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510(k) Data Aggregation
(290 days)
4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM
The 4CIS® SOLAR Spine System and 4CIS® APOLLON Spine System are a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bon graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
In addition, the 4CIS® SOLAR Spine System and 4CIS® APOLLON Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative Spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor and failed previous fusion (pseudarthrosis).
The 4C15® SOLAR Spine System and 4CIS® APOLLON Spine System are a toploading multiple component, posterior spinal fixation system which consists of pedicle screws, rods, nuts, and a transverse (cross) linking mechanism.
The 4CIS® SOLAR Spine System and 4CIS® APOLLON Spine System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. 4CIS® SOLAR Spine System and 4CIS® APOLLON Spine System implant components are supplied non-sterile are single use and are fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F136. Various sizes of these implants are available. Specialized instruments are available for the application and removal of the 4CIS® SOLAR Spine System and 4CIS® APOLLON Spine System.
The provided text describes a medical device, the "4CIS® SOLAR Spine System and 4CIS® APOLLON Spine System," which is a pedicle screw spinal fixation system. However, the document does not contain any information regarding acceptance criteria, device performance metrics, or a study that specifically addresses these points as typically expected for software or AI-based devices.
The core of the document is a 510(k) summary for a spinal implant system, focusing on its substantial equivalence to predicate devices based on mechanical testing. It does not involve AI or software performance metrics that would require the detailed study information you've requested.
Therefore, I cannot populate the requested sections because the information is not present in the provided text. The document discusses:
- Device Identification: Trade name, common name, classification.
- Substantially Equivalent Predicate Devices: Identification of similar devices already on the market.
- Device Description: What the device is made of and its components.
- Indications for Use: What the device is intended to treat and where it can be used in the spine.
- Performance Data and Test Method: This section explicitly states: "Mechanical testing has been carried out as listed in APPENDIX 10 which includes the static compression test and static torsion test as well as the dynamic compressive fatigue testing in accordance with ASTM F1717 demonstrates equivalence to the above predicate devices." This refers to physical, mechanical tests of the implant's strength and durability, not performance criteria for a diagnostic/AI tool.
The question's structure (acceptance criteria, sample size, ground truth, expert opinions, MRMC studies, standalone performance, training set) is typically relevant for evaluating AI/machine learning algorithms or diagnostic devices. Since this document describes a physical surgical implant, these types of details are not applicable as presented.
In conclusion, the input text does not contain the information requested regarding the acceptance criteria and the study that proves the device meets those criteria, as understood in the context of device performance metrics for AI/software/diagnostic tools.
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(78 days)
4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM
The 4CIS® SOLAR Spine System and 4CIS® APOLLON Spine System are a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S1 vertehra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
In addition, the 4CIS® SOLAR Spine System and 4CIS® APOLLON Spine System are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative Spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis).
The 4CIS® SOLAR Spine System and 4CIS® APOLLON Spine System are a toploading multiple component, posterior spinal fixation system which consists of pedicle screws, rods, nuts, and a transverse (cross) linking mechanism.
The 4CIS® SOLAR Spine System and 4CIS® APOLLON Spine System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. 4CIS® SOLAR Spine System and 4CIS® APOLLON Spine System implant components are supplied non-sterile are single use and are fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F136. Various sizes of these implants are available. Specialized instruments are available for the application and removal of the 4C1S * SOLAR Spine System and 4CIS * APOLLON Spine System.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the 4CIS® SOLAR Spine System and 4CIS® APOLLON Spine System:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical performance in accordance with ASTM F1717. | "Mechanical testing as listed in APPENDIX 10 that was conducted in accordance with ASTM F1717 demonstrates equivalence to the above predicate devices." |
| Substantial equivalence to predicate devices (Global Spinal Fixation System (K001668) and OPTIMA™ Spinal System (K031585)) in function, design, composition, material, and intended use. | The FDA letter (K050471) states, "We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becamined the device is substantially equivalent (for the indications felerenced above and nave ustermined ly marketed predicate devices marketed in interstate for use stated in the encrosure) to regally to regard cate of the Medical Device Amendments, or to commerce prof to May 20, 1976, the ensordance with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA). and Cosment Act (Act) that do not require approvisions of the general controls provisions of the Act." This implies the device met the criteria for substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size for the "test set" in the context of clinical data. The primary performance data cited is mechanical testing. For this, the sample size would refer to the number of implants/components tested. The document refers to "APPENDIX 10" for details, which is not provided, so the exact sample size for the mechanical tests is unknown from the given text.
- Data Provenance: Not applicable in the context of mechanical testing. This is a laboratory-based study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This submission relies on mechanical testing against an ASTM standard, not clinical data requiring expert review for ground truth.
4. Adjudication Method for the Test Set
Not applicable. This is not a clinical study involving human readers or expert adjudication.
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 is a spinal implant system, not an AI-powered diagnostic or assistive device.
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 is a physical medical device (spinal implant), not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the performance data is predominantly defined by the ASTM F1717 standard for mechanical testing and the definition of substantial equivalence to predicate devices by the FDA. In essence, the ground truth is established engineering and regulatory benchmarks.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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