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The CONCORDE Bullet Spinal System is indicated for use as intervertebral body fusion devices in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Patients should have six months of non-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine and are placed via either a PLIF or TLIF approach using autogenous bone. When used as interbody fusion devices, these implants are intended for use with DePuy Spine supplemental internal fixation products.

The CONCORDE Bullet Spinal System is indicated for use in the thoracolumbar spine (i.e., T1-L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore height of a collapsed vertebral body. This system is also indicated for treating fractures of the thoracic and lumbar spine. This system is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period. When used as a vertebral body replacement device, this system is intended for the use with DePuy Spine supplemental internal fixation products.

The CONCORDE Bullet Spinal System is a system of intervertebral body fusion devices consisting of cages and implantation instrumentation. The cages feature a bulleted nose to aid in implant insertion. The proposed cages will offer a titanium alternative at certain geometries to the primary predicate system, which is currently only available in polymer/carbon fiber composite. The cages are available in varying shape and size configurations to match patient anatomy. The cages have ridges or teeth that resist rotation and migration and have cavities to accept packing of bone graft. The proposed cages will be implanted with the same instrumentation currently used in the system. The proposed cages will be offered sterile or non-sterile.

This document is a 510(k) premarket notification for a medical device called the CONCORDE Bullet Spinal System. It seeks to demonstrate substantial equivalence to previously cleared predicate devices. The "study" described herein is not a clinical study to assess patient outcomes or clinical effectiveness in the traditional sense, but rather an engineering and materials performance study to demonstrate the mechanical safety of a new material for an existing device.

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

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

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

• Sample size for test set: Not explicitly stated as a "sample size" in the context of a clinical trial. The performance data refers to mechanical testing. The number of physical samples tested for dynamic axial compression and the specific models involved in the finite element analysis are not detailed.
• Data provenance: Not applicable in the context of patient data. The tests are engineering tests performed on the device itself.
• Retrospective or prospective: Not applicable. These are laboratory-based mechanical tests.

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 in this context refers to engineering standards and specifications (ASTM F-2077) and comparisons to existing predicate device performance. This would be established by engineers and materials scientists, not medical experts like radiologists, as it's a mechanical device performance evaluation, not a diagnostic or treatment outcome evaluation.

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

Not applicable. Adjudication methods like 2+1 or 3+1 refer to agreement among multiple human readers for clinical assessments. This document describes mechanical testing of a physical device.

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 not an AI/software device. It is a physical intervertebral body fusion device.

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

No. This is not an algorithm/software.

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

The "ground truth" for demonstrating the device meets acceptance criteria is based on:

• Engineering Standards: Conformance to ASTM F136 for Ti-6A1-4V-Eli titanium alloy and mechanical testing per ASTM F-2077.
• Comparison to Predicate Devices: Demonstrating that the mechanical performance (dynamic axial compression, axial compressive strength) of the new titanium cages is equivalent to or better than the performance of the previously cleared polymer/carbon fiber composite predicate devices.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable.

Summary of the Study:

The "study" described is a materials and mechanical performance evaluation designed to demonstrate that a new material (titanium alloy) proposed for the CONCORDE Bullet Spinal System cages is substantially equivalent to the previously cleared polymer/carbon fiber composite material used in the predicate devices.

• Acceptance Criteria: Mechanical strength as characterized by dynamic axial compression testing per ASTM F-2077 and axial compressive strength confirmed by finite element analysis, with the benchmark being equivalence or superiority to the predicate device's performance.
• Methodology:
  • Dynamic axial compression testing: Physical samples of the proposed titanium implants were subjected to dynamic axial compression testing according to ASTM F-2077. The results "verified the mechanical strength."
  • Finite Element Analysis (FEA): FEA was used to confirm the axial compressive strength of the titanium material in comparison to the predicate's material.
• Justification for Limited Testing: The document explicitly states that "No other testing was required because the only modification that would affect performance compared to predicate and reference devices... is the material, which is used for the same indications in the predicate DEVEX System (K023835)." This indicates that since the design and intended use are similar, and the new material itself has been used in other cleared devices for similar applications, extensive re-testing beyond mechanical integrity was deemed unnecessary for substantial equivalence.

This is a typical approach for demonstrating substantial equivalence for minor material changes in a physical medical device under a 510(k) pathway, focusing on engineering safety and performance rather than clinical efficacy.

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The CONCORDE, COUGAR, DEVEX, and LEOPARD Systems are indicated for use as intervertebral body fusion devices in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine L2-S1). Patients should have six months of non-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine and are placed via either a PLF (CONCORDE), TLIF (CONCORDE, DEVEX, LEOPARD) or anterior (COUGAR) approach using autogenous bone. When used as interbody fusion devices these implants are intended for use with DePuy Spine supplemental internal fixation.

The CONCORDE, COUGAR, DEVEX, and LEOPARD Systems are indicated for use in the thoracolumbar spine (i.e., T1-L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. These systems are also indicated for treating fractures of the thoracic and lumbar spine. These systems are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal, column even in the absence of fusion fora prolonged period. When used as a vertebral body replacement device these systems are intended for use with DePuy Spine supplemental internal fixation.

The BENGAL System is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one level of the cervical spine with accompanying radicular symptoms. Patients should have six weeks of non-operative treatment prior to surgery. BENGAL implants are used to facilitate fusion in the cervical spine (C2-T1) and are placed via an anterior approach using autogenous bone. When used as an interbody fusion device, DePuy Spine supplemental fixation should be used.

The BENGAL System is indicated for use in the thoracolumbar spine (i.e., T1-L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. This system is also indicated for treating fractures of the thoracic and lumbar spine. This system is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged . period. When used as a vertebral body replacement device this system is intended for use with DePuy Spine supplemental internal fixation.

The VBR Spinal System is indicated for use in the thoracolumbar spine (i.e., T1 to L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The VBR Spinal Systems are also indicated for treating fractures of the thoracic and lumbar spine. The VBR Spinal Systems are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. The VBR Spinal System is intended for use with supplemental internal fixation.

The Concorde VBR Spinal System is indicated for use in the thoracolumbar spine (i.e., T1-L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Concorde VBR Spinal System is also indicated for treating fractures of the thoracic and lumbar spine. The Concorde VBR Spinal System is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. The Concorde VBR Spinal System is intended for use with supplemental internal fixation.

The CONCORDE, CONCORDE Bullet, CONCORDE Curve, COUGAR, DEVEX, and LEOPARD Systems are indicated for use as intervertebral body fusion devices in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (1-2-51). Patients should have six months of non-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine and are placed via either a PLIF (CONCORDE, CONCORDE Bullet), TLIF (CONCORDE, CONCORDE Bullet, CONCORDE Curve, DEVEX, LEOPARD) or anterior (COUGAR) approach using autogenous bone. When used as interbody fusion devices these implants are intended for use with DePuy Spine supplemental internal fixation products.

The CONCORDE, CONCORDE Bullet, CONCORDE Curve, COUGAR,DEVEX, and LEOPARD Systems are indicated for use in the thoracolumbar spine (i.e., T1-1-5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. These systems are also indicated for treating fractures of the thoracic and lumbar spine. These systems are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. When used as a vertebral body replacement device these systems are intended for use with DePuy Spine supplemental internal fixation products.

The DePuy AcroMed VBR System is indicated for use in the thoracolumbar spine (i.e., Tl to L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The DePuy AcroMed VBR System is also indicated for treating fractures of the thoracic and lumbar spine. The DePuy AcroMed VBR System is designed to restore the biomechanical integrity of thie anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. The DePuy AcroMed VBR System is intended for use with supplemental internal fixation.

The COUGAR LS Lateral Cage System is indicated for use in the thoracolumbar spine(i.e., T1 to L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. This system is also indicated for treating fractures of the thoracic and lumbar spine. The system is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. When used as a vertebral body replacement device, this system is intended for use with DePuy Spine supplemental internal fixation. The COUGAR LS Lateral Cage System is also indicated for intervertebral body fusion 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 1 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 implants may be implanted via an open or a minimally invasive lateral approach. When used as an interbody fusion device, this system is intended for use with DePuy Spine supplemental internal fixation.

The Devex Mesh System is indicated for use in the thoracolumbar spine (TI-L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Devex Mesh System is also indicated for treating fractures of the thoracic and lumbar · spine. The Devex Mesh System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period. The Devex Mesh System is intended for use with supplemental internal fixation.

The Stackable Cage System is indicated for use in the thoracolumbar spine (i.e., T1 to L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Stackable Cage System is also indicated for treating fractures of the thoracic and lumbar spine. The Stackable Cage System is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. The Stackable Cage System is intended for use with supplemental internal fixation.

The BENGAL® System is a carbon fiber reinforced polymer (CFRP) interbody fusion and VBR device. The cage distracts and maintains the intervertebral height, as well as providing restoration of cervical lordosis. The range of cages available is based on natural anatomical variation.

The Bengal® Stackable System is a radiolucent, multilevel corpectomy solution that provides a system approach to restoring natural lordosis. The BENGAL® Stackable Cage System offers versatility in footprint options (3 are available), height options (18 to 66 mm increments), and lordotic angle options. The stackable cages (LRG and XLG) are held together by a titanium locking screw and nut. The titanium locking screw is used for all stackable constructs.

The CONCORDE Bullet implants. manufactured from Carbon Fiber Reinforced Polymer (CFRP), are interbody cages designed with a bulleted nose for ease of insertion into the interbody space. The CONCORDE Bullet offers optimized area for bone graft and tantalum markers.

The CONCORDE® Inline Lumbar Interbody System completes the offering within the CONCORDE® family of products with an implant designed to facilitate ease of posterior insertion and improve resistance to migration. The CONCORDE Inline is designed with a bulleted nose for ease of insertion into the interbody space and are manufactured from Carbon Fiber Reinforced Polymer (CFRP).

The COUGAR® System is an Anterior Spinal Implant System manufactured of Carbon Fiber Reinforced Polymer (CFRP). COUGAR® is available in three footprints - Small, Medium and Large and varying heights from 10-20mm. incorporates an anatomic design with 5, 10, 15, and 20 degrees of lordosis. The cages offer tantalum marker beads for radiographic location and orientation of the implant.

The COUGAR® LS Lateral Cage System consists of the PEEK/carbon fiber composite cages (CFRP).Cages are available in parallel or lordotic configurations and are available in various sizes to match patient anatomy. The cage structure is radiolucent with tantalum x-ray wire so that healing can be assessed by normal radiographic methods. The cages have teeth that resist rotation and migration and have cavities to accept packing of autogenous bone graft. The implants may be utilized in either an open or a minimally invasive surgical approach. The implants areplaced using a lateral surgical approach.

The DEVEX® System is indicated for use in the thoracolumbar spine (i.e., T1 to L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The DEVEX® System is also indicated for treating fractures of the thoracic and lumbar spine. The DEVEX® System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period.

The LEOPARD® System is made of carbon fiber reinforced polymer (CFRP) material that has a modulus of elasticity approximating that of cortical bone. The LEOPARD® System meets the structural requirements of anterior column support while optimizing the fusion environment through an open, load-sharing design.

The OCELOT® Stackable Cage System provides anterior column support for single or multi-level corpectomies or total vertebrectomies from T1 to 15. The system consists of one or more PEEK™ Carbon Fiber Polymer cages that are stacked to a desired height, accommodating various patient needs. The PEEK™ Carbon Fiber Reinforced Polymer material emulates the biomechanical properties of human cortical bone, optimizing the likelihood of a sound arthrodesis.

This document describes a 510(k) premarket notification for several spinal intervertebral body fixation orthoses and intervertebral body fusion devices. The core of the submission is the addition of a sterile configuration to previously cleared non-sterile implants.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document explicitly states: "Performance data is not provided in this submission."
Therefore, there are no specific quantified acceptance criteria or reported device performance metrics in this document. The submission relies on demonstrating substantial equivalence to predicate devices.

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

No performance data is provided, so there is no test set or related sample size. The submission's core argument is that the sterile versions of the devices are identical in design, materials, indications, and technology to their non-sterile predicate devices, with the only change being the terminal sterilization via gamma radiation.

Data Provenance: Not applicable as no new performance data was generated for this submission. The devices themselves are spinal implants and would typically be used in patients.

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

Not applicable. As no new performance data was generated, there was no "test set" requiring expert ground truth establishment in the context of this 510(k) submission.

4. Adjudication Method for the Test Set:

Not applicable. No test set requiring adjudication was used.

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

No MRMC study was done. This type of study is typically used for diagnostic or screening devices to assess human reader performance with and without AI assistance. This submission is for spinal implants where the primary comparison relies on material and design equivalence, and the addition of sterilization, rather than interpretive performance.

6. Standalone Performance Study (Algorithm only without human-in-the-loop performance):

No standalone performance study was done. This concept is generally relevant for AI/software algorithms. This submission is for physical medical devices (spinal implants), not an algorithm.

7. Type of Ground Truth Used:

Not applicable. As no new performance data needing ground truth was generated, there's no ground truth specified in the context of this submission. The "truth" being established here is that the new sterile devices are substantially equivalent to the previously cleared non-sterile devices, primarily based on manufacturing changes (sterilization) and material properties remaining unchanged.

8. Sample Size for the Training Set:

Not applicable. This submission does not involve a machine learning algorithm that requires a training set.

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

Not applicable, as there is no training set.

Summary of the Study and "Proof" for this Specific Submission (K140759):

The "study" in this context is a substantial equivalence determination by the FDA, not a clinical or performance study in the traditional sense.

• Acceptance Criteria/Core Argument: The primary acceptance criterion for this 510(k) (K140759) is that the modified devices (sterile versions) are as safe, as effective, and perform as well as their predicate devices (non-sterile versions). This is achieved by demonstrating that the only change is the addition of terminal sterilization via gamma radiation, and that the design, materials, indications for use, and technology remain identical.

• Proof: The submitter "proves" this by:

  • Identifying specific predicate devices for each product line (BENGAL System, OCELOT Stackable Cage System, etc.), all of which were previously cleared by the FDA for similar indications.
  • Stating explicitly that "The subject devices are identical to the predicate devices... except that the subject devices will be terminally sterilized via gamma radiation. The design, materials, indications, and technology remain identical to the predicate systems."
  • Confirming that "The materials of the subject implants remain unchanged from that of the previously cleared implants."
  • Not providing new performance data because the change (sterilization) is considered not to alter the fundamental performance characteristics, relying instead on the established safety and effectiveness of the equivalent, non-sterile predicate devices.

In essence, the submission relies on the established regulatory history and scientific understanding that gamma sterilization, when appropriately validated, does not fundamentally alter the mechanical performance or biological safety of these types of materials/devices in a way that requires new extensive performance testing beyond demonstrating material compatibility and sterility. The FDA's clearance letter confirms their agreement with this assessment by stating that the device is "substantially equivalent."

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The Alamo C is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with the degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment prior to treatment with an intervertebral cage. The device system must be used with supplemental fixation and autograft to facilitate fusion and is to be implanted via an open, anterior approach.

The Alamo C is designed for use as a cervical intervertebral body fusion device. The device is manufactured from PEEK Optima® LT1 per ASTM F2026 and includes tantalum markers per ASTM F560 for radiographic visualization.

The device footprint has a hollow centre to accommodate bone graft to facilitate bone integration and fusion between the end plates from an anterior (ACIF) surgical approach. The device is available in various axial footprints and heights to accommodate variability among patients and the inferior and superior surfaces are designed with ridges to improve fixation and stability and prevent back out and migration.

Here's an analysis of the provided text regarding the Alamo C device, focusing on the requested information:

Summary of Acceptance Criteria and Study Details for Alamo C

The provided text describes a 510(k) submission for the "Alamo C" intervertebral body fusion device. Crucially, this submission is for minor modifications (additional axial footprints) to an already cleared device. Therefore, the "study" described is a mechanical performance study to demonstrate that these modifications do not negatively impact the device's safety and effectiveness compared to the predicate device. This is not a clinical study involving human subjects or AI.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified. The document only mentions "Performance testing" and "mechanical testing." For mechanical testing, this typically refers to a set number of physical samples of the modified device.
• Data Provenance: The data is generated from mechanical testing of the device itself (likely in a lab setting). It is not clinical data from human subjects and thus doesn't have a "country of origin" or "retrospective/prospective" designation in the typical sense for clinical studies.

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

• This question is not applicable as this is a mechanical performance study, not a clinical study that requires expert judgment for ground truth.

4. Adjudication Method for the Test Set

• This question is not applicable for a mechanical performance study.

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

• No, an MRMC comparative effectiveness study was not done. This device is an intervertebral body fusion device, not an imaging or diagnostic AI tool that would typically undergo such a study.

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

• No, this question is not applicable. The Alamo C is a physical medical device (an implant), not an algorithm or AI.

7. The Type of Ground Truth Used

• The "ground truth" for this study is the established performance standards and criteria defined by ASTM F2077 for intervertebral body fusion devices. The device's performance is compared against these pre-defined mechanical requirements.

8. The Sample Size for the Training Set

• This question is not applicable. There is no "training set" as this is a mechanical test of a physical device, not an AI model.

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

• This question is not applicable. There is no ground truth for a training set in this context.

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

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

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

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

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

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

1. Table of Acceptance Criteria and Reported Device Performance

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

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

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

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

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

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

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

4. Adjudication Method for the Test Set

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

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

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

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

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

7. The Type of Ground Truth Used

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

8. The Sample Size for the Training Set

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

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

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

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

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The SynCage Evolution spacer is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion combined with supplemental fixation. The interior of the SynCage Evolution spacer should be packed with autogenous bone graft (i.e. autograft). 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 have had six months of non-operative treatment.

The Synthes SynCage Evolution spacer is a radiolucent device for use in interbody fusion. It is to be used in conjunction with supplemental fixation to provide structural stability in skeletaly mature individuals. The Synthes SynCage Evolution spacer is fabricated from Invibio® PEEK-OPTIMA® LT-1 (ASTM F2026-10) with four anterior and one posterior tantalum (ASTM F560-08) radiopaque markers. The markers allow intra-operative radiographic assessment of the position of the implant. Implantation is through an anterior or anterolateral approach. The Synthes SynCage Evolution spacer is provided sterile. The Synthes SynCage Evolution spacer is available in three footprints (Small: 32x25mm; Medium, 36x28mm; Large, 40x31mm), four lordotic angles (6°, 10°, 14°, 18°), and a range of heights (9-19mm) to suit individual pathology and anatomical conditions. Pyramidal teeth that assist in stabilization of the construct are located on the inferior and superior surfaces of the spacers. The open architecture of the device allows it to be packed with autogenous bone graft material (i.e., autograft).

The provided text describes a 510(k) summary for the Synthes SynCage Evolution Spacer, an intervertebral body fusion device. It details the device's description, intended use, and a comparison to predicate devices, focusing on non-clinical performance data.

Here's an analysis based on your request:

1. Acceptance Criteria and Reported Device Performance

The document does not specify explicit acceptance criteria in terms of numerical thresholds or performance targets for a device meeting clinical or diagnostic accuracy. Instead, it states that the device's performance was evaluated through non-clinical bench testing and compared to predicate devices for substantial equivalence.

Table of Acceptance Criteria and Reported Device Performance (as inferred from the document):

2. Sample Size for the Test Set and Data Provenance

The document explicitly states: "Clinical data and conclusions were not needed for this device."
Therefore, there was no test set of clinical data used to evaluate the device's performance in humans. The evaluation was based solely on non-clinical bench testing.

• Sample Size for Test Set: Not applicable (no clinical test set).
• Data Provenance: Not applicable (no clinical data).

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

As no clinical data was used for evaluation, there was no ground truth established by experts for a test set. The evaluation relied on engineering principles and bench testing standards.

• Number of Experts: Not applicable.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Since no clinical test set was used, there was no adjudication method employed.

• Adjudication Method: Not applicable.

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

No MRMC study was conducted. The document states: "Clinical data and conclusions were not needed for this device."

• MRMC Study: No.
• Effect Size of Human Readers with vs. without AI: Not applicable.

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

This device is an intervertebral fusion spacer, not an algorithm or AI system. Therefore, the concept of "standalone performance" for an algorithm is not applicable. The device's performance was evaluated through bench testing.

• Standalone Study: Not applicable (device is not an algorithm).

7. The Type of Ground Truth Used

For the non-clinical performance evaluation, the "ground truth" was established by standardized engineering testing protocols as defined by ASTM F2077-11 and ASTM F2267-04. The performance was then compared to that of legally marketed predicate devices, implying that their established performance under these tests served as a reference for "substantial equivalence."

• Type of Ground Truth: Bench testing standards (ASTM F2077-11 and ASTM F2267-04) and performance of predicate devices.

8. The Sample Size for the Training Set

This document describes a physical medical device, not an AI or machine learning model. Therefore, the concept of a "training set" is not applicable.

• Sample Size for Training Set: Not applicable.

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

As there is no training set mentioned or implied for this physical device, this question is not applicable.

• How Ground Truth for Training Set Was Established: Not applicable.

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The Mecta-C intervertebral body fusion device is indicated for anterior cervical interbody fusion procedures 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 supplemental spinal fixation.

The Mecta-C device is intended for use at one level in the cervical spine, from C2-T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies). The cervical device is to be used in patients who have had six weeks of non-operative treatment prior to treatment with the device.

The Mecta-C Intervertebral Body Fusion Devices are fusion devices intended for stabilization and to promote bone fusion during the normal healing process following surgical correction of disorders of the cervical spine. The Mecta-C body fusion device is indicated for the treatment of degenerative diseases of the cervical disc and can be used for cervical fusion from C2-T1. The Mecta-C intervertebral body fusion devices consist of a PEEK (Polyetheretherketone) body and tantalum markers. The markers are placed in the implant on each end of the PEEK cages to allow easier radiological assessment of the position and orientation of the radiolucent PEEK cages. The cages are offered in various widths, heights, footprint geometries and lordosis which can be inserted between two cervical vertebra bodies to give support and correction during cervical interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone graft.

The provided text describes a 510(k) premarket notification for the Mecta-C Intervertebral Body Fusion Device. This type of submission relies on demonstrating substantial equivalence to predicate devices, primarily through mechanical performance testing, rather than clinical studies with human participants or AI performance metrics. Therefore, many of the requested criteria related to studies involving AI, human readers, ground truth establishment for clinical data, and specific sample sizes for training/test sets are not applicable to this document.

However, I can extract information related to the performance testing conducted to demonstrate substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

For this device, the "acceptance criteria" are implied by the performance of the predicate devices. The Mecta-C device aims to demonstrate "similar" or "substantially equivalent" mechanical performance according to specific ASTM standards.

Study Proving Device Meets Acceptance Criteria:

The study that proves the device meets the acceptance criteria is a series of mechanical performance tests conducted according to established ASTM standards. These tests compare the Mecta-C Intervertebral Body Fusion Device to identified predicate devices (Vu cPOD and Bengal Cage).

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

• Sample Size for Test Set: The document does not specify the exact number of Mecta-C devices or predicate devices used in each mechanical test. Mechanical testing typically involves multiple samples (e.g., 5-10 per test condition) to ensure statistical significance, but these details are not provided in this 510(k) summary.
• Data Provenance: The data provenance is from mechanical laboratory testing, not human or clinical data. The tests were performed to ASTM standards, which are international standards. The country where the testing took place is not explicitly stated, but Medacta International SA is based in Switzerland and Medacta USA is in California.

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

• Not Applicable. For mechanical testing of medical devices, "ground truth" is established by the physical properties and performance characteristics of the predicate devices and the specifications of the ASTM standards. There are no human experts "establishing ground truth" in the way clinical studies would.

4. Adjudication Method for the Test Set:

• Not Applicable. Adjudication methods (like 2+1, 3+1) are used in clinical studies when there's ambiguity in human interpretation of data. For mechanical tests, the results are quantitative measurements against predefined criteria in the ASTM standards.

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

• No. This is a mechanical device submission, not an AI or imaging diagnostic device. MRMC studies analyze human reader performance, often in conjunction with AI.

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

• No. This refers to AI algorithm performance. This submission is for a physical implantable device.

7. The Type of Ground Truth Used:

• Objective Mechanical Performance Data: The "ground truth" in this context is the quantitative mechanical performance data obtained from testing both the Mecta-C device and the predicate devices according to established ASTM standards (ASTM F2077 for various compression/shear/torsion tests and ASTM F2267 for subsidence). The FDA's acceptance of "substantial equivalence" relies on the Mecta-C device's performance falling within acceptable limits relative to these predicate devices.

8. The Sample Size for the Training Set:

• Not Applicable. There is no "training set" in the context of mechanical performance testing for substantial equivalence. This concept applies to machine learning algorithms.

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

• Not Applicable. See point 8.

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The ANATOMIC PEEK CERVICAL FUSION SYSTEM is indicated for cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. This device is to be used in patients who have had six weeks of non-operative treatment. The ANATOMIC® PEEK™ device is to be used with supplemental fixation. The ANATOMIC PEEK CERVICAL FUSION SYSTEM is also required to be used with autogenous bone graft and is to be implanted via an open, anterior approach.

The ANATOMIC PEEK™ CERVICAL FUSION SYSTEM is designed for use as a cervical interbody fusion device. The device is manufactured from PEEK™ OPTIMA™ and is to be used with autogenous bone graft. The ANATOMIC PEEK™ CERVICAL FUSION SYSTEM consists hemicylindrical of cages of various widths, heights and depths. The hollow geometry of the implants allows them to be inserted between two cervical vertebral bodies packed with autogenous bone graft in cervical fusion procedures. The ANATOMIC PEEK™ device is to be used with cleared cervical supplemental fixation.

The provided text describes a 510(k) premarket notification for the "ANATOMIC PEEK™ CERVICAL FUSION SYSTEM" and does not contain information about a study proving the device meets acceptance criteria in the context of a software or AI-based medical device. Instead, it details non-clinical testing performed on the physical device to demonstrate substantial equivalence to predicate devices.

Therefore, many of the requested categories in your prompt are not applicable to the provided document. I will fill in the information that is present and indicate where information is not available or not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria were based on established ASTM standards: ASTM F2077-03, ASTM F2267-04, and ASTM F-04.25.02.02 (Draft Static Push-out Test Method). The specific numerical thresholds for acceptance are not detailed in this document but are implied to be part of these standards.

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

This information is not applicable as the document describes non-clinical physical device testing (mechanical characteristics) rather than testing related to AI/software performance or human subject data.

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

This information is not applicable. The "ground truth" for the physical device performance was established by the technical specifications outlined in the ASTM standards for mechanical testing.

4. Adjudication Method for the Test Set

This information is not applicable. The mechanical tests would have objective pass/fail criteria based on measured physical properties, rather than expert adjudication.

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

This information is not applicable. No MRMC study was conducted or is relevant for this type of physical device submission.

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

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

7. The Type of Ground Truth Used

The ground truth was based on pre-defined mechanical performance specifications as outlined by the standards ASTM F2077-03, ASTM F2267-04, and ASTM F-04.25.02.02. This is a form of engineering or objective performance metrics, not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

This information is not applicable. This is a physical device, and there is no "training set" in the context of machine learning.

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

This information is not applicable. As there is no training set for a physical device, no ground truth was established for it.

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The CORNERSTONE® PSR Cervical device is indicated for cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. This device is to be used in patients who have had six weeks of nonoperative treatment. The CORNERSTONE® PSR device is to be used with supplemental fixation. The CORNERSTONE® PSR device is also required to be used with autograft.

The CORNERSTONE® PSR Cervical Fusion System consists of spacers which can be inserted between two cervical vertebral bodies to give support and correction until fusion occurs. The hollow geometry of the implant allows it to be packed with autogeneous bone graft. The CORNERSTONE® PSR Cervical Fusion System also includes instrumentation that enables the surgeon to implant the devices via an open, anterior approach. The device sizes are available in various heights and in a 4º lordotic angle option. The implant devices are manufactured from medical grade polyetheretherketone (PEEK -OPTIMA® LT1) per ASTM F2026 and also contain either tantalum markers per ASTM F-560 or titanium alloy markers per ASTM F-136 so that the position of the implant can be determined on X-ray or other imaging.

This document is a 510(k) summary for the CORNERSTONE® PSR Cervical Fusion System, which is an intervertebral body fusion device. It describes the product, its indications for use, and how it demonstrates substantial equivalence to legally marketed predicate devices.

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

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

Study Proving Acceptance Criteria:

The document states: "The following pre-clinical studies were conducted using worst case CORNERSTONE® PSR devices: static and dynamic compression, static and dynamic torsion, static and dynamic compression shear per ASTM F2077-03; subsidence per ASTM F2267-04; and expulsion. The results of these studies were found to be substantially equivalent to legally marketed devices."

The study described is a series of pre-clinical mechanical and physical performance tests designed to demonstrate that the CORNERSTONE® PSR system performs similarly to existing, legally marketed predicate devices. The basis of acceptance in a 510(k) submission is showing "substantial equivalence" to a predicate device, meaning it is as safe and effective.

The remaining information requested is not available in the provided text, as this is a 510(k) summary for a medical device (an intervertebral fusion device), not an AI/software device. The questions are specifically tailored for AI/ML performance evaluations and thus do not apply to this type of regulatory submission.

Therefore, for questions 2 through 9, the answer is: This information is not applicable or not provided in the context of a 510(k) summary for this type of medical device. The document focuses on demonstrating substantial equivalence through pre-clinical mechanical testing and material compatibility, not on human-AI interaction or algorithm performance on a test set.

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When used as a cervical intervertebral body fusion device, the Aleutian implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. Cervical IBF implants are intended for use at one level in the cervical spine, from C2 to T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is intended to be used in patients who have had six weeks of non-operative treatment.

When used as a lumbar intervertebral body fusion device, the Aleutian implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. The lumbar IBF implants 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 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 intended to be used in patients who have had six months of non-operative treatment.

When used as vertebral body replacement devices the Aleutian implants are indicated for use in the thoracolumbar spine (T1 to L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body, resected or excised for the treatment of tumors or trauma/fracture in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Aleutian implants are designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period.

For all the above indications the Aleutian implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including K2M Pedicle Screw and Hook Systems, and K2M Spinal Plate Systems.

The Aleutian IBF System consists of a hollow tube or horseshoe-shaped structures manufactured from Medical Grade PEEK (Polyetheretherketone). The devices are available in a variety of different sizes and heights to match more closely the patient's anatomy. The implants have machined teeth which are designed to engage with the vertebral body end plates.

Materials: The devices are manufactured from Medical Grade PEEK (Polyetheretherketone) OPTIMA® LT1 (Invibio™) per ISO 10993-1 USP Class VI and ASTM F2026. Tantalum beads /rods to be Grade UNS R05200, UNS R05400 according to ASTM F560.

Function: The system functions as an intervertebral body fusion device to provide support and stabilization of the cervical and lumbar segments of the spine.

The provided text describes a 510(k) summary for the Aleutian IBF System, which is an intervertebral body fusion device. The focus of the document is on establishing substantial equivalence to previously cleared predicate devices, primarily through comparison of technological characteristics and preclinical testing.

Based on the information provided, here's an analysis of the acceptance criteria and study as requested:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not applicable. This submission relies on preclinical testing (Finite Element Analysis and static mechanical testing) and comparison to predicate devices, not clinical patient data with a test set.
• Data Provenance: Not applicable in terms of country of origin or retrospective/prospective human data. The testing described is preclinical engineering analysis and mechanical testing.

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

• Not applicable. As a preclinical mechanical evaluation, there's no "ground truth" derived from expert clinical interpretation of data in the way one would for diagnostic imaging. Expertise in biomechanical engineering and material science would have been involved in the design and interpretation of the Finite Element Analysis and mechanical testing.

4. Adjudication Method for the Test Set

• Not applicable. There is no clinical test set requiring adjudication in this submission.

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. This type of study is relevant for diagnostic devices (e.g., AI in radiology) comparing human performance with and without AI assistance. This document is for an intervertebral body fusion device, which is a physical implant.

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

• No, a standalone (algorithm only) performance study was not done. This concept is applicable to software or AI algorithms. The device is a physical medical implant.

7. The Type of Ground Truth Used

• For the preclinical testing mentioned (Finite Element Analysis and static compression/torsion), the "ground truth" refers to established engineering principles, material properties (e.g., ASTM F2077 standards for spinal implants), and the performance characteristics of the predicate devices. The aim was to demonstrate that the new device components do not introduce new safety or effectiveness concerns compared to these established benchmarks.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/ML device, so there is no "training set."

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

• Not applicable. As there is no training set, there is no corresponding ground truth to establish for it.

In summary: The provided document is a 510(k) summary for a physical medical implant, the Aleutian IBF System. The "study" described is a preclinical engineering evaluation consisting of Finite Element Analysis validated by static compression and torsion testing. Acceptance criteria revolve around demonstrating substantial equivalence in technological characteristics (materials, design, mechanical performance) and intended use to existing legally marketed predicate devices, rather than clinical performance metrics in a patient population or AI model performance.

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The Stryker Spine AVS® Anchor-C Cervical Cage System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. The AVS® Anchor-C Cervical Cage is to be used with autogenous bone graft and implanted via an open, anterior approach.

The AVS® Anchor-C Cervical Cage must be used with the internal screw fixation provided by AVS® Anchor-C Fixation Screws. This cervical device is to be used in patients who have had six weeks of non-operative treatment.

The AVS® Anchor-C Cervical Cage is a hollow, rectangular-shaped PEEK Optima® LT1 (per ASTM F2026) cage assembled to a titanium alloy Ti6Al4V (per ASTM F136 and ISO 5832-3) plate and has one tantalum marker (per ASTM F560). It is intended for use as an interbody fusion device and is offered in a variety of heights, footprints, and lordotic angles to adapt to varying patient anatomies. The PEEK Optima® LTI cage portion consists of one closed pocket for graft containment and has serrations on the superior and inferior surfaces of the cage. The implant is designed to be used exclusively with the internal supplemental fixation provided (AVS® Anchor-C Fixation Screws). The AVS® Anchor-C Fixation Screws are constructed from titanium alloy Ti6Al4V (per ASTM F136 and ISO 5832-3) and possess clips (also constructed from titanium alloy Ti6Al4V per ASTM F136 and ISO 5832-3) that mate with internal features located within the AVS® Anchor-C Cervical Cage. Once fully seated into the holes, the screws are designed to lock into the titanium plate.

The provided document describes the Stryker Spine AVS® Anchor-C Cervical Cage System, a medical device. It focuses on the mechanical testing performed to demonstrate substantial equivalence to predicate devices, rather than the performance of an AI system. Therefore, many of the requested fields regarding AI system performance, ground truth, and expert evaluation are not applicable or cannot be extracted from this document.

Here's an analysis of the available information:

Acceptance Criteria and 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® Anchor-C implant system and demonstrated substantially equivalent performance to the identified predicate device systems."

The acceptance criteria are implicitly defined by the successful demonstration of "substantially equivalent performance" to predicate devices based on the mechanical tests listed. The document does not provide specific numerical acceptance thresholds or reported performance values for the device itself. Instead, it indicates that the device met the criteria by performing comparably to already approved devices.

Table of Acceptance Criteria and Reported Device Performance:

Additional Requested Information:

2. Sample size used for the test set and the data provenance:

• Sample Size: The document does not specify the sample size for each mechanical test. Mechanical tests typically use a small number of physical samples (e.g., 3-6) per test condition to represent the device.
• Data Provenance: The data is from mechanical testing of the device, performed in compliance with FDA guidance. The country of origin of the data is not specified but is implicitly associated with the manufacturer (Stryker Spine, located in New Jersey, USA). The data is prospective, generated specifically for this 510(k) submission.

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

• Not Applicable. This device is a physical implant, and the "ground truth" for mechanical testing is based on the physical properties and performance measured against established engineering standards (ASTM and ISO). There are no human "experts" establishing ground truth in the context of diagnostic interpretation for this type of submission.

4. Adjudication method for the test set:

• Not Applicable. As this is mechanical testing of a physical device, there is no adjudication method in the context of human interpretation or AI output. The evaluation is based on engineering measurements and comparisons to predicate device performance.

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-enabled device or a diagnostic imaging device requiring human reader studies.

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

• Not Applicable. This is a physical medical implant, not an algorithm or AI system.

7. The type of ground truth used:

• For the mechanical tests, the "ground truth" is defined by the objective measurements obtained from the various tests (e.g., compression strength, shear strength, expulsion resistance) and their comparison to the performance of predicate devices as per the relevant ASTM and ISO standards and FDA guidance.

8. The sample size for the training set:

• Not Applicable. This is a physical medical implant. There is no training set in the context of machine learning or AI.

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

• Not Applicable. As there is no training set, this question is not relevant.

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