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The Streamline OCT Occipito-Cervico-Thoracic System is intended to provide immobilization of spinal segments as an adjunct to fusion when using autograft for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1 to T3): traumatic spinal fractures and/ or traumatic dislocations; instabilitity of deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.

The system is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

In order to achieve additional levels of fixation, the Streamline OCT System may be connected to the Quantum Spinal Fixation System, Streamline MIS Spinal Fixation System or Streamline TL Spinal System using connectors and/or transition rods.

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. System components are manufactured from ASTM F136 medical grade titanium alloy and ASTM F1537 medical grade cobalt chromium molybdenum alloy. Medical grade titanium alloy and medical grade cobalt chromium molybdenum alloy may be used together. The system should be implanted using only the surgical instruments designed for the system. Cases and caddies are supplied for sterilization and transport of the implants and instruments. The purpose of this submission is to modify and add components to the system.

This document is a 510(k) premarket notification for a medical device called the "Streamline OCT Occipito-Cervico-Thoracic System." This kind of document focuses on demonstrating that a new device is "substantially equivalent" to existing legally marketed devices, rather than establishing acceptance criteria and proving performance against them in the same way one might for a novel device or software.

Therefore, the requested information, particularly regarding acceptance criteria, specific performance metrics, sample sizes for training/test sets, ground truth establishment by experts, and MRMC studies, is not typically found or required in a 510(k) submission for this type of device (spinal fixation system). The demonstration of substantial equivalence relies more on comparing the new device's design, materials, indications for use, and mechanical performance to existing predicate devices.

However, I can extract the information that is available in the document that somewhat aligns with your request:

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

There isn't a table of "acceptance criteria" and reported device performance in the sense of accuracy, sensitivity, or specificity for an AI/software device. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence through non-clinical mechanical testing. The "reported device performance" refers to the results of these mechanical tests compared to predicate devices.

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 this 510(k) for a spinal fixation system. There isn't a "test set" of clinical data or images as typically understood for AI/software. The testing involved mechanical tests of the devices themselves.
• Data Provenance: Not applicable. The "data" comes from mechanical testing conducted in a laboratory setting, not clinical patient data.

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

Not applicable. Ground truth as established by clinical experts for a test set is not relevant for this type of device's 510(k) submission. Mechanical testing relies on engineering standards and measurements.

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

Not applicable. This concept is for clinical data review, not mechanical 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

Not applicable. This device is a physical spinal fixation system, not an AI or software device that assists human readers.

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

Not applicable. This is a physical medical device, not an algorithm.

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

For the mechanical testing, the "ground truth" is established by validated engineering test standards (ASTM F1798, ASTM F1717, and ASTM F2706) and the results derived from those specified testing protocols.

8. The sample size for the training set

Not applicable. There is no "training set" for a physical medical device. Device design and refinement are based on engineering principles, materials science, and testing, not machine learning training.

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

Not applicable (as there's no training set). The design and development of the device components are informed by established engineering practices and biomechanical understanding of spinal anatomy and mechanics.

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The Streamline OCT Occipito-Cervico-Thoracic System is intended to provide immobilization of spinal segments as an adjunct to fusion when using autograft for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1 to T3): traumatic spinal fractures and/ or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.

The system is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

In order to achieve additional levels of fixation, the Streamline OCT System may be connected to the Quantum Spinal Fixation System, Streamline MIS Spinal Fixation System or Streamline TL Spinal System using connectors and/or transition rods.

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. System components are manufactured from ASTM F136 medical grade titanium alloy and ASTM F1537 medical grade cobalt chromium molybdenum alloy. Medical grade titanium alloy and medical grade cobalt chromium molybdenum alloy may be used together. The system should be implanted using only the surgical instruments designed for the system.

The purpose of this submission is to: expand the use of the system to include the use of screws in the posterior cervical spine, add line extension components and modify an existing component.

This document is a 510(k) premarket notification for a medical device called the "Streamline OCT Occipito-Cervico-Thoracic System." It describes the device, its intended use, and argues for its substantial equivalence to previously cleared predicate devices. The information provided is about the device itself and its regulatory clearance process, rather than a study proving performance against specific acceptance criteria for AI or diagnostic performance metrics.

Therefore, many of the requested sections about acceptance criteria and study details for an AI-powered diagnostic device cannot be extracted from this document.

However, I can extract information related to the non-clinical testing performed for this physical medical device.

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

The document does not provide a table of precise acceptance criteria with numerical thresholds for performance (e.g., tensile strength > X, fatigue life > Y), nor does it report specific measured values for device performance against such criteria. Instead, it generally states that engineering analysis and re-creation testing demonstrated improvements and confirmed that the physical components met regulatory expectations.

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

For the non-clinical mechanical testing, the document does not specify the sample size used for each test (e.g., number of constructs tested for fatigue or static loading). It simply refers to "engineering analysis" and "re-creation testing."

The term "data provenance" (e.g., country of origin, retrospective/prospective) is not applicable here as the testing is physical mechanical testing on device components, not clinical data from patients.

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

This question is not applicable to the non-clinical mechanical testing of this physical medical device. "Ground truth" in this context would typically refer to clinical diagnoses or outcomes, which are not part of the described engineering or mechanical testing.

4. Adjudication method for the test set

This question is not applicable to the non-clinical mechanical testing of this physical medical device. Adjudication methods like "2+1" or "3+1" are used in clinical studies to resolve discrepancies in expert interpretations of medical data, which is not what was performed for this submission.

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. This type of study is relevant for diagnostic devices that involve human interpretation of medical images or data, often with AI assistance, to assess improvements in reader performance. This document is about a spinal implant system.

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

No, a standalone (algorithm only) performance study was not done. This is also not applicable to a physical spinal implant system.

7. The type of ground truth used

For the non-clinical mechanical testing described, the "ground truth" would be established by the physical properties and behavior of the materials and constructs under specific, controlled loading conditions, as defined by engineering standards (e.g., ASTM F1717, ASTM F2706). It is not "expert consensus," "pathology," or "outcomes data" in the clinical sense.

8. The sample size for the training set

This concept is not applicable as this document is not describing an AI/machine learning device that requires a training set. The "training set" refers to data used to train an algorithm.

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

Not applicable, as there is no training set for this type of device.

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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.

Ask a specific question about this device

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), spondylolisthesis, 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 stabilization to promote 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 Occipito-Cervico-Thoracic System consists of a variety of rods, hooks, polyaxial pedicle screws, high-angle pedicle screws, locking caps, occipital bone screws, occipital plates and connecting components used to build an occipito-cervico-thoracic spinal construct.

The purpose of this submission is to add components to the system.

This is a medical device submission (K133374) for the Streamline OCT Occipito-Cervico-Thoracic System, which is a spinal fixation system. The provided text primarily focuses on demonstrating substantial equivalence to predicate devices through various comparisons, including pre-clinical testing.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

• Static and Dynamic Compression Bending and Torsion Testing (per ASTM F1717)
• Interconnection mechanisms and subassemblies testing (per ASTM F1798) | Pre-Clinical Performance Data:
• Subject system evaluated per ASTM F1717.
• Subject system evaluated per ASTM F1798.
• Conclusion: "Testing demonstrated that the device is as safe, as effective and performs as well as or better than predicate systems." |
  | Technological Characteristics:
• Intended use
• Basic design (rod-based with screw/hook/plate anchors and connecting components)
• Materials (Titanium alloy and cobalt chromium alloy)
• Sizes (dimensions comparable to predicates)
• Sterilization and cleaning methods
• Performance (equivalent mechanical test results) | Technological Characteristics:
• "The subject and predicate systems are overall similar in: Intended use, Basic design, Materials, Sizes, Sterilization and cleaning methods, Performance (equivalent mechanical test results)."
• "The fundamental scientific technology of the subject system is the same as predicate devices." |
  | Material Equivalence:
• Medical grade ASTM F136 titanium alloy
• Medical grade ASTM F71537 cobalt chromium alloy | Materials:
• "The system components are manufactured from medical grade ASTM F136 titanium alloy and ASTM F71537 cobalt chromium alloy."
• "Medical grade titanium alloy and cobalt chromium alloy may be used together." |

2. Sample size used for the test set and the data provenance:
   The provided text describes pre-clinical performance data which typically refers to laboratory or bench testing, not human subject testing. Therefore, there is no "test set" in the sense of patient data. The "samples" would be the spinal implant components themselves, tested in a lab setting. The provenance is the testing conducted by Pioneer Surgical Technology, Inc. There is no information regarding the number of components tested in the provided summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   This section is not applicable as the "testing" described is mechanical bench testing, not expert review of clinical data to establish ground truth. The "ground truth" here is the specific mechanical properties and failure points determined by the standardized ASTM tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   Not applicable. Adjudication methods are used for clinical studies involving interpretation of data by multiple experts. This submission focuses on engineering and mechanical 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:
   Not applicable. This device is a spinal implant, not an AI-powered diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   Not applicable. This device is a spinal implant. Performance is evaluated through mechanical testing and comparison to predicate devices, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   For the mechanical testing, the "ground truth" is defined by the objective, quantitative criteria established in the ASTM standards (ASTM F1717 and ASTM F1798). These standards define acceptable levels of performance for spinal fixation devices related to static and dynamic compression, bending, torsion, and connector integrity.

8. The sample size for the training set:
   Not applicable. This is a medical device submission for a physical implant, not a machine learning model that requires a training set.

9. How the ground truth for the training set was established:
   Not applicable (no training set for an AI model).

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