Search Results

The Streamline TL Spinal System components are non-cervical spinal fixation devices intended as an adjunct to fusion for use as a pedicle screw (T1-S2), sacral/iliac screw fixation or as an anterolateral fixation system (T8-L5). Pedicle screw fixation is limited to skeletally mature patients. These devices are indicated for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, pseudoarthosis, and failed previous fusion.

The Streamline TL Spinal System consists of a variety of rods, pedicle screws, connectors, set screws and other connection components used to build a spinal construct. Cross-links available for use with the Streamline TL system include the Quantum X-Link and the SpineWorks FixxSure Crosslink. The implant components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. Instrumentation is also available to facilitate implant of device components. The purpose of this submission is to include the FixxSure Cross Link to the Streamline TL System. The Cross Link is designed to provide added fixation to the spinal construct and is available in fixed (23-28mm) and variable lengths (28-66mm).

The provided text describes a 510(k) premarket notification for the Streamline TL Spinal System. This is a medical device for spinal fixation, and the submission is focused on adding a new component, the FixxSure Crosslink, to the existing system. The document outlines the device's description, intended use, materials, and performance data used to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the provided information regarding acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state numerical acceptance criteria (e.g., "must withstand X N of force"). Instead, the acceptance is based on demonstrating that the modified device (Streamline TL with FixxSure Crosslink) performs comparably to the previously accepted predicate device (Streamline TL without the new crosslink, and the predicate FixxSure Crosslink). This is a common approach for 510(k) submissions, where substantial equivalence rather than absolute performance metrics is the primary goal.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly stated. The document mentions "testing was presented to characterize the performance of the Streamline TL construct with the additional FixxSure Crosslink," implying a series of tests, but not the number of units or repetitions used for each test.
• Data Provenance: The study described is a mechanical performance study (ASTM F1717) conducted to characterize the device's performance. It is a prospective study as it involves testing a newly configured device. The country of origin of the data is not specified, but given the sponsor is in Marquette, MI, USA, and the FDA is reviewing it, it's likely the testing was conducted in the USA or by a lab adhering to international standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable to this type of study. The ground truth for mechanical performance studies like this is objective, measurable physical properties (e.g., force, displacement, cycles to failure) determined by standardized test methods (ASTM F1717). There is no human interpretation or expert consensus involved in establishing the "ground truth" for the device's mechanical strength.

4. Adjudication Method for the Test Set

This information is not applicable as there is no human adjudication for mechanical testing data. The results are quantitative and directly measured.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. MRMC studies are typically used to assess the impact of a diagnostic or assistive technology on human reader performance, often in imaging. This submission deals with the mechanical performance of a spinal implant, which does not involve human readers in an interpretive capacity.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

Yes, a standalone performance study was done. The performance data presented consists of mechanical testing (ASTM F1717 dynamic compression bending, static compression bending, and static torsion testing) to characterize the performance of the spinal construct. This is a "standalone" assessment of the device's physical properties without human intervention or interpretation for its primary function.

7. The Type of Ground Truth Used

The ground truth used is objective physical measurements obtained through standardized mechanical testing (ASTM F1717). This includes measurements of dynamic compression bending, static compression bending, and static torsion. The "truth" is whether the device withstands certain forces and cycles per defined standards.

8. The Sample Size for the Training Set

This information is not applicable. This submission describes mechanical testing of a medical device, not a machine learning algorithm. Therefore, there is no "training set" in the context of AI or data-driven models.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no training set for mechanical performance testing.

Ask a specific question about this device