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510(k) Data Aggregation
(150 days)
STALIF (TM) C
The STALIF C is intended to be used as an intervertebral body fusion cage as a stand alone system used with the bone screws provided and requires no additional supplementary fixation systems. It is inserted between the vertebral bodies into the disc space from levels C2 to T1 for the treatment of cervical degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The device system is designed for use with autograft bone to facilitate fusion. STALIFTM C is intended to be used at one level.
The cervical cage is to be used in a skeletally mature patient who has had six weeks of non-operative treatment prior to implantation of the cage.
STALIFTM C is a radiolucent intervertebral body fusion device and unicortical cancellous bone screws and is intended to be used as an IBF cage without supplementary fixation. The cross section profile of the STALIFTM C is similar to that of the vertebral body endplate with a central cavity that can be packed with autograft. STALIFTM C is manufactured from PEEK-Optimad LTI.
This 510(k) summary does not contain the kind of information typically found in acceptance criteria or a study proving a device meets those criteria, particularly for an AI/ML powered device. This document is for a medical device called the STALIFT™ C, which is an intervertebral body fusion device (a physical implant) and not an AI/ML system.
Therefore, many of the requested fields (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set ground truth) are not applicable to the provided text.
However, I can extract the information that is present:
Acceptance Criteria and Device Performance for STALIFT™ C
Based on the provided 510(k) summary, the device's acceptance criteria are primarily defined by its substantial equivalence to predicate devices and its ability to meet recognized performance standards for physical medical implants.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Aspect | Reported Device Performance (from the document) |
|---|---|
| Substantial Equivalence to Predicate Devices | "Substantial equivalence for the Surgicraft STALIFT™ C is based on its similarities in indications for use, design features, operational principles and material composition when compared to the predicate devices cleared under the following submissions: P980048 S003 BAK/C Vista Cervical Interbody Fusion Device, Zimmer Spine, USA; P000028 AFFINITY Anterior Cervical Cage System Medtronic Sofamor Danek, USA; K071833 Mosaic Device (a PEEK Cervical IBF device), Spinal Elements, Inc." |
| Material Composition | Manufactured from PEEK-Optimad LTI. Similar to predicate devices. |
| Design Features | Radiolucent intervertebral body fusion device with unicortical cancellous bone screws. Cross-section profile similar to vertebral body endplate with a central cavity for autograft. Similar to predicate devices. |
| Operational Principles | Intended to be used as an IBF cage without supplementary fixation, with bone screws provided. Designed for use with autograft bone to facilitate fusion. Similar to predicate devices. |
| Indications for Use | Intended for intervertebral body fusion cage as a stand-alone system with bone screws, C2 to T1 for cervical degenerative disc disease treatment (discogenic neck pain with degeneration confirmed by history and radiographs). Used with autograft bone at one level in skeletally mature patients after six weeks of non-operative treatment. Similar to predicate devices. |
| Mechanical Performance / Conformity to Standards | Demonstrated to comply with FDA Recognized Performance Standards: ASTM 2077-03, ASTM F2267-04, ASTM F1877-98(03). |
2. Sample size used for the test set and the data provenance
Not applicable. This is a physical implant device, not an AI/ML algorithm requiring a test set of data. The "testing" involved engineering drawings, labeling, and mechanical testing of the physical device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth for a physical implant's mechanical properties is established through standardized engineering tests, not expert consensus on data sets.
4. Adjudication method for the test set
Not applicable.
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
Not applicable. This is a physical implant; there are no human readers or AI involved in its direct function.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.
7. The type of ground truth used
For the physical device, the "ground truth" is based on:
- Mechanical Test Standards: Compliance with ASTM standards (ASTM 2077-03, ASTM F2267-04, ASTM F1877-98(03)) for materials and device performance.
- Physical Properties: Specifications regarding material composition (PEEK-Optimad LTI) and physical dimensions/design.
- Bench Testing: Mechanical testing to ensure the device meets predefined specifications and performs equivalently to predicate devices.
8. The sample size for the training set
Not applicable. This is a physical implant, not an AI/ML system.
9. How the ground truth for the training set was established
Not applicable.
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