(81 days)
The 2.4mm VA-LCP Intercarpal Fusion System is indicated for fusion of small bones of the hand including: hamate, capitate, lunate, and triquetrum, for the revision of failed partial wrist fusions, and is indicated for use in patients suffering pain and/or loss of function due to:
- -Osteoarthritis
- -Rheumatoid arthritis
- -Post-traumatic or degenerative wrist arthritis
- -Carpal instability
The 2.4mm VA-LCP Intercarpal Fusion System features low profile circular plates. The plates are available in two sizes: ø15mm (6 holes) and øl 7mm (7 holes). The plates each feature variable angle locking technology. The plates also feature K-wire holes for positioning and temporary fixation.
This document is a 510(k) summary for a medical device called the "2.4mm VA-LCP Intercarpal Fusion System." It describes a traditional medical device (bone fixation system), not a software or AI-powered device. Therefore, the questions related to AI/software performance, such as acceptance criteria based on AI metrics, sample sizes for test/training sets, expert ground truth, adjudication methods, and MRMC studies, are not applicable here.
The "study that proves the device meets the acceptance criteria" in this context refers to the engineering and mechanical testing performed to demonstrate substantial equivalence to predicate devices. The acceptance criteria are implicit in showing that the new device performs comparably to or better than existing, legally marketed devices for its intended use.
Here's the information as it applies to this specific document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit from Substantial Equivalence to Predicate Devices) | Reported Device Performance (Summary in Document) |
|---|---|
| Material Composition: Use of biocompatible and mechanically suitable materials comparable to predicate devices. | "The subject and predicate devices are made from stainless steel and titanium alloy (TAN)." |
| Mechanical Strength & Functional Properties: Demonstrate comparable or superior mechanical strength and functional performance for its intended orthopedic application (e.g., bone fusion) to predicate devices. | "Functional and mechanical testing demonstrates the comparable mechanical & functional properties of the subject 2.4mm VA-LCP Intercarpal Fusion System to the predicate devices. In support of this submission 1-point bending was performed." |
| Intended Use: Device is suitable for the specified indications for use. | "The 2.4mm VA-LCP Intercarpal Fusion System is indicated for fusion of small bones of the hand... for the revision of failed partial wrist fusions, and is indicated for use in patients suffering pain and/or loss of function due to: Osteoarthritis, Rheumatoid arthritis, Post-traumatic or degenerative wrist arthritis, Carpal instability." |
| Design Characteristics: Features (plate size, hole count, locking technology, K-wire holes) are functionally equivalent to predicate devices. | "The plates are available in two sizes: ø15mm (6 holes) and øl 7mm (7 holes). The plates each feature variable angle locking technology. The plates also feature K-wire holes for positioning and temporary fixation." These features are presented as similar to predicate designs. |
| Manufacturing, Packaging, Sterilization: Methods are identical or comparable to predicate devices. | "In addition, the intended use, manufacturing methods, packaging, and sterilization of the predicate and subject components are identical." |
2. Sample size used for the test set and the data provenance
- Not Applicable / Not Specified. This document describes a medical device (surgical implant) cleared based on substantial equivalence through mechanical testing, not a data-driven device evaluated with a test set of patient data. The "test set" would be the physical devices subjected to mechanical testing. The exact number of devices tested for 1-point bending is not specified in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. Ground truth in this context is established by engineering standards and direct physical measurements during mechanical testing, not by human expert interpretation of imaging or clinical data.
4. Adjudication method for the test set
- Not Applicable. Mechanical testing results are objective measurements against established engineering principles and predicate device performance, not subjective interpretations requiring adjudication.
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
- Engineering Standards and Physical Measurements: The "ground truth" for this device's performance is derived from established mechanical engineering principles, material science data, and direct physical measurements obtained through tests like 1-point bending. The acceptance criteria are implicitly met by demonstrating "comparable mechanical & functional properties" to legally marketed predicate devices.
8. The sample size for the training set
- Not Applicable. This is not a machine learning or AI device that requires a "training set."
9. How the ground truth for the training set was established
- Not Applicable. This is not a machine learning or AI 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.