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SPIRA Open Matrix ALIF: 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 radios. Patients should have received 6 months of nonoperative treatment prior to 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 bone graft or allogenic bone graft composed of cancellous and/or corticocancellous bone graft.

SPIRA Open Matrix LLIF: The Camber Spine Technologies SPIRA Open Matrix LLIF 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 radios. Patients should have received 6 months of nonoperative treatment prior to 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 LLF is intended to be used with additional FDA-cleared supplementary fixation systems. The Camber Spine Technologies SPIRA Open Matrix LLIF system must be used with autogenous bone graft or allogenic bone graft composed of cancellous and/or corticocancellous bone graft.

SPIRA Open Matrix ALIF is an interbody fusion device with an open matrix design consisting primarily of arched support members to permit bone growth (i.e., interbody fusion) throughout the implant, SPIRA Open Matrix ALIF. With the exception of the perimeter, all surfaces have a roughened texture to help prevent movement of the device.

SPIRA Open Matrix LLIF is an interbody fusion device with an open matrix design consisting primarily of spiral support members to permit bone growth (i.e., interbody fusion) throughout the implant, SPIRA-L Open Matrix LLIF.

The purpose of this submission is the addition of the allogenic bone graft indication to both SPIRA ALIF and SPIRA LLIF devices that have been cleared under K162986 and K180724 respectively.

The provided text is a 510(k) summary for a medical device (SPIRA Open Matrix ALIF and LLIF) and does NOT contain information about acceptance criteria or a study proving that a device meets those criteria, particularly in the context of an AI/algorithm-driven device.

The document describes the device, its indications for use, and a comparison to predicate devices for substantial equivalence. It briefly mentions "Performance Data" but this refers to a Finite Element Analysis (FEA) performed to evaluate the effects of design changes on the implant, not an AI or algorithm's performance against clinical endpoints or ground truth.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them based on the provided text, as this information is not present. The questions you posed are typically relevant for AI/ML-driven medical devices, which this submission is not.

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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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