(280 days)
The MEDICON Spinal Spreading Systems are used to spread soft tissue and maintain surgical access in spine surgery and may only be used by surgeons with proper training and adequate experience in spine surgery.
The MEDICON Spinal Spreading System is made up of multiple reusable manual spreader systems. The spreaders include components for all approaches in spine surgery, including those specifically for cervical spine surgery, as well as inter-laminar, trans-laminar, extra-foraminal and dorsolateral approaches. The multiple components support classic and minimally invasive procedures. The components are made from a radiolucent x-ray compatible material, from titanium, some from stainless steel, and some from anodized aluminum.
This document describes the MEDICON Spinal Spreading Systems, a set of reusable manual retractor systems used in spine surgery. The information provided is for regulatory clearance (510(k)) and focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance characteristics of an AI/ML device. Therefore, many of the requested details concerning AI/ML device acceptance criteria and study designs are not applicable or cannot be extracted from this medical device submission.
Here's an analysis based on the information provided, highlighting the differences due to the nature of the device:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (General Safety & Performance) | Reported Device Performance |
|---|---|
| Biocompatibility | Acceptable results |
| Cleaning Validation (AAMI TIR30:2011) | No visible soil on test articles |
| Steam Sterilization Validation (ISO 17665-1: 2006) | Each component met acceptance criteria |
| Strength of blade supports | Blade supports met acceptance criteria |
| Strength of blades | Blades met acceptance criteria |
| Engineering analysis for strength testing worst case | Worst case was determined |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable as this is not an AI/ML device, but a physical medical instrument. The "test set" here refers to the physical devices undergoing non-clinical technical testing. Specific sample sizes for each test (e.g., number of blade supports tested) are not provided, only the qualitative outcome. The data provenance is internal testing performed by the manufacturer, MEDICON eG, which is based in Germany.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable. "Ground truth" in the context of expert consensus is relevant for diagnostic or AI/ML devices where interpretation is involved. For a physical surgical instrument, the acceptance criteria are based on objective engineering and sterilization standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods like 2+1 or 3+1 refer to how discrepancies in expert interpretations (e.g., in reading medical images) are resolved to establish a ground truth. For the physical testing of surgical instruments, results are objective and measured against established standards, not subject to expert interpretation discrepancies in the same way.
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
This is not applicable. An MRMC study is designed to evaluate the performance of diagnostic systems or AI assistance in a clinical setting with human readers. This device is a surgical instrument, not a diagnostic or AI-assisted system. No clinical studies (including MRMC) were performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. There is no algorithm or AI component in this medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established by adherence to recognized engineering standards for mechanical strength, biocompatibility standards, and sterilization validation standards. This is not an expert consensus or pathology-based ground truth typical for AI/ML or diagnostic devices.
8. The sample size for the training set
This is not applicable. This is a physical medical device, not an AI/ML system, so there is no training set.
9. How the ground truth for the training set was established
This is not applicable. No training set exists for this device.
§ 882.4800 Self-retaining retractor for neurosurgery.
(a)
Identification. A self-retaining retractor for neurosurgery is a self-locking device used to hold the edges of a wound open during neurosurgery.(b)
Classification. Class II (performance standards).