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The Dyn-ALIF device is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device is designed for use with autogenous bone graft to facilitate fusion.

The Dyn-ALIF device is intended for use at either one level or two contiguous levels in the lumbar spine from L2 to S1 for the treatment of degenerative disc disease (DDD) with up to grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used in patients who have had at least six months of non-operative treatment. The device is intended to be used with supplemental internal spinal fixation systems which are cleared by the FDA for use in the lumbar spine.

The Dyn-ALIF Anterolateral Intervertebral Body Fusion Device is an implantable device manufactured from titanium alloy which is available in the abutting plate interface dimension of 20mm x 30mm and a vertically expandable height ranging from 11mm anterior /9mm posterior to 15mm anterior/13mm posterior to suit the individual anatomic conditions of the patient. The assembled device consists of five components: two abutting plates with hollow threaded shafts, a central turnbuckle sleeve and two locking set screws. The components can be rigidly locked into a variety of heights, with each construct height measured for the individual case

This document describes a 510(k) premarket notification for a medical device, the Dyn-ALIF Anterolateral Intervertebral Body Fusion Device. It focuses on demonstrating substantial equivalence to previously cleared devices rather than proving performance against specific acceptance criteria in a study. Therefore, most of the requested information regarding acceptance criteria, study details, and ground truth establishment is not available in this document.

Here's a breakdown of the available and unavailable information based on the provided text:

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

• Not Applicable / Not Available. This document describes a 510(k) submission, which primarily focuses on demonstrating "substantial equivalence" to predicate devices, not on proving device performance against specific, pre-defined acceptance criteria through a clinical or performance study in the way a PMA (Pre-Market Approval) or a clinical trial for a novel device would.
• The document states: "Data was provided which demonstrate the Dyn-ALIF Anterolateral Intervertebral Body Fusion Device to be substantially equivalent to previously cleared devices. The substantial equivalence is based upon equivalence in indications for use, design, function, material, labeling, biocompatibility, performance and standards with the named intervertebral body fusion predicate devices and upon equivalence in design (vertical expansion), material and labeling with the named vertebral body replacement predicate devices." This implies that the 'performance' of the device is considered equivalent to the predicate devices, rather than being measured against explicit numerical acceptance criteria.

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

• Not Available. The document explicitly states "H. Summary of Clinical Tests (Not Applicable)". This indicates that no clinical studies were performed to generate a "test set" in the context of human data. The testing mentioned is "G. Summary of Non-Clinical Tests Mechanical testing data was presented." This would typically involve bench testing of the device for mechanical properties, not a "test set" of clinical cases or 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 / Not Available. Since no clinical test set was used to evaluate the device's performance against a ground truth, there were no experts establishing ground truth for a test set.

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

• Not Applicable / Not Available. As no clinical test set was utilized for performance evaluation requiring expert adjudication, there is no mention of such a method.

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 Available. This document describes an intervertebral body fusion device (an implantable spinal device), not an AI or imaging diagnostic tool. Therefore, an MRMC study is irrelevant to this submission.

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

• Not Applicable / Not Available. This refers to an implantable medical device, not a diagnostic algorithm.

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

• Not Applicable / Not Available. For a mechanical implant like this, the "ground truth" for non-clinical testing would relate to engineering specifications and material properties, verified through lab tests (e.g., tensile strength, fatigue life, etc.), which are not detailed in this summary. No clinical ground truth is mentioned. The "Indications for Use" section mentions "degeneration of the disc confirmed by history and radiographic studies" as part of the DDD definition, but this refers to patient diagnosis, not the ground truth for evaluating the device itself.

8. The sample size for the training set

• Not Applicable / Not Available. As this is a physical medical device and not a machine learning algorithm, there is no concept of a "training set" in this context.

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

• Not Applicable / Not Available. (See point 8).

Summary of the Study (as described in the document):

The document details a 510(k) premarket notification for the Dyn-ALIF Anterolateral Intervertebral Body Fusion Device. The primary "study" presented is a demonstration of substantial equivalence to previously cleared predicate devices.

• Type of Study: Substantial Equivalence Demonstration (not a performance or clinical efficacy study in the traditional sense).
• Methodology for Substantial Equivalence: Comparison of the Dyn-ALIF device against predicate devices (NuVasive CoRoent System, Surgical Dynamics Ray TFC, Ionics Levante Intervertebral Pillar, Medtronic Sofamor Danek Verte-Span Spinal System) based on:
  • Indications for Use
  • Design
  • Function
  • Material (Titanium alloy)
  • Labeling
  • Biocompatibility
  • Performance (implied to be equivalent to predicates, likely through non-clinical testing)
  • Standards adherence
• Non-Clinical Tests: "Mechanical testing data was presented." (No further details on the nature or results of these tests are provided in the summary).
• Clinical Tests: Explicitly stated as "Not Applicable," meaning no human clinical trials were conducted or submitted as part of this 510(k) according to the summary provided.
• Data Provenance: Not applicable for clinical data. For mechanical testing, the provenance would be internal laboratory testing by the manufacturer.

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