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510(k) Data Aggregation
(50 days)
Skyway Anterior Cervical Plate System
The Skyway Anterior Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2-C7) as an adjunct to fusion. These implants have been designed to provide stabilization for the treatment of the following indications: degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis, or scoliosis), tumor, pseudarthrosis or failed previous fusion.
The 4-Hole 1-Level Plates are limited to use at one contiguous level.
The KMTI Tesera-k SC System is indicated for intervertebral body fusion procedures in skeletally mature patients with cervical degenerative disc disease at one or two levels from C2-T1. KMTI Tesera-k SC System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six weeks of non-operative treatment prior to implantation. When used with the Skyway Anterior Cervical Plate System plates designed with spacer attachment, the assembly takes on the indications of the KMTI Tesera-k SC Interbody Spacer, with the Skyway Anterior Cervical Plate System acting as the supplemental fixation.
The Kyocera Medical Technologies, Inc. (KMTI) Skyway Anterior Cervical Plate System consists of anterior cervical plates, bone screws, and a locking screw. The implant components are composed of titanium alloy Ti-6Al-4V ELI per ASTM F136. The Skyway Anterior Cervical Plate System is offered in various sizes to accommodate patient anatomical needs. The subject 1-Level plates are compatible with and may be permanently attached to the Tesera-k SC System interbody spacers.
The purpose of this Special 510(k) is to introduce non-sterile plate options to the sterile packaged plates which were previously cleared and to modify the geometry of the plate's screw holes and the screw heads with minor dimensional changes.
This document is an FDA 510(k) clearance letter for a medical device called the Skyway Anterior Cervical Plate System. It is focused on demonstrating substantial equivalence to a previously cleared predicate device, rather than providing the kind of performance data (e.g., AI model performance metrics, clinical study outcomes) typically associated with acceptance criteria for novel software-based devices, especially those using artificial intelligence.
The information provided explicitly states: "No performance testing was required for this 510(k)." This is because the submission is a "Special 510(k)" to introduce minor changes (non-sterile plate options and minor geometric modifications) to an already cleared device. Therefore, the questions related to AI model performance, sample size for test/training sets, expert adjudication, MRMC studies, ground truth establishment, etc., are not applicable to this specific 510(k) submission.
Based on the provided text, here's an attempt to answer the questions within the scope of what is stated:
Acceptance Criteria and Device Performance for the Kyocera Medical Technologies, Inc. (KMTI) Skyway Anterior Cervical Plate System (K250486)
As this is a Special 510(k) for minor modifications to an already cleared device, the "acceptance criteria" primarily revolve around demonstrating that the changes do not adversely affect the foundational safety and efficacy already established for the predicate device. The "study" described is a regulatory review process to confirm this, rather than a de novo clinical or performance study of the device's functional performance in a use-case scenario.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied for a Special 510(k)) | Reported Device Performance (as per document) |
|---|---|
| A. Equivalence to Predicate Device: Changes do not raise new questions of safety or efficacy compared to the predicate. | "There are no differences between the subject and predicate device which raise questions for safety and efficacy." |
| B. Sterilization Equivalence: Non-sterile options can be adequately sterilized using established methods. | "The modification to offer non-sterile plates was evaluated to determine that the sterilization set for the subject non-sterile devices is adopted into the sterilization adoption per ISO 17665-1 of a worst-case sterilization set." |
| C. Geometric Modification Impact: Minor dimensional changes to screw holes and screw heads do not compromise performance. | "to modify the geometry of the plate's screw holes and the screw heads with minor dimensional changes." (Implicitly accepted as not raising new safety/efficacy questions). |
| D. Adherence to Regulations: Compliance with all applicable FDA regulations (e.g., 21 CFR 888.3060, 888.3080). | Device cleared as Class II under 21 CFR 888.3060; also refers to QS regulation, UDI Rule, etc. |
| Conclusion of Substantial Equivalence: Overall evaluation confirms substantial equivalence. | "The overall technology characteristics and evaluations lead to the conclusion that the Skyway Anterior Cervical Plate System is substantially equivalent to the predicate device." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable for this type of submission. No performance testing on a "test set" of clinical data or patient outcomes was conducted or required. The review focused on engineering changes and regulatory compliance.
- Data Provenance: Not applicable. The "study" was a regulatory review of engineering specifications and manufacturing process changes (sterilization adoption), not a data-driven performance study.
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)
- Number of Experts & Qualifications: Not applicable. Given "No performance testing was required," there was no "test set" requiring ground truth establishment by clinical experts in the context of device performance. The experts involved would be FDA reviewers (e.g., Engineer & Regulatory Specialist Nathan Wright from KMTI, and the FDA's Division of Spinal Devices staff like Colin O'Neill and Maziar Shah Mohammadi), who assess regulatory compliance and engineering specifications against predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. There was no "test set" of performance data requiring adjudication. The FDA's review process serves as the "adjudication" against regulatory standards and comparison to predicate devices.
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
- MRMC Study: No. This device is not an AI-powered diagnostic tool. It is a physical implant (spinal plate system). Therefore, an MRMC study and AI assistance effect size are not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: No. This device is a physical implant, not an algorithm. Therefore, "standalone (algorithm only)" performance is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: Not applicable in the context of clinical performance data. The "ground truth" for this 510(k) submission relates to established engineering principles, material science standards (e.g., ASTM F136 for titanium alloy), and regulatory requirements (e.g., ISO 17665-1 for sterilization). The substantial equivalence claim is the ultimate "ground truth" sought.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. No AI model training was involved for this physical medical device.
9. How the ground truth for the training set was established
- Ground Truth for Training Set Establishment: Not applicable. No AI model training was involved.
Summary of this Specific 510(k):
This 510(k) clearance (K250486) is a "Special 510(k)" for minor modifications to an existing, already-cleared device. Its purpose is to assure the FDA that changes (adding non-sterile options, minor geometric changes) do not alter the previously established safety and efficacy profiles. Therefore, it does not involve the kind of performance studies, particularly those related to AI model validation, that the questions typically imply. The core "study" is the demonstration of substantial equivalence through regulatory and engineering assessment, not a clinical trial or AI performance evaluation.
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(39 days)
Skyway Anterior Cervical Plate System
The Skyway Anterior Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2-C7) as an adjunct to fusion. These implants have been designed to provide stabilization for the treatment of the following indications: degenerative disc disease (defined as neck pain of discogenic origin with the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis, or scoliosis), tumor, pseudarthrosis or failed previous fusion.
The 4-Hole 1-Level Plates are limited to use at one contiguous level.
The KMTI Tesera-k SC System is indicated for intervertebral body fusion procedures in skeletally mature patients with cervical degenerative disc disease at one or two levels from C2-T1. KMTI Tesera-k SC System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six weeks of non-operative treatment prior to implantation. When used with the Skyway Anterior Cervical Plate System plates designed with spacer attachment, the assembly takes on the indications of the KMTI Tesera-k SC Interbody Spacer, with the Skyway Anterior Cervical Plate System acting as the supplemental fixation.
The KMTI Skyway Anterior Cervical Plate System is an anterior cervical plating fixation system consisting of implants and associated instrumentations to provide supplemental fixation between two adjacent cervical vertebral bodies as an adjunct to fusion or for spinal correction. The Skyway Anterior Cervical Plate System is implanted via an anterior surgical approach.
The subject devices proposed in this submission are a line extension of the Skyway Anterior Cervical Plate System (K231766) with the introduction of additional length and configuration options for the 1-Level Plates and 2-hole and 3-hole 1-Level Plates. This subject line extension also includes non-sterile bone screw and locking screw options. The Skyway Anterior Cervical Plate System plates, bone screws, and locking screws are manufactured from Ti-6Al-4V per ASTM F136.
I am sorry, but the provided text is a 510(k) premarket notification for a medical device (Skyway Anterior Cervical Plate System) and does not contain information related to software, imaging, or AI studies. Therefore, I cannot extract the acceptance criteria for a device from this text, nor can I describe any study proving that the device meets such criteria because the information is not present.
The document discusses the regulatory approval of a physical medical implant (a cervical plate system) and its mechanical testing, not software performance. As such, sections related to sample size for test sets, data provenance, expert adjudication, MRMC studies, standalone algorithm performance, ground truth, and training set information are not applicable to the content of this document.
Ask a specific question about this device
(88 days)
Skyway Anterior Cervical Plate System
The Skyway Anterior Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2-C7) as an adjunct to fusion. These implants have been designed to provide stabilization for the following indications: degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis), tumor, pseudarthrosis or failed previous fusion. The 4-Hole 1-Level Plates are limited to use at one contiguous level.
The KMTI Tesera-K SC System is indicated for intervertebral body fusion procedures in skeletally mature patients with cervical degenerative disc disease at one or two levels from C2-T1 . KMTI Tesera-K SC System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six weeks of non-operative treatment prior to implantation. When used with the Skyway Anterior Cervical Plate System plates designed with spacer attachment, the assembly takes on the indications of the KMTI Tesera-K SC Interbody Spacer, with the Skyway Anterior Cervical Plate System acting as the supplemental fixation.
The Kyocera Medical Technologies, Inc. (KMT) Skyway Anterior Cervical Plate System consists of anterior cervical plates, bone screws, and a locking screw. The implant components are composed of titanium alloy Ti-6A1-4V ELI per ASTM F136. The Skyway Anterior Cervical Plate System is offered in various sizes to accommodate patient anatomical needs. The subject 1-Level plates are compatible with and may be permanently attached to the Tesera-K SC System interbody spacers.
I am sorry, but the provided text does not contain information about an AI/ML-driven medical device, its acceptance criteria, or a study proving its performance.
The document is a 510(k) premarket notification for the Kyocera Medical Technologies, Inc. (KMTI) Skyway Anterior Cervical Plate System, which is a spinal intervertebral body fixation orthosis. It discusses the device's indications for use, technological characteristics, and performance data based on mechanical testing (e.g., static and dynamic compression bending, static torsion).
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as the document does not describe such a study for an AI/ML device.
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