(80 days)
The DePuy ALPS Small Bone Locked Plating System is 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 DePuy ALPS Small Bone Locked Plating System consists of a series of plates and screws manufactured from Titanium alloy and CoCr used in bone fixation and the management of fractures and reconstructive surgeries.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the DePuy ALPS Small Bone Locked Plating System:
Based on the provided text, the device is a DePuy ALPS Small Bone Locked Plating System, which is a metallic bone fixation appliance. The documentation is a 510(k) summary, aiming to demonstrate substantial equivalence to legally marketed predicate devices rather than fulfilling specific performance acceptance criteria for a novel device.
Therefore, the "acceptance criteria" here are not performance metrics (like sensitivity or specificity) but rather the demonstration of substantial equivalence to predicate devices. The "study" proving this is a pre-clinical engineering comparison and testing report, not a clinical study involving human or even animal subjects.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Demonstration of Substantial Equivalence) | Reported Device Performance (Summary of Pre-clinical Data) |
|---|---|
| Technological Characteristics Similarity: Device's material and design are similar to predicate devices. | The technological characteristics of the DePuy ALPS Small Bone Locked Plating System are similar to the predicate devices including design and material. |
| Mechanical Performance Equivalence: Device meets mechanical performance standards comparable to predicate devices. | Testing included construct static bending. |
| Biocompatibility/Corrosion Resistance Equivalence: Device demonstrates similar corrosion resistance to predicate devices. | Testing included galvanic corrosion testing. |
| Indications for Use Comparison: Device's intended use aligns with predicate devices. | Comparison of indications for use. |
| Device Geometry and Design Comparison: Device's physical attributes are comparable to predicate devices. | Comparison of device geometry and design. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable in the context of this 510(k) summary. The "test set" here refers to the physical samples of the device and predicate devices used for pre-clinical engineering tests. The exact number of samples tested for static bending and galvanic corrosion is not specified, but it would have been a limited number of physical prototypes or manufactured units of the device and its predicates.
- Data Provenance: Not explicitly stated. Given that DePuy Orthopaedics, Inc. is based in Warsaw, Indiana, USA, it's highly probable the testing was conducted either internally in the US or outsourced to testing facilities, possibly in the US or Europe, but this is not confirmed by the document. The data is retrospective in the sense that it's a comparison to existing, already marketed predicate devices.
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. "Ground truth" in this context would generally refer to clinical outcomes or expert diagnoses, which are not part of a pre-clinical 510(k) submission for mechanical equivalence. The "truth" here is established by engineering standards and comparison data from predicate devices, likely interpreted by engineers and regulatory specialists.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods like 2+1 or 3+1 typically refer to expert review processes for clinical data (e.g., medical image interpretation). For pre-clinical mechanical testing and substantial equivalence, the "adjudication" is typically a regulatory review process by the FDA based on the provided engineering test reports and comparisons.
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 comparative effectiveness study was not done. This type of study is relevant for diagnostic devices, particularly those involving interpretation by human readers (e.g., radiology AI). The DePuy ALPS Small Bone Locked Plating System is a surgical implant, not a diagnostic tool requiring human interpretation comparison in this manner.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, an algorithm-only standalone performance study was not done. This device is a physical surgical implant, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For this 510(k) submission, the "ground truth" for demonstrating substantial equivalence is primarily based on:
- Engineering Standards and Measurements: Objective measurements from static bending and galvanic corrosion tests.
- Predicate Device Data: Existing, legally marketed predicate device materials, design specifications, and performance data.
- Regulatory Definitions: Compliance with regulatory definitions of "substantial equivalence" based on comparison of indications for use, materials, device geometry, and design.
8. The sample size for the training set
- Not applicable. This device is not an AI or machine learning model that requires a "training set."
9. How the ground truth for the training set was established
- Not applicable for the same reason as above.
§ 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.