(53 days)
The Mini Variable System, when used with the Mini MaxLock Extreme® Plating System, is intended to stabilize and aid in the repair of fractures, fusions, and osteotomies for small bones and bone fragments.
The Mini Variable System, when used with the MaxLock Extreme® Distal Radius Plates and Screws, is intended for fractures and osteotomies of the distal radius in adult patients.
The submission is a modification to the Mini MaxLock Extreme® Plating System and MaxLock Extreme® Distal Radius Plates and Screws to add Mini Variable components. No modifications were made to the existing plates or screws - this addition will be compatible with all plates in the current systems. The OrthoHelix Mini Variable construct consists of a polymer ring which mates with the locking holes in a plate and allows for a specially designed locking screw to be inserted at angles up to 15° in any direction while maintaining angular stability.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Mini Variable System:
This device (OrthoHelix Mini Variable System) is a physical medical device (fixation plates and screws), not an AI/software-based medical device. Therefore, the typical "acceptance criteria" and "study" questions related to AI performance metrics, expert adjudication, or training/test sets are not directly applicable in the way they would be for an AI algorithm.
Instead, the "acceptance criteria" for a physical device like this revolve around mechanical performance, biocompatibility, and substantial equivalence to legally marketed predicate devices. The "study" typically involves mechanical testing and comparisons.
I will interpret your questions in the context of a physical medical device submission, focusing on the information available for mechanical testing and substantial equivalence.
Analysis of Acceptance Criteria and Study for OrthoHelix Mini Variable System
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Bending Strength | Supports substantial equivalence to predicate devices. |
| Torsional Strength | Supports substantial equivalence to predicate devices. |
| Indications for Use | Substantially equivalent to predicate devices. |
| Design | Substantially equivalent to predicate devices. |
| Materials | Substantially equivalent to predicate devices. |
Explanation: The 510(k) summary explicitly states that "Calculations and mechanical testing comparing the bending and torsional strength of the subject and predicate devices were performed and the results support substantial equivalence." This implies that the acceptance criteria for these mechanical properties were that the Mini Variable System performed comparably to or better than the predicate devices, thereby demonstrating substantial equivalence. The document doesn't provide specific numerical thresholds or results, but rather a summary of the outcome relative to predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the sample size for the mechanical testing (e.g., number of constructs tested, number of cycles). This is common for 510(k) summaries where detailed testing protocols and results might be in the full submission but not summarized in public-facing documents. For mechanical testing, sample sizes are often determined by ISO standards (e.g., ISO 17140 for bone plates) or internal company protocols, typically involving a small number of samples (e.g., 5-10 per test condition).
- Data Provenance: The mechanical testing was conducted by OrthoHelix Surgical Designs, Inc. It is in vitro testing, not human-derived data.
3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts
- Not Applicable. For a physical medical device undergoing mechanical testing, there is no "ground truth" to be established by human experts in the way an AI algorithm's output would be validated. The ground truth lies in the physical laws governing material science and mechanics, measured objectively by testing equipment.
- The "experts" involved would be the engineers and scientists who designed and conducted the mechanical tests, interpreting the raw data against established engineering principles and predicate device performance. Their qualifications would typically include degrees in biomedical engineering, mechanical engineering, or related fields.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
- Not Applicable. Adjudication methods like 2+1 or 3+1 are used to establish a consensus ground truth for complex, subjective interpretations (e.g., medical image diagnosis). Mechanical test results are objective measurements (e.g., force, displacement, cycles to failure) that do not require such adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. An MRMC study is not applicable as this is a physical medical device. These studies are used for evaluating diagnostic or interpretive AI systems where human readers are involved.
6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)
- Not Applicable. This device is a physical implant, not an algorithm. Its performance is inherent in its design and material properties, tested in vitro.
7. Type of Ground Truth Used
- Objective Mechanical Measurements and Predicate Device Performance. The "ground truth" for this device's performance is established by:
- Direct measurements of bending strength and torsional strength.
- Comparison to the known, established performance of legally marketed predicate devices. The substantial equivalence claim is the ultimate "ground truth" for regulatory approval in this context.
8. Sample Size for the Training Set
- Not Applicable. This is a physical device, not an AI algorithm. There is no concept of a "training set" in this context. The design of the device is based on engineering principles and knowledge gained from previous designs (which could be considered analogous to a "training" process in a very loose sense, but not for an algorithm).
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set for a physical device, this question is not relevant. The "ground truth" in design and manufacturing relies on engineering specifications, material properties, and manufacturing quality control.
§ 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.