Search Results

The SS Fenestrated Facet Screw System (FFS) is indicated for the posterior surgical treatment at L1-S1 (inclusive) spinal levels for the following: Spondylolisthesis; Spondylolysis; Pseudarthrosis or failed previous fusions which are symptomatic; Degenerative Disc Disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies and/or degenerative disease of the facets with instability. The system is intended for use with only autogenous bone graft material.

The SS Fenestrated Facet Screw System (FFS) is a permanent implant device made from Cobalt Chrome Alloy Per ASTM 1537. It is to be implanted from the posterior approach. The device is provided in one diameter and multiple lengths to accommodate the various anatomy of the spine. The device is intended to provide mechanical support and stability to the implanted level until biologic fusion is achieved. The SS Fenestrated Facet Screw System is cannulated and fenestrated which allows it to be used as a delivery system for bone graft. The system is not to be used with bone cement.

The provided text describes the regulatory submission for a medical device called the "SS Fenestrated Facet Screw System." It does not contain information about a study involving software or AI. Therefore, I cannot extract details about acceptance criteria or a study proving device performance in the context of AI.

The document discusses the substantial equivalence of the SS Fenestrated Facet Screw System to predicate devices based on performance testing for mechanical properties. However, this is for a physical implantable device, not an AI software.

Here's a breakdown of what is present in the document related to performance and testing for the physical device:

Device: SS Fenestrated Facet Screw System (FFS)

Acceptance Criteria and Reported Device Performance (for the physical device):

The document states:

• "Testing of the FFS to demonstrate substantial equivalence included static and dynamic 3-point bending, screw axial pullout, and torque to failure."
• "The testing standards utilized were, ASTM F543-07 'Standard Specification and Test Methods for Metallic Medical Bone Screws', F2193-02, 'Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System,' and ASTM F1264-03 'Standard Specification and Test Methods for Intrameduliary Fixation Devices.'"

While the specific numerical acceptance criteria and reported performance values are not detailed in the provided text, the successful 510(k) clearance implies that the device met the requirements outlined in these ASTM standards and was deemed substantially equivalent to its predicate devices in terms of safety and effectiveness.

Regarding your specific questions related to AI/Software:

1. A table of acceptance criteria and the reported device performance: This information is not present for an AI/software device. The document describes mechanical testing of a physical implant.
2. Sample sized used for the test set and the data provenance: Not applicable for an AI/software study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for an AI/software study.
4. Adjudication method: Not applicable for an AI/software study.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable for an AI/software study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable for an AI/software study.
7. The type of ground truth used: Not applicable for an AI/software study.
8. The sample size for the training set: Not applicable for an AI/software study.
9. How the ground truth for the training set was established: Not applicable for an AI/software study.

In summary, the provided text is a 510(k) summary for a physical medical implant (a facet screw system) and does not describe an AI or software device, nor does it contain the type of study data you are asking for regarding AI acceptance criteria and performance.

Ask a specific question about this device

The Spartan S2 Facet System is indicated for the posterior surgical treatment of any or all of the following at the C2 to S1 (inclusive) spinal levels:

1. Trauma, including spinal fractures and/or dislocations;

2. Spondylolisthesis;

3. Pseudoarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity;

4. Degenerative diseases which include: (a) degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by patient history with degeneration of the disc as confirmed by radiographic studies and/or (b) degenerative disease of the facets with instability.

The Spartan S2 Facet System will provide temporary stabilization as an adjunct to spinal fusion.

The Spartan S Facet System is a permanent implant device made from a titanium alloy TI 6AL4V-ELI. It is to be implanted from the posterior approach. The device is provided in two diameters and each diameter screw is provided in multiple lengths to accommodate the various anatomy of the spine. The device is intended to provide mechanical support and stability to the implanted level until biologic fusion is achieved.

The provided text describes a 510(k) summary for the Spartan S2 Facet System, a medical device. This document focuses on establishing substantial equivalence for market clearance, rather than presenting a study demonstrating the device meets a predetermined set of acceptance criteria based on performance metrics like accuracy, sensitivity, or specificity.

Therefore, many of the requested sections (e.g., acceptance criteria table, sample size, expert qualifications, adjudication method, MRMC study, standalone performance, ground truth types for test/training sets, training set size, ground truth establishment for training) cannot be answered from the provided text.

The document states: "The pre-clinical testing performed indicates that the Spartan S2 Facet System is substantially equivalent to the predicate devices and is adequate for the intended use." This implies that the 'acceptance criteria' for this clearance process was the demonstration of substantial equivalence through pre-clinical testing, likely mechanical or material testing as is common for implants. However, the specific details of these tests and their results are not provided.

Here is what can be inferred or explicitly stated from the provided text, recognizing the limitations:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not Applicable / Not Provided. The document refers to "pre-clinical testing," which typically involves mechanical and material testing, not human subject data or a "test set" in the context of AI performance evaluation. The type of data provenance would likely be laboratory test results, not country of origin for patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable / Not Provided. Ground truth establishment by experts for a test set is relevant for diagnostic or AI-driven devices. This document refers to a physical implant.

4. Adjudication method for the test set:

• Not Applicable / Not Provided. Adjudication methods are typically used in clinical studies involving observer interpretation, not for mechanical device testing.

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. This is a 510(k) summary for a physical implant, not an AI-assisted diagnostic device. Therefore, an MRMC study related to AI assistance would not be performed.

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

• No. This is a physical implant, not an algorithm.

7. The type of ground truth used:

• Not Applicable / Not Provided for typical AI/diagnostic ground truth. For a physical implant, "ground truth" would relate to material properties and mechanical performance meeting engineering specifications, rather than expert consensus, pathology, or outcomes data in a clinical sense for diagnostic accuracy.

8. The sample size for the training set:

• Not Applicable / Not Provided. Training sets are relevant for machine learning algorithms.

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

• Not Applicable / Not Provided.

Ask a specific question about this device