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510(k) Data Aggregation
(115 days)
ESCALATE LAMINOPLASTY SYSTEM
The Escalate™ Laminoplasty System is intended for use in the lower cervical and upper thoracic spine (C3-T3) in laminoplasty procedures. The system is intended to hold the lamina open following a laminoplasty procedure.
The Escalate™ System consists of a comprehensive set of implants and instruments designed for a systematic approach to cervical laminoplasty procedures. The system features an expandable laminoplasty plate, a hinge (“Base”) plate, bone screws for fixation, and a set of instrumentation to assist in the implantation and removal of the implants. The plates have screw holes, which allow for attachment to the vertebral body. The screws to be used with the plates are available in a variety of lengths and diameters and are designed to match the anatomical requirements. The Escalate™ Laminoplasty plates and screws are manufactured from Titanium alloy and will be provided non-sterile.
The Stryker Spine Escalate™ Laminoplasty System is a mechanical device intended to hold the lamina open following a laminoplasty procedure. The acceptance criteria and the study that proves the device meets those criteria are detailed below, as per the provided 510(k) summary.
1. Table of Acceptance Criteria and Reported Device Performance
For mechanical devices like the Escalate™ Laminoplasty System, "acceptance criteria" generally refer to established engineering standards or performance thresholds that the device must meet to demonstrate safety and effectiveness for its intended use. "Reported device performance" refers to the results of tests designed to measure how the device performs against these standards.
| Acceptance Criteria (Standard/Test Type) | Reported Device Performance (Outcome) |
|---|---|
| Static Compression Loading | Data demonstrates substantial equivalence to predicate devices; met all mechanical test requirements. (Modified ASTM 1717-11a) |
| Dynamic Compression Loading | Data demonstrates substantial equivalence to predicate devices; met all mechanical test requirements. (Modified ASTM 1717-11a) |
| Screw Driving Insertion Torque | Data demonstrates substantial equivalence to predicate devices; met all mechanical test requirements. (ASTM F543-07) |
| Screw Removal Torque | Data demonstrates substantial equivalence to predicate devices; met all mechanical test requirements. (ASTM F543-07) |
| Screw Torque to Failure | Data demonstrates substantial equivalence to predicate devices; met all mechanical test requirements. (ASTM F543-07) |
| Axial Screw Pull-Out | Data demonstrates substantial equivalence to predicate devices; met all mechanical test requirements. (ASTM F543-07) |
| Substantial Equivalence | The Escalate™ Laminoplasty System was determined to be substantially equivalent to the predicate devices (Medtronic Centerpiece™ Plate Fixation System (K050082) and Synthes Arch™ Fixation System (K032534)). The subject system does not present any new issues of safety and effectiveness. |
Study Proving Acceptance Criteria are Met:
The study proving the device meets the acceptance criteria was a series of performance tests conducted to demonstrate substantial equivalence to existing legally marketed predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The provided 510(k) summary does not specify the exact sample sizes (e.g., number of implants tested, number of screws tested) for each biomechanical test. It only states that "performance testing was conducted."
- Data Provenance: This information is not explicitly stated in terms of country of origin. Given that Stryker Spine is in New Jersey, USA, and is submitting to the US FDA, it is highly probable that the testing was conducted in the USA or by a testing facility compliant with US regulatory standards. The data is retrospective in the sense that it describes tests performed on physical device prototypes, not data gathered from a clinical trial in patients.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable to this type of device and study. The "ground truth" for mechanical performance is established by the specifications of the ASTM standards and engineering principles, not by expert consensus in the way a medical image diagnosis would be. The "experts" involved would be biomechanical engineers and technicians conducting and analyzing the tests, but their specific number and detailed qualifications are not typically reported in this summary format.
4. Adjudication Method for the Test Set
This section is not applicable. Adjudication methods (like 2+1, 3+1) are used in studies involving human interpretation or clinical outcomes where there might be disagreement, such as in reading medical images. For biomechanical testing, the results are quantitative measurements against established standards, not subject to subjective adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. MRMC studies are relevant for diagnostic devices where human readers interpret medical data, often with or without AI assistance, to assess diagnostic performance. The Escalate™ Laminoplasty System is a surgical implant, and its evaluation focuses on mechanical integrity and equivalence, not diagnostic accuracy or human interpretation.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not applicable to this device. A "standalone" performance evaluation typically refers to the performance of an AI algorithm independent of human input. The Escalate™ Laminoplasty System is a physical implant; it does not involve an algorithm.
7. The Type of Ground Truth Used
For this device, the "ground truth" is defined by:
- Established engineering standards and specifications: Specifically, the ASTM standards (ASTM 1717-11a for compression loading and ASTM F543-07 for screw-related tests) provide the benchmarks for acceptable performance.
- Performance of predicate devices: The "ground truth" for substantial equivalence is that the subject device performs similarly to or better than predicate devices already on the market and deemed safe and effective.
8. The Sample Size for the Training Set
This question is not applicable. The Escalate™ Laminoplasty System is a mechanical implant, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The design and manufacturing processes are informed by established engineering principles and prior device experience, but not by a machine learning training dataset.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the same reasons as #8. There is no training set for this mechanical device.
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