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The RESOLUTE Threaded Cage System is intended to be used bilaterally for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). It is to be used in patients who have had at least six months of non-operative treatment.

The Resolute Threaded Cage System intended to be used with autograft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and a supplemental internal spinal fixation system (e.g., pedicle screw or anterolateral plating system) that is cleared for use in the lumbosacral spine.

The Resolute Threaded Cage System implants are devices intended to serve as an intervertebral body fusion device. The implant is available in a range of diameters and lengths to suit the individual pathology and anatomical conditions of the patient. It is fabricated and manufactured from titanium alloy (Ti-6Al-4V ELI) described by ASTM F136. The implant is hollow to permit packing with autograft bone graft and/or allogeneic composed of cancellous and/or corticocancellous bone and a supplemental fixation system (e.g., pedicle screw or anterolateral plating system) that is cleared for use in the lumbosacral spine to help promote intervertebral body fusion. The cylindrical surface has threads to assist in the interface with the vertebral endplates to prevent migration.

All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the Resolute Threaded Cage System components with components from any other system or manufacturer. The Resolute Threaded Cage System components should never be reused under any circumstances

The provided document is a 510(k) premarket notification summary for the Life Spine Resolute™ Threaded Cage System. This type of submission is for medical devices and focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing clinical performance data or acceptance criteria related to an AI/algorithm-based device.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, specifically concerning AI/algorithm performance. The "performance data" section refers to mechanical testing of the implant itself, not to the performance of any AI or algorithm.

To explicitly address the numbered points in the request:

1. A table of acceptance criteria and the reported device performance: Not applicable. The document discusses mechanical testing of the physical implant (Static Axial Compression, Static Axial Compression Shear, Dynamic Compression Shear & Dynamic Axial Compression testing) to demonstrate substantial equivalence to predicate devices, not performance against specific AI/algorithm acceptance criteria.

2. Sample sized used for the test set and the data provenance: Not applicable. No test set for an AI/algorithm is mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth for an AI/algorithm test set is mentioned.

4. Adjudication method for the test set: Not applicable. No test set for an AI/algorithm is mentioned.

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: Not applicable. This document is about a physical medical implant, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This document is about a physical medical implant.

7. The type of ground truth used: Not applicable. No ground truth for an AI/algorithm is mentioned.

8. The sample size for the training set: Not applicable. No training set for an AI/algorithm is mentioned.

9. How the ground truth for the training set was established: Not applicable. No training set for an AI/algorithm is mentioned.

In summary, the provided FDA 510(k) clearance letter and summary pertain to the physical characteristics and mechanical performance of an intervertebral body fusion device and do not involve an AI or algorithm. Therefore, the requested information about AI acceptance criteria and study details cannot be extracted from this document.

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