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The TRANSITION™ Stabilization System is intended to provide 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 in skeletally mature patients: degenerative spondylolisthesis with objective evidence of neurologic impairment, kyphosis, and failed previous fusion (pseudoarthrosis).

In addition, the TRANSITION™ Stabilization System is indicated for use in patients: who are receiving fusions with autogenous graft only; who are having the device fixed or attached to the lumbar or sacral spine; and who are having the device removed after the development of a solid fusion mass.

TRANSITION™ is only indicated for use when fusion with autogenous bone graft is being performed at all instrumented levels.

The TRANSITION™ Stabilization System implants include pedicle screws and implant assemblies which are provided pre-assembled or can be assembled intraoperatively.

TRANSITION™ pedicle screws are coated with hydroxyapatite (HA). Either TRANSITION™ HA coated pedicle screws or specified REVERE® pedicle screws may be used in conjunction with the implant assemblies. Specifically, REVERE® polyaxial (solid, cannulated and dual outer diameter) screws and monoaxial screws 6.5mm diameter and larger, and 35mm length and larger, may be used with the TRANSITION™ implant assemblies.

Implant assemblies consist of a polyethylene terepthalate (PET) cord, polycarbonate urethane (PCU) spacers and bumpers, and titanium alloy spools, end spools and set screw ends. The cord passes through the entire implant such that the spools are positioned to sit within the screw heads and the spacer sits between the spools. The end spool includes one end of the secured cord. The bumper followed by a set screw end is positioned at the other end of the cord.

Implant assemblies are available in single or multi-level configurations. REVERE® locking caps with inner set screws are used to rigidly connect the pedicle screws to the implant assemblies.

TRANSITION™ implants are available in a variety of sizes to accommodate varied patient anatomy.

TRANSITION™ implants are manufactured from titanium alloy Ti6AI4V (ASTM F136) or Ti6Al7Nb (ASTM F1295), polyethylene terepthalate (PET), and/or polycarbonate urethane (PCU). Titanium alloy TRANSITION™ screws are hydroxyapatite (HA) coated (ASTM F1185).

The provided text is a 510(k) summary for the TRANSITION™ Stabilization System, which is a medical device. This type of document is a regulatory submission to the FDA (Food and Drug Administration) to demonstrate that a medical device is substantially equivalent to a legally marketed predicate device.

The context of this document is therefore not a study proving device performance against acceptance criteria in the way a research paper or clinical trial might. Instead, the "acceptance criteria" here refer to regulatory requirements for substantial equivalence, and the "study" is the information provided by the manufacturer to demonstrate that equivalence.

Consequently, many of the requested categories (like sample size for test/training sets, data provenance, number/qualification of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth) are not applicable or not present in a 510(k) summary as it is primarily focused on demonstrating equivalence to an already approved device through comparisons of indications, design, materials, and potentially some mechanical testing data (though not detailed here).

Here's an analysis based on the provided text:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria for Substantial Equivalence (as understood in a 510(k) submission):
The primary "acceptance criteria" for a 510(k) submission like this are that the device is substantially equivalent to a legally marketed predicate device in terms of:

• Intended Use/Indications for Use: The new device has the same intended use as the predicate.
• Design and Function: The device has similar technological characteristics (e.g., materials, principle of operation, mechanical properties).
• Safety and Effectiveness: Differences in technological characteristics do not raise new questions of safety and effectiveness.

Reported Device Performance (as summarized in the document):

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

• Not applicable/Not provided in this 510(k) summary. This document does not detail specific clinical or analytical studies with test sets in the typical research sense. The "study" here is the comparison to predicate devices, usually supported by design specifications, material testing, and potentially bench testing data, none of which are detailed here with sample sizes or data provenance.

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/Not provided. Ground truth determination by experts is typically for diagnostic/AI devices, not for spinal implant systems demonstrating substantial equivalence to predicates.

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

• Not applicable/Not provided. This is not relevant for a 510(k) submission for a spinal implant device.

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/Not provided. MRMC studies are for diagnostic imaging devices, not spinal implants.

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

• Not applicable/Not provided. This device is a physical spinal implant, not an algorithm.

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

• Not applicable/Not provided in this summary. For a 510(k) of this nature, the "ground truth" for showing safety and effectiveness is largely based on the established safety and effectiveness of the predicate devices, combined with engineering analysis and bench testing to demonstrate similar performance characteristics.

8. The sample size for the training set

• Not applicable/Not provided. There is no "training set" in the context of an AI/machine learning model for this physical medical device.

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

• Not applicable/Not provided. As there is no training set, this question is not relevant.

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