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510(k) Data Aggregation
(207 days)
SYNTHES(USA)TITANIUM LOCKING PLATE SYSTEM(TILPS)
The Synthes TiLPS is intended for anterior intravertebral body screw fixation/attachment to the LI-S1 spine over one vertebral body extending onto the adjacent intervetebral space. Due to variations in the anatomy, the plate is designed for applications caudal to the bifurcation of the great vessels. Specifically, the device is intended for stabilization and buttressing of bone graft over one motion segment following anterior structural reconstruction for degenerative disc disease. DDD is defined as follows: back pain of a discogenic origin with degeneration of the disc confirmed by history and radiographic studies
The system consists of a two hole locking plate, 4.35 mm expansion screws with 1.8 mm locking screws. The two hole plate is available in various lengths and is manufactured from commercially pure titanium.
The provided document is a 510(k) premarket notification for the Synthes Titanium Locking Plate System (TiLPS). This document establishes substantial equivalence to previously marketed devices and outlines the intended use and limitations. It does not contain information about acceptance criteria or a study proving the device meets those criteria in the way typically expected for a diagnostic or AI-based device.
The concept of "acceptance criteria" and "device performance" in this context refers to the device being substantially equivalent to existing predicate devices, primarily in terms of materials, design principles, and intended use. The "study" proving this is the 510(k) submission itself, where the manufacturer provides a comparison to legally marketed predicate devices.
Here's an attempt to answer your questions based only on the provided information, interpreting "acceptance criteria" and "device performance" in the context of a 510(k) submission for a spinal implant:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (for Substantial Equivalence to Predicate Devices) | Reported Device Performance (Synthes TiLPS) |
|---|---|
| Intended Use: Anterior intravertebral body screw fixation/attachment to the L1-S1 spine over one vertebral body extending onto the adjacent intervertebral space, for stabilization and buttressing of bone graft over one motion segment following anterior structural reconstruction for degenerative disc disease. | Intended Use: The Synthes TiLPS is intended for anterior intravertebral body screw fixation/attachment to the L1-S1 spine over one vertebral body extending onto the adjacent intervertebral space. Due to variations in the anatomy, the plate is designed for applications caudal to the bifurcation of the great vessels. Specifically, the device is intended for stabilization and buttressing of bone graft over one motion segment following anterior structural reconstruction for degenerative disc disease. (Matches predicate devices' similar indications). |
| Materials: Commercially pure titanium. | Materials: Manufactured from commercially pure titanium. (Matches predicate devices: Synthes Anterior Cervical Vertebrae Plate System, K926453 and K945700, and Synthes Anterior Spinal Plate System, K925351). |
| Design Principles: Two-hole locking plate, expansion screws with locking screws. | Design Principles: The system consists of a two-hole locking plate, 4.35 mm expansion screws with 1.8 mm locking screws. Plate is similar in plate width, thickness, and length to the Anterior Cervical Vertebrae Plate System. The locking mechanism utilizes an expansion screw head engaged by a locking screw to create locking force between the screw and plate. (Similar to predicate devices' design for fixation). |
| Safety and Effectiveness: Demonstrated through substantial equivalence to legally marketed devices. | Safety and Effectiveness: Determined to be substantially equivalent to Synthes Anterior Cervical Vertebrae Plate System (K926453 and K945700) and Synthes Anterior Spinal Plate System (K925351) based on comparison of indications for use, technological characteristics (materials, design, function). |
2. Sample Size Used for the Test Set and the Data Provenance
This document does not describe a "test set" in the context of clinical studies for performance metrics. The "test set" here refers metaphorically to the comparison set of predicate devices.
- Sample Size: Three predicate devices (Synthes Anterior Cervical Vertebrae Plate System (K926453 and K945700) and Synthes Anterior Spinal Plate System (K925351)).
- Data Provenance: Not applicable in the typical sense. The information comes from the design specifications, materials, and intended uses of the predicate devices already cleared by the FDA, and a comparison of the new device to these. This is analogous to a retrospective review of existing product data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. "Ground truth" in this context refers to the established safety, effectiveness, and regulatory status of the predicate devices. The "experts" are the FDA reviewers who previously cleared the predicate devices and who are reviewing this 510(k) submission. The document doesn't specify the number or qualifications of the FDA reviewers, but they are regulatory experts within the Office of Device Evaluation.
4. Adjudication Method for the Test Set
Not applicable. There's no "adjudication method" described for a test set. Substantial equivalence is determined by the FDA based on the provided comparison to predicate devices, material specifications, and design.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. This document does not describe an MRMC study. These studies are typically for diagnostic AI devices assessing human reader performance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
No. This document describes a physical medical implant, not a software algorithm.
7. The Type of Ground Truth Used
The "ground truth" is the established regulatory clearance and perceived safety/effectiveness of the predicate devices based on their prior 510(k) submissions. The "truth" is that these predicate devices are legally marketed, and the new device is sufficiently similar to them.
8. The Sample Size for the Training Set
No "training set" is mentioned as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set mentioned.
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