(127 days)
Intended for use in stabilization and fixation of fractures, revision procedures, fusions, reconstructions (osteotomy) and non-unions of the bones of the hand, foot, wrist, ankle, finger, toe, humerus, olecranon, clavicle, scapula and pelvis, particularly in osteopenic bone. The system can be used in both adult and pediatric patients (adolescents [>12 - 21 years of age]), where the implant would not cross open epiphyseal plates in skeletally immature patients.
The ALPS 2.5mm Inline Fusion Plate consists of a 2.5mm Titanium alloy fusion plate offered to be used with non-locking, locking and variable angle screws manufactured from Titanium alloy and CoCr for bone fixation and the management of fractures, fusions, revisions and reconstructive surgeries.
The provided text is a 510(k) summary for a medical device called the ALPS 2.5mm Inline Fusion Plate. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document describes a bone fixation plate, which is a physical implant, not an AI or software-based medical device. Therefore, the questions related to AI/algorithm performance, ground truth, expert opinions, and reader studies are not applicable to this submission.
The acceptance criteria and supporting "study" relate to the physical and mechanical properties of the plate compared to existing devices.
Here's a breakdown of the relevant information provided:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a physical medical device (bone plate), the "acceptance criteria" are related to its mechanical performance and biocompatibility. The summary states:
| Criterion | Reported Device Performance |
|---|---|
| Substantial Equivalence | "The ALPS 2.5mm Inline Fusion Plate is substantially equivalent to currently marketed devices..." |
| Pre-clinical Data | "...demonstrated with pre-clinical data including axial load construct testing and evaluation of galvanic corrosion potential." |
| Safety and Efficacy Concerns | "No new issues of safety or efficacy have been raised." |
| Technological Characteristics | "The technological characteristics of the ALPS 2.5mm Inline Fusion Plate are similar to the predicate devices including design, dimensions and material." |
Study Proving Acceptance Criteria:
The study referenced is "pre-clinical data" that includes:
- Axial load construct testing: This is a mechanical test to assess the device's ability to withstand forces along its axis, simulating how it would hold bones together.
- Evaluation of galvanic corrosion potential: This test assesses the likelihood of corrosion when different metals are in contact within a biological environment.
This "study" (series of tests) demonstrated that the ALPS 2.5mm Inline Fusion Plate performed similarly to its predicate devices concerning these crucial mechanical and material properties, confirming substantial equivalence.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. This is a physical device submission. "Sample size" in this context would refer to the number of plates tested in mechanical and material evaluations, which is not specified in the summary. Data provenance is also not relevant for these types of engineering tests.
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)
- Not applicable. There is no "ground truth" to be established by medical experts in this context. The "truth" is determined by established engineering standards and test methods for mechanical and material properties of implants.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are relevant for human interpretation or clinical studies, not for mechanical device 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
- Not applicable. This is not an AI/software device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/software device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable. For a physical device, the "ground truth" relates to compliance with engineering specifications, material properties, and performance in standardized mechanical tests, rather than a clinical "ground truth."
8. The sample size for the training set
- Not applicable. This is not an AI/software device.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/software device.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.