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The Camber Spine Technologies SPIRA™ Open Matrix ALIF is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment with the devices. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Camber Spine Technologies SPIRA™ Open Matrix ALIF is intended to be used with additional FDA-cleared supplementary fixation systems.

The Camber Spine Technologies SPIRA™ Open Matrix ALIF system must be used with autogenous graft material.

The Camber Spine Technologies SPIRA Open Matrix ALIF is an Interbody Fusion Device that has spiral support arches to allow for a hollow chamber to permit packing with autogenous bone to facilitate fusion. The superior and inferior surfaces of the device have a rough surface to help prevent movement of the device while fusion takes place.

The provided text describes the regulatory clearance of a medical device, the SPIRA™ Open Matrix ALIF intervertebral body fusion device, based on substantial equivalence to predicate devices, rather than a clinical study evaluating its performance with human readers and AI assistance. Therefore, most of the requested information regarding acceptance criteria for AI performance in a clinical setting (e.g., sample size for test sets, experts for ground truth, MRMC studies, standalone performance) is not applicable to this document.

However, the document does contain information about the mechanical performance testing of the device for regulatory purposes. I can extract and present the relevant information that is available:

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

The document does not provide a specific table of acceptance criteria with numerical values and reported device performance. Instead, it states the following regarding mechanical testing against predicate devices:

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

The document does not specify the sample size for the "test set" in terms of mechanical testing, nor does it detail the provenance of the data (e.g., country of origin, retrospective or prospective). Mechanical testing typically uses a certain number of identical physical devices for each test, but this information is not explicitly provided in the summary.

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

This question is not applicable as the "ground truth" here pertains to mechanical properties of the device, not a diagnosis or interpretation requiring human expert readers.

4. Adjudication method for the test set

Not applicable, as this refers to human expert review for establishing ground truth, not mechanical testing.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, an MRMC study was not done. This device is an implantable medical device, and the evaluation for its 510(k) clearance focused on demonstrating substantial equivalence in design, materials, function, manufacturing, and mechanical performance to existing predicate devices, not on a comparative effectiveness study involving human readers and AI assistance.

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

Not applicable. This is not an AI diagnostic or assistive device. "Standalone performance" would refer to the mechanical performance of the device itself, which was indeed tested.

7. The type of ground truth used

For the mechanical performance testing, the "ground truth" was established by standardized laboratory testing protocols (ASTM F2077-14 and F2267-04) and comparison to the performance of existing, legally marketed predicate devices.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of this device's regulatory submission, as it is not an AI/ML algorithm.

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

Not applicable, as there is no training set mentioned in the context of this device.

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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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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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