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Internal fixation implants are load-sharing devices intended to stabilize and maintain alignment until normal healing occurs. Implants are not intended to replace normal body structures or bear the weight of the body in the presence of incomplete bone healing.

The CONQUEST Spinal System, when properly used, is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients. It provides stabilization and immobilization of spinal segments as an adjunct to fusion.

When used as a posterior spine thoracic/lumbar system, the CONQUEST Spinal System is indicated for one or more of the following: (1) degenerative disc disease (is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), (2) trauma (i.e. fracture or dislocation), (3) curvatures (scoliosis, kyphosis, and/or lordosis), (4) spinal tumor, (5) failed previous fusion (6) pseudarthrosis, (7) spinal stenosis, (8) spondylolisthesis.

The CONQUEST Spinal System is a titanium alloy multiple component system comprised of a variety of non-sterile, single use implantable components. When assembled, the components create a rigid structure providing stabilization and promote spinal fusion. The system consists of an assortment of rods, screws, and locking caps.

This 510(k) summary describes a spinal implant system, not an AI/ML powered medical device. Therefore, many of the requested criteria related to AI/ML device studies (such as sample size for test sets and training sets, expert consensus, MRMC studies, standalone performance, etc.) are not applicable in this context.

However, I can provide the available information regarding the device's acceptance criteria and the study performed as described in the provided text.

Acceptance Criteria and Device Performance for CONQUEST® Spinal System

Explanation for AI-specific questions (Not Applicable for this Device):

This device, the CONQUEST® Spinal System, is a traditional medical implant, specifically a spinal fixation system. The provided 510(k) summary focuses on demonstrating its mechanical properties and equivalence to existing, legally marketed devices. It does not involve any artificial intelligence or machine learning components for diagnosis, prognosis, or treatment decisions. Therefore, the following information is not provided nor applicable:

1. Sample size used for the test set and the data provenance: Not applicable. The "test set" for this type of device would refer to physical prototypes undergoing mechanical testing, not a dataset for an algorithm.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI algorithm is irrelevant here. The "ground truth" for a spinal implant's performance would be derived from mechanical test standards (ASTM F1717) and engineering principles.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
4. 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 does not involve human readers interpreting data with or without AI assistance.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the biomechanical performance, the "ground truth" is adherence to established engineering standards (ASTM F1717) and functional equivalence to predicate devices, rather than clinical outcomes or diagnostic ground truth.
7. The sample size for the training set: Not applicable. This device does not involve a training set.
8. How the ground truth for the training set was established: Not applicable.

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