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510(k) Data Aggregation
(57 days)
QSR
MySpine S2-Alar/Alar-Iliac and MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides are intended to be used with any 510(k) cleared, legally marketed, pedicle screw system (for its approved indications for use) and its respective compatible components for non-cervical open, posterior spinal fixation procedures intended for fusion. The SI trajectory of the MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guide is only intended to be used with M.U.S.T. SI Headless Screw System and its cleared indications for use. The MySpine S2-Alar/Alac and MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides (hereinafter referred to as "MySpine guides") are intended to be used as anatomical perforating guides, specific to a patient's anatomy, to assist intraoperatively in the screw trajectory in S1, S2 and in the Ilium. The guides are created using a surgical planning software which pre-operatively plans the positions of the components based upon radiological images of the patients' anatomical landmarks and the selected surgical equipment. The MySpine guides are intended for single use only.
The MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides are a line extension to Medacta's MySpine Pedicle Screw Placement Guides. Identically to the other Medacta MySpine products, the MySpine S2-S1 Pedicle and Sacro-Iliac Screw Placement Guides are a patient matched, pedicle targeted, technology involving the production of patient specific guides for placement of pedicle and sacro-iliac screws based on patient's anatomy. Specifically, the subject MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides are intended to be used as anatomical perforating guides to assist intra-operatively in the preparation of the screw trajectory in S1, S2 and in the Ilium.
The MySpine software platform allows the surgeon to complete 3D pre-operative planning based on the patient's spinal CT scans. CT images are used to create a 3D model of the vertebrae that will represent the template used to generate the corresponding MySpine Screw Placement Guides fitting the patient's vertebral anatomy.
The MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides as well as their bone models are single-use and they can be provided in sterile or non-sterile version.
The provided 510(k) summary does not contain specific acceptance criteria or details of a study proving the device meets said criteria as would typically be presented for an AI/ML powered device. This document describes a traditional medical device (surgical guides) and thus the standard clinical study information requested for AI/ML devices is not applicable.
However, based on the non-clinical studies mentioned, we can infer some performance aspects:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA summary does not explicitly state acceptance criteria or performance metrics in a quantitative table for this device. The listed non-clinical studies are:
| Acceptance Criteria (Inferred) | Reported Device Performance (Inferred from Study Type) |
|---|---|
| Software functions correctly and produces accurate models/guides based on CT scans. | Passed software validation. |
| Surgical guides provide accurate trajectory for screw placement in S1, S2, and Ilium. | Acceptable guide accuracy demonstrated through cadaver testing. |
| Guides are fit for purpose in a simulated surgical environment. | Acceptable performance in cadaver testing. |
2. Sample Size for the Test Set and Data Provenance
- Cadaver Testing: The document mentions "Cadaver testing" but does not specify the number of cadavers or the origin of the cadavers (e.g., country).
- Software Validation: The document mentions "Software validation" which would typically involve a test set of radiological images (CT scans). The sample size for this test set and its provenance are not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided. For cadaver testing, ground truth would likely be established through post-procedure imaging (e.g., CT scans) to verify screw placement accuracy, potentially assessed by surgeons or radiologists. For software validation, ground truth for image-based measurements would be established by experts.
4. Adjudication Method
This information is not provided.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was conducted or is mentioned, as this is a surgical guide and not an AI-assisted diagnostic device. The device assists surgeons directly in placement, rather than providing an interpretation for a human reader.
6. Standalone Performance
The concept of "standalone performance" (algorithm only performance without human-in-the-loop) is not directly applicable in the same way it would be for an AI diagnostic device. The MySpine guides are a physical device derived from a surgical planning software, intended for human use during surgery. The device itself (the guide) has no "standalone" diagnostic or interpretive function. The software validation would speak to the accuracy of the software's output in creating the guides, but this is always in the context of human surgical use.
7. Type of Ground Truth Used
- For Cadaver Testing: Likely involved a combination of direct observation during simulated surgery and post-procedure imaging (e.g., CT scans) to verify the accuracy of screw trajectory relative to the planned trajectory. This would be a form of expert assessment based on anatomical and imaging verification.
- For Software Validation: Ground truth for image segmentation and measurement accuracy would be established by expert annotation or reference measurements on CT scans.
8. Sample Size for the Training Set
The document mentions "surgical planning software which pre-operatively plans the positions of the components based upon radiological images of the patients' anatomical landmarks." This implies that the software was trained, but the sample size of the training set (number of patients/CT scans) is not specified.
9. How the Ground Truth for the Training Set was Established
The document states the guides are "created using a surgical planning software which pre-operatively plans the positions of the components based upon radiological images of the patients' anatomical landmarks and the selected surgical equipment." This suggests that the software's training likely involved manual identification of anatomical landmarks and desired screw trajectories by clinical experts (e.g., surgeons) on a collection of patient CT images. However, the specific methodology for establishing ground truth for training is not detailed.
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