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510(k) Data Aggregation
(59 days)
When intended to promote fusion of the cervical spine and occipito-cervico-thoracic iunction (occiput - T3), the MOUNTAINEER Occipito-Cervical-Thoracic (OCT) Spinal Svstem 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 monoaxial and polyaxial 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 MOUNTAINEER OCT Spinal System, allows for wire/cable attachment to the posterior cervical spine.
The MOUNTAINEER OCT Spinal System can also be linked to the ISOLA®, TiMX®, MONARCH®, EXPEDIUM®, VIPER® and MOSS® MIAMI Systems using the dual wedding band and axial connectors, and via dual diameter rods.
The MOUNTAINEER OCT Spinal System consists of plates, nuts, bone screws, rods, transverse rod connectors, lateral offset connectors, head-to-head connectors, cable connectors, dual wedding band and axial connectors, set screws, minipolyaxial screws, monoaxial screws, hooks and SONGER® Cables.
The MOUNTAINEER OCT System Titanium Rods (Ti-6AL-4V) are offered in both Straight and Dual Diameter designs. The Straight Rod diameter is 3.5mm and has lengths ranging from 25mm-100mm in increments of 5mm and lengths ranging from 100mm-400mm in increments of 20mm. The Dual Diameter Rods consists of 3.5 - 4.5mm, 3.5 -4.75mm. 3.5 - 5.5mm. and 3.5 - 6.35mm diameters with Rod lengths of 420mm and 600mm.
The proposed MOUNTAINEER Cobalt Chromium (Co-Cr) Rods also consist of both Straight and Dual Diameter designs. The Straight Rod diameter is 3.5mm and available in lengths ranging from 25mm to 100mm (increments of 5mm) and 120, 200, 340 and 400mm. The Dual Diameter MOUNTAINEER Co-Cr Rods consist of 3.5 – 4.5mm, 3.5 – 4.75mm, 3.5 – 5.5mm and 3.5 – 6.35mm and available in lengths of 420 and 600mm.
Other than the modifications to the material from Ti-6Al-4V to Co-Cr, no other modifications have been made. The proposed Cobalt Chromium rods are not being made to address a known recall or adverse events. These proposed components have been developed as additions to the existing MOUNTAINEER OCT Spinal System.
The MOUNTAINEER OCT Spinal System is not an AI/ML powered medical device. The information provided describes a traditional medical device (Spinal System) and its 510(k) submission. Therefore, it does not have the acceptance criteria or study details typically associated with AI/ML device performance.
The submission focuses on demonstrating substantial equivalence to a predicate device based on material change (from Titanium to Cobalt Chromium) while maintaining identical design, indications for use, and technology.
Here's an analysis based on the provided text, focusing on the available "Performance Data" which is relevant to a non-AI device submission:
1. Table of Acceptance Criteria and Reported Device Performance
For this device, the "acceptance criteria" are tied to mechanical performance standards to ensure the new material (Cobalt Chromium) performs equivalently to the predicate Titanium device. The reported performance refers to the results of these tests.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Mechanical Equivalence to Predicate Device: | |
| Static Compression-Bending strength (per ASTM F 1717) | (Not explicitly stated in numerical terms in the summary, but the conclusion states that performance testing demonstrates that the device is as safe, as effective, and performs as well as the predicate device. This implies the new material met or exceeded the predicate's performance in these tests.) |
| Dynamic Compression-Bending (Fatigue) strength (per ASTM F 1717) | (Not explicitly stated in numerical terms in the summary, but the conclusion states that performance testing demonstrates that the device is as safe, as effective, and performs as well as the predicate device. This implies the new material met or exceeded the predicate's performance in these tests.) |
| Static Torsion strength (per ASTM F 1717) | (Not explicitly stated in numerical terms in the summary, but the conclusion states that performance testing demonstrates that the device is as safe, as effective, and performs as well as the predicate device. This implies the new material met or exceeded the predicate's performance in these tests.) |
| Compliance with ASTM F 1717: | Performance data per ASTM F 1717 were submitted to characterize the subject MOUNTAINEER OCT Spinal System rods addressed in this notification. This indicates that the testing methodology aligned with the standard, and the results were deemed acceptable for regulatory clearance. |
| Overall Safety and Effectiveness Equivalence: | Both the Performance Testing and Substantial Equivalence Justification demonstrate that the device is as safe, as effective, and performs as well as the predicate device. This is the ultimate acceptance criterion for this type of 510(k) submission, confirming that the new Cobalt Chromium rods meet the required performance standards. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated in the provided text. Mechanical testing typically involves a sufficient number of samples to achieve statistical significance for each test (static, dynamic, torsion).
- Data Provenance: The data is from "Performance data per ASTM F 1717" submitted by the manufacturer, DePuy Spine, Inc. This is prospective testing of the device itself, not retrospective patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. For a mechanical device, performance is established through objective, standardized physical testing (e.g., ASTM F 1717), not through expert consensus on medical images or patient outcomes. The "ground truth" is the physical properties and performance of the device under specific load conditions.
4. Adjudication method for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for human expert review of clinical data, especially in studies involving AI/ML where ground truth needs to be established from subjective interpretations. This submission involves objective 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 is not an AI/ML powered device, and no MRMC study was conducted or is relevant for this type of device submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm.
7. The type of ground truth used
The "ground truth" for this device's performance is derived from mechanical testing standards (ASTM F 1717). The measured physical properties and performance characteristics (e.g., strength, fatigue resistance) of the Cobalt Chromium rods, when compared against the established performance of the Titanium predicate device, serve as the ground truth for demonstrating substantial equivalence.
8. The sample size for the training set
Not applicable. This is not an AI/ML powered device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML powered device.
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