Search Results

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.

Ask a specific question about this device

The Solus Anterior Lumbar Interbody Fusion (ALIF) System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1 with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). 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 Solus implant is intended to be used with autograft. The device is intended for use with supplemental fixation that is in addition to the integrated blades.

The Solus Anterior Lumbar Interbody Fusion (ALIF) System is an intervertebral body fusion system for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1 with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The Solus System consists of implants with various sizes and heights available in 7º or 12º lordosis to accommodate individual patient pathology. The implants are manufactured from polyetheretherkeytone (PEEK Optima LT)) material conforming to ASTM F2026 and tantalum radiographic markers (ASTM F560) with internal anchoring blades of titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136.

The provided text describes the Solus Anterior Lumbar Interbody Fusion (ALIF) System, a medical device for spinal fusion. The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices, primarily through mechanical performance testing.

Here's an analysis of the provided information, specifically addressing the requested fields:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state numerical sample sizes for each mechanical test performed. For instance, it mentions "cadaveric fatigue testing" but doesn't specify the number of cadavers or specimens used. The provenance of the test data (e.g., country of origin, retrospective or prospective) is also not specified, though it would typically be internal testing by the manufacturer or contracted labs.

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

This information is not applicable and is not provided in the document. The "ground truth" for this type of device (spinal implant) is established through standardized mechanical testing according to ASTM standards, not through expert consensus on medical images or patient outcomes in the same way an AI diagnostic device would.

4. Adjudication Method for the Test Set

This is not applicable as the "ground truth" is established through engineering and mechanical testing, not through human interpretation requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices where human readers (e.g., radiologists) interpret images with and without AI assistance. The Solus ALIF System is a physical implant, and its performance is assessed through mechanical testing.

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

This is not applicable. The Solus ALIF System is a physical medical device, not an algorithm. Its "standalone performance" refers to its mechanical integrity and function as tested in a laboratory setting.

7. The Type of Ground Truth Used

The "ground truth" for the Solus ALIF System's performance is established through standardized mechanical testing. This includes:

• Physical testing according to ASTM standards (e.g., ASTM 2077-03 for axial compression, dynamic compression; ASTM 2267 for subsidence; draft standard ASTM F-04.25.02.02 for static push-out).
• Cadaveric fatigue testing.
• Finite Element Analysis (FEA) for the blade/vertebral body interface.

The performance is then compared to predicate devices to demonstrate substantial equivalence, implying that the established "ground truth" for the predicate devices (which have been deemed safe and effective) serves as the benchmark.

8. The Sample Size for the Training Set

This is not applicable. The Solus ALIF System is a physical medical device, not an AI or machine learning model that requires a "training set."

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

This is not applicable, as there is no "training set" for this type of device.

Ask a specific question about this device