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510(k) Data Aggregation
(49 days)
LINOS MOH HAND PLATING SYSTEM
The LINOS MOH Hand Plating System is used for stabilization and fixation of fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, wrist, fingers, feet, ankles and toes.
The LINOS MOH Hand Plating System consists of plates of various shapes and thicknesses for bone fixation. Plate features include a low profile with angulated-locking threaded screw holes. The system also includes locking and non-locking screws of various lengths and diameters and the necessary instruments to facilitate placement of the implants. The purpose of the Special 510(k) submission is to gain marketing clearance for modifications to the existing plates and screws in the previously cleared KLS Martin Hand Plating System.
Here's a breakdown of the acceptance criteria and the study details for the LINOS MOH Hand Plating System, based on the provided documents:
The provided documents describe a Special 510(k) submission for the LINOS MOH Hand Plating System, where the device is considered substantially equivalent to a previously cleared predicate device (KLS Martin Hand Plating System, K040598). This type of submission focuses on demonstrating equivalence to an existing device rather than proving de novo performance against a new set of clinical acceptance criteria. Therefore, the "acceptance criteria" discussed here relate to the device meeting performance requirements comparable to its predicate, rather than independently established goals for a new kind of device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Requirements) | Reported Device Performance |
|---|---|
| Material Composition (matching predicate) | CP Titanium or Ti-6Al-4V Titanium Alloy (Matches predicate) |
| Intended Use (matching predicate) | Stabilization and fixation of fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, wrist, fingers, feet, ankles and toes. (Matches predicate) |
| Anatomical Sites (matching predicate) | Small bones of the hand, wrist, fingers, feet, ankles, toes (Matches predicate) |
| Sterilization Method (matching predicate) | Provided Nonsterile (Steam) (Matches predicate) |
| Plate Geometry (matching predicate for core feature) | Pre-curved to follow natural curves of hand and feet bones (Matches predicate. The new system expands to include threaded plates, while predicate was non-threaded, but this is a modification and not a change to the core pre-curved geometry.) |
| Plate Thickness Range (matching predicate) | 0.6mm – 3.0mm (Matches predicate) |
| Screw Diameter Range (matching predicate) | 1.0mm – 2.7mm (Matches predicate) |
| Screw Length Range (matching predicate) | 2mm – 32mm (Matches predicate) |
| Mechanical Performance (Fatigue, Bending, Torsion strengths) (per ASTM F382-99 and ASTM F543-13) | Met performance requirements and demonstrated to be as safe and effective as their predicate devices through mechanical testing. (Specific values are not provided, only stating compliance with standards and equivalence to predicate) |
| Risk Management (per ISO 14971:2007) | Evaluation demonstrated design change did not present hazards outside acceptability criteria, and risk-related issues were controlled and verified during design control review process. (Demonstrates adherence to risk management standards and internal controls) |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The documents do not specify a "test set" in the context of clinical data. The evaluation was primarily based on nonclinical mechanical testing and comparison of technological characteristics to a predicate device.
- Data Provenance: The nonclinical mechanical testing was performed in accordance with ASTM (American Society for Testing and Materials) standards. The results from these tests are generally from laboratory settings, not patient data. No "country of origin of the data" or "retrospective/prospective" study design is applicable as this was not a human clinical study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- This information is not applicable as there was no clinical test set requiring expert ground truth or human readers. The evaluation was based on engineering and performance specifications and comparison to a predicate device.
4. Adjudication Method for the Test Set
- This information is not applicable as there was no clinical test set requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study was done. This submission is for a medical implant (bone plating system) and its modifications, not a diagnostic imaging or AI-assisted device that would typically involve human readers.
6. Standalone (Algorithm Only) Performance Study
- No standalone algorithm performance study was done. This device is a physical medical implant, not an algorithm or software-based device.
7. Type of Ground Truth Used
- The "ground truth" for the nonclinical testing was defined by the performance requirements outlined in ASTM F382-99 and ASTM F543-13, demonstrating that the device meets safety and efficacy standards by performing comparably to the predicate device under mechanical stress. For the substantial equivalence claim, the ground truth was the established characteristics and performance of the legally marketed predicate device.
8. Sample Size for the Training Set
- This information is not applicable. "Training set" typically refers to data used to train machine learning models. This submission is for a physical medical device, not an AI/ML product.
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable for the same reason as point 8.
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