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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.

The provided text is a 510(k) summary for the ORIA Spinal Clip System. It describes a medical device (spinal clip system) and its intended use, but it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.

The summary states that the "ORIA Spinal Clip System Lengthened Lateral Connector (AL06)" was found substantially equivalent to a previously cleared device (Lateral Connector AL02). This equivalence is based on design principles, materials, manufacturing methods, and intended use, not on a performance study against specific acceptance criteria.

Therefore, I cannot fulfill your request for the detailed table and study information as it is not present in the provided text.

Here's why and what kind of information is present:

• Substantial Equivalence: The document is a 510(k) submission, a common pathway for medical device clearance in the US. This pathway relies on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than requiring extensive new clinical trials or performance studies with specific acceptance criteria in all cases.
• Focus on Design and Materials: The core of the substantial equivalence argument for this device revolves around the lengthened lateral connector being made of the same material (titanium alloy), having similar manufacturing methods, an equivalent interconnection mechanism, and a basic design similar to the previously cleared connector.

To directly answer your specific points based only on the provided text, many cannot be addressed:

1. Table of acceptance criteria and reported device performance: Not applicable. No specific performance acceptance criteria or reported performance metrics are mentioned. The comparison is based on substantial equivalence to a predicate device's design and materials.
2. Sample size for the test set and data provenance: No test set or associated data 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 establishment for a test set is discussed.
4. Adjudication method for the test set: Not applicable. No test set requiring adjudication is described.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This type of study is not mentioned. The device is a spinal implant, not typically evaluated through MRMC studies in this context.
6. Standalone performance study (algorithm only without human-in-the-loop performance): Not applicable. This is a hardware device, not an algorithm.
7. Type of ground truth used: Not applicable. No ground truth determination for performance evaluation against acceptance criteria is described.
8. Sample size for the training set: Not applicable. This is a hardware device, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established: Not applicable. No training set is involved.

The K030253 document is primarily a regulatory clearance document demonstrating substantial equivalence based on material, design, and intended use, not a performance study report with acceptance criteria.

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