(151 days)
The Life Spine Lumbar Fixation System (SENTRY®) is intended for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), pseudoarthrosis, spondylolisthesis, scoliosis, lordotic deformities of the spine, spinal stenosis, or a failed previous spine surgery.
Anterior Lumbar: The SENTRY Anterior Lumbar Fixation System consists of a variety of plates and screws to suit the individual pathology and anatomical conditions of the patient. All components are fabricated and manufactured from titanium alloy 6AL-4V-ELI per ASTM F-136. The plates are manufactured in a variety of configurations with options including different lengths and curvature. The screws are manufactured in variable and fixed configurations with diameters of and lengths. Fixation is provided by bone screws inserted through the plates and into the vertebral body of the Lumbar spine using an anterior approach. The responsible surgeon will determine the correct size of the implant in accordance with the size of the individual patient. The SENTRY Anterior Lumbar Fixation System also utilizes a variety of standard orthopedic instruments to assist in the placement of the devices.
Lateral Lumbar: The SENTRY Lateral Plating System consists of a variety of plates and screws to suit the individual pathology and anatomical conditions of the patient. All components are fabricated and manufactured from titanium alloy 6AL-4V-ELI per ASTM F-136. The plates are manufactured in a variety of configurations with options including different lengths. The screws are manufactured in a variable configuration with different diameters and lengths. Fixation is provided by bone screws inserted through the plates and into the vertebral body of the Lumbar spine using an Lateral approach. The responsible surgeon will determine the correct size of the implant in accordance with the size of the individual patient. The SENTRY Lateral Plating System also utilizes a variety of standard orthopedic instruments to assist in the placement of the devices.
All implants are provided non-sterile and intended for SINGLE USE ONLY and should not be reused under any circumstances. Do not use any of the Life Spine Lumbar Fixation System (SENTRY®) components with components from any other system or manufacturer.
The provided text describes a 510(k) premarket notification for a medical device called the "Life Spine Lumbar Fixation System (SENTRY®)". This type of submission aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, rather than proving its safety and effectiveness through clinical trials with specific acceptance criteria as would be the case for a novel device or one requiring a PMA.
Therefore, the information you're requesting regarding acceptance criteria, study details, expert qualifications, and ground truth establishment, which are typical for studies evaluating diagnostic or AI-driven devices, is not present in this document.
The "Performance Data" section mentions "Axial Static and Dynamic compression. Bending and Static Torsion Testing to ASTM F1717, was presented to demonstrate the substantial equivalency of the Life Spine Lumbar Fixation System (Sentry)." This indicates that the performance criteria are related to the mechanical properties of the device and its ability to withstand certain forces, aligning with a mechanical engineering assessment rather than a clinical study with diagnostic accuracy metrics.
Here's how to address your request based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in the format of a clinical study or diagnostic performance metrics. Instead, it refers to mechanical testing standards.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical performance according to ASTM F1717 to demonstrate substantial equivalence to predicate devices (Life Spine Sentry 2 (K172131) and Life Spine Presidio (K132589)). | Axial Static and Dynamic compression, Bending, and Static Torsion Testing performed to ASTM F1717. The document states this testing demonstrated the substantial equivalency of the Life Spine Lumbar Fixation System (SENTRY®). |
Missing Information from the Document:
The following information is not present in the provided text, as it describes a 510(k) submission focused on substantial equivalence through mechanical testing, not a clinical study on diagnostic accuracy or AI performance:
- Sample size used for the test set and the data provenance: Not applicable in this context, as the "test set" refers to mechanical samples of the device components, not patient data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is based on engineering specifications and physical measurements, not expert clinician consensus.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 a spinal fixation system, not an AI-driven diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's performance is its mechanical integrity and adherence to engineering standards for spinal implants, as evaluated through physical testing.
- The sample size for the training set: Not applicable. There is no training set for a mechanical device like this.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document is a 510(k) clearance letter and summary for a spinal implant, which relies on demonstrating mechanical equivalence to previously cleared devices. It does not involve the types of clinical studies, data analysis, or AI performance metrics that your questions typically address.
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.