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The DVX 5.5 Spine System is intended for posterior, noncervical, pedicle fixation in order to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine, including degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the DVX Spine System is intended for skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra, who are receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 and below), with removal of the implants after the attainment of solid fusion.

The DVX 5.5 Spine System (like the predicate The DVX Spine System) consists of four or more pedicle screws and two solid rods in a symmetric. bilateral arrangement. The pedicle screws are placed axially in the pedicles with two screws in the cephalad position and two screws in the caudad position. The rods are secured in the heads of the pedicle screws so that fixed stabilization is provided between the cephalad and caudad vertebrae. Cross-links can be used if additional stabilization is necessary. The DVX5.5 Spine System ( See Figure 1) is made of components for fixation of the spine: multi-axial pedicle screws, locking cap, rod and cross-link . The materials, sterilization and packaging are the same as those in DVX Spine System, the predicate.

The provided text is a 510(k) summary for the DVX 5.5 Spinal System. It primarily focuses on demonstrating substantial equivalence to a predicate device based on mechanical testing. It does not contain information typically associated with clinical studies involving human patients or complex data analysis for acceptance criteria related to diagnostic or AI devices. Therefore, many of the requested categories (sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, training set details) are not applicable to the information contained in this document.

Here's the information that can be extracted and a clear indication of what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified in terms of number of devices tested, but the testing was for the DVX 5.5 Spine System components.
• Data Provenance: The testing was conducted for the specific device by the manufacturer (BK MEDITECH Co., Ltd.). It is a laboratory, mechanical test, not derived from patient data.

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

• Not Applicable. Ground truth, in this context, refers to clinical or diagnostic accuracy. For a mechanical device, performance is evaluated against engineering standards (ASTM F1717-04). No human experts are used to establish "ground truth" for mechanical performance in the way they would for medical image interpretation.

4. Adjudication Method for the Test Set

• Not Applicable. Mechanical testing against an ASTM standard does not involve an adjudication method. The results are quantitative measurements interpreted against the standard's specifications.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

• Not Applicable. This is a mechanical spinal implant. It is not an AI-assisted diagnostic or treatment device, and no MRMC studies were conducted as part of this submission.

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

• Not Applicable. This is a mechanical device, not an algorithm, and does not involve human-in-the-loop performance.

7. The Type of Ground Truth Used

• Mechanical performance standards. Specifically, ASTM F1717-04, which outlines standard test methods for spinal implant constructs in a corpectomy model. The "ground truth" is adherence to the specified mechanical properties and performance characteristics defined by this standard.

8. The Sample Size for the Training Set

• Not Applicable. This is a mechanical device, not a machine learning model. There is no concept of a "training set" in this context.

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

• Not Applicable. As there is no training set, this question is not relevant.

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The DVX Spine System is intended for posterior, noncervical, pedicle fixation in order to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine, including degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; spinal turnor; and failed previous fusion (pseudarthrosis). In addition, when used as a pedicle screw fixation system, the DVX Spine System is intended for skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra, who are receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 and below), with removal of the implants after the attaimment of solid fusion.

The DVX Spine System consists of four or more pedicle screws and two DVX solid rods in a symmetric, bilateral arrangement. The pedicle screws are placed axially in the pedicles with two screws in the cephalad position and two screws in the caudad position. The DVX rods are secured in the heads of the pedicle screws so that fixed stabilization is provided between the cephalad and caudad vertebrae. Cross-links can be used if additional stabilization is necessary. The DVX Spine System is fabricated from titanium alloy (Ti-6A1-4V ELI) that conforms to the ASTM F136 -02a, Standard Specifications for Wrought Titanium-6Aluminum-4VanadiumELI (Extra Low Interstitial) Alloy or Surgical Implant Applications (UNS R56401

The provided text describes a 510(k) submission for the DVX Spinal System, a medical device for spinal fusion. However, it does not include information about acceptance criteria or a study proving the device meets said criteria in the context of device performance, clinical efficacy, or AI system-specific metrics.

Instead, the document focuses on demonstrating substantial equivalence to previously cleared predicate devices (NFix Fusion System, K053623, and MEGA Spine System, K072436). The basis for substantial equivalence is the similarity in materials, design, indications for use, operational principles, and source manufacturer.

Therefore, most of the requested information cannot be extracted from the provided text.

Here's what can be inferred or explicitly stated:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. The submission does not detail specific acceptance criteria for a new performance study or report new device performance metrics. Its claim is based on substantial equivalence to predicate devices, implying that the predicate devices' performance (which met their own acceptance criteria) is sufficient.

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

Not applicable. No new performance testing in a "test set" (clinical or otherwise) is described for the DVX Spinal System. The evaluation relies on the equivalence to existing devices.

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

Not applicable. No new test set requiring expert ground truth establishment is mentioned.

4. Adjudication Method for the Test Set

Not applicable. No test set requiring adjudication is mentioned.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

No. The document does not describe any MRMC study, nor does it refer to an AI device that would typically be evaluated in such a study.

6. Standalone (i.e. algorithm only without human-in-the loop performance) Study

No. The document describes a physical medical device (spinal system) and does not refer to an algorithm or AI system for which a standalone performance study would be relevant.

7. Type of Ground Truth Used

Not applicable. Since no new performance studies are detailed, there is no mention of ground truth (expert consensus, pathology, or outcomes data) being used for the DVX Spinal System itself. The evaluation is based on the characteristics of the device and its predicate devices.

8. Sample Size for the Training Set

Not applicable. The DVX Spine System is a physical medical device. It does not involve machine learning or AI, and 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, this question is not relevant.

Summary of the Study (and its absence) described in the document:

The provided document describes a 510(k) submission for substantial equivalence. The "study" in this context is primarily a design and materials comparison between the DVX Spinal System and its predicate devices (NFix Fusion System and MEGA Spine System).

The key statement is: "No additional testing is required because the test results applicable to the N SPINE System and MEGA spinal system components are directly applicable to the DVX Spine System since they are virtually identical in design and materials. Designs are directly compared to demonstrate equivalence."

This means that:

• The acceptance criteria for the DVX Spinal System are implicitly those that were met by the predicate devices during their own clearance processes.
• No new study data is presented for the DVX Spinal System, as it is considered substantially equivalent based on design and material identity to already cleared devices.

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