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The Halis™ Lumbar Cage System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S 1 whose condition requires use of interbody fusion combined with supplemental fixation. These DDD patients may also have up to Grade 1 Spondylolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients should have had six months of non-operative treatment prior to surgery. The Halis™ Lumbar Cage System is intended to be used with autogenous bone graft comprised of cancellous and/or corticocancellous bone graft. The devices are intended to be used with supplemental fixation. The devices may be implanted through several surgical approaches: transforaminal, posterior, oblique, and direct lateral. When implanted through the direct lateral approach, the Halis™ Lumbar Cage System is only indicated for use in levels L2-L5.

The Caro™ Cervical Cage System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These patients should have had six weeks of non-operative treatment prior to surgery. Caro™ Cervical Cage System implants are placed via an anterior approach and is to be used with autogenous bone graft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The devices are intended to be used with supplemental fixation.

The Lydia™ Anterior Lumbar Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as discogence back pain 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. These implanted via a laparoscopic or an open anterior approach. The devices are intended to be used with supplemental fixation. This device is not intended for cervical spine use.

The Dica™ Direction Changeable Lumbar Cage System is indicated for interbody fusion with autogenous bone graft in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients should have six months of non-operative treatment prior to surgery. The devices are intended to be used with supplemental fixation.

The Shanghai Sanyou PEEK Cage System consists of four different models of fusion devices:

• Caro™ Cervical Cage System
• Halis™ Lumbar Cage System
• Lydia™ Anterior Lumbar Fusion System
• . Dica™ Direction Changeable Lumbar Cage System

All components are made of polyetheretherketone (PEEK). All fusion devices are intended for stabilization use and to promote bone fusion during the normal healing process following surgical correction of disorders of the cervical or lumbar spine. These Fusion Devices consist of PEEK cages of various heights, widths and lengths, which can be inserted between two lumbar or cervical vertebral bodies to give support and correction during intervertebral body fusion surgeries. All components have serrations on the superior and inferior surfaces of the implant to aid in fixation. The hollow geometry of the implants allows them to be packed with allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.

Radiopaque Markers manufactured from unalloyed tantalum have been embedded within the implant to allow for visualization in radiographic images. Associated instruments are available to facilitate the implantation of device.

The provided document is a 510(k) premarket notification from the FDA for the Shanghai Sanyou PEEK Cage System. This document focuses on demonstrating substantial equivalence of a new medical device to existing predicate devices, rather than proving a device meets specific acceptance criteria through a clinical study or AI performance evaluation.

Therefore, the information you've requested regarding acceptance criteria, study details (sample size, data provenance, expert adjudication, MRMC studies, standalone performance), and ground truth establishment is not typically found in this type of regulatory submission for a PEEK cage system.

A 510(k) submission for an intervertebral body fusion device primarily relies on non-clinical performance testing to demonstrate that the new device is as safe and effective as a legally marketed predicate device.

Here's what can be extracted and what cannot be from the provided text:

1. A table of acceptance criteria and the reported device performance:

• Acceptance Criteria: Not explicitly stated as pass/fail thresholds for clinical endpoints, but rather compliance with recognized standards. The acceptance criteria essentially boil down to meeting or exceeding the performance of predicate devices in mechanical testing and adherence to relevant ASTM standards.
• Reported Device Performance:
  • Mechanical Testing: Static and dynamic axial compression, static shear compression, static torsion.
  • Subsidence Testing: Completed according to ASTM F2267-04.
  • Overall Conclusion: "Performance testing demonstrates that the subject device meets or exceeds performance of predicate devices demonstrating that the subject devices are substantially equivalent to the predicate devices."

This is how the performance is generally reported in this context, focusing on equivalence rather than specific performance metrics against a defined standard (e.g., 90% accuracy, 0.9 AUC).

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Not Applicable. This document describes mechanical performance testing of the device itself, not clinical testing on human subjects with a test set of data. The "test set" would be the physical devices subjected to the mechanical tests.
• Data Provenance: Not applicable for a clinical study, but the manufacturing facilities are in Shanghai, China.

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):

• Not Applicable. No human experts were used for adjudication of a ground truth for a clinical dataset. The "ground truth" here is established by the relevant ASTM standards for mechanical properties.

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

• Not Applicable. There's no adjudication method described as it refers to mechanical testing by standard protocols, not expert consensus on clinical data.

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 is a physical medical device (PEEK cage), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies are irrelevant to this submission.

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

• Not Applicable. This is a physical medical device, not an algorithm.

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

• For the performance testing, the "ground truth" is defined by the ASTM standards (ASTM F2077-14 for mechanical tests and ASTM F2267-04 for subsidence testing) and the established performance characteristics of the legally marketed predicate devices. The device is considered to meet acceptance criteria if its mechanical properties meet or exceed those of the predicates and comply with the specified ASTM standards.

8. The sample size for the training set:

• Not Applicable. There is no "training set" as this is not an AI/machine learning device. The "training" for the device's design and manufacturing implicitly comes from engineering principles, material science, and the design history of similar predicate devices.

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

• Not Applicable. As there's no training set in the context of AI, there's no ground truth establishment for it. The standards and predicate device characteristics guide the design and testing process, but not in the sense of a "training set" ground truth.

In summary, the provided document is a regulatory submission for a physical implantable device (intervertebral body fusion cage), not an AI/software as a medical device. The "acceptance criteria" and "study" are described in terms of compliance with regulatory standards and mechanical performance testing demonstrating substantial equivalence to predicate devices, rather than clinical efficacy studies on patient data or AI algorithm performance tests.

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