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The Reliance Posterior Cervical-Thoracic System is intended to promote fusion of the cervical spine and cervicothoracic junction (C1-T3), and is indicated for the following:

• ddd (neck pain of discogenic origin with degeneration of the disc as confirmed by . patient history and radiographic studies)
• Spondylolisthesis .
• Spinal stenosis •
• Fracture/dislocation •
• Revision of previous cervical spine surgery .
• . Tumors

The use of the polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) for anchoring the system only. They are not intended to be placed in the cervical spine.

Hooks and Rods

The rod and hook components are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

WARNING: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic (T4–T12), or lumbar spine. Pedicle screws are intended for placement only in T1-T3 as a means of anchoring the system.

The Reliance Posterior Cervical-Thoracic System is comprised of implant and instrument components. The implant component, the Reliance Posterior Cervical-Thoracic device, consists of posterior attachment elements with a set screw and rod. The Posterior Cervical-Thoracic pedicle screw component is offered in a mono-axial configuration. In addition to this components, there are also ancillary components such as hooks, connectors, cross-links, and lateral offset connectors. There are also thoracic poly-axial screw components. Furthermore, the Reliance Posterior Cervical-Thoracic System has a variety of configurations to meet specific patients' needs.

The Reliance Posterior Cervical-Thoracic instrument components include screw drivers, drill guides, plate holders, and drill bits. These instruments are manufactured from stainless steel, high grade plastic, and silicone rubber. There are also instrument trays that house these components.

The provided document describes a medical device called the "Reliance Posterior Cervical-Thoracic System," for which the FDA is confirming substantial equivalence to a predicate device. This document does not describe the acceptance criteria and a study proving a device meets the acceptance criteria in the way a clinical trial or AI/ML performance study would.

Instead, this document focuses on demonstrating substantial equivalence for a medical implant device, which involves showing that the new device is as safe and effective as a legally marketed predicate device. For this type of device, the "acceptance criteria" are typically met through non-clinical testing and comparison to predicate devices, rather than through studies involving human readers or expert consensus on observations.

Here's an analysis based on the information provided, framed as closely as possible to your request, but acknowledging the different nature of this submission:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated as "sample size" in the context of clinical data for a test set. Instead, it refers to multiple test configurations for the mechanical testing of the device components. The number of samples tested for each mechanical property (e.g., number of constructs for static compressive testing) is not specified but would follow ASTM F1717 guidelines.
• Data Provenance: The data is generated from non-clinical laboratory testing of the device prototypes. No human data (e.g., country of origin, retrospective/prospective) is involved in this described performance evaluation.

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

• Not applicable in the context of this submission. The "ground truth" for the mechanical testing is based on the physical testing results against established international standards (ASTM F1717). No human experts are used to interpret clinical images or establish ground truth in a diagnostic sense for this type of submission.

4. Adjudication Method for the Test Set

• Not applicable. No adjudication method for a test set of clinical cases is described as this is not a study assessing diagnostic performance or human interpretation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size.

• Not applicable. This submission does not include an MRMC study. It is a premarket notification for a spinal fixation device, focusing on mechanical properties and substantial equivalence to existing devices, not on human diagnostic performance with or without 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 implant, not an algorithm or AI software. There is no standalone algorithm performance to evaluate.

7. The Type of Ground Truth Used

• The "ground truth" for the non-clinical performance evaluation is based on established engineering and biomechanical standards (ASTM F1717) and the performance characteristics of the identified predicate devices. This includes material properties, mechanical strength under various loads, sterilization, and biocompatibility.

8. The Sample Size for the Training Set

• Not applicable. This submission describes a physical medical device, not an AI/ML algorithm. Therefore, there is no "training set."

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

• Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.

In summary: The provided text details a 510(k) premarket notification for a spinal implant. The "acceptance criteria" discussed are related to the mechanical performance, materials, and intended use of the device, demonstrated through non-clinical testing and comparison to legally marketed predicate devices by showing "substantial equivalence." This is a different type of evaluation than those typically performed for AI-driven diagnostic devices.

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The Reliance Posterior Cervical-Thoracic System is intended to promote fusion of the cervical spine and cervicothoracic junction (C1-T3), and is indicated for the following:
· ddd (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)

• spondylolisthesis
• · spinal stenosis
• · fracture/dislocation
• · revision of previous cervical spine surgery
• tumors

The use of the mini polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.

Hooks and Rods

The rod and hook components are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

WARNING: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic (T4-T12), or lumbar spine. Pedicle screws are intended for placement only in T1-T3 as a means of anchoring the system.

The Reliance Posterior Cervical-Thoracic System contains posterior spinal attachment elements in a variety of configurations based upon rod diameter. These include a Titanium alloy based Ø3.5mm rod configuration, a Titanium alloy based Ø4.0mm rod configuration and a Titanium alloy based 04.5mm rod configuration. All configurations, regardless of rod size, are available in 03.5mm, 04.0mm, and 04.5mm major screw diameters. These screw diameters are offered in lengths ranging from 10mm to 20mm, with the 04.0mm, and 04.5mm available up to 50mm. All of these screws are available in both mono-axial options. The polyaxial screws in all of these configurations have an internal taper bushing that circumferentially grasps the rod when the device is locked. Additionally, both the mono-axial and poly-axial screws have a double lead thread.

In addition to the screw sizes mentioned above, reduction-tabbed screws are also available. The reduction-tabbed screws are available in all of the previously mentioned sizes. The Reliance Posterior Cervical-Thoracic System also offers a series of crosslink connectors. Furthermore, the Reliance Posterior Cervical-Thoracic System includes a series of hooks for attaching to the posterior elements of the cervico-thoracic spine. All of the components discussed above are " fabricated from Titanium alloy and should not be used with implants of different materials.

This document describes a spinal fixation device, not an AI or diagnostic medical device. Therefore, the requested information (acceptance criteria, study details including sample sizes, expert involvement, and ground truth establishment) is not applicable to this submission. The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing for mechanical properties.

Here's a breakdown of why the requested information cannot be provided based on the given input:

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

• Not Applicable. The document states: "The Reliance Posterior Cervical-Thoracic System has undergone Non-Clinical Testing including Static Compressive, Static Torsion, Dynamic Compressive and Dynamic Torsion in accordance with ASTM F1717." It then concludes, "The Reliance Posterior Cervical-Thoracic System is substantially equivalent to the predicate devices."
• While ASTM F1717 outlines test methods for spinal implant constructs, the document does not provide specific acceptance criteria values or the quantitative results of these tests for the Reliance system. It only states that the testing was performed and that the device is "substantially equivalent."

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

• Not Applicable. The "test set" in this context refers to the physical devices tested according to ASTM F1717. The document does not specify the number of devices (samples) tested for each non-clinical test (Static Compressive, Static Torsion, Dynamic Compressive, Dynamic Torsion).
• Data provenance (country of origin, retrospective/prospective) is relevant for clinical studies, not for the non-clinical mechanical testing described here.

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" and expert review are concepts associated with diagnostic performance studies, typically involving human interpretation of data (e.g., medical images). This document describes the mechanical testing of a physical implant. The "ground truth" for these tests would be the measured physical properties against a standard, not expert consensus.

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

• Not Applicable. Adjudication methods like 2+1 or 3+1 are used in clinical trials or diagnostic studies to resolve disagreements among human readers or expert reviewers. This is not pertinent to the non-clinical mechanical testing of a spinal implant.

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 is explicitly an AI/diagnostic performance study question. The submission is for a physical medical device (spinal fixation system) and does not involve AI, human readers, or diagnostic interpretation.

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

• Not Applicable. This question is also for AI/algorithm performance. The device is a physical implant.

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

• Not Applicable. As explained in point 3, the concept of "ground truth" for a diagnostic or AI device is not applicable here. For the mechanical testing performed, the "truth" is established by the specifications and measurable performance outlined in the ASTM F1717 standard.

8. The sample size for the training set:

• Not Applicable. "Training set" refers to data used to train an AI algorithm. This document is about a physical medical device and does not involve AI.

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

• Not Applicable. Similar to point 8, this question is for AI algorithms and not relevant to the described device.

Summary of Device Performance and Acceptance Criteria (as much as can be inferred from the document):

Study Details:

• Study Type: Non-clinical (benchtop) mechanical testing.
• Testing Standard: ASTM F1717 (Standard Test Methods for Spinal Implant Constructs in a Corpectomy Model).
• Sample Size (Test Set): Not specified in the document.
• Data Provenance: Not applicable for non-clinical benchtop testing.
• Ground Truth Establishment: Performance against parameters and criteria outlined in ASTM F1717.
• Training Set Sample Size/Ground Truth: Not applicable as this is not an AI/algorithm-based device.
• Expert involvement, adjudication, MRMC studies, standalone performance: Not applicable for this type of device submission.

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