Search Results
Found 7 results
510(k) Data Aggregation
(104 days)
MOUNTAINEER OCT Spinal System, SUMMIT SI OCT Spinal Fixation System, SYMPHONY OCT System, SUMMIT Fixation
The SUMMIT SI OCT Spinal Fixation System and MOUNTAINEER OCT Spinal System are intended to provide immobilization and stabilization of spinal segments as an adjunct to following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1-T3):
- · Traumatic spinal fractures and/or traumatic dislocations;
• Instability or deformity;
· Failed previous fusions (e.g. pseudarthrosis); - · Tumors involving the cervical/thoracic spine;
· Degenerative disease, including intractable radiculopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and
· Degenerative disease of the facets with instability.
The SUMMIT and MOUNTAINEER Systems are 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.
The SONGER Wire/Cable System to be used with the SUMMIT and MOUNTAINEER Systems allows for wire/cable attachment to the posterior cervical spine.
The SUMMIT and MOUNTAINEER Systems can also be linked to the ISOLA, MONARCH, MOSS MIAMI, VIPER and EXPEDIUM Spine Systems using the dual wedding band and axial connectors, and via dual diameter rods.
The SYMPHONY OCT System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the upper thoracic spine (T1-T3):
- · Traumatic spinal fractures and/or traumatic dislocations;
- Instability or deformity;
- · Failed previous fusions (e.g. pseudarthrosis);
- · Tumors involving the cervical/thoracic spine;
· Degenerative disease, including intractable radiculopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and
· Degenerative disease of the facets with instability.
The SYMPHONY OCT 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.
The SYMPHONY OCT System is compatible with occipital fusion components (plates, rods and clamps) from the SYNAPSE Occipital-Cervical-Thoracic (OCT) System and the MOUNTAINEER OCT Spinal System. Additionally, the SYMPHONY OCT System is compatible with SYNAPSE OCT System hooks and rods.
The SONGER Wire/Cable System may be used with the SYMPHONY OCT System to allow for wire/cable attachment to the posterior cervical spine.
The SYMPHONY OCT System may be connected to the EXPEDIUM Spine System using connectors and tapered rods. The SYMPHONY OCT System can also be linked to the USS Spinal System and MATRIX Spine System using connectors and tapered rods.
The SUMMIT Plate System is intended for use in treating fractures of small bones such as the metacarpals, uha, radius, humerus, and metatarsals, and in treating fractures of the lateral malleoulus, olecranon, and intra-articular distal tibia.
The SUMMIT Rod System is intended for use in treating fractures of the pelvis, acetabulum, clavicle, scapula, and distal humerus.
The MOUNTAINEER OCT Spinal System, SUMMIT SI OCT Spinal Fixation System, and SYMPHONY OCT System are posterior spinal fixation systems intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion of the craniocervical junction, the cervical spine (C1 to C7) and the upper thoracic spine (T1-T3). The systems are composed of multiple components to allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. The systems consist of bone anchors (such as screws) for connection by longitudinal components (such as rods) via an interconnection mechanism (e.g., set screws) with optional transverse connectors (e.g., cross connectors) to link the longitudinal components for additional stability.
The SUMMIT Fixation System is intended for fracture fixation. The device may be removed after healing of the fracture has occurred. The system includes various lengths of 3 mm rods, 3.5 mm, 4.0 mm and 4.5 mm bone screws, plates, washers, connector plates, pin nuts, and outer nuts.
This document is a 510(k) Pre-market Notification from the FDA for a medical device. It does not describe a study involving an AI/Machine Learning device or its acceptance criteria. Instead, it concerns the substantial equivalence of an orthopedic spinal fixation system (MOUNTAINEER OCT Spinal System, SUMMIT SI OCT Spinal Fixation System, SYMPHONY OCT System, and SUMMIT Fixation System) to previously cleared predicate devices, primarily for the purpose of adding Magnetic Resonance (MR) compatibility labeling.
Therefore, most of the requested information regarding acceptance criteria and performance studies for an AI/ML device is not present in this document. The document focuses on physical device characteristics and their MR compatibility through non-clinical testing.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table for acceptance criteria in the context of an AI/ML device's performance. Instead, it refers to non-clinical testing conducted in alignment with ASTM standards for magnetic resonance compatibility. The "performance" reported is simply that "Results demonstrated compatibility conditions of the subject devices in the MR environment."
| Acceptance Criteria (based on ASTM Standards for MR compatibility) | Reported Device Performance |
|---|---|
| Measurement of Magnetically Induced Torque (ASTM F2213) | Compatibility demonstrated |
| Measurement of Magnetically Induced Displacement Force (ASTM F2052) | Compatibility demonstrated |
| Evaluation of MR Image Artifacts (ASTM F2119) | Compatibility demonstrated |
| Measurement of Radio Frequency Induced Heating (ASTM F2182) | Compatibility demonstrated |
2. Sample size used for the test set and the data provenance
This document describes non-clinical testing of physical devices, not an AI/ML test set. Therefore, "sample size" and "data provenance" as applied to AI/ML models are not applicable. The testing was conducted on the devices themselves.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as this is not an AI/ML device requiring clinical expert ground truth for its performance evaluation. The ground truth for MR compatibility is established by objective physical measurements based on ASTM standards.
4. Adjudication method for the test set
Not applicable. There is no adjudication method described as it's not a human-in-the-loop or expert consensus study.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done
No. This document does not mention any MRMC study, as it is not for a diagnostic AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is not an AI/ML device. The "standalone" performance here refers to the physical device's MR compatibility.
7. The type of ground truth used
The ground truth used for the MR compatibility testing was based on physical measurements and established ASTM standards for evaluating how medical devices interact with an MR environment (e.g., torque, displacement, heating, image artifacts). It is not expert consensus, pathology, or outcomes data.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set for an AI/ML device.
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(56 days)
SUMMIT SI OCT Spinal Fixation System, MOUNTAINEER OCT Spinal System
The SUMMIT® SI OCT Spinal Fixation System and MOUNTAINEER® OCT Spinal System are intended to provide immobilization and stabilization of spinal segments as an adjunct to following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1-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, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and
· degenerative disease of the facets with instability.
The SUMMIT and MOUNTAINEER Systems are 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.
The SONGER® Wire/Cable System to be used with the SUMMIT and MOUNTAINEER Systems allows for wire/cable attachment to the posterior cervical spine.
The SUMMIT and MOUNTAINEER Systems can also be linked to the ISOLA®, MONARCH®, MOSS® MIAMI, VIPER® and EXPEDIUM® Spine Systems using the dual wedding band and axial connectors, and via dual diameter rods.
The SUMMIT and MOUNTAINEER Systems are posterior spinal fixation systems intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1-T3). The systems are composed of multiple components to allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. The systems consist of bone anchors including hooks, SONGER® cables and screws, longitudinal members including rods and occipital plates, transverse connectors including cross connectors and interconnection mechanisms including lateral offset connectors, cable connectors, set screws, nuts, axial and wedding band connectors. The system components are implanted using class I exempt manual surgical instruments. This premarket notification expands the indications for use of the SUMMIT and MOUNTAINEER Systems to include posterior cervical screw fixation.
The provided text does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria in the context of AI/ML device performance. This document is a 510(k) premarket notification for a spinal fixation system, focusing on its substantial equivalence to predicate devices based on technological characteristics and mechanical performance testing, rather than an AI/ML driven device and its performance metrics.
Therefore, I cannot extract the requested information from the provided text.
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(27 days)
MOUNTAINEER OCT SPINAL SYSTEM
The MOUNTAINEER OCT Spinal System is intended to promote fusion of the cervical spine and occipitocervico-thoracic junction (occiput-T3), and is indicated for the following:
- 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® wire/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, MONARCH, MOSS MIAMI, VIPER and EXPEDIUM 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 components are manufactured from Titanium Alloy.
The MOUNTAINEER® OCT Spinal System Longitudinal rods are also available in cobalt-chromium-molybdenum alloy conforming to ASTM F-1537. Cobaltchromium-molybdenum alloy rods are intended for use with titanium components only.
The provided text does not describe the acceptance criteria for a device, nor does it detail a study proving the device meets acceptance criteria in the manner requested.
This document is a 510(k) summary for the MOUNTAINEER® OCT Spinal System. It focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a performance study with acceptance criteria.
Specifically, it states:
- "Performance data is not provided in this submission."
- "The Substantial Equivalence Justification demonstrates that the devices are as safe, as effective, and perform as well as the predicate devices."
Therefore, I cannot extract the requested information to fill in the table and answer the study-related questions. The device's approval is based on its similarity to existing, cleared devices, and not on new performance data provided in this particular submission.
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(59 days)
MOUNTAINEER OCT SPINAL SYSTEM
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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(28 days)
MOUNTAINEER OCT SPINAL SYSTEM
The indications for use for the modified devices described in this submission are the same as those for the MOUNTAINEER OCT Spinal System. The indications are as follows:
When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput - T3), the MOUNTAINEER 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 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.
Addition of the 3.5mm diameter monoaxial screw to the existing MOUNTAINEER® OCT Spinal System. This system also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.
The KIO3100 submission describes the addition of a 3.5mm diameter monoaxial screw to the existing MOUNTAINEER® OCT Spinal System. The device's performance is demonstrated through non-clinical mechanical testing, comparing it to predicate devices. This is a medical device, not an AI/ML device, so many of the requested categories are not applicable.
Here's the breakdown of the available information:
- A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Test) | Reported Device Performance |
|---|---|
| Static cantilever beam in accordance with ASTM F1798 | Testing conducted and results supported substantial equivalence. The submission implies that the new components meet the same performance standards as the predicate devices under these conditions. Specific numerical results are not provided in the summary, but the conclusion states "Based on the predicate comparison and testing, the subject MOUNTAINEER® OCT Spinal System is device substantially equivalent to the predicate device." |
| Static axial slip in accordance with ASTM F1798 | Testing conducted and results supported substantial equivalence. The submission implies that the new components meet the same performance standards as the predicate devices under these conditions. |
| Dynamic cantilever beam in accordance with ASTM F1798 | Testing conducted and results supported substantial equivalence. The submission implies that the new components meet the same performance standards as the predicate devices under these conditions. |
| Intended Use, Design Characteristics, Materials, Performance, and Packaging (comparison to predicate devices) | The proposed components "have the same intended use, design characteristics, materials, performance, and packaging as the predicate devices." |
-
Sample size 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. The study involved non-clinical mechanical testing, not clinical human subject data. -
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. This is a mechanical device, and "ground truth" as it applies to AI/ML or diagnostic studies is not relevant here. The ground truth for mechanical testing is established by the ASTM standards themselves and the physical measurements obtained. -
Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This is a mechanical device. -
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 a mechanical device. -
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a mechanical device. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For mechanical testing, the "ground truth" is defined by the physical properties measured under standardized ASTM test methods (ASTM F1798 in this case) and the established performance characteristics of the predicate devices. -
The sample size for the training set
Not applicable. This is a mechanical device, not an AI/ML system requiring a training set. -
How the ground truth for the training set was established
Not applicable.
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(94 days)
MOUNTAINEER OCT SPINAL SYSTEM
The indications for use for the modified devices described in this submission are the same as those for the MOUNTAINEER OCT Spinal System. The indications are as follows:
When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput – T3), the MOUNTAINEER 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 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™ and MOSS® MIAMI™ Systems using the dual wedding band and axial connectors, and via dual diameter rods.
Expansion of the size offering of MOUNTAINEER OCT Spinal System Minipolyaxial Screws. The MOUNTAINEER OCT Spinal System also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.
The provided text does not describe an AI/ML device, nor does it contain information about acceptance criteria and studies that prove a device meets those criteria in the context of AI/ML.
Instead, the document is a 510(k) summary for a medical device called the "MOUNTAINEER OCT Spinal System" (specifically, an expansion of its size offering). A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device.
The "Performance Data" section explicitly states: "Performance data were submitted to characterize the additional components of the MOUNTAINEER OCT Spinal System." This refers to mechanical performance data for the physical spinal implant components, not performance data for an AI/ML algorithm.
Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth related to an AI/ML device from this document.
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(22 days)
SUMIT OCT SPINAL SYSTEM AND MOUNTAINEER OCT SPINAL SYSTEM
When intended to promote fusion of the cervical spine and occipito-cervicothoracic junction (occiput -- T3), the Summit Occipito-Cervical-Thoracic (OCT) Spinal System and the Mountaineer 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 .
- atianto/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 and Mountaineer OCT Spinal System, allows for wire/cable attachment to the posterior cervical spine.
The Summit OCT Spinal System and the Mountaineer OCT Spinal System can also be linked to the ISOLA, TIMX, MONARCH, MOSS MIAMI, and EXPEDIUM Systems using the dual wedding band and axial connectors, and via dual diameter rods.
Addition of components to the Summit OCT Spinal System and Mountaineer OCT Spinal System.
The Summit OCT Spinal System and Mountaineer OCT Spinal Systems also contain Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.
This document is a 510(k) summary for the Summit OCT Spinal System and Mountaineer OCT Spinal System, specifically for an addition of components. It does not describe a study related to an AI/ML powered device, nor does it provide acceptance criteria or performance data in the typical sense of a clinical or performance study for such a device. Rather, it focuses on the substantial equivalence of additional components for an existing spinal fixation system.
Therefore, many of the requested elements for describing an AI/ML device study are not applicable or cannot be extracted from the provided text.
Here is an attempt to answer the questions based on the provided text, highlighting where information is not available due to the nature of the submission:
1. A table of acceptance criteria and the reported device performance
The provided document does not contain a table of acceptance criteria or reported device performance in the context of an AI/ML device study. This submission is for an addition of components to an existing spinal fixation system. The "Performance Data" section states: "Performance data were submitted to characterize the additional components of the Summit OCT Spinal System and Mountaineer OCT Spinal System." However, the details of this performance data and the specific acceptance criteria are not included in the provided 510(k) summary. These would typically involve mechanical testing, material characterization, and compliance with ASTM standards, not clinical performance metrics for an AI system.
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. This is a 510(k) submission for an addition of components to a spinal fixation system, not an AI/ML device for which a "test set" of data would be used to evaluate algorithm performance.
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. This is a 510(k) submission for an addition of components to a spinal fixation system.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is a 510(k) submission for an addition of components to a spinal fixation system.
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 a 510(k) submission for an addition of components to a spinal fixation system, not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a 510(k) submission for an addition of components to a spinal fixation system, not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. This is a 510(k) submission for an addition of components to a spinal fixation system. The "ground truth" for such devices typically involves established engineering principles, material science, and mechanical testing standards.
8. The sample size for the training set
Not applicable. This is a 510(k) submission for an addition of components to a spinal fixation system, not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. This is a 510(k) submission for an addition of components to a spinal fixation system.
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