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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, pseudoarthrosis, and failed previous fusion.

The Streamline TL Spinal System consists of a variety of rods, screws (poly-axial, fixed, and reduction), transverse connectors, set screws and other connecting 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. Sacral/iliac screws are designed for posterior fixation. The Streamline TL Spinal System includes Class I manual instrumentation to facilitate implantation of the device components. The Streamline TL Spinal System may be used with the Streamline TL Crosslink. SpineWorks FixxSure Crosslink or the Quantum® Spinal System X-Link®. The purpose of this submission is to add components to the System. The implant components of the Streamline TL Spinal System are manufactured from the implant grade Titanium Alloy, Grade 23 per ASTM F136. Spinal rods are also available in cobalt chromium alloy per ASTM F1537.

This document is a 510(k) summary for the Streamline TL Spinal System, a spinal fixation device. It describes the device, its intended use, and its equivalence to previously cleared predicate devices.

Here's an analysis of the acceptance criteria and study information provided, focusing on what's missing as the document is a regulatory submission for a physical medical device, not an AI/software device:

Important Note: The provided text is a 510(k) summary for a physical medical device (spinal fixation system), not a software or AI-powered diagnostic device. Therefore, many of the requested categories (like acceptance criteria for performance metrics like sensitivity/specificity, sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance) are not applicable in the context of this type of submission. The performance assessment here is entirely based on mechanical testing of the physical components.

Analysis for the Streamline TL Spinal System:

Given that this is a 510(k) summary for a physical implantable device (spinal fixation system) and not an AI or software device, the acceptance criteria and study details are focused on mechanical performance and material characteristics, not diagnostic accuracy metrics.

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

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 in the context of clinical patient data. For mechanical testing, the "sample size" would refer to the number of physical device units or components tested. This is not specified in the document, but standard ASTM testing protocols dictate the number of samples required for robust mechanical evaluation.
• Data Provenance: Not applicable for clinical patient data as this is mechanical testing. The testing was conducted internally or by a contracted lab to industry standards (ASTM).

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. "Ground truth" in this context refers to established engineering standards (ASTM F1717, F1798) and the performance of predicate devices. There are no human "experts" establishing a clinical ground truth for a test set in pre-clinical mechanical testing. The "experts" would be the engineers and technicians performing and analyzing the mechanical tests, adhering to the specified ASTM standards.

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

• Not Applicable. This concept is relevant for clinical studies involving human interpretation or data disagreements. Mechanical testing results are objective measurements against defined standards.

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 entirely irrelevant for a physical medical device. MRMC studies are used to evaluate diagnostic performance of AI or imaging devices with human readers.

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

• No. This is entirely irrelevant for a physical medical device. "Standalone" performance refers to an algorithm's diagnostic accuracy without human intervention.

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

• The "ground truth" for the mechanical testing is based on established engineering standards (ASTM F1717, ASTM F1798) and the demonstrated performance of the legally marketed predicate devices. The goal is to show equivalence or superiority in mechanical performance.

8. The sample size for the training set

• Not Applicable. There is no "training set" for physical device mechanical testing. This concept applies to machine learning algorithms.

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

• Not Applicable. As there is no training set, there is no ground truth established for it.

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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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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.

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