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The Camber Spine Alcantara Thoracolumbar Plate System 2, 3 and 4-screw plates are indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of the thoracic and thoracolumbar (T1-L5) spine or via an anterior approach below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine. The system is intended to provide additional support during fusion in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities: Degenerative Disc Disease (defined as back pain of discogenic origin with deqeneration of the disc confirmed by patient history and radioaraphic studies): Pseudoarthrosis: Spondylolisthesis: Spinal stenosis: Tumors; Trauma (i.e. Fractures including dislocation and subluxation) Deformities (i.e. Scoliosis, Kyphosis or Lordosis); Failed Previous Fusion.

The Camber Spine Alcantara Thoracolumbar Plate System Buttress Plate is intended to stabilize the allograft or autograft at one level (T1-S1) as an aid to spinal fusion and to provide temporary stabilization and augment of a solid spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials. This device is not intended for load bearing applications.

The Camber Spine Alcantara Thoracolumbar Plate System is an anterior/ anterolateral/ lateral plate system that may be used in the thoracic, lumbar, and sacral spine (T1-S1). The Camber Spine Alcantara Thoracolumbar Plate System consists of plates that include bone screw holes and blocking mechanisms to prevent screw back-out, and bone screws, as well as associated manual general surgical instrumentation. The implants are available in a variety of sizes to accommodate various patient anatomies. All Alcantara Thoracolumbar plates and screws are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136.

The provided text does not describe an AI/ML powered device, but rather a thoracolumbar plate system. Therefore, an analysis of acceptance criteria and study details related to AI/ML device performance is not applicable. The text focuses on the mechanical performance and substantial equivalence of the Alcantara Thoracolumbar Plate System to predicate devices.

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The Camber Sacroiliac (SI) Fixation System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis. When the Camber SI Fixation System is implanted, it must be used with a SICONUS SI Joint Fixation System screw implanted across the same sacroiliac joint.

The Camber SI Fixation System is a fusion device consisting primarily of an open architecture 3D generated titanium body to permit bone growth (fusion) throughout the implant. All internal surfaces have a roughened texture. The upper and lower faces have specifically designed surface approximately 0.5 mm thick to provide a trabecular support structure. In addition, the device utilizes a set of two sharpened anchor plates that translate from within the device in slightly angular opposing lateral directions which provide an anchoring system to fixate the implant between ilium and sacrum. The Camber SI Fixation System device has one footprint: 23x26 mm. Implant heights range from 9 to 13mm in 2 mm increments with 8° angulation.

This document is a 510(k) summary for a medical device (Camber Sacroiliac (SI) Fixation System), not a study analyzing AI performance. Therefore, most of the requested information about acceptance criteria, study design, and AI performance metrics is not applicable.

However, I can extract the relevant information regarding the performance testing of the device itself and how it meets acceptance criteria based on predicate devices.

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)

This information is not provided in the given document. The document states "Testing performed indicate that the Camber SI Fixation System is as mechanically sound as the cleared devices," but does not detail the specific sample sizes for mechanical testing or cadaveric/usability testing.

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)

This information is not applicable as this document describes mechanical and cadaveric testing for a physical implant, not an AI or diagnostic device that requires expert-established ground truth.

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

This information is not applicable for mechanical or cadaveric testing of a physical implant.

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

This information is not applicable as this document describes a physical medical device (sacroiliac joint fixation system), not an AI-powered diagnostic or assistive tool for human readers.

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

This information is not applicable as this document describes a physical medical device, not an algorithm.

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

For the mechanical testing, the "ground truth" or benchmark was established by the performance of the predicate devices. For cadaveric and usability testing, the "ground truth" would be related to anatomical feasibility, surgical ease of use, and stabilization, which is typically assessed by surgeons or technical experts during the testing process. The document does not specify the exact methods or criteria for "ground truth" in these non-mechanical tests beyond indicating they were performed to establish substantial equivalence.

8. The sample size for the training set

This information is not applicable as this document describes a physical medical device and its mechanical testing, not a machine learning model that requires a training set.

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

This information is not applicable as this document describes a physical medical device and its mechanical testing, not a machine learning model.

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SPIRA®-P Posterior Lumbar Spacers are lumbar interbody fusion devices 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 prior to treatment with the device must be used with autogenous bone graft or allogenic bone graft composed of cancellous and/or corticocancellous bone graft. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The SPIRA®-P Posterior Lumbar Spacers are intended to be used with additional FDA-cleared supplementary fixation systems.

SPIRA®-T Oblique Posterior Lumbar interbody fusion devices 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. The device must be used with autogenous bone graft or allogenic bone graft composed of cancellous and/or corticocancellous bone graft. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The SPIRA®-T Oblique Posterior Lumbar Spacers are intended to be used with additional FDA-cleared supplementary fixation systems.

SPIRA Posterior Lumbar Spacers (SPIRA-P Open Matrix PLIF, SPIRA-T Oblique Open Matrix TLIF) are lumbar interbody fusion devices used to provide structural stability following discectomy. SPIRA Posterior Lumbar Spacers have different shapes to accommodate posterior and transforaminal approaches.

The provided text describes a 510(k) premarket notification for SPIRA®-T Oblique Posterior Lumbar Spacers and SPIRA®-P Posterior Lumbar Spacers. This is a submission to demonstrate substantial equivalence to previously cleared devices, not a study evaluating an AI/ML-based device. Therefore, the detailed information typically requested for AI/ML device performance (e.g., sample size for test sets, number of experts for ground truth, MRMC studies, standalone performance, training set details) is not applicable to this document.

The document discusses mechanical performance testing of intervertebral body fusion devices, not the diagnostic performance of an imaging AI.

Here's the information that can be extracted regarding the acceptance criteria and proof of mechanical performance for this physical device:

Acceptance Criteria and Device Performance (Mechanical Testing)

The study described in this document is a series of mechanical performance tests, not a clinical study involving human readers or an AI algorithm.

Therefore, most of the specific questions regarding AI/ML device performance metrics (sample size for test set, data provenance, ground truth establishment, MRMC studies, standalone performance, training set details) are not relevant or answerable from the provided text, as the device is a physical medical implant, not a software device.

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