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510(k) Data Aggregation
(54 days)
The Lineum OCT Spine 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 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 and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Lineum OCT Spine 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.
In order to achieve additional levels of fixation, the Lineum OCT Spine System can also be connected to the Biomet Polaris System via transitional rods or using the 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 Lineum OCT Spine System consists of various screws, hooks, plates, rods, connectors, etc. that are used to build a construct to provide supplemental stabilization of spinal segments to support fusions. The system can be assembled in a variety of configurations, allowing the surgeon to tailor the construct to the particular needs of the patient. The implants are designed for the occiput, cervical, and/or upper thoracic spine (Occiput – T3) and consist of medical grade titanium alloy and CoCrMo alloy, similar to the predicate device.
The provided document is a 510(k) premarket notification summary for a medical device called the "Lineum OCT Spine System." This type of document is for demonstrating substantial equivalence to a legally marketed predicate device, primarily through performance data focusing on mechanical and material properties, rather than clinical efficacy studies often seen with AI/ML devices. As such, the information required for a detailed AI/ML device study description (acceptance criteria, sample sizes, ground truth establishment, expert qualifications, etc.) is not present in this document.
The document discusses mechanical performance data, not AI/ML algorithm performance. Therefore, I cannot provide the requested information about acceptance criteria for an AI/ML device, the study proving it meets them, sample sizes for AI/ML tests, ground truth details, expert qualifications, or MRMC studies, as these concepts are not applicable to the content of this regulatory submission.
Here's what the document does provide regarding performance data:
Performance Data (Mechanical)
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated as acceptance criteria, but implied to meet or exceed. | The modified device functions as intended. The observed test results demonstrate that the device performs as well as or better than the unmodified system. |
Study Details (Mechanical Testing):
- Study Type: Non-clinical mechanical construct and component testing.
- Standards Used: Based on ASTM F2706 (Standard Test Method for Static and Fatigue Testing of a Spinal Orthosis for the Occiput-Cervical-Thoracic Spine) and ASTM F1798 (Standard Guide for Evaluation of Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Anterolateral Cervical Spine Fusion Constructs).
- Purpose: To support the substantial equivalence of the modified Lineum OCT Spine System to its predicate device.
- Conclusion: The mechanical testing provided demonstrates the substantial equivalence of the subject Lineum OCT Spine System.
Missing Information (Not applicable to this type of device submission):
- Sample size used for the test set and data provenance (e.g., country of origin, retrospective or prospective) for an AI/ML algorithm.
- Number of experts used to establish ground truth for a test set and their qualifications.
- Adjudication method for the test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study or effect size of human readers with/without AI assistance.
- Standalone (algorithm only) performance study.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for an AI/ML algorithm.
- Sample size for the training set (for an AI/ML algorithm).
- How the ground truth for the training set was established (for an AI/ML algorithm).
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(98 days)
The Polaris Spinal System is a non-cervical spinal fixation device intended for immobilization and stabilization as an adjunct to fusion as a pedicle screw fixation system, a posterior hook and sacral/iliac screw fixation system, or as an anterior or anterolateral fixation system. Pedicle screw fixation is limited to skeletally mature patients and for use with autograft and/or allograft. The device is indicated for all the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). spondylolisthesis, trauma, (i.e., fracture or dislocation), deformity or curvature (i.e., scoliosis, kyphosis, and/or lordosis), tumor, stenosis, pseudoarthrosis, or failed previous fusion.
The Ballista/Ballista II instruments are intended to be used with Ballista II/Polaris 5.5mm implants. Cannulated screws and percutaneous rods may be used with the Ballista/Ballista II instruments to provide the surgeon with a percutaneous approach for posterior spinal surgery for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, (i.e., fracture or dislocation), deformity or curvature (i.e., scoliosis, and/or lordosis), tumor, stenosis, pseudoarthrosis, or failed previous fusion that warrant the use of a non-cervical spinal fixation device intended for use as a pedicle screw fixation system or sacral/iliac screw fixation system. Pedicle screw fixation is limited to skeletally mature patients and for use with autograft and/or allograft.
The Polaris Spinal System may be used with the instruments in the AccuVision Minimally Invasive Spinal Exposure System to provide the surgeon with a minimally invasive approach for posterior spinal surgery.
The dominos in the Polaris Spinal System can be used to connect the Polaris Spinal System to the Altius Spinal System, the Array Spinal System, the Biomet Omega21 Spinal System, or the Synergy Spinal System to achieve additional levels of fixation. Please refer to the individual system's Package Insert for a list of the indications for use for each system.
The Polaris Spinal System is a non-cervical spinal fixation device. The system includes screws, various types and sizes of rods, locking nuts, hooks, lateral connectors, plugs, fixation washers, rod connectors/dominos and various cross connectors. Various instruments are also available for use by the surgeon to facilitate implantation of the device. This submission is a line extension to Polaris Spinal System to add other styles of multiaxial screw, including a screw with translating feature, and to provide the Polaris Spinal System sterile packed.
The provided document describes a 510(k) summary for the Biomet Spine Polaris Spinal System - Translation Screw, which is a non-cervical spinal fixation device.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Testing: | |
| Static compression bending per ASTM 1717-11a | Met all mechanical test requirements based on worst-case construct testing. |
| Static torsion per ASTM 1717-11a | Met all mechanical test requirements based on worst-case construct testing. |
| Dynamic compression bending fatigue per ASTM 1717-11a | Met all mechanical test requirements based on worst-case construct testing. |
| Substantial Equivalence: | Reported as substantially equivalent to predicate devices regarding material, design, operational principles, intended use, indications, and fundamental technology. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of clinical data for algorithmic performance. The testing performed was mechanical testing of the device hardware.
- Test Set Sample Size: Not applicable in the context of clinical data or algorithm performance.
- Data Provenance: Not applicable. The "data" comes from physical mechanical tests conducted on the device components.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Ground truth, in the context of algorithm performance, typically refers to expert-validated clinical diagnoses or outcomes. This submission focuses on mechanical performance data of a physical medical device.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods are relevant for resolving discrepancies in expert opinions for clinical ground truth. Mechanical testing has well-defined pass/fail criteria per ASTM 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
No, an MRMC comparative effectiveness study was not done. This device is a physical spinal fixation system, not an AI or imaging diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not done. This submission is for a physical medical device.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The "ground truth" for the mechanical testing was the established pass/fail criteria defined by ASTM 1717-11a standard test methods for static and fatigue testing of spinal implant constructs in a vertebrectomy model.
8. The Sample Size for the Training Set
Not applicable. This device is a physical implant, not an AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a physical device.
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