated substantially equivalent performance characteristics to the identified predicate device systems." However, it does not provide a table of specific acceptance criteria (e.g., minimum compression strength, fatigue life) or the numerical 'reported device performance' values for these criteria. It only indicates that the device met the requirements for substantial equivalence.
• Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth): None of these details are present in the provided text. The document is a regulatory submission summary, not a scientific paper detailing the methodology and results of specific tests with a test set. It mentions "mechanical testing results" but does not elaborate on the specifics of these tests as would be required to answer your questions.
• Training Set Information: Similarly, there is no mention of a training set, how its ground truth was established, or its sample size. This type of information is relevant for AI/machine learning models, which are not described as being part of this device or its evaluation. This device is a physical intervertebral body fusion device.

In summary, the provided text confirms that certain tests were conducted to demonstrate substantial equivalence to a predicate device, but it lacks the granular detail about acceptance criteria, performance metrics, and study methodologies that you are requesting.

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