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When used as a nonpedicle, noncervical posterior system, the ORIA Spinal Clip System is indicated for: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); (2) spondylolisthesis; (3) fracture; (4) spinal stenosis; (5) deformities (i.e., scoliosis, kyphosis, lordosis), (5) tumor, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.

ORIA Spinal Clip System is indicated for skeletally mature patients: (1) having severe spondylolisthesis (Grades 3 and 4) at L5-S1 joint; (2) who are receiving fusions using autogenous bone graft only; (3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of solid fusion mass.

When used as a pedicle screw system in the non-cervical spine of skeletally mature patients, the ORIA Spinal Clip System is indicated for immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: (1) degenerative spondylolisthesis with objective evidence of neurological impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and (7) failed previous fusion (pseudarthrosis).

The ORIA Spinal Clip System includes components that fit together to form a construct for use during spinal fusion surgery. The system contains components of various designs and sizes that allow the surgeon to build an implant system for each of four defined indications and to fit the patient's anatomical and physiological requirements. The components include: lumbar, thoracic, and pedicular hooks; sacral screws; pedicle screws; set screws; locking nuts; rods in various lengths; connectors with set screws (sacral, transverse, lateral); connecting elements; instruments and sterilizer trays.

This 510(k) summary for the ORIA Spinal Clip System does not contain information commonly found in a study proving a device meets acceptance criteria for an AI/ML medical device. Instead, it is a submission for a traditional medical device (spinal clip system) focusing on demonstrating substantial equivalence to previously cleared devices.

Therefore, many of the requested points related to acceptance criteria and study design for an AI/ML device simply aren't applicable or available in this document.

Here's an analysis based on the provided text, highlighting what can be extracted and what is not present:

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

• Acceptance Criteria (Implicit): Substantial equivalence in indications for use, anatomic sites, design, material of manufacture, and function compared to predicate devices.
• Reported Device Performance: The document states that "Documentation was provided which demonstrated the ORIA Spinal Clip System Domino and Tube Connectors to be substantially equivalent to previously cleared devices." No specific performance metrics (e.g., strength, durability, biocompatibility) are provided in this summary, but rather a general statement of equivalence.

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 as this is a mechanical device submission, not an AI/ML algorithm submission. There is no "test set" in the context of an algorithm's performance evaluation. The "data" here would be the physical testing of the device components.

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 for a mechanical device submission. There is no concept of "ground truth" established by experts for performance in this context.

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

• This information is not applicable for a mechanical device submission.

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 is not an AI-assisted device.

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

• This information is not applicable as this is not an AI device.

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

• This information is not applicable for a mechanical device. The "ground truth" for a mechanical device typically involves engineering specifications, material standards (e.g., ASTM F136, F138), and performance testing according to recognized standards (e.g., fatigue testing, pull-out strength). However, the specific details of these tests are not included in this summary.

8. The sample size for the training set

• This information is not applicable as this is not an AI/ML device.

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

• This information is not applicable as this is not an AI/ML device.

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