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Found 3 results
510(k) Data Aggregation
(266 days)
NEXTGEN ALTIUS OCT SYSTEM
When intended for stabilization as an adjunct to fusion of the cervical spine and occipito-cervico-thoracic junction (occiput -T3), the Nextgen Altius OCT System is intended for use with allograft or autograft and indicated for: DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies); spondylolisthesis; deformities or curvatures (i.e., scoliosis, kyphosis and/or lordosis); pseudoarthrosis; spinal stenosis; trauma, (i.e., fracture or dislocation); atlanto/axial fracture with instability; occipitocervical dislocation; revision of previous cervical spine surgery; and tumors.
The occipital bone screws are limited to occipital fixation only.
The use of pedicle screws is limited to placement in T1-T3 in treating thoracic conditions only. They are not intended to be placed in or treat conditions involving the cervical spine.
The Nextgen Altius OCT System can also be linked to the Biomet Polaris Systems via transitional rods or using Altius Rod Connectors or Polaris Dominoes. Please refer to the individual system's package insert for a list of indications for use for each system.
This submission is a line extension to Nextgen Altius OCT System to add an alternate style of multiaxial screws to the system.
The provided documents describe findings for a spinal fixation system, not an AI/ML device. Therefore, the questions related to AI/ML device performance (such as sample size for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for training) cannot be answered from the provided text.
However, I can extract information related to the device's mechanical performance and the study conducted.
Here is the information based on the provided text:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (What was tested) | Reported Device Performance (How the device performed) |
|---|---|
| Static interconnection testing | Met all mechanical test requirements based on worst-case construct testing. |
| Compression bending fatigue | Met all mechanical test requirements based on worst-case construct testing. |
| Dissociation testing | Met all mechanical test requirements based on worst-case construct testing. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified for individual tests. The text refers to "worst-case construct testing."
- Data Provenance: Not applicable. This refers to mechanical testing, not clinical data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth for mechanical testing is established by engineering standards and measurements, not expert consensus.
4. Adjudication method for the test set
Not applicable. Mechanical tests have pass/fail criteria based on engineering standards.
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 not an AI/ML diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a mechanical spinal fixation system.
7. The type of ground truth used
For mechanical testing, the "ground truth" or reference criterion is based on established engineering standards (ASTM F1717, ASTM F1798) and relevant FDA guidance (FDA's Guidance for Industry and FDA Staff - Spinal System 510(k)s dated May 3, 2004).
8. The sample size for the training set
Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
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(45 days)
NEXTGEN ALTIUS OCT SYSTEM
When intended for stabilization as an adjunct to fusion of the cervical spine and occipito-cervicothoracic junction (occiput -T3), the Nextgen Altius OCT System is intended for use with allograft or autograft and indicated for: DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies); spondylolisthesis; deformities or curvatures (i.e., scoliosis, kyphosis and/or lordosis); pseudoarthrosis; spinal stenosis; trauma, (i.e., fracture or dislocation); atlanto/axial fracture with instability; occipitocervical dislocation; revision of previous cervical spine surgery; and tumors.
The occipital bone screws are limited to occipital fixation only.
The use of pedicle screws is limited to placement in T1-T3 in treating thoracic conditions only. They are not intended to be placed in or treat conditions involving the cervical spine.
The Nextgen Altius OCT System can also be linked to the Biomet Polaris Systems via transitional rods or using Altius Rod Connectors or Polaris Dominoes. Please refer to the individual system's package insert for a list of indications for use for each system.
The Nextgen Altius OCT System is an occipito-cervico-thoracic spinal fixation system. The titanium alloy (Ti-6Al-4V) components in the system includes screws, locking plugs, various types and styles of rods, hooks, lateral connectors, set screws, occipital plates, rod connectors/dominos and various cross connectors. The system also includes CoCr rods fabricated from Co-28Cr-6Mo alloy. Bone screws are placed in the thoracic spine (T1-T3) and hooks are placed in the cervical spine. The rod is inserted and the construct is locked with plugs. Cross connectors can be added to the construct for additional stability. This submission is a line extension to Nextgen Altius OCT System to add alternate styles of occipital plates, occipital screws and occipital locking plugs to the system.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Static compression bending requirements (ASTM F2706) | Met |
| Static torsion fatigue requirements (ASTM F2706) | Met |
| Compression bending fatigue requirements (ASTM F2706) | Met |
| Interconnection fatigue test of plate and rod assembly | Met |
| Substantial equivalence with predicate devices (intended use, indications, technological characteristics, operational principles, safety, efficacy) | Demonstrated substantially equivalent |
2. Sample Size Used for the Test Set and Data Provenance
The study does not explicitly mention a "test set" in the context of clinical data or human evaluation. The performance data presented are based on mechanical testing of the device components.
- Sample Size for Mechanical Testing: Not explicitly stated as a numerical count of individual components. The testing was conducted on "worst-case construct testing" to represent the system.
- Data Provenance: Not applicable in the context of human data. The data originates from laboratory mechanical testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
Not applicable. The "ground truth" for this device's performance is established through adherence to recognized mechanical testing standards (FDA Guidance and ASTM F2706) and comparison to predicate devices, rather than expert interpretation of clinical data.
4. Adjudication Method for the Test Set
Not applicable. This was a mechanical engineering study, not a clinical study involving human assessment and adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This document describes mechanical testing for a spinal fixation system, not a study involving human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a medical implant, not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance is established by:
- Mechanical Testing Standards: Adherence to established industry standards like ASTM F2706 for various force and fatigue tests, as well as FDA's Guidance for Spinal System 510(k)s.
- Predicate Device Performance: Comparison to the known performance and safety profiles of legally marketed predicate devices.
8. The Sample Size for the Training Set
Not applicable. There is no mention of a "training set" as this is a mechanical device, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for a machine learning model, no ground truth needed to be established in that context.
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(134 days)
NEXTGEN ALTIUS OCT SYSTEM
When intended for stabilization as an adjunct to fusion of the cervical spine and occipito-cervicothoracic junction (occiput -T3), the Nextgen Altius OCT System is intended for use with allograft or autograft and indicated for: DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies); spondylolisthesis; deformities or curvatures (i.e., scoliosis, kyphosis and/or lordosis); pseudoarthrosis; trauma, (i.e., fracture or dislocation); atlanto/axial fracture with instability; occipitocervical dislocation; revision of previous cervical spine surgery; and tumors.
The occipital bone screws are limited to occipital fixation only.
The use of pedicle screws, is limited to placement in T1-T3 in treating thoracic conditions only. They are not intended to be placed in or treat conditions involving the cervical spine.
The Nextgen Altius OCT System can also be linked to the Biomet Polaris Systems via transitional rods or using Altius Rod Connectors or Polaris Dominoes. Please refer to the individual system's package insert for a list of indications for use for each system.
The Nextgen Altius OCT System is an occipito-cervico-thoracic spinal fixation system. This submission is a line extension to Altius OCT System to add CoCr rods and alternate styles of rods, and screws, as well as other system components to the system and to update the indications for use for the system as a whole.
Here's a breakdown of the acceptance criteria and the study information based on the provided document:
This 510(k) summary is for a spinal fixation system, which falls under the category of a medical device and not an AI/ML algorithm. Therefore, many of the requested points related to AI/ML studies (like MRMC, standalone algorithm performance, AI improvement over human readers, training set details) are not applicable to this document. The study described is a series of mechanical tests to demonstrate substantial equivalence to existing predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from FDA Guidance) | Reported Device Performance |
|---|---|
| Mechanical Test Requirements: | |
| Static compression bending | Met all mechanical test requirements based on worst-case construct testing |
| Static torsion fatigue | Met all mechanical test requirements based on worst-case construct testing |
| Compression bending fatigue | Met all mechanical test requirements based on worst-case construct testing |
| Substantial Equivalence to Predicate Devices (design, indications, operational principle, safety, effectiveness) | The subject components are substantially equivalent to predicate devices (Altius OCT System, Depuy Mountaineer OCT Spinal System, Vertex Max® & Select™ Reconstruction Systems); did not present any new issues of safety or effectiveness. |
| Compliance with ASTM F2706 | Conducted in accordance with ASTM F2706 |
| Compliance with ASTM F1717 | Conducted in accordance with ASTM F1717 |
| Compliance with ASTM F1798 | Conducted in accordance with ASTM F1798 |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: This information is not explicitly stated in the summary. For mechanical tests, the "sample size" would refer to the number of constructs tested for each configuration.
- Data Provenance: The data is generated from mechanical laboratory testing of the device components, not from patient data. Therefore, concepts like "country of origin" or "retrospective/prospective" studies are not applicable.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not Applicable. As this is a mechanical testing study for a physical device, expert-established ground truth (in the clinical sense, e.g., for image interpretation) is not relevant. The "ground truth" here is adherence to established mechanical testing standards (ASTM standards) and the comparison of performance metrics against predicate devices.
4. Adjudication Method for the Test Set
- Not Applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements in expert clinical assessments or diagnostic interpretations. This study involves objective mechanical performance measurements, not subjective expert reviews.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
- No. An MRMC study is relevant for evaluating the impact of an AI/ML system on human reader performance. This document describes mechanical testing of a spinal fixation device, which does not involve human readers for diagnostic interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- No. This is not an AI/ML algorithm. It is a physical medical device.
7. The Type of Ground Truth Used
- The "ground truth" in this context is based on established mechanical testing standards (ASTM F2706, F1717, F1798) and performance characteristics of legally marketed predicate devices. The goal is to demonstrate that the new device's components meet these engineering and regulatory benchmarks, indicating that they are at least as safe and effective as existing devices.
8. The Sample Size for the Training Set
- Not Applicable. There is no "training set" in the context of mechanical testing for a spinal fixation system. This concept applies to the development of AI/ML algorithms.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. As there is no training set, there is no ground truth established for one.
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