(99 days)
The LTD Polyaxial Fixation System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the lumbar and/or sacral spine, specifically as follows:
When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the LTD Polyaxial Fixation system is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) spinal tumor, and/or (5) failed previous fusion (pseudarthrosis).
In addition, when used as a pedicle screw fixation system, the LTD Polyaxial Fixation System is indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (d) who are having the device removed after the development of a solid fusion mass.
When used as a posterior, non-cervical, non-pedicle screw fixation system, the LTD Polyaxial Fixation System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) fracture, (5) pseudarthrosis, (6) tumor resection and/or (7) failed previous fusion.
The LTD Polyaxial Fixation System consists of a variety of shapes and sizes of rods, screws and connecting components, sold with or without the surgical instrument tray. These components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. The LTD Polyaxial Fixation System implant components are fabricated from medical grade titanium or titanium allow described by such standards at ASTM F67 or ASTM F136 for ISO 5832-2/3.
This Pre-market Notification adds 5.5mm rods and associated polyaxial screws to the LTD Polyaxial System.
The provided text describes the 510(k) summary for the LTD Polyaxial Fixation System, a spinal fixation device. The study described focuses on biomechanical testing to demonstrate the device's mechanical integrity and performance, rather than clinical efficacy or diagnostic accuracy. Therefore, many of the typical acceptance criteria and study design elements for AI/diagnostic devices (e.g., sample size for test sets, ground truth establishment, MRMC studies) are not applicable here.
Here's an analysis based on the information provided:
Acceptance Criteria and Device Performance
The provided 510(k) summary does not explicitly list numerical "acceptance criteria" for each performance metric in a table format, nor does it provide specific "reported device performance" values beyond a general statement of meeting acceptance criteria. This is common for predicate device submissions where the focus is on demonstrating equivalence to already marketed devices through similar testing.
However, the "Performance Data" section indicates the types of tests conducted and a general statement of their success:
| Test Type | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Static Axial Compression Bending Test | Met the acceptance criteria (implying performance within established limits for predicate devices) | Met the acceptance criteria |
| Static Torsion Test | Met the acceptance criteria (implying performance within established limits for predicate devices) | Met the acceptance criteria |
| Dynamic Axial Compressing Bending Test | Met the acceptance criteria (implying performance within established limits for predicate devices) | Met the acceptance criteria |
Note: The specific numerical acceptance limits for these biomechanical tests are not provided in the summary. For spinal fixation devices, these limits are typically derived from standards (e.g., ASTM, ISO) or established by comparison to predicate devices, ensuring the device can withstand physiological loads without failure.
Study Details
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable in the context of this biomechanical testing. The "test set" would refer to the number of device components or constructs tested. The specific number of samples tested for each biomechanical test (e.g., number of rods, screws, or constructs) is not specified in this summary.
- Data Provenance: Not applicable. Biomechanical tests are laboratory-based and do not involve human data.
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 biomechanical study, not a study requiring expert interpretation or ground truth establishment based on human or biological data. The "ground truth" in this context would be the physical properties and performance characteristics of the materials and device constructs as measured by specialized testing equipment.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. As this is biomechanical testing, no expert adjudication is involved.
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 not a study involving human readers or AI assistance. It is a biomechanical performance study of a physical medical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. There is no algorithm or AI involved in this device or its testing as described.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Mechanical Performance Standards/Specifications: The "ground truth" or reference for passing these tests would be the established industry standards (e.g., ASTM F1717-96 for Spinal Implant Constructs, which often specifies testing methods and acceptance criteria) or the measured performance of legally marketed predicate devices. The device is expected to meet or exceed these established benchmarks for strength and durability.
8. The sample size for the training set
- Not Applicable. There is no "training set" as this is not an AI/machine learning study.
9. How the ground truth for the training set was established
- Not Applicable. There is no "training set" or corresponding ground truth establishment process for this type of device submission.
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.