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510(k) Data Aggregation
(448 days)
Double Medical Universal Spine System
Double Medical Universal Spine System is intended for posterior, non-cervical, pedicle fixation for the following indications: severe spondylolisthesis (grade 3 or 4) of the L5-S1 vertebrae; trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudarthrosis, and failed previous fusion. The device is to be used in skeletally mature patients, and for stabilization of the spine as an adjunct to fusion with bone graft. The levels of fixation are T8 - S1.
Double Medical Universal Spine System consists of pedicle screws, rods, transconnector and nut etc. It is made of Ti-6A1-4V ELI, which meets ASTM F 136 "Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications" and is widely used for surgical implants. The proposed devices are provided non-sterile but sterilized by the end user.
The provided document is a 510(k) premarket notification for a medical device called the "Double Medical Universal Spine System." This type of document is for a medical device that has been deemed substantially equivalent to a previously cleared device. It focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than proving performance against specific acceptance criteria like a novel AI/software medical device would.
Therefore, much of the requested information, such as multi-reader multi-case studies, standalone algorithm performance, number of experts for ground truth establishment, training set details, and adjudication methods, is not applicable to this type of traditional medical device submission.
Here's a breakdown of the relevant information from the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Bench Tests) | Reported Device Performance |
|---|---|
| ASTM F 1717-14 "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model": | Demonstrated to meet design specifications and be substantially equivalent to the predicate device. Specific numerical results are not provided in this summary but would have been included in the full submission. |
| - Static compression bending test | (Met) |
| - Dynamic compression bending test | (Met) |
| - Static torsion test | (Met) |
| ASTM F 1798-13 "Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants": | Demonstrated to meet design specifications and be substantially equivalent to the predicate device. Specific numerical results are not provided in this summary but would have been included in the full submission. |
| - Axial gripping capacity test | (Met) |
| Technological Characteristics Equivalence: | The device incorporates the same technological characteristics as the predicate device (Trauson General Spinal System K082617). |
| - FDA Product Codes: MNI and MNH | MNI and MNH |
| - Equivalent intended uses | Indicated for posterior, non-cervical, pedicle fixation for specified spinal conditions. |
| - Components are manufactured from Ti-6Al-4V ELI as per ASTM F 136 | Made of Ti-6Al-4V ELI, meeting ASTM F 136. |
| - Polyaxial and monoaxial pedicle screws are used to attach to the vertebrae | Polyaxial and monoaxial pedicle screws are used. |
| - Same pedicle screw thread form configuration | Same pedicle screw thread form configuration. |
| - Construct support mechanism | Same construct support mechanism. |
| - Use of instrumentation to aid the placement of pedicle screws and rods | Uses instrumentation to aid placement. |
| - Mechanical performance | Mechanical performance shown to be equivalent. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set: For the bench tests (ASTM F 1717-14 and ASTM F 1798-13), the "sample size" refers to the number of physical devices or constructs tested. This information is not provided in the summary document. It would typically be detailed in the full test reports submitted to the FDA.
- Data Provenance: This refers to laboratory bench testing conducted to internationally recognized standards (ASTM standards). It is not clinical data, so concepts like "country of origin" or "retrospective/prospective" don't apply in the common sense.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. The "ground truth" for the bench tests is established by the specifications of the ASTM standards and the measurements of a testing laboratory, not by expert medical opinion. For a physical device like this, performance is measured against engineering and material science standards.
4. Adjudication Method for the Test Set
- Not Applicable. As the tests are based on objective physical measurements against established standards, an adjudication method by experts is not required.
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. This is a hardware device (spine system), not an AI/software device. MRMC studies are used for evaluating diagnostic image interpretation by humans, often with AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
- No. This is a hardware device.
7. The Type of Ground Truth Used
- For the bench tests: Engineering specifications and material science standards as defined by the ASTM F 1717-14 and ASTM F 1798-13 standards.
- For the overall device: Substantial equivalence to a legally marketed predicate device (Trauson General Spinal System K082617) in terms of intended use, materials, function, sizes, and mechanical test results.
8. The Sample Size for the Training Set
- Not Applicable. There is no "training set" in the context of this traditional hardware medical device submission. Training sets are relevant for machine learning algorithms.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set, this question is not relevant.
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