(231 days)
The DYNA-LINK ELITE Stand-Alone Anterior Lumbar System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). It is to be used in patients who have had at least six months of non-operative treatment. This device is intended to be used with autogenous bone graft.
The DYNA-LINK ELITE Stand-Alone Anterior Lumbar System is intended for use with four titanium alloy screws which are provided with the system. If the physician chooses to use fewer than four of the provided screws, then a supplemental internal spinal fixation system that is cleared for use in the lumbosacral spine must be used.
The DYNA-LINK Elite Stand-Alone Anterior Lumbar System implants are intervertebral body fusion devices comprised of a variety of spacer implants manufactured from Polyetheretherketone (PEEK-OPTIMA LT1 or Zeniva ZA-500) with tantalum markers. The spacers are hollow to permit packing with bone graft to help promote intervertebral body fusion. The superior and inferior surfaces have teeth to assist in the interface with the vertebral end plates to help prevent rotation and/or migration. Additionally, the implants incorporate a titanium alloy (6AL-4V-ELI per ASTM F-136) anterior fixation plate which has integrated screw holes to allow for placement of four titanium alloy screws that anchor the implant to the adjacent vertebrae. The implants are available in a range of sizes and footprints to suit the individual pathology and anatomical conditions of the patient.
All implant components are intended for single use only and should not be reused under any circumstances. Do not use any of the DYNA-LINK Elite Stand-Alone Anterior Lumbar System components with components from any other system or manufacturer. The DYNA-LINK Elite Stand-Alone Anterior Lumbar System components should never be reused under any circumstances
This document is a 510(k) premarket notification for a medical device called the "DYNA-LINK ELITE Stand-Alone Anterior Lumbar System." It's a regulatory submission to the FDA demonstrating that the new device is substantially equivalent to legally marketed predicate devices. As such, it does not contain details about clinical studies involving human patients or complex AI algorithms with associated acceptance criteria for performance metrics like sensitivity, specificity, or reader studies.
Instead, the "acceptance criteria" and "study" described in this document relate to mechanical performance testing demonstrating the structural integrity and equivalence of the device to existing predicate devices.
Here's a breakdown of the information requested, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not provide a table with quantitative acceptance criteria for clinical performance metrics (e.g., fusion rates, pain reduction), nor does it report such device performance. Instead, it refers to mechanical testing.
| Acceptance Criteria Category | Specific Test Standard / Type | Reported Device Performance |
|---|---|---|
| Mechanical Testing | ASTM F1717-04 Static Compression | Performed to demonstrate substantial equivalence to predicate device. (Specific numerical results not provided in this summary.) |
| Mechanical Testing | ASTM F1717-04 Dynamic Compression | Performed to demonstrate substantial equivalence to predicate device. (Specific numerical results not provided in this summary.) |
| Mechanical Testing | ASTM F1717-04 Shear | Performed to demonstrate substantial equivalence to predicate device. (Specific numerical results not provided in this summary.) |
| Mechanical Testing | ASTM F1717-04 Torsion | Performed to demonstrate substantial equivalence to predicate device. (Specific numerical results not provided in this summary.) |
| Mechanical Testing | ASTM F543 Screw Pushout | Performed to demonstrate substantial equivalence to predicate device. (Specific numerical results not provided in this summary.) |
The acceptance criterion for these mechanical tests is typically that the new device's performance meets or exceeds the established performance of the predicate device, or falls within acceptable engineering specifications defined by the standards. The summary states that the testing "was presented to demonstrate the substantial equivalency," implying these criteria were met.
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable in the context of clinical patient data. For mechanical testing, the "sample size" would refer to the number of physical devices tested for each mechanical property. This specific number is not provided in the summary but would be detailed in the full test report.
- Data Provenance: Not applicable for clinical data. For mechanical testing, the "data" is derived from laboratory tests on manufactured device samples. There is no country of origin for patient data as it's not a clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a premarket notification for a physical medical device based on mechanical testing, not a clinical study requiring expert ground truth for diagnostic accuracy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is not a clinical study involving human readers or interpretation.
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 device is an intervertebral body fusion device, not an AI-powered diagnostic tool. Therefore, no MRMC comparative effectiveness study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the mechanical testing performed, the "ground truth" is established by the engineering specifications of the materials and design, and the performance of the legally marketed predicate device as measured through standardized ASTM tests. The goal is to show that the new device performs equivalently or better mechanically than the predicate.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is a physical medical device.
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.