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The KINETIC®-SL Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. This system is indicated for use in temporary stabilization of the anterior spine from C2 to T1 during the development of a cervical spinal fusion in patients with: (1) Degenerative disc disease, DDD (as defined by neck pain of discogenic origin with degeneration of disc confirmed by patient history and radiographic studies); (2) Spondylolisthesis; (3) Trauma (including fractures or dislocations); (4) Spinal cord stenosis; (5) Deformity or curvatures (i.e. kyphosis, lordosis and/or scoliosis); (6) Tumors; (7) Pseudarthrosis; (8) Failed previous fusions. Nota Bene: This device system is intended for anterior cervical intervertebral body fusions only. WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

The KINETIC® -SL Anterior Cervical Plate System consists of various sizes of anterior cervical bone plates and screws. Components are available in a variety of sizes to fit patient anatomy. All components are manufactured from implant grade titanium alloy 6A1-4V ELI per ASTM F-136. KINETIC®-SL Anterior Cervical Plate System components will be supplied clean and "NON-STERILE".

The provided document does not contain information regarding software or AI/ML device performance studies. Instead, it describes a medical device called the "KINETIC®-SL Anterior Cervical Plate System," which is a spinal implant. The document is a 510(k) summary for this physical medical device.

Therefore, I cannot provide the requested information about acceptance criteria and study details related to AI/ML device performance. The sections about sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth are not applicable to the content of this document.

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The Life Spine Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. This system is indicated for use in temporary stabilization of the anterior spine from C2 to T1 during the development of a cervical spinal fusion in patients with (1) degenerative disc disease, DDD (as defined by neck pain of discogenic origin with degeneration of disc confirmed by patient history and radiographic studies), (2) spondylolisthesis, (3) trauma (including fractures or dislocations), (4) spinal cord stenosis, (5) deformity or curvatures (i.e. kyphosis, lordosis and/or scoliosis), (6) tumors, (7) pseudarthrosis, (8) failed previous fusions.

Nota Bene: This device system is intended for anterior cervical interverterbral body fusions only.

WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

The Life Spine Anterior Cervical Plate consists of various sizes of anterior cervical bone plates and screws. Components are available in a variety of sizes to fit patient anatomy. All components are manufactured from implant grade titanium alloy 6A1-4V ELI per ASTM F-136. The Life Spine Anterior Cervical Plate components will be supplied clean and "NON-STERILE'.

The provided 510(k) summary for the Life Spine Anterior Cervical Plate System does not include acceptance criteria or a study demonstrating the device meets performance criteria in the way typically expected for an AI/CADe device. This document is for a physical medical implant (a spinal fixation system), and as such, the performance evaluation focuses on biomechanical properties and material compatibility rather than diagnostic accuracy metrics.

Therefore, many of the requested categories for AI/CADe device studies are not applicable to this 510(k) submission. Below, I've filled in the relevant information based on the provided text, and noted when information is not applicable or not present.

Acceptance Criteria and Device Performance for Life Spine Anterior Cervical Plate System

Study Details:

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

   • Sample Size: Not applicable. Biomechanical testing (ASTM F1717) uses physical test specimens of the device, not a "test set" of patient data as would be used for AI/CADe. The number of physical units tested is not specified.
   • Data Provenance: Not applicable. The testing is laboratory-based biomechanical testing of the device itself.

2. 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. Ground truth, in the context of AI/CADe devices, refers to an agreed-upon clinical diagnosis or finding. For a physical implant, "ground truth" relates to material properties and mechanical performance measured against standards, not expert medical consensus on a dataset.

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

   • Not applicable. This refers to adjudication of clinical findings by experts, which is not relevant for biomechanical testing of a physical implant.

4. 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 an AI/CADe device.

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

   • Not applicable. This is not an AI/CADe device.

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

   • Ground Truth: For this type of device, the "ground truth" for performance is defined by established engineering standards and material specifications. Specifically, ASTM F1717 provides the methods and criteria for testing spinal implant constructs, and ASTM F136 specifies the standard for the titanium alloy material. The device's performance is compared against the expected behavior for devices meeting these standards and the performance of the chosen predicate devices.

7. The sample size for the training set:

   • Not applicable. This is not an AI/CADe device.

8. How the ground truth for the training set was established:

   • Not applicable. This is not an AI/CADe device.

Summary of the Device Evaluation:

The Life Spine Anterior Cervical Plate System's acceptance criteria and proof of performance are based on demonstrating substantial equivalence to legally marketed predicate devices. This is achieved through:

• Material Specification: Using an implant grade titanium alloy (Ti 6A1-4V-ELI) that conforms to ASTM F-136, a recognized standard for surgical implant materials.
• Biomechanical Testing: Conducting biomechanical tests in accordance with ASTM F1717, a standard specifically for spinal implant constructs. These tests evaluate the mechanical properties and stability of the device. The results from these tests would have been compared to the performance of the predicate devices to show that the new device performs at least as safely and effectively.
• Comparison of Indications for Use, Design, and Function: The submission explicitly states that the device was shown to be substantially equivalent to predicate devices in these aspects. This means clinical indications, physical design, and how the device is intended to perform its function were determined to be similar enough that no new safety or effectiveness concerns are raised.

In essence, for this physical medical device, "acceptance criteria" are implied by the requirements for substantial equivalence, which primarily involve adherence to recognized material standards and performance comparable to existing, legally marketed devices as demonstrated through established biomechanical testing protocols.

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