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The T-PLATE ANTERIOR PLATE FIXATION SYSTEM is indicated for use as an anteriorly placed supplemental fixation device for the lumbosacral level below the bifurcation of the vascular structures. When properly used this system will help provide temporary stabilization until a solid spinal fusion develops. Specific indications include: 1) Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); 2) Pseudoarthrosis; 3) Spondylolysis; 4) Spondylolisthesis; 5) Fracture; 6) Neoplastic disease; 7) Unsuccessful previous fusion surgery; 8) Lordotic deformities of the spine; 9) Idiopathic thoracolumbar or lumbar scoliosis; 10) Deformity (i.e., scoliosis, lordosis, and/or kyphosis) associated with deficient posterior elements such as that resulting from laminectomy, spina bifida, or myelomenigocele; and/or 11) Neuromuscular deformity (i.e., scoliosis, lordosis, and / or kyphosis) associated with pelvic obliquity.

The T-PLATE Anterior Fixation System is a temporary implant used for the correction and stabilization of the spine. The system is also intended to help provide temporary stabilization and to help augment the development of a solid spinal fusion. The T-PLATE Anterior Fixation System is a supplemental fixation device consisting of a variety of sizes of plates, and screws, as well as ancillary products and instrument sets. The T-PLATE Anterior Fixation System components can be locked into a variety of configurations, with each construct being tailor-made for the individual case. The implant components are made from medical grad titanium alloy. Stainless steel and titanium components must not be used together in a construct.

The provided text describes a medical device, the T-PLATE Anterior Fixation System, and its regulatory approval process, specifically a 510(k) premarket notification. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting a full clinical study with acceptance criteria and performance metrics in the way one might for a novel AI device or a drug.

Therefore, many of the requested categories for a study proving device meets acceptance criteria are not applicable to this document. The "study" mentioned is mechanical testing to demonstrate substantial equivalence, not a clinical trial with human subjects, AI algorithms, or ground truth established by experts.

Here's an breakdown based on the provided text, indicating which information is available and which is not:

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

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

• Sample Size: Not specified (refers to mechanical testing, not a patient test set).
• Data Provenance: Not specified. It's mechanical testing of the device itself, not human data.

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. Ground truth in the context of expert consensus on medical images or diagnoses is not relevant for mechanical testing of a spinal fixation system. Substantial equivalence is based on engineering principles and comparison to a predicate device.

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

• Not applicable. There was no "test set" of patient data requiring adjudication in a clinical or diagnostic sense.

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 document describes a physical medical device (spinal implant), not an AI system.

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. The "ground truth" for substantial equivalence under 510(k) is the performance and characteristics of the legally marketed predicate device (PYRAMID™ ANTERIOR PLATE FIXATION SYSTEM). The new device is evaluated against engineering benchmarks to ensure it is similar enough to the predicate.

8. The sample size for the training set

• Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

• Not applicable. There is no "training set" for this type of device.

Summary based on the document:

The T-PLATE Anterior Fixation System gained regulatory clearance through a 510(k) premarket notification. This process determines substantial equivalence to an existing legally marketed device (the PYRAMID™ ANTERIOR PLATE FIXATION SYSTEM, K013665). The evidence provided for this equivalence was mechanical testing of the device. The document does not describe clinical studies involving human subjects, AI performance, or ground truth established by medical experts for a diagnostic task.

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