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The Testa™ TP Pivoting Spacer System with TiCell® Nano Advanced Surface Technology is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Testa™ TP Pivoting Spacer System is to be used with autograft bone and/or allogenic bone graft composed of cortical, cancellous, and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. The Testa™ TP Pivoting Spacer System is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral body fusion device.

The Testa™ TP Pivoting Spacer System consists of new interbody implants that are provided sterile and intended to be surgically implanted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar intervertebral body fusion. The system is provided in a range of sizes to accommodate the anatomic needs for range of patients and is designed with a central graft window to accommodate graft material. The implant features TiCell® Nano Advanced Surface Technology, a proprietary etched surface with micro and nano-scale features, on the superior and inferior latticed surfaces. This is intended to help with resistance to migration and to facilitate fusion. The components of the implant are fabricated from Titanium-6 Aluminum-4 Vanadium ELI (Ti-6Al-4V ELI) conforming to ASTM F3001 and ASTM F136.

The provided document, an FDA 510(k) Clearance Letter for the Testa TP Pivoting Spacer System, does not contain information regarding an AI/ML-based device. Instead, it describes a traditional medical device: an intervertebral body fusion device.

Therefore, many of the requests in your prompt, which are specific to the regulatory approval process for AI/ML medical devices (such as acceptance criteria for AI performance, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone AI performance, and AI ground truth establishment), cannot be answered from this document.

The document states: "Nonclinical testing was performed on the Testa™ TP Pivoting Spacer System to support substantial equivalence to the predicate device. The following testing was performed: Static and dynamic axial compression testing per ASTM F2077, Static and dynamic compression shear testing per ASTM F2077, Subsidence testing per ASTM F2267, Particulate and wear analysis per ASTM F1877. Clinical testing is not applicable." This indicates that the device was evaluated through bench testing and mechanical performance standards, not through AI/ML performance metrics or studies involving human readers or expert consensus on AI outputs.

Summary based on the provided document:

Since the device is a physical medical implant (intervertebral body fusion device) and not an AI/ML software, the requested information on AI-specific acceptance criteria and study methods is not applicable and is not present in the provided FDA 510(k) clearance letter. The document focuses on demonstrating physical and mechanical substantial equivalence to predicate devices through non-clinical bench testing.

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