(249 days)
The CASPIAN OCT / MESA Mini / DENALI Mini Spinal System is intended to provide stabilization as an adjunct to fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3) when used with autograft or allograft and is indicated for the following:
- DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
- . Spondylolisthesis
- . Spinal stenosis
- Fracture/dislocation
- . Revision of previous cervical spine surgery
- . Tumors
- Atlantoaxial fracture with instability
- t Occipitocervical dislocation
The occipital bone screws are limited to occipital fixation only.
The rod and hook components are intended for use in the cervical/upper thoracic (C1-T3) spine. The pedicle screws are limited to placement in T1-T3 in treating thoracic conditions only. The pedicle screws are not intended to be placed in or treat conditions involving the cervical spine.
The CASPIAN OCT / MESA Mini / DENALI Mini System can also be linked to the Range Spinal System using the 3.5mm/5.5mm rod connectors or transitional rods.
The Caspian OCT Spinal System is a top-loading, multiple component, posterior (occipital-cervicalthoracic) spinal fixation system. The purpose of this submission is to add the Occipital Anchor to the system.
Materials: The subject devices are manufactured from Ti6A14V Eli per ASTM and ISO standards.
Function: The system functions as an adjunct to fusion to provide immobilization of the posterior cervical and thoracic spine.
The provided text describes a 510(k) summary for the Caspian OCT Spinal System, specifically focusing on the addition of an Occipital Anchor. The submission details the device, its intended use, and a comparison to predicate devices, along with mechanical and biomechanical testing to demonstrate substantial equivalence.
However, the document does not contain the kind of information typically associated with acceptance criteria for device performance in the context of clinical studies, diagnostic accuracy, or AI models. Instead, the "acceptance criteria" here refers to the demonstration of substantial equivalence to a previously cleared device, primarily through mechanical and biomechanical testing in accordance with ASTM standards.
Therefore, many of the requested categories in your prompt cannot be directly answered from the provided text, as they pertain to clinical or diagnostic performance studies that were not conducted or reported in this 510(k) summary. The summary focuses on the physical and functional characteristics of an implantable medical device.
I will fill in the table and address the other points based only on the information available in the provided text. Where information is not present, I will explicitly state that.
Acceptance Criteria and Study for the Caspian OCT Spinal System
The "acceptance criteria" for this 510(k) submission revolve around demonstrating substantial equivalence to predicate devices. This was primarily achieved through mechanical and biomechanical testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Demonstration of Substantial Equivalence) | Reported Device Performance |
|---|---|
| Performance equal to or better than original Caspian OCT Spinal constructs in static compression (per ASTM F2706) | Performed equally to or better than the original Caspian OCT Spinal constructs in static compression. |
| Performance equal to or better than original Caspian OCT Spinal constructs in static torsion (per ASTM F2706) | Performed equally to or better than the original Caspian OCT Spinal constructs in static torsion. |
| Performance equal to or better than original Caspian OCT Spinal constructs in dynamic compression (per ASTM F2706) | Performed equally to or better than the original Caspian OCT Spinal constructs in dynamic compression. |
| Biomechanical performance substantially the same as predicate devices (in cadaver testing) | Devices were found to perform substantially the same in biomechanical (cadaver) testing. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: The document does not specify exact sample sizes (e.g., number of constructs or cadaveric specimens) for the mechanical or biomechanical testing. It refers to "the constructs" and "the devices."
- Data Provenance: The mechanical testing was conducted by K2M, Inc. to ASTM standards. The biomechanical testing was "cadaver" testing, implying human cadaveric tissue. The country of origin for the data is not specified, but the submitter is K2M, Inc. in Leesburg, VA, USA. The studies are prospective in nature for validating the device's performance against established standards and predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The "ground truth" for this device's performance is based on standardized mechanical testing (ASTM F2706) and comparative biomechanical testing against predicate devices, rather than expert interpretation of data.
4. Adjudication method for the test set
This information is not provided as the evaluation method was based on objective mechanical and biomechanical measurements against established standards and predicate device performance, not expert adjudication of subjective assessments.
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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices, particularly those involving image interpretation or AI assistance, which is not the nature of the Caspian OCT Spinal System (an implantable spinal fixation system).
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
No, a standalone algorithm performance study was not done. This concept is not applicable to an implantable spinal fixation system.
7. The type of ground truth used
The "ground truth" used for demonstrating substantial equivalence was:
- Engineering Standards: Adherence to ASTM F2706 for static and dynamic mechanical properties.
- Predicate Device Performance: Direct comparison of the new device's mechanical and biomechanical performance to that of previously cleared predicate devices (K2M Caspian OCT Spinal System K101084 and Medtronic Vertex K052402).
8. The sample size for the training set
This information is not provided and is not applicable. The listed studies are for device verification/validation, not for training an algorithm.
9. How the ground truth for the training set was established
This information is not provided and is not applicable. There was no "training set" in the context of an algorithm or AI model development for this 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.