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The indications for use for the modified devices described in this submission are the same as those for the Summit OCT Spinal System (K022190). The indications are as follows:

When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput -T3), the Summit Occipito-Cervical-Thoracic (OCT) Spinal System is intended 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
• 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 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.

Addition of 3.5mm rod to the Summit OCT Spinal System.

The Summit OCT Spinal System also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.

This document describes a 510(k) submission for an addition of a 3.5mm rod to the Summit OCT Spinal System. This is a submission for a modified medical device, not for a novel diagnostic device or AI algorithm. As such, the information typically expected for acceptance criteria and studies proving performance for AI/diagnostic devices (such as sample sizes, expert ground truth, MRMC studies, standalone performance) is not applicable in this context.

The "PERFORMANCE DATA" section simply states: "Performance data were submitted to characterize the modified Summit OCT Spinal System." The FDA's response confirms that the device is "substantially equivalent" to predicate devices, meaning it meets the same safety and effectiveness standards, likely through engineering analyses and mechanical testing, rather than clinical studies with human subjects that establish diagnostic performance metrics.

Therefore, many of the requested fields cannot be filled as they pertain to a different type of medical device submission.

Here's the closest interpretation of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: In the context of a 510(k) for a modified implantable device like this, acceptance criteria typically revolve around demonstrating that the new component (the 3.5mm rod) does not compromise the safety and effectiveness of the overall system and that it meets established mechanical and material standards. The "reported device performance" here is the conclusion that these criteria were met, leading to the substantial equivalence determination.

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

• Not Applicable. This submission is for a modified implantable device. "Test set" and "data provenance" (in the context of clinical or AI data) are not relevant here. Performance data for such devices usually involves mechanical testing (e.g., fatigue, static strength), which doesn't involve clinical "test sets" in the same way.

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

• Not Applicable. Ground truth in the context of clinical/AI data is not relevant for this type of device submission. Device performance is evaluated against engineering specifications and material standards.

4. Adjudication method for the test set

• Not Applicable. See notes above.

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 is an implantable surgical device, not a diagnostic AI tool. MRMC studies are not relevant.

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

• Not Applicable. This is an implantable surgical device, not an AI algorithm.

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

• Not Applicable. For a spinal fixation system, performance is established through engineering principles, material specifications, and potentially mechanical testing, rather than ground truth from medical diagnoses or outcomes data in the way an AI diagnostic would.

8. The sample size for the training set

• Not Applicable. This is an implantable surgical device, not an AI algorithm.

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

• Not Applicable. This is an implantable surgical device, not an AI algorithm.

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The indications for use for the modified devices described in this submission are the same as those for the Summit OCT Spinal System (K022190). The indications are as follows:

When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput -T3), the Summit Occipito-Cervical-Thoracic (OCT) Spinal System is intended 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
• 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 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 Minipolyaxial Screws are designed to accept a 3.0mm rod and are available in various sizes and geometries.

The Summit OCT Spinal System also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.

Manufactured from ASTM F-136 implant grade titanium alloy.

The provided text is a 510(k) summary for a medical device (Summit OCT Spinal System Minipolyaxial Screws) and contains regulatory information, indications for use, and a description of the device. However, it does not contain any information about acceptance criteria, detailed study designs, or performance data beyond a general statement that "Performance data were submitted to characterize the modified Summit OCT Spinal System minipolyaxial screws."

Therefore, I cannot provide the requested information from the given text.

To answer your questions, I would need a document that includes:

• Specific acceptance criteria (e.g., tensile strength, fatigue life, torsional stability thresholds).
• Details of mechanical or other performance studies.
• Results of those studies demonstrating compliance with the acceptance criteria.
• Information on human reader studies or ground truth establishment if this were an AI/image-based device, which it is not.

Ask a specific question about this device