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510(k) Data Aggregation
(165 days)
Elevation Spine
The Elevation Spine Saber-C System is a cervical interbody fusion device intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) and is for use in one or two adjacent spinal levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. The SABER-C Spacer is to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone.
The SABER-C Spacer is intended to be used with supplemental fixation, such as anterior cervical plates or posterior cervical screw fixation. When the SABER-C Spacer is used with the SABER-C Anterior Cervical Plate and screws, the plate-spacer-screw assembly can be used as a stand-alone device with the SABER-C Anterior Cervical Plate acting as the supplemental fixation. When the SABER-C Spacer is used with the SABER-C Anterior Cervical Plate and spikes, the plate-spacer-spike assembly should be used with additional supplemental fixation such as posterior cervical screw fixation.
The SABER-C Anterior Cervical Plate, when used without the spacer component and with screws, is intended for anterior screw fixation to the cervical spine (C2-C7) for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis. The Anterior Cervical Plate is not to be used with spikes when used without the Spacer component.
The SABER-C System is a cervical interbody fusion device used to provide structural stability in skeletally mature individuals following discectomy. The SABER-C System is inserted through an anterior cervical approach and is available in various geometric and material options to fit the clinical needs of the patient. The SABER-C System Anterior Cervical Plate is an anterior cervical fixation device this is available in various geometric and fixation options and can be used with various types of interbody spacers.
The previously cleared SABER-C interbody devices are offered manufactured from titanium alloy per ASTM F136 or titanium-coated radiolucent polyether ether ketone (PEEK), with titanium alloy or tantalum markers, as specified in ASTM F2026, ASTM F136, ASTM F1295, and ASTM F560. The SABER-C Anterior Cervical Plate and two fixation options, spikes or screws, are manufactured from titanium alloy, as specified in ASTM F136 and ASTM F1295. The plate is not to be used with spikes when used without the Spacer component.
The subject submission seeks to expand size offerings and gain clearance for expanded indications and minor design modifications to the previously cleared devices.
The provided text is a 510(k) clearance letter for the SABER-C System, an intervertebral body fusion device. It details the regulatory clearance, indications for use, device description, and a brief summary of performance testing.
However, the document does not contain information related to a study proving the device meets acceptance criteria specific to an AI/ML algorithm, nor does it specify any AI/ML components within the SABER-C System. The performance testing listed is entirely mechanical/physical bench testing for a physical implant (Axial Screw Pullout, Insertion Torque, plate pushoff), which is standard for orthopedic devices.
Therefore, it is not possible to complete the requested table and answer questions about AI/ML acceptance criteria, study design, sample sizes for AI, expert involvement for AI ground truth, MRMC studies, or standalone algorithm performance based on the provided text. The document is for a traditional medical device, not a software as a medical device (SaMD) or an AI-enabled device.
To address the prompt directly based on the provided text, the answer is that the document does not contain the information requested, as the device is a physical implant and not an AI/ML enabled medical device.
Summary of missing information directly related to AI/ML acceptance criteria and study:
- No AI/ML Component: The document describes a physical interbody fusion device and its associated plates and screws. There is no mention of any AI or machine learning functionality.
- Acceptance Criteria for AI/ML: Since there's no AI component, there are no acceptance criteria related to AI performance metrics (e.g., accuracy, sensitivity, specificity, AUC).
- Study Proving AI Compliance: There is no study described that would evaluate AI performance. The performance testing mentioned is purely mechanical (bench testing).
- Sample Size (AI): Not applicable, as there's no AI component.
- Data Provenance (AI): Not applicable.
- Experts for Ground Truth (AI): Not applicable.
- Adjudication Method (AI): Not applicable.
- MRMC Study: Not applicable.
- Standalone Performance (AI): Not applicable.
- Type of Ground Truth (AI): Not applicable.
- Training Set Sample Size (AI): Not applicable.
- Training Set Ground Truth (AI): Not applicable.
If the prompt assumed an AI/ML component was present and requested how one would describe these aspects for a hypothetical AI/ML device in a similar FDA clearance, I would construct a general example. However, as the instruction is to describe "the study that proves the device meets the acceptance criteria" based on the input, and the input clearly does not describe an AI/ML device, the direct answer is that the information is not present.
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(125 days)
Elevation Spine
The Elevation Spine Saber-C System is a cervical interbody for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) and is for use at a single spinal level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. The SABER-C Spacer is to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone.
The SABER-C Spacer is intended to be used with supplemental fixation, such as anterior cervical plates or posterior cervical screw fixation. When the SABER-C Spacer is used with the SABER-C Anterior Cervical Plate and screws, the plate-spacer-screw assembly can be used as a stand-alone device with the SABER-C Anterior Cervical Plate acting as the supplemental fixation. When the SABER-C Spacer is used with the SABER-C Anterior Cervical Plate and spikes, the plate-spacer-spike assembly should be used with additional supplemental fixation such as posterior cervical screw fixation.
The SABER-C Anterior Cervical Plate, when used without the spacer component and with screws, is intended for anterior screw fixation to the cervical spine (C2-C7) for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis. The Anterior Cervical Plate is not to be used with spikes when used without the Spacer component.
The SABER-C System is a cervical interbody fusion device used to provide structural stability in skeletally mature individuals following discectomy. The SABER-C System is inserted through an anterior cervical approach and is available in various geometric and material options to fit the clinical needs of the patient. The SABER-C System Anterior Cervical Plate is an anterior cervical fixation device this is available in various geometric and fixation options and can be used with various types of interbody spacers.
The SABER-C System is made from radiolucent polymer, with titanium alloy or tantalum markers, as specified in ASTM F2026. ASTM F136. ASTM F1295, and ASTM F560. The SABER-C Anterior Cervical Plate and two fixation options, spike or screws, are manufactured from titanium alloy, as specified in ASTM F136 and ASTM F1295. The plate is not to be used with spikes when used without the Spacer component.
The provided text describes a 510(k) submission for the Elevation Spine Saber-C System, an intervertebral body fusion device. The document focuses on demonstrating substantial equivalence to predicate devices through performance testing.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Test/Standard | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|---|
| Mechanical Performance | Static Axial Compression | Device performance should be comparable or superior to predicate devices, demonstrating structural integrity under static axial loading. | Tested per ASTM F2077-14. "The results of the performance testing demonstrate that the Elevation Spine SABER-C is substantially equivalent..." implying it met expectations of comparable performance. |
| Dynamic Axial Compression | Device performance should be comparable or superior to predicate devices, demonstrating structural integrity and fatigue resistance under dynamic axial loading. | Tested per ASTM F2077-14. "The results of the performance testing demonstrate that the Elevation Spine SABER-C is substantially equivalent..." implying it met expectations of comparable performance. | |
| Compression-Shear | Device performance should be comparable or superior to predicate devices, demonstrating stability under combined compression and shear forces. | Tested per ASTM F2077-14. "The results of the performance testing demonstrate that the Elevation Spine SABER-C is substantially equivalent..." implying it met expectations of comparable performance. | |
| Torsion | Device performance should be comparable or superior to predicate devices, demonstrating resistance to torsional forces. | Tested per ASTM F2077-14. "The results of the performance testing demonstrate that the Elevation Spine SABER-C is substantially equivalent..." implying it met expectations of comparable performance. | |
| Subsidence | Device resistance to subsidence into vertebral bodies should be comparable or superior to predicate devices. | Tested per ASTM F2267-11. "The results of the performance testing demonstrate that the Elevation Spine SABER-C is substantially equivalent..." implying it met expectations of comparable performance. | |
| Expulsion | Device resistance to expulsion from the intervertebral space should be comparable or superior to predicate devices. | Tested for expulsion (standard not explicitly cited, but likely related to F2077 or F2267). "The results of the performance testing demonstrate that the Elevation Spine SABER-C is substantially equivalent..." implying it met expectations of comparable performance. | |
| Implantation Compatibility | Cadaver Implantation Study | Successful implantation and stability of the plate and spacer assembly with spiked fixation in cadaveric models. | "Additionally, a cadaver implantation study was performed on the plate and spacer assembly when used with spiked fixation." This indicates successful demonstration of implantation. |
| Material Compliance | Material Standards (PEEK, Titanium, Coating) | Materials used must conform to specified ASTM standards for surgical implant applications. | All listed materials (Implant Grade PEEK, Titanium, Titanium alloy coating) are explicitly stated to conform to their respective ASTM standards (F2026-17, F136-13, F1472-14, F1580-18). |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify the exact numerical sample size for individual mechanical tests (e.g., number of devices tested for axial compression). It only states that "Three configurations of the Elevation Spine Saber-C System were tested". For the cadaver implantation study, the sample size is also not specified, only that "a cadaver implantation study was performed".
- Data Provenance: The data provenance is not explicitly mentioned (e.g., country of origin, specific testing facility). However, given that it's an FDA submission, the testing would typically be performed in a controlled laboratory setting, likely in the US or a country with comparable regulatory standards. The studies appear to be prospective in nature, as they involve testing the actual device configurations.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- This type of information is not applicable to the mechanical and cadaveric testing described. These tests rely on objective physical measurements and adherence to engineering standards (ASTM), not on expert human interpretation of data for ground truth establishment.
4. Adjudication Method for the Test Set:
- This is not applicable as the tests performed are objective mechanical and implantation studies, not studies involving human interpretation or consensus.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- A MRMC comparative effectiveness study was not conducted. The provided text describes mechanical performance testing and a cadaver implantation study, not studies involving human readers and interpretation of medical images.
6. Standalone (Algorithm Only) Performance Study:
- A standalone performance study of an algorithm was not conducted. This device is a physical intervertebral fusion system, not an AI/algorithm-based diagnostic or therapeutic tool. The testing focuses on its mechanical and physical performance.
7. Type of Ground Truth Used:
- The "ground truth" for the performance testing is based on objective engineering standards and physical measurements. For mechanical tests, this means adherence to the specifications and performance envelopes outlined in ASTM F2077-14 and F2267-11, and comparison to predicate device performance. For the cadaver study, successful implantation and observation of stability would serve as the "ground truth" for that aspect.
8. Sample Size for the Training Set:
- This information is not applicable. This submission details a physical medical device. There is no AI model or algorithm that requires a "training set" in the context described.
9. How the Ground Truth for the Training Set Was Established:
- This information is not applicable as there is no training set for an algorithm.
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