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The Opus™ Spinal System is intended for posterior, noncervical pedicle and non-pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture and dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and failed previous fusion.

The Opus™ Spinal System is also intended to be used in conjunction with the titanium hooks from the OSS/Diapason Spinal System and the Xia Spinal System. The Opus™ Spinal System is also intended to be used in conjunction with the Multi-Axis Cross Connectors.

The Opus Spinal System is made up of a range of screws, which are compatible with both the rod and plate components of the system. The components of the system are manufactured from ISO 5832/3 Titanium Alloy (Ti-6Al-4V).

Here's an analysis of the acceptance criteria and study information for the Opus™ Spinal System based on the provided document:

This document is a 510(k) summary for an additional indication for the Opus™ Spinal System. It primarily focuses on demonstrating substantial equivalence to a predicate device through mechanical testing. It does not contain information about AI/ML device performance, human reader studies, ground truth establishment, or training data for such applications.

Here's a breakdown of the requested information based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and the Data Provenance

The document does not specify a "test set" in the context of clinical data or image-based diagnostics. The testing involved mechanical performance on device constructs. The sample size for these mechanical tests is not explicitly stated in the provided text. The provenance is the testing facility, not patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. This device is a spinal fixation system, not a diagnostic AI/ML device. Ground truth, in this context, would relate to mechanical engineering standards and material properties, not expert interpretations of medical images or clinical outcomes in the usual AI/ML sense.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like "2+1" or "3+1" are typically used for establishing ground truth in clinical or image-based studies where expert consensus is needed. This document describes mechanical testing, which relies on engineering standards and measurements, not expert adjudication in the same way.

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 is for a spinal implant, not an AI-assisted diagnostic tool. No MRMC studies were performed related to AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a physical spinal implant; there is no algorithm or standalone performance in the context of AI/ML.

7. The Type of Ground Truth Used

The ground truth for this device's performance evaluation is based on mechanical engineering standards and benchmark performance of the predicate device. The goal was to demonstrate "comparable mechanical properties" to the legally marketed predicate device (OSS/Diapason and Xia® Titanium Hooks).

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML system that utilizes a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no training set for this device in the AI/ML context.

Summary of Device and Study Focus:

The Opus™ Spinal System's 510(k) summary focuses on demonstrating substantial equivalence to existing predicate devices (OSS/Diapason and Xia® Titanium Hooks) for additional indications. This equivalence is primarily supported by mechanical performance data (static and fatigue tests) showing "comparable mechanical properties" between the Opus™ Spinal System constructs and the predicate device. The document does not describe any clinical trials, human-in-the-loop studies, or AI/ML performance evaluations.

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When used as a pedicle screw fixation system of the non-cevical posterior spine in skeletally mature patients, the Opus" Spinal System is indicated for one or more of the following: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
In addition, the Opus" Spinal System is indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint, having fusions using autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (with pedicle placement at L3 and below) with removal of the implants after the development of a solid fusion mass.

The Opus" Spinal System is a spinal fixation device for the noncervical spine. All components are manufactured from ISO 5832/3 (equivalent to ASTM F-136-96) titanium alloy (Ti6Al-4V ELL). The system consists of conical and cylindrical screws, rods, lateral connectors, and plates.
Bone Screws: These screws are threaded at both the distal and the proximal ends. The distal aspect of the screws features cancellous bone threads. The proximal aspect of the screws features standard metric threads. The area between the proximal and distal threads has a hexagonal cross-section used to remove the screw. Screws are available in a variety of diameters and lengths. Additionally, the screws are available in extended proximal length and/or extended hexagonal section configurations.
Rods: The spinal rods are 6mm in diameter and range in length from 40mm to 480mm. A 600mm rod is also available. Rods are assembled to the screws through the use of a lateral connector and a rod nut.
Plates: The plates have 2 or 3 holes and their lengths range from 41mm to 75mm. Plates are assembled to the screws through the use of a washer and a plate nut.

The provided text describes a 510(k) premarket notification for the Opus™ Spinal System, a medical device for spinal fixation. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a de novo clinical study with specific performance criteria.

Therefore, the concept of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the traditional sense (e.g., sensitivity, specificity, AUC for an AI/diagnostic device) does not apply here. Instead, the "acceptance criteria" are related to mechanical and material equivalence to the predicate device, and the "study" is a comparison of these properties.

Here's a breakdown of the requested information based on the provided text:

Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for a spinal fixation system, the "acceptance criteria" are implicitly tied to demonstrating mechanical and material equivalence and safety/effectiveness comparable to a predicate device. There are no explicit performance metrics like sensitivity or specificity.

Study Information

1. Sample size used for the test set and the data provenance:

   • No human subject test set or data provenance is mentioned as this device relies on mechanical testing and material comparison to a predicate, not clinical performance data.

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 a clinical test set is not relevant for this 510(k) submission type.

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

   • Not applicable. There is no clinical test set requiring adjudication.

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 is not an AI/diagnostic device.

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

   • Not applicable. This is a spinal implant, not an algorithm.

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

   • For the mechanical aspects, the "ground truth" would be the established mechanical and material specifications of the predicate device and industry standards (e.g., ISO 5832/3, ASTM F-136-96). The "study" involves demonstrating that the Opus™ Spinal System's mechanical and material properties meet or exceed these established benchmarks, or are comparable to the predicate.

7. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning device that requires a training set.

8. How the ground truth for the training set was established:

   • Not applicable.

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