(64 days)
The Eagle Anterior Cervical Plate System is intended for anterior cervical intervertebral body fixation. These systems are 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, post-traumatic kyphosis or lordosis, tumor, degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), reoperation for failed fusion, or instability following surgery for the above indications.
The Eagle Anterior Cervical Plate System consists of an assortment of plates and screws. The Eagle Anterior Cervical Plate System also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification. Manufactured from ASTM F-136 implant grade MATERIALS: titanium alloy.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Eagle Anterior Cervical Plate System.
It's important to note that the provided documents (sections {0} through {4}) are a 510(k) Summary and an FDA clearance letter for a medical device (Spinal Intervertebral Body Fixation Orthosis). Such documents typically focus on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study results with explicit performance criteria, sample sizes, and expert review methodologies as would be found in a clinical trial report for an AI/software as a medical device (SaMD).
Therefore, much of the requested information (especially regarding AI-specific criteria, ground truth, expert adjudication, MRMC studies, and detailed performance metrics) is not present in these documents because they describe a physical implant, not an AI-driven diagnostic device.
Revised Analysis Based on Provided Text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from Substantial Equivalence to Predicate) | Reported Device Performance (Inferred) |
|---|---|
| Mechanical/Physical Performance: Equivalent to predicate device (Peak Polyaxial Anterior Cervical Plate System K971730) in terms of: | "Performance data were submitted to characterize the Eagle Anterior Cervical Plate System." (Specific metrics are not provided in this summary, but presumably demonstrated adequate mechanical strength, fatigue resistance, and biocompatibility in comparison to the predicate). |
| - Strength | Satisfactory (Implied by clearance) |
| - Fatigue Life | Satisfactory (Implied by clearance) |
| - Biocompatibility | Satisfactory (Manufactured from ASTM F-136 implant grade titanium alloy, similar to predicate) |
| Material Composition: Use of implant-grade materials. | Manufactured from ASTM F-136 implant grade titanium alloy. |
| Intended Use/Indications: Same as predicate device. | "The indications for use for the modified devices described in this submission are the same as those for the previously cleared Peak Polyaxial Anterior Cervical Plate System (K971730)." |
Study Proving Device Meets Acceptance Criteria:
The document states: "Performance data were submitted to characterize the Eagle Anterior Cervical Plate System." However, the specific details of these performance data (e.g., in vitro mechanical testing results, specific values for strength, fatigue, etc.) are not included in this 510(k) summary. The summary only implies that such data were submitted and found acceptable by the FDA to demonstrate substantial equivalence to the predicate device. For mechanical devices like this, the "study" would primarily involve bench testing (e.g., static and dynamic load testing, pull-out strength, torque tests) and material characterization, rather than clinical trials with human subjects in the typical sense of showing diagnostic accuracy.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable in the context of this 510(k) summary for a physical implant. The "test set" would primarily refer to the physical specimens (e.g., number of plates or screws tested) for mechanical characterization. This information is not provided in the summary.
- Data Provenance: Not applicable in the context of this 510(k). The data would be from laboratory bench testing.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- This is not applicable. For a physical implant, "ground truth" is typically established by engineering specifications, material standards (e.g., ASTM F-136 for titanium alloy), and mechanical testing results compared against predefined thresholds or predicate device performance, not by expert consensus on diagnostic images.
4. Adjudication Method for the Test Set
- This is not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in human interpretation of data (e.g., medical images). For mechanical testing, the "adjudication" is typically the comparison of quantitative test results against acceptance criteria.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC study was not done. This type of study is relevant for diagnostic devices (especially AI in medical imaging) to assess how human readers perform with and without AI assistance. This device is a physical implant, not a diagnostic tool.
6. Standalone (Algorithm Only) Performance Study
- No, a standalone study was not done. This concept applies to AI algorithms. The Eagle Anterior Cervical Plate System is a physical medical implant.
7. Type of Ground Truth Used
- Engineering specifications, material standards, and mechanical test results. For a physical implant, the "ground truth" relates to its material properties, structural integrity, and functional performance under simulated physiological stresses, all measured against established engineering benchmarks and comparisons to the predicate device's known performance.
8. Sample Size for the Training Set
- Not applicable. This device is a physical implant. The concept of a "training set" is relevant for machine learning algorithms.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As above, this concept does not apply to a physical implant.
In summary: The provided 510(k) documentation focuses on demonstrating the substantial equivalence of a physical medical implant (Eagle Anterior Cervical Plate System) to a previously cleared predicate device. It highlights the device's material, intended use, and general statement about performance data, but does not contain the detailed clinical study information relevant to AI/SaMD, such as specific acceptance criteria for diagnostic accuracy, expert review methodologies, or training/test set details.
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| IX. 510(k) Summary | APR - 2 2004 |
|---|---|
| SUBMITTER: | DePuy Spine, Inc.325 Paramount DriveRaynham, MA 02780 |
| CONTACT PERSON: | Lisa A. Gilman |
| DATE PREPARED: | January 22, 2004 |
| CLASSIFICATION NAME: | Spinal Intervertebral Body Fixation Orthosis |
| PROPRIETARY NAME: | Eagle Anterior Cervical Plate System |
| PREDICATE DEVICES: | Peak Polyaxial Anterior Cervical Plate System(K971730) |
| DEVICE DESCRIPTION: | The Eagle Anterior Cervical Plate System consists ofan assortment of plates and screws. |
| The Eagle Anterior Cervical Plate System alsocontains Class 1 manual surgical instruments andcases that are considered exempt from premarketnotification. | |
| INTENDED USE: | The indications for use for the modified devicesdescribed in this submission are the same as thosefor the previously cleared Peak Polyaxial AnteriorCervical Plate System (K971730). The indicationsare as follows: |
| The Eagle Anterior Cervical Plate System is intendedfor anterior cervical intervertebral body fixation.These systems are indicated for patients in whichstability is desired following anterior cervical fusion forthe indications listed below. The intended levels fortreatment range from C2 to T1. | |
| Indications include symptomatic cervical spondylosis,trauma, fracture, post-traumatic kyphosis or lordosis,tumor, degenerative disc disease (defined asdiscogenic pain with degeneration of the disc |
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2 af 2
Eagle Anterior Cervical Plate System
confirmed by history and radiographic studies), reoperation for failed fusion, or instability following surgery for the above indications.
- Manufactured from ASTM F-136 implant grade MATERIALS: titanium alloy.
PERFORMANCE DATA:
Performance data were submitted to characterize the Eagle Anterior Cervical Plate System.
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 2 2004
Ms. Lisa Gilman Regulatory Affairs Associate Depuy Spine 325 Paramount Drive Raynham, Massachusetts 02767
Re: K040197
Trade Name: Eagle Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Namc: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: March 10, 2004 Received: March 12, 2004
Dear Ms. Gilman:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Ms. Lisa Gilman
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours.
Mark N Milbersen
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use III.
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Eagle Anterior Cervical Plate System Device Name:
Indications For Use:
The Eagle Anterior Cervical Plate System is intended for anterior cervical The Eagle Antonor ocernoal + late systems are indicated for patients in which Intervertebrar body incuses 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 traumatic kyphoolo of leraosteration of the disc confirmed by history and discogents "pair" with" dogemendation for failed fusion, or instability following surgery for the above indications.
Mark N. Millkeusen
Division of General, Restorative, and Neurological Devices
510(k) Number K010197
(Please do not write below this line - continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
× ____________________________________________________________________________________________________________________________________________________________________________ OR Over-The-Counter Use: __ Prescription Use: __ (Per 21 CFR 801.109)
§ 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.