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When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3), the Streamline OCT Occipito-Cervico-Thoracic System is intended for: degenerative disc disease (as defined by neck or back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, fracture/ dislocation, atlanto/axial fracture with instability, occipito-cervical dislocation, deformities or curvature, tumors, pseudoarthrosis, and revision of previous cervical and upper thoracic spine surgery.

The occipital bone screws are limited to occipital fixation only. The use of the pedicle screws (standard and high angle) is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. The pedicle screws are not intended for use in the cervical spine.

The hooks, connectors, and rods are also intended to provide fusion following reduction of fracture/ dislocation or trauma in the cervical/ upper thoracic (C1-T3) spine.

The Streamline OCT System can also be linked to FDA cleared pedicle screw systems (e.g., Quantum Spinal Fixation System, Streamline MIS Spinal Fixation System or Streamline TL Spinal System) using connectors.

The Streamline OCT System consists of a variety of rods, hooks, polyaxial screws, high-angle screws, locking caps, occipital plates, occipital screws, and connecting components used to build an occipito-cervico-thoracic spinal construct. The purpose of this submission is to add components to the predicate K133374 Streamline OCT System.

The provided text is a 510(k) summary for the Streamline OCT Occipito-Cervico-Thoracic System. It describes the device, its intended use, and claims substantial equivalence to predicate devices based on design, materials, technological characteristics, and performance.

However, the document does not contain the specific information required to answer your questions regarding acceptance criteria, device performance, and study details like sample size, ground truth establishment, expert qualifications, or multi-reader multi-case studies.

The section "Non-Clinical Performance Data" states: "Engineering analysis was sufficient to demonstrate that the subject components do not introduce new worst-case components. Previously completed Streamline OCT System testing is sufficient to support the performance of the subject product and therefore, no new testing was required for the determination of substantial equivalence."

This indicates that no new performance studies were conducted for this specific 510(k) submission (K150254). Instead, it relies on prior testing of the predicate device (K133374 Pioneer Streamline OCT Occipito-Cervico-Thoracic System) and engineering analysis.

Therefore, many of your questions cannot be answered from the provided text.

Here's an attempt to answer based on the available information and highlight what's missing:

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

The document does not provide a table of acceptance criteria or specific reported device performance metrics for the Streamline OCT Occipito-Cervico-Thoracic System. It generally states that "Previously completed Streamline OCT System testing is sufficient to support the performance of the subject product."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. As no new testing was reported for this submission, there is no mention of a test set sample size or data provenance.

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)

This information is not provided. The device is a spinal fixation system, and the "ground truth" would relate to its mechanical performance and biocompatibility. Expert review might be part of the engineering analysis, but details are not given.

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

This information is not provided.

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 is not applicable. The device is a medical implant (spinal fixation system), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance would not be relevant.

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

This is not applicable. The device is a physical implant, not an algorithm. Standalone performance for an algorithm is not relevant here.

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

The document implies that the ground truth for the predicate device's performance was established through engineering analysis and testing, which would typically include mechanical testing (e.g., fatigue, static strength), material characterization, and potentially pre-clinical studies or cadaveric testing. It does not refer to expert consensus, pathology, or outcomes data in the context of establishing performance for this 510(k).

8. The sample size for the training set

This information is not provided and is not relevant as this is a physical medical device, not an AI/ML device requiring a training set in that context.

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

This information is not provided and is not relevant for the same reasons as #8.

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