(90 days)
The Aesculap Implant Systems Laminoplasty Plating System is intended for use in the lower cervical and upper thoracic spine (C3-T3) after a laminoplasty has been performed. The Laminoplasty Plating System holds or buttresses the allograft in place in order to prevent expulsion of the allograft, or impingement of the spinal cord.
The AIS Laminoplasty Plating System is an implant system comprised of various sizes of plates that are designed to fit anatomy of the elevated lamina. The plates have screw holes, which allow for attachment to the vertebral body and the allograft. The screws to be used with the plates are available in a 2mm length with various diameters and are designed to match the anatomical requirements. The AIS Laminoplasty Plating System is manufactured from Titanium Alloy and will be provided non-sterile and or sterile.
The provided text describes a 510(k) summary for the Aesculap Implant Systems Laminoplasty Plating System. This document focuses on establishing substantial equivalence to a predicate device, rather than presenting a study to prove performance against specific acceptance criteria for a new device. Therefore, much of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" is not present in the provided text.
Here is an analysis based on the information available:
1. Table of acceptance criteria and the reported device performance:
The document states: "Biomechanical testing of the subject device was found to be similar in performance to previously cleared spinal systems with similar indications." and "Testing results demonstrate the AIS Laminoplasty Plating System is safe and effective comparable to other predicate systems currently on the market."
However, specific numerical acceptance criteria (e.g., minimum load to failure, maximum displacement) and the corresponding quantitative performance results of the Aesculap device are not provided. The assessment relies on a qualitative statement of "similar in performance" and "comparable to other predicate systems."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated as numerical criteria, but implied to be similar to legally marketed spinal systems. | Similar in performance to previously cleared spinal systems with similar indications. |
| Not explicitly stated as numerical criteria, but implied to be comparable in safety and effectiveness to predicate systems. | Safe and effective comparable to other predicate systems currently on the market. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not provided in the document. The text only mentions "biomechanical testing" and "testing results" without details on sample sizes or data provenance.
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 information is not applicable as the document describes biomechanical testing of a medical device, not a diagnostic or screening device that would require expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable for biomechanical testing.
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 information is not applicable as this is a physical implant device, not an AI-assisted diagnostic or imaging device.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:
This information is not applicable as this is a physical implant device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for biomechanical testing would typically be engineering standards or established physical properties. The document states that testing was done per "Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Elements" and "Spinal System 510(k)s." This implies the use of established engineering and regulatory testing standards to define acceptance.
8. The sample size for the training set:
This information is not applicable as this is a physical implant device, not an AI/ML system that requires a training set.
9. How the ground truth for the training set was established:
This information is not applicable as this is a physical implant device, not an AI/ML system.
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.