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The General Spinal System is intended for posterior, non-cervical, pedicle fixation for the following indications: severe spondylolisthesis (grade 3 or 4) of the L5-S1 vertebrae; trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. The device is to be used in skeletally mature patients, and for stabilization and immobilization of the spine as an adjunct to fusion with bone graft. The levels of fixation are T8 - S1.

The spinal system consists of screws, rods, crosslink plates, set screws and hooks.

It is made of Titanium Alloy (Ti6Al4VELI), which meets ASTM F136-02a, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications, which are widely used for surgical implants with well known biocompatibility.

The proposed devices are provided non-sterile. It is required to be sterilized via autoclave method to reach a SAL of 10 by the hospital prior to surgery. The recommended sterilization method was validated per ISO 17665-1: 2006 Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development. validation, and routine control of a sterilization process for medical devices

The provided text describes a 510(k) submission for a spinal system and focuses on demonstrating substantial equivalence to a predicate device through non-clinical bench testing. It does not contain information about the use of AI, human readers, or clinical study data for device performance as would be relevant for acceptance criteria in the context of an AI-powered diagnostic device.

Therefore, the following information regarding acceptance criteria and a study proving device performance as typically applied to AI devices (especially those involving diagnostic accuracy) cannot be extracted from the given text:

1. A table of acceptance criteria and the reported device performance: Not available. The document refers to "design specifications" being met, but these are not defined in terms of specific performance metrics suitable for a table.
2. Sample size used for the test set and the data provenance: Not applicable, as no test set beyond bench testing materials is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no expert evaluation for ground truth is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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 device is 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 device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as clinical ground truth establishment is not mentioned for this type of device. The studies are bench tests.
8. The sample size for the training set: Not applicable, as this is not an AI device.
9. How the ground truth for the training set was established: Not applicable.

However, based on the provided text, here's what can be extracted regarding the device's "acceptance criteria" (in the context of a 510(k) submission for a physical implant) and the study that proves it meets them:

Acceptance Criteria and Device Performance for the General Spinal System (K122994)

Study Details:

• Type of Study: Non-clinical bench tests.
• Sample Size for Test Set: Not explicitly stated, typical for bench testing where a representative number of samples are tested according to defined standards.
• Data Provenance: Not applicable, as these are laboratory bench tests, not clinical data.
• Ground Truth Establishment: For bench tests, the "ground truth" is defined by the specified performance limits and methodologies outlined in the ASTM and ISO standards used. The device's physical properties and performance are verified against these objective criteria.
• Training Set: Not applicable as this is not an AI device.
• Adjudication Method: Not applicable for bench testing against established engineering standards.
• MRMC Comparative Effectiveness Study: Not applicable.
• Standalone Performance: The non-clinical bench tests evaluate the device's standalone physical performance parameters. The "algorithm only" concept does not apply here.

The core of the submission relies on demonstrating that the proposed device, the General Spinal System, performs similarly to a legally marketed predicate device (CD HORIZON® Spinal System, K042790) by meeting the same widely accepted industry standards for spinal implants.

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