(68 days)
The EAGLE Plus Micro Anterior Cervical Plate System is intended for anterior cervical intervertebral body fixation. This system is indicated for patients in which stability is desired following anterior cervical fusion for the indications listed below. The intended levels for treatment range from C2 to T1.
Indications include symptomatic cervical spondylosis, trauma, fracture, posttraumatic kyphosis or lordosis, tumor, degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, re-operation for failed fusion, or instability following surgery for the above indications.
The EAGLE Plus Micro Anterior Cervical Plate System consists of a variety of plates and screws designed for use alone or adjacent to a previously implanted anterior cervical plate.
The EAGLE Plus Micro Anterior Cervical Plate System also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.
The provided text describes a 510(k) submission for a medical device called the "EAGLE Plus Micro Anterior Cervical Plate System." This is a premarket notification for a medical device, which typically relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than extensive de novo clinical trials with acceptance criteria for device performance in the same way a new drug or novel high-risk device might.
Based on the provided text, here's an analysis of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
This section is not applicable in the traditional sense for this 510(k) submission. The document states "Performance data were submitted to characterize the EAGLE Plus Micro Anterior Cervical Plate System." However, it does not provide a table of acceptance criteria (e.g., minimum tensile strength, fatigue life, etc.) or reported device performance against specific criteria in the way a clinical study would report efficacy or accuracy.
For medical implants like this, performance data typically refers to:
- Mechanical Testing: Benchtop tests for strength, fatigue, torsional stability, pull-out strength of screws, etc., demonstrating that the device meets relevant ASTM or ISO standards for medical implants and is comparable to the predicate device.
- Biocompatibility Testing: Ensuring the materials are safe for implantation.
- Sterilization Validation: Demonstrating the device can be effectively sterilized.
The 510(k) process primarily uses these types of data to show substantial equivalence to a predicate device, meaning it performs as safely and effectively as a device already on the market. The text does not provide the specific numerical results of these tests or their acceptance thresholds.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the given text. For mechanical testing, the "sample size" would refer to the number of devices or components tested. The data provenance would be the laboratory where the tests were conducted. Since this is a hardware device, there wouldn't typically be a "test set" of patient data for clinical performance in a 510(k) submission unless clinical studies were specifically required (which is rare for Class II devices demonstrating substantial equivalence).
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable as this submission is for a physical medical implant, not a diagnostic or AI-driven device requiring expert-established ground truth from images or other patient data.
4. Adjudication Method for the Test Set
This information is not applicable for the same reasons as (3).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not applicable. An MRMC study is relevant for diagnostic devices, especially those involving human interpretation (e.g., radiologists reading images) where AI assistance might improve performance. This device is a surgical implant.
6. Standalone (Algorithm Only) Performance Study
This information is not applicable. This device is a physical implant, not an algorithm.
7. Type of Ground Truth Used
This information is not applicable. For a surgical implant, the "ground truth" concept in the context of clinical efficacy would be observed patient outcomes, but these are not typically part of a 510(k) submission for substantial equivalence. Instead, the "truth" is that the device passes specific engineering and material standards and performs equivalently to a predicate device in benchtop testing.
8. Sample Size for the Training Set
This information is not applicable. This device is a physical implant, not an algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as (8).
Summary of Device and 510(k) Approach based on provided text:
- Device Name: EAGLE Plus Micro Anterior Cervical Plate System
- Intended Use: Anterior cervical intervertebral body fixation following fusion, for stability.
- Indications: Symptomatic cervical spondylosis, trauma, fracture, post-traumatic kyphosis or lordosis, tumor, degenerative disc disease, spinal stenosis, re-operation for failed fusion, or instability.
- Levels: C2 to T1.
- Materials: ASTM F-136 implant grade titanium alloy.
- 510(k) Strategy: The submission relies on demonstrating substantial equivalence to existing predicate devices (K070994 Eagle Plus Anterior Cervical Plate System and K914362 Acroplate Anterior Cervical Plate System).
- "Study" type: "Performance data were submitted to characterize the EAGLE Plus Micro Anterior Cervical Plate System." This implies benchtop mechanical, material, and potentially biocompatibility testing to show that the new device performs comparably to the predicate devices and meets relevant industry standards for safety and effectiveness. The details of these tests, specific acceptance criteria, and observed performance values are not included in the provided 510(k) summary. The FDA's letter confirms a substantial equivalence determination based on these submissions.
§ 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.