(204 days)
The intended use of the Sierra spinal system is to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3). The indications for use are as follows:
- degenerative disc disease (DDD) as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,
- spondylolisthesis. .
- trauma (i.e., fracture or dislocation), .
- . spinal stenosis.
- atlantoaxial fracture with instability, .
- occipitocervical dislocation, .
- revision of previous cervical spine surgery, and/or
- . spinal tumor.
The occipital bone screws are limited to occipital fixation only.
The use of the polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.
Rod connectors, crossbars and set screws are being added to the Sierra spinal system. All products are fabricated from titanium alloy. All products are supplied "NON-STERILE" and must be sterilized prior to use.
This document describes a 510(k) premarket notification for the Sierra™ spinal system, specifically referring to the addition of rod connectors, crossbars, and set screws. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a full clinical study to prove novel efficacy or safety. Therefore, the provided information does not include details on acceptance criteria, a study proving performance against those criteria, or specific metrics like sensitivity, specificity, or reader improvement with AI.
Here's an analysis based on the provided text, highlighting the absence of the requested information due to the nature of a 510(k) submission:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as performance metrics in the provided document. For 510(k) submissions, the “acceptance criteria” typically revolve around demonstrating substantial equivalence in terms of functionality, technological characteristics, and safety to a predicate device. This is often achieved through comparative testing (e.g., mechanical, material) and analysis rather than clinical performance metrics.
- Reported Device Performance: Not reported in terms of clinical outcomes or specific performance metrics (e.g., sensitivity, specificity, accuracy). The submission asserts that the new components have "substantially equivalent technological characteristics to the predicate devices."
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/not provided. This document does not describe a clinical study in the traditional sense involving a "test set" of patients or data for performance evaluation. The "testing" likely involved mechanical and material characterization of the new components against established standards or predicate device specifications.
- Data Provenance: Not applicable/not provided.
3. 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/not provided. Ground truth establishment by medical experts is typically part of clinical performance studies, which are not detailed in this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/not provided. Adjudication methods are relevant for clinical studies that involve expert review of cases, which is not the focus of this document.
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
- MRMC Study: No. This document concerns a conventional medical device (spinal fixation system components), not an AI-powered diagnostic or assistive tool.
- Effect size of human reader improvement with AI: Not applicable, as no AI component is described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable, as no algorithm or AI component is described.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. The "ground truth" for a 510(k) submission like this would involve demonstrating that the new components meet established engineering and material standards, and perform comparably to predicate devices in mechanical and functional tests. It is not about clinical ground truth derived from patient data.
8. The sample size for the training set
- Not applicable. There is no mention of an algorithm or AI requiring a training set.
9. How the ground truth for the training set was established
- Not applicable. There is no mention of an algorithm or AI requiring a training set or ground truth establishment in this context.
Summary of what the document does provide:
- Predicate Devices: SeaSpine, Inc.'s Sierra Spinal System (K062934) and Interpore Cross International's Altius OCT System (K022048, K033961 and K043229).
- Basis for Equivalence: "The overall designs of the rod connectors, crossbars and set screws in this submission are substantially equivalent to the predicate devices." and "The devices in this submission have substantially equivalent technological characteristics to the predicate devices."
- Materials: All products are fabricated from titanium alloy.
- Intended Use: Promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3) for various conditions (degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, atlantoaxial fracture with instability, occipitocervical dislocation, revision of previous cervical spine surgery, and spinal tumor).
- Limitations: Occipital bone screws limited to occipital fixation; polyaxial screws limited to T1-T3 for thoracic conditions only, not for cervical spine.
In conclusion, this document is a 510(k) summary for a conventional medical device modification, which focuses on demonstrating substantial equivalence to existing devices based on technological characteristics and intended use, rather than presenting clinical study results with performance metrics or AI algorithm validation.
§ 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.