(196 days)
MySpine Cervical is intended to be used with any 510(k) cleared, legally marketed, posterior cervical screw system (for its cleared indications for use) and its respective compatible components for cervical posterior spinal fixation procedures intended for fusion. MySpine Cervical guides are patient specific devices intended to be used as anatomical perforating quides, specific to a single patient's anatomy, to assist intra-operatively in the positioning of screws during posterior cervical fixation surgery between the levels of C2 to C7.
For pedicle diameters equal or less than ø4mm. Medacta provides for the pilot hole preparation into the lateral mass without penetrating the pedicle.
The use of the guides involves a surgical planning software, with which the surgeon preoperatively plans the surgical placement of the implants based upon the radiological images of the patients' anatomical landmarks and the selected surgical equipment. These components include patientspecific guides fabricated based on the surgical plan to precisely reference the placement of the implant components intra-operatively per the surgical plan. MySpine Cervical guides are intended for single use only.
MySpine Cervical guides are patient specific devices intended to be used as anatomical perforating guides, specific to a single patient's anatomy, to assist intra-operatively in the positioning of screws during posterior cervical fixation surgery between the levels of C2 to C7.
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 Cervical Guide fitting the patient's vertebral anatomy.
The MySpine Cervical Guides as well as their bone models are single-use and they can be provided in sterile or non-sterile version.
The provided text is a 510(k) summary for the MySpine Cervical Guides. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing an acceptance criteria study. Therefore, much of the requested information about device performance against acceptance criteria, sample sizes for test and training sets, expert qualifications, and ground truth establishment is not present in this document.
However, based on the Performance Data section, we can infer some information about validation and the type of studies conducted.
Here's a breakdown of the available and missing information:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not explicitly provided in the document. The document states that "Design Validation workshops... were conducted... to validate the design and the overall functionality of the subject device as well as to evaluate their accuracy." It also mentions "MySpine Cervical stability assessment to evaluate the stability of the subject lateral mass guides." However, specific numerical acceptance criteria and the corresponding reported performance values from these validation activities are not detailed.
2. Sample Size Used for the Test Set and Data Provenance
This information is not explicitly provided. The document states that "Two validation workshops, one for the unilateral and the other for the mass lateral guides, have been performed." It does not specify the number of cases or subjects included in these workshops, nor the country of origin or whether the data was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not explicitly provided. While "Design Validation workshops" imply expert involvement, the number of experts and their qualifications are not mentioned.
4. Adjudication Method for the Test Set
This information is not provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
This type of study was not explicitly conducted or reported. The document focuses on design validation and stability assessment, not a comparative effectiveness study with human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The device described is a physical surgical guide generated by software (MySpine software platform). The validation activities mentioned ("Design Validation workshops" and "stability assessment") seem to relate to the physical guides and their interaction (functionality, accuracy, stability), rather than a standalone assessment of the software algorithm's performance independent of the physical guide or human surgeon. So, a standalone algorithm-only performance study in the typical sense of AI algorithms detecting pathologies is not applicable/not reported for this type of device. The accuracy evaluation would likely be for the guide's ability to direct screw placement as planned.
7. The Type of Ground Truth Used
The document mentions that the surgical planning software uses "radiological images of the patients' anatomical landmarks" to create a "3D model of the vertebrae." The guides are "patient-specific guides fabricated based on the surgical plan." The "accuracy" of the guides was evaluated. It is highly probable that the ground truth for evaluating the accuracy of the guides would involve comparing the intended screw placement (from the surgical plan) with the actual placement achieved using the guide, potentially through post-operative imaging or cadaveric studies. However, the exact type of ground truth (e.g., expert consensus on optimal placement, direct measurement from a phantom/cadaver after guide use, pathology) is not explicitly stated.
8. The Sample Size for the Training Set
The document describes the device as a "patient-specific device" generated from a patient's CT scans. It does not mention a "training set" in the context of machine learning or AI models learning from a dataset. The MySpine software platform "allows the surgeon to complete 3D pre-operative planning based on the patient's spinal CT scans." This implies a custom generation for each patient rather than a model trained on a large dataset. Therefore, the concept of a "training set" as typically understood for AI algorithms is not applicable here.
9. How the Ground Truth for the Training Set Was Established
As the concept of a "training set" is not applicable, this information is not provided.
Summary of Available Information from the Document:
- Acceptance Criteria & Performance: Not explicitly stated, but "design validation workshops" focused on "overall functionality" and "accuracy," and a "stability assessment" were performed.
- Study Type: Non-clinical studies (design validation workshops, stability assessment). No clinical studies were conducted.
- Sample Size (Test Set): Not specified beyond "Two validation workshops."
- Data Provenance (Test Set): Not specified.
- Experts for Ground Truth: Implied by "validation workshops," but number and qualifications not specified.
- Adjudication Method: Not specified.
- MRMC Study: Not conducted.
- Standalone Performance: Not applicable/not reported in the AI sense; validation likely involved the physical guides' performance.
- Type of Ground Truth: Not explicitly stated, but likely related to comparing planned vs. actual screw placement using the guides.
- Training Set Size: Not applicable.
- Training Set Ground Truth: Not applicable.
§ 888.3075 Posterior cervical screw system.
(a)
Identification. Posterior cervical screw systems are comprised of multiple, interconnecting components, made from a variety of materials that allow an implant system to be built from the occiput to the upper thoracic spine to fit the patient's anatomical and physiological requirements, as determined by preoperative cross-sectional imaging. Such a spinal assembly consists of a combination of bone anchors via screws (i.e., occipital screws, cervical lateral mass screws, cervical pedicle screws, C2 pars screws, C2 translaminar screws, C2 transarticular screws), longitudinal members (e.g., plates, rods, including dual diameter rods, plate/rod combinations), transverse or cross connectors, interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors), and closure mechanisms (e.g., set screws, nuts). Posterior cervical screw systems are rigidly fixed devices that do not contain dynamic features, including but not limited to: non-uniform longitudinal elements or features that allow more motion or flexibility compared to rigid systems.Posterior cervical screw systems are intended to provide immobilization and stabilization of spinal segments in patients as an adjunct to fusion for acute and chronic instabilities of the cervical spine and/or craniocervical junction and/or cervicothoracic junction such as: (1) Traumatic spinal fractures and/or traumatic dislocations; (2) deformities; (3) instabilities; (4) failed previous fusions (
e.g., pseudarthrosis); (5) tumors; (6) inflammatory disorders; (7) spinal degeneration, including neck and/or arm pain of discogenic origin as confirmed by imaging studies (radiographs, CT, MRI); (8) degeneration of the facets with instability; and (9) reconstruction following decompression to treat radiculopathy and/or myelopathy. These systems are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.(b)
Classification. Class II (special controls). The special controls for posterior cervical screw systems are:(1) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(2) Nonclinical performance testing must demonstrate the mechanical function and durability of the implant.
(3) Device components must be demonstrated to be biocompatible.
(4) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(5) Labeling must include the following:
(i) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(ii) Intended use and indications for use including levels of fixation;
(iii) Device specific warnings, precautions, and contraindications that include the following statements:
(A) “Precaution: Preoperative planning prior to implantation of posterior cervical screw systems should include review of cross-sectional imaging studies (
e.g., CT and/or MRI) to evaluate the patient's cervical anatomy including the transverse foramen, neurologic structures, and the course of the vertebral arteries. If any findings would compromise the placement of these screws, other surgical methods should be considered. In addition, use of intraoperative imaging should be considered to guide and/or verify device placement, as necessary.”(B) “Precaution: Use of posterior cervical pedicle screw fixation at the C3 through C6 spinal levels requires careful consideration and planning beyond that required for lateral mass screws placed at these spinal levels, given the proximity of the vertebral arteries and neurologic structures in relation to the cervical pedicles at these levels.”
(iv) Identification of magnetic resonance (MR) compatibility status;
(v) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user, and;
(vi) Detailed instructions of each surgical step, including device removal.