(200 days)
The Aesculap Ennovate Cervical Spinal and Occiput System is intended to provide immobilization of spinal segments as an adjunct to following acute and chronic instabilities of the craniocervical junction, the cervical spine (Cl to C7) and the thoracic spine (Tl-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radior myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Aesculap Ennovate Cervical Spinal and Occiput System is 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.
In order to achieve additional levels of fixation, the Aesculap Ennovate Lumbar System may be connected to the Aesculap Ennovate Cervical Spinal and Occiput System using connectors and rods.
The Aesculap ENNOVATE Cervical Spinal and Occiput System is implant systems used to facilitate the biological process of spinal fusion. This system is intended to promote fusion of the cervical and thoracic spine (C1-T3) and occipito-cervico-thoracic junction (occiput-T3). The Aesculap ENNOVATE Cervical Spinal and Occiput System consist of various plates, screws, rods, hooks, and connectors.
The provided text is a 510(k) Summary for the Aesculap ENNOVATE Cervical Spinal and Occiput System, which is a medical device. This document focuses on demonstrating substantial equivalence to a predicate device, primarily through bench testing (performance data).
The request asks for information about the acceptance criteria and the study that proves the device meets the acceptance criteria, specifically in the context of an AI/algorithm-based device. The original document does not describe an AI/algorithm-based device. It describes a physical implant system (screws, rods, plates, etc.) for spinal stabilization. Therefore, the questions related to AI/algorithm performance studies (such as MRMC studies, standalone algorithm performance, ground truth establishment for training/test sets, training set sample size, expert consensus, etc.) are not applicable to this submission.
The "Performance Data" section solely lists ASTM standards that the physical device was tested against. These standards evaluate the mechanical properties of the implant system (e.g., strength, fatigue, static properties) to ensure it performs as safely and effectively as the predicate device.
Given that the request is for an AI/algorithm device study and the provided document is for a physical orthopedic implant, I can only address the "acceptance criteria" and "device performance" in the context of the mechanical and material testing described for this specific physical device.
Acceptance Criteria and Device Performance (Based on the provided document for a physical implant):
The acceptance criteria for this physical device are implicitly tied to the successful completion of the listed ASTM standard tests, demonstrating equivalence in mechanical performance to the predicate device. The performance is stated to be "as safely and effectively" as the predicate device based on these tests.
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria Category (Implied by Standards) | Reported Device Performance (Implied Statement) |
|---|---|
| Spinal Implant Constructs in a Vertebrectomy Model (ASTM F1717-18) | Successfully met standards, performing "as safely and effectively as the primary predicate." |
| Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies (ASTM F1798-13) | Successfully met standards, performing "as safely and effectively as the primary predicate." |
| Components Used in Surgical Fixation of the Spinal Skeletal System (ASTM F2193-18a) | Successfully met standards, performing "as safely and effectively as the primary predicate." |
| Metallic Medical Bone Screws (ASTM F543-17) | Successfully met standards, performing "as safely and effectively as the primary predicate." |
| Overall Safety and Effectiveness (compared to predicate) | "substantially equivalent in design, materials, intended use, and performs as safely and effectively as the primary predicate currently on the market." |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the document. For physical device testing, this typically refers to the number of implants or components tested according to the ASTM standards.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, since it's bench testing, the "data" originates from the physical tests performed on the device samples in a laboratory setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is a physical device, and its performance is evaluated against engineering standards, not by expert interpretation of images or data. Ground truth here is based on the objective measurements from the mechanical testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods are relevant for human interpretation or complex data analysis, not for direct physical property measurements against engineering standards.
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:
- Not Applicable. This is not an AI/algorithm-based device. An MRMC study would not be performed for a physical implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an AI/algorithm-based device.
7. The type of ground truth used:
- Mechanical Performance Standards: The ground truth for this physical device is the set of mechanical and material properties defined by the ASTM standards (e.g., tensile strength, fatigue life, torque limits) which are universally accepted engineering benchmarks for such implants. Compliance with these quantitative standards serves as the "ground truth."
8. The sample size for the training set:
- Not Applicable. This is a physical device, not an algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not Applicable. As above, no training set for an algorithm is involved.
In summary, the provided document describes a 510(k) submission for a physical medical device. The "acceptance criteria" and "study proving device meets criteria" are based on a series of bench tests against pre-defined ASTM engineering standards to demonstrate substantial equivalence to an existing predicate device, primarily in terms of mechanical and material performance. The questions related to AI/algorithm studies are not relevant to this specific premarket notification.
§ 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.