(87 days)
The Cervical Plate is intended for anterior screw fixation to the cervical spine (C2-C7) for immobilization and stabilization as an adjunct to fusion in skeletally mature patients for the following indications:
-Degenerative disc disease (DDD, defined as neck pain of discogenic origin with degenertion of the disc confirmed by history and radiographic studies)
-Spondylolisthesis
- -Fracture
-Spinal stenosis
-Tumors (primary and metastatic)
-Failed previous fusions
-Pseudoarthrosis
-Deformity (i.e. kyphosis, lordosis, and/or scoliosis).
The Eisertech, LLC. Cervical Plate (K113170) is a spinal internal fixation device which is provided in a variety of sizes ranging from 20mm in length. The device is designed to accommodate fusion of one to four levels of the cervical spine. Two screws may be affixed to each vertebral body associated with the spinal fusion. Instrumentation to facilitate implantation of the cervical plate is included with the device. This instrumentation is the subject of the present Traditional 510(k) submission. Specifically, the present Traditional 510(k) submission seeks to add two additional base material options as well as a surface treatment to all previously cleared instruments for use with the cervical plate system. The purpose of the surface treatment is to add scratch resistance and hydrophobicity to the instruments. There are no changes to the implants and the surface treatment is not being applied to the implants.
This document is a 510(k) summary for a medical device called a "Cervical Plate". However, the submission K190565 is not for the cervical plate itself, but rather for instrumentation to facilitate implantation of the cervical plate. Specifically, it seeks to add two additional base material options and a surface treatment to these previously cleared instruments. The core cervical plate device, identified as the predicate, is K113170.
Therefore, the performance testing and acceptance criteria described in the document are focused on demonstrating that the changes to the instruments do not negatively impact safety and effectiveness, nor do they raise new questions. It does not describe a study proving the performance of the cervical plate itself, but rather the performance of the modified instruments.
Given this, I will answer the questions based on the information provided regarding the modified instrumentation.
Here's an analysis of the provided text:
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A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in a numerical or pass/fail threshold format for the performance tests. Instead, it states that testing was performed to "ensure" or "demonstrate" certain outcomes. The reported performance is a conclusion that these aims were met.
Acceptance Criteria Description (Implicit) Reported Device Performance Ensure that the addition of a surface treatment to previously cleared instruments does not negatively impact biocompatibility of the instruments. "Biocompatibility Testing was performed to ensure that the addition of a surface treatment to all previously cleared instruments for use with the cervical plate system does not negatively impact biocompatibility of the instruments." (Implies successful demonstration, i.e., no negative impact found). Demonstrate that the coating provides additional wear resistance to the instruments. "Additionally, ball on flat wear testing... was performed to demonstrate that the coating provides additional wear/corrosion resistance to the instruments." (Implies successful demonstration, i.e., coating provides additional wear resistance). Demonstrate that the coating provides additional corrosion resistance to the instruments. "Additionally, ... corrosion resistance testing was performed to demonstrate that the coating provides additional wear/corrosion resistance to the instruments." (Implies successful demonstration, i.e., coating provides additional corrosion resistance). Demonstrate the effect of the surface treatment on the instruments' mechanical properties related to indentation. "Additionally, ... instrumented indentation testing... was performed to demonstrate that the coating provides additional wear/corrosion resistance to the instruments." (Implies successful demonstration regarding the mechanical properties under indentation, likely linking to wear resistance, as the primary stated purpose of the coating is scratch resistance and hydrophobicity, and the performance testing aims to show additional wear/corrosion resistance.) The document does not state specific acceptance criteria values (e.g., "indentation depth less than X µm") nor does it provide quantitative results. It only states the testing was performed to demonstrate the effect. -
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample sizes used for the biocompatibility, wear, indentation, or corrosion resistance testing. It also does not provide information about the provenance of data (e.g., country of origin, retrospective or prospective). These types of tests are typically in vitro or in vivo (for biocompatibility) and not based on patient data provenance.
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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 type of information (number and qualifications of experts for ground truth) is relevant to clinical studies involving human interpretation or pathology. Since the described tests are device performance tests related to materials science (biocompatibility, wear, corrosion, indentation) for surgical instruments, the concept of "ground truth" established by clinical experts for a "test set" in the context of diagnostic or interpretive performance does not apply here. The "ground truth" for these tests would be derived from validated testing methodologies and their results.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
Similar to point 3, adjudication methods like 2+1 or 3+1 are typically used in clinical studies where multiple human readers interpret data (e.g., medical images) and a consensus or tie-breaking mechanism is needed to establish a "ground truth" for comparison with an AI system. This concept is not applicable to the material and mechanical performance testing described in this document.
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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
No. An MRMC study is a type of clinical study used to evaluate the performance of diagnostic devices, often involving AI assistance, by comparing the performance of multiple human readers on multiple cases. The submission K190565 is for changes to surgical instruments (not a diagnostic device, and no AI component is mentioned). Therefore, no MRMC comparative effectiveness study was done, and no effect size for human reader improvement with AI assistance is applicable or reported.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question relates to the performance of an AI algorithm in isolation. Since the device in question (modified surgical instruments) does not involve an AI algorithm, no standalone algorithm performance testing was done.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the material and mechanical tests (biocompatibility, wear, indentation, corrosion), the "ground truth" is established by the results of standardized and validated laboratory testing methods. This is not based on expert consensus, pathology, or outcomes data in the clinical sense, but rather objective measurements and observations from controlled experiments. For biocompatibility, this usually involves in vitro (e.g., cytotoxicity) and/or in vivo (e.g., irritation, sensitization) tests against recognized standards (e.g., ISO 10993 series).
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The sample size for the training set
The concept of a "training set" and "test set" is central to machine learning and AI development. Since this submission is for physical surgical instruments and does not involve AI, there is no training set in this context. The "tests" described are physical performance tests, not AI model evaluations.
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How the ground truth for the training set was established
As there is no training set for an AI model, this question is not applicable.
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.