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The Streamline TL Spinal System components are non-cervical spinal fixation devices intended as an adjunct to fusion for use as a pedicle screw (TI-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. 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 Streamline TL Crosslink to the Streamline TL System. The Cross Link is designed to provide added fixation to the spinal construct and is available in fixed (16-45mm) and variable lengths (37 - 85mm).

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Streamline TL Spinal System, structured according to your request:

Based on the provided K111502 510(k) summary for the Streamline TL Spinal System, the device in question is a spinal implant for fixation, not an AI/ML-driven device or an imaging device. Therefore, the questions related to AI performance metrics, expert adjudication, MRMC studies, standalone algorithm performance, and ground truth for training sets are not applicable to this submission. This 510(k) pertains to a hardware medical device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify the exact number of test samples (e.g., number of constructs or specific components) used for the mechanical tests. ASTM F1717 would define the minimum number of specimens for such tests, but this detail is not present in the summary.
• Data Provenance: The data is generated from retrospective mechanical testing conducted by the manufacturer, Pioneer Surgical Technology, Inc., likely at their facilities or a contracted lab. The country of origin for the data generation is implicitly the USA, where the company is based.

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

This question is not applicable. For a spinal implant, "ground truth" is defined by established engineering standards for mechanical performance (e.g., ASTM F1717) rather than expert radiographic or clinical interpretation. Performance is assessed against these quantifiable engineering benchmarks.

4. Adjudication Method for the Test Set

This question is not applicable. Mechanical testing results are objective measurements and do not typically involve an adjudication process in the way clinical or imaging studies do. The results are compared directly against the performance of the predicate device under the same test conditions.

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

This question is not applicable. The device is a spinal implant, not an AI diagnostic tool.

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

This question is not applicable. The device is a spinal implant, not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for evaluating the performance of this device is based on established mechanical engineering standards (specifically ASTM F1717 for compression bending fatigue and torsional static mechanical testing) and comparison to the performance of a legally marketed predicate device (K110692 - Streamline TL Spinal System). The goal is to demonstrate "substantial equivalence" in mechanical performance.

8. The Sample Size for the Training Set

This question is not applicable. The device is a physical medical device, not an AI model, and therefore does not have a "training set."

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

This question is not applicable. As stated above, there is no training set for this type of device.

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