(271 days)
The Simple Locking IntraMedullary (SLIM) System is intended as a temporary implant for alignment, stabilization and fixation of long bones that have been surgically prepared (osteotomy) for correction of deformities, or have sustained fractures due to trauma or disease. This includes:
- Femur and tibia in the pediation (child and adolescent), and small-stature adults such as patient with small intramedullary canals affected by skeletal dysplasias, osteogenesis imperfecta or other bone diseases.
. Humerus, ulna, fibula in all patient populations
The Simple Locking Intra-Medullary (SLM) system consists of intramedullary fixation devices for use in long bones. The solid shaft, bevelled point, and pre-determined or blank length options is designed for easy insertion in the medullar canal. Anchorage of the device is achieved through a conical thread to obtain a stable fixation in the epiphyses or cortical bone, which aims to reduce the risk of migration. Internal features, such as a hexagonal drive and an internal mechanical thread in the device, are designed for capture and guidance during insertion and retrieval. Additional proximal and distal locking holes allow pinning to ensure fixation with locking pegs when required, and the Bullet screws allow fixation of smaller diameter shafts that cannot be cross-pinned due to their size. The SLIM implants are manufactured in medical grade Stainless Steel (SS316L, ASTM F138). The rods are available in seven diameters: 2.0.2.6.3.2. 4.0. 4.8. 5.6 and 6.4 mm, from 80mm up to 400 mm in length allows end user to customize the length of the rod.
The provided text describes a medical device's 510(k) submission to the FDA, focusing on substantial equivalence to predicate devices, rather than detailed acceptance criteria and a study proving device performance against such criteria. As such, much of the requested information is not available in the text.
Here's what can be extracted and what is not available:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicit in text | Four-point static bending: Bullet screws found equivalent for intended uses. |
| Fatigue four-point bending: Bullet screws found equivalent for intended uses. | |
| Pull-out & Push-out strength: Not explicitly stated, but performed. | |
| Migration resistance of Shaft to Bullet assembly (static loading): Performed and evaluated. | |
| Migration resistance of Shaft to Bullet assembly (cyclic loading/fatigue): Performed and evaluated. | |
| Comparative loading in physiological relevant setting of SLIM and Bullet against predicate: Performed. | |
| Functional testing of Intro-OP Implant Cutter (ICON) Prototype on SLIM blank: Performed. | |
| Mechanical Resistance (SLIM blanks): Same as previously cleared SLIM rods | SLIM blanks: identical diameters and material as previously cleared SLIM rods. |
| Mechanical Resistance (Added pins and pegs): Same or higher than previously cleared pins | Added pins and pegs: same or larger diameter and same material than previously cleared pins. |
| Equivalence of locking pegs vs. simple locking pin (torsion, drive torque, axial pull-out): Locking pegs perform equivalently | Locking pegs: considered to perform equivalently than simple locking pin. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified for any of the non-clinical tests.
- Data Provenance: Not specified, but based on the nature of the tests (bench testing, animal model) and the "non-clinical" designation, it would be laboratory-generated data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This submission details non-clinical bench testing and an animal model, not studies requiring expert review for ground truth establishment.
4. Adjudication method for the test set:
- Not Applicable. No human-based adjudication methods were mentioned as this was non-clinical testing.
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:
- No, an MRMC study was not done. This is a mechanical device, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This device is an implant, not an algorithm.
7. The type of ground truth used:
- For the non-clinical tests, the "ground truth" would be established by validated test methodologies and measurements against engineering specifications or comparative performance to predicate devices (e.g., comparing load-bearing capacity, fatigue life, pull-out strength).
- For the animal model validation, the "ground truth" would be related to successful surgical technique demonstration and expected biological/mechanical outcomes in the animal.
8. The sample size for the training set:
- Not Applicable. This device doesn't involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established:
- Not Applicable. (See above)
Summary of the Study that Proves the Device Meets Acceptance Criteria (based on the provided text):
The text describes a series of non-clinical, bench-top mechanical tests and validation in an animal model to demonstrate the substantial equivalence of “The Simple Locking IntraMedullary (SLIM) System” to its predicate devices. The primary goal was to ensure that new components (Bullet screws, new pins/pegs, SLIM blanks) and the system as a whole performed equivalently or better than previously-cleared components and predicate devices.
Key tests performed include:
- Static four-point bending bench testing
- Fatigue four-point bending bench testing
- Pull-out & Push-out strength
- Surgical technique validation on an animal model
- Evaluation of Shaft to Bullet assembly migration resistance (static and cyclic loading)
- Static and fatigue four-point bending of the Bullet screws
- Comparative loading in a physiologically relevant setting of the SLIM and Bullet against the predicate device
- Functional testing of a cutting operation for an associated instrument (Intro-OP Implant Cutter (ICON) Prototype).
The conclusion of these tests was that the Bullet screws were "found equivalent for their intended uses," and the locking pegs were "considered that they perform equivalently" to simple locking pins in terms of torsion, drive torque, and axial pull-out. The SLIM blanks were deemed to have the same mechanical resistance due to identical materials and dimensions, and new pins/pegs were expected to have the same or higher mechanical resistance due to similar or larger diameters and materials.
No clinical testing was provided as a basis for substantial equivalence. The justification for this device's acceptance relied entirely on these non-clinical performance data and the conclusion that the "anticipated benefits of such a system clearly outweigh the possible residual risks."
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.