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When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3), the Summit Occipito-Cervico-Thoracic (OCT) Spinal System is indicated for:

• ddd (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
• spondylolisthesis
• spinal stenosis
• fracture/dislocation
• atlantoaxial fracture with instability
• occipitocervical dislocation
• revision of previous cervical spine surgery
• tumors

The occipital bone screws are limited to occipital fixation only.

The use of the minipolyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.

The Songer Cable System to be used with the Summit OCT Spinal System allows for wire/cable attachment to the posterior cervical spine.

The Summit OCT System can also be linked to the ISOLA, TiMX, Monarch and MOSS Miami Systems using the dual wedding band and axial connectors, and via dual diameter rods.

The Summit OCT Spinal System consists of plates, nuts, bone screws, rods, transverse rod connectors, cable connectors, dual wedding band and axial connectors, set screws, minipolyaxial screws and Songer Cables. For occipitocervicothoracic fusion, the transition rod is bent and cut to the appropriate length. The occipital plate is fixed to the occiput with bone screws and the transition rod is attached to the plate by a locking mechanism. This locking mechanism consists of a bolt and a washer which are free to rotate and translate along a slot in the occipital plates. The rod loads from the top and is fixed and locked into place with a mini outer nut. Sub-axially, cable connectors are fixed to the transition rod and attached to the spine via sublaminar cabling looped through the cable connectors. The end of the construct is stabilized with polyaxial screws and mini outer nuts to the upper thoracic spine, as required.

The Summit OCT System can also be linked to the ISOLA, TiMX. Monarch and MOSS Miami Systems using the dual wedding bands and axial connectors, and via dual diameter rods.

The provided text describes a medical device, the Summit Occipito-Cervico-Thoracic (OCT) Spinal System, and its submission for 510(k) clearance. It does not contain information about software, AI, or performance criteria typically associated with such technologies. Therefore, I cannot generate the requested table and study details.

The document focuses on the intended use, device description, and a general statement about "Biomechanical testing, including static and dynamic cantilever beam testing and axial slip testing" as performance data. This type of testing is standard for mechanical medical devices to establish their structural integrity and biocompatibility, not for assessing diagnostic accuracy or algorithmic performance.

Specifically, the document lacks information on:

• Acceptance Criteria for an AI/Software Device: There are no metrics like sensitivity, specificity, accuracy, F1-score, or any other performance thresholds typical for AI or software.
• Reported Device Performance of an AI/Software Device: No numerical results are provided that would correspond to the acceptance criteria.
• Sample Size for Test Set: There is no mention of a test set, only biomechanical testing performed on the physical device.
• Data Provenance: Not applicable as there's no data in the context of AI.
• Number of Experts & Qualifications for Ground Truth: Not applicable, as there's no algorithmic ground truth being established.
• Adjudication Method: Not applicable.
• MRMC Comparative Effectiveness Study: Not mentioned.
• Standalone Performance: Not applicable for a mechanical device.
• Type of Ground Truth: Not applicable for a mechanical device.
• Training Set Size and Ground Truth Establishment: Not applicable for a mechanical device.

The FDA letter confirms the device's substantial equivalence to predicate devices based on the information provided by the submitter, DePuy AcroMed, Inc. This 510(k) clearance process is for traditional medical devices, not for AI-enabled software.

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When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3), the Summit Occipito-Cervico-Thoracic (OCT) Spinal System is indicated for:

• ddd (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
• spondylolisthesis
• spinal stenosis
• fracture/dislocation
• atlantoaxial fracture with instability
• occipitocervical dislocation
• revision of previous cervical spine surgery
• tumors

The occipital bone screws are limited to occipital fixation only.

The use of the minipolyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.

The Songer Cable System to be used with the Summit OCT Spinal System allows for wire/cable attachment to the posterior cervical spine.

The Summit OCT System can also be linked to the ISOLA, TiMX, Monarch and MOSS Miami Systems using the dual wedding band and axial connectors, and via dual diameter rods.

The Summit OCT Spinal System consists of plates, nuts, bone screws, rods, transverse rod connectors, cable connectors, dual wedding band and axial connectors, set screws, minipolyaxial screws and Songer Cables. For occipitocervicothoracic fusion, the transition rod is bent and cut to the appropriate length. The occipital plate is fixed to the occiput with bone screws and the transition rod is attached to the plate by a locking mechanism. This locking mechanism consists of a bolt and a washer which are free to rotate and translate along a slot in the occipital plates. The rod loads from the top and is fixed and locked into place with a mini outer nut. Sub-axially, cable connectors are fixed to the transition rod and attached to the spine via sublaminar cabling looped through the cable connectors. The end of the construct is stabilized with polyaxial screws and mini outer nuts to the upper thoracic spine, as required.

The Summit OCT System can also be linked to the ISOLA, TiMX, Monarch and MOSS Miami Systems using the dual wedding band and axial connectors, and via dual diameter rods.

Manufactured from ASTM F-136 implant grade titanium alloy.

The provided text describes a medical device, the Summit OCT Spinal System, and its indications for use, but it does not contain acceptance criteria for device performance or any study that proves the device meets such criteria.

The document is a 510(k) summary, which is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. This process typically relies on comparing the new device's technological characteristics and proposed indications to those of a predicate device, along with summary data from testing (often bench testing for mechanical devices). It doesn't usually involve clinical trials with human subjects to establish performance metrics like sensitivity, specificity, accuracy, or to study human reader improvement with AI.

Here's how the requested information maps to the provided text:

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

• Acceptance Criteria for Performance: Not specified in the provided text. The 510(k) summary focuses on substantial equivalence based on materials, design, and intended use, rather than specific performance metrics (e.g., sensitivity, specificity for a diagnostic device, or failure rates for a therapeutic device).
• Reported Device Performance: The document states: "Biomechanical testing, including static and dynamic construct axial compression bending and static construct torsion, were conducted." However, the results of this testing (i.e., what performance was achieved or what acceptance criteria were met) are not provided.

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

• Not applicable/Not provided. The document mentions "biomechanical testing" but does not detail the sample sizes (e.g., number of constructs tested), provenance, or whether it was a retrospective or prospective test. Given it's biomechanical testing, it would likely involve in-vitro or simulated environments.

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/Not provided. This type of information is relevant for studies involving human interpretation or clinical outcomes, which are not detailed here.

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

• Not applicable/Not provided. Adjudication methods are typically used in studies where human readers are involved in making assessments, which is not described for this device's performance evaluation.

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 MRMC study was described. This device is a spinal implant system (hardware), not an AI-assisted diagnostic tool. Therefore, a study comparing human reader performance with and without AI assistance is not relevant or included.

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

• No standalone algorithm performance was described. As stated above, this is a physical medical device, not an algorithm or AI system.

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

• For the "biomechanical testing" mentioned, the "ground truth" would likely be engineering specifications, material properties, and established testing standards (e.g., ASTM standards for biomechanical implants). However, the specific details are not provided.

8. The sample size for the training set

• Not applicable/Not provided. This concept is relevant for machine learning algorithms, which is not the nature of this device or its evaluation as described.

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

• Not applicable/Not provided, for the same reasons as point 8.

Summary:

The provided 510(k) summary for the Summit OCT Spinal System focuses on demonstrating substantial equivalence to predicate devices, outlining its materials, components, and intended use. While it mentions "biomechanical testing," it does not include any specific acceptance criteria or the results of such testing. The document does not describe any clinical studies, studies involving human readers, or the use of artificial intelligence. Therefore, it does not contain the information requested regarding acceptance criteria, study methodologies, or performance metrics typically associated with device performance claims in the context of clinical or diagnostic efficacy.

Ask a specific question about this device

Ask a specific question about this device

When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3), the Summit Occipito-Cervico-Thoracic (OCT) Spinal System is indicated for:

• ddd (neck pain of discogenic origin with degeneration of the disc as . confirmed by patient history and radiographic studies)
• spondylolisthesis t
• spinal stenosis .
• fracture/dislocation .
• atlanto/axial fracture with instability .
• occipitocervical dislocation .
• revision of previous cervical spine surgery
• tumors .

The occipital bone screws are limited to occipital fixation only.

The use of the minipolyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.

The Songer Cable System to be used with the Summit OCT Spinal System allows for wire/cable attachment to the posterior cervical spine.

The Summit OCT Spinal System consists of rods, plates, nuts, bolts, washers, bone screws, transverse rod connectors, cable connectors, set screws, minipolyaxial screws and Songer Cables. For occipitocervicothoracic fusion, the transition rod is bent and cut to the appropriate length. The occipital plate is fixed to the occiput with bone screws and the transition rod is attached to the plate by a locking mechanism. This locking mechanism consists of a bolt and a washer which are free to rotate and translate along a slot in the occipital plates. The rod loads from the top and is fixed and locked into place with a mini outer nut. Sub-axially, cable connectors are fixed to the transition rod and attached to the spine via sublaminar cabling looped through the cable connectors. The end of the construct is stabilized with polyaxial screws and mini outer nuts to the upper thoracic spine, as required.

The provided text describes a medical device, the Summit Occipito-Cervico-Thoracic (OCT) Spinal System, and its submission for 510(k) clearance. However, it does not contain acceptance criteria for device performance nor any details of a study structured to prove device performance against such criteria.

The "Performance Data" section merely states that "Biomechanical testing, including static axial slippage, static torsion slippage, static and dynamic construct axial compression bending and static and dynamic construct torsion, were conducted." This indicates that tests were performed, but does not provide specific acceptance criteria, test results, or details about the study design that would allow for an assessment of whether the device met any defined performance thresholds.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them, nor can I fill in a table of acceptance criteria and reported performance, or provide details on sample size, ground truth, expert involvement, or comparative effectiveness studies. These types of detailed performance data and study breakdowns are typically found in a more comprehensive premarket submission or a scientific publication rather than the summary provided here.

Ask a specific question about this device