Search Results

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 back 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.

The Sierra spinal system will include polyaxial screws, rods, locking caps, occipital plates, occipital screws, lateral connectors, crossbars, hooks, and components. All products are fabricated from titanium alloy, with the exception of the screws which have a cobalt alloy component, and are being offered in a wide variety of sizes. All product is supplied "NON-STERILE" and must be sterilized prior to use.

Sierra will also offer a wide variety of instruments that range from bone awls to occipital screwdrivers. These instruments will be made from various grades of stainless steel with Radel and aluminum alloy being used in a few handles. All items are supplied "NON-STERILE" and must be sterilized prior to use.

The provided document is a 510(k) Pre-Market Notification for the Sierra™ spinal system. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving de novo safety and effectiveness through clinical trials with specific acceptance criteria and performance metrics.

Therefore, many of the requested categories regarding acceptance criteria, study details, ground truth, and training sets are not applicable to this type of regulatory submission. The document explicitly states: "A financial certification and/or disclosure statement is not needed for this submission as no clinical studies have been undertaken in regards to the products under consideration."

Here's a breakdown of the available information:

Acceptance Criteria and Study Details for Sierra™ Spinal System

1. A table of acceptance criteria and the reported device performance:

Since no clinical studies were performed to establish specific performance metrics or acceptance criteria for clinical outcomes, this cannot be provided as it would for a device relying on de novo clinical data. Instead, the "acceptance criteria" for this 510(k) submission revolve around demonstrating substantial equivalence to predicate devices. The performance reported relates to mechanical strength per applicable standards.

2. Sample size used for the test set and the data provenance:

• Not Applicable. No clinical test set or human data was used for this 510(k) submission. The evaluation was based on technological characteristics and mechanical testing.

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. No ground truth was established by external experts in the context of clinical performance or diagnostic accuracy. The substantial equivalence argument relies on comparison to existing legally marketed devices.

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

• Not Applicable. No test set requiring adjudication was used.

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 a medical device (spinal system implants and instruments), not an AI-powered diagnostic or assistive tool. No MRMC study was conducted.

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

• Not Applicable. This is a medical device, not an algorithm. Therefore, no standalone performance study was conducted.

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

• Not Applicable. As no clinical studies were performed, no ground truth based on clinical outcomes or expert consensus for a test set was established. The "ground truth" for the submission is the regulatory acceptance of the predicate devices whose characteristics the Sierra system mimics.

8. The sample size for the training set:

• Not Applicable. No machine learning or AI models were used, so there was no training set.

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

• Not Applicable. No machine learning or AI models were used, so there was no training set or ground truth establishment for such.

Ask a specific question about this device