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510(k) Data Aggregation
(226 days)
MAHE FIXATION PLATE AND SCREW SYSTEM
The Mahe Fixation Plate and Screw System is indicated for fracture fixation and joint fusion in the pelvis, small bones and long bones. Examples include fractures of the tibia, fibula, femoral condyle, pelvis, acetabulum, metacarpals, metatarsals, clavicle, humerus, ulna, middle hand and middle foot bones; and treatment of the calcaneus. The system is indicated for use in adult patients. All implants are intended for single use only.
Mahe Fixation Plate and Screw System consists of various shape and sizes plates featuring compression and locking or non-locking holes, fullthreaded-cortical, short threaded-cancellous, locking or non-locking, cannulated, self-tapping or non-self-tapping screws, compression and dynamic screws, implantable K-wires, pins, washers, and appropriate instrumentation. Surgical instrumentation is provided to facilitate modification, insertion, and removal of implants. The plates and screws are fabricated from stainless steel and titanium. The system contains several modules based on the size of the device and application site such as fixation/reconstruction of small fragment bones, forefoot, mid-foot, rear-foot, ankle, or other bones appropriate for the size of the device. The plate implants are in following models available: Tubular Plates, Reconstruction Plates, Cloverleaf Plates, Calcaneus Plates, Anatomical Plates, Clavicula Hook Plates, Small Fragment, Locking Plates, and DHSP/DCSP Screw Plates. The thickness of the plates varies from 1.2mm to 10mm; the length varies from 26mm to 317mm; and the number of the holes varies from 2 to 22. The screw implants are in three different diameter sizes (2.7mm, 3.5mm, and 4.0mm) and the K-wire implants are in various lengths (from 70mm to 310mm) and diameter sizes (from 0.8 to 3mm) available. The system is sold non-sterile, the products have to be sterilized prior to use.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standards Met) | Reported Device Performance (Summary) |
|---|---|
| ISO 5838 "Implants for surgery - Skeletal pins and wires" | The device demonstrates compliant performance with this standard. |
| ASTM F366-04 "Standard Specification for Fixation Pins and Wires" | The device demonstrates compliant performance with this standard. |
| ASTM F0543-07 "Standard Specification and Test Methods for Metallic Medical Bone Screws" | The device demonstrates compliant performance with this standard. |
| ASTM F 382-99 "Standard Specification and Test Method for Metallic Bone Plates" | The device demonstrates compliant performance with this standard. |
| Biocompatibility | Biocompatibility tests were performed, indicating no new safety concerns. |
| Mechanical Properties (compared to predicate devices) | Functional and mechanical testing demonstrates comparable mechanical properties to the predicate devices. |
| Safety & Effectiveness | The device is deemed safe and effective for its intended use, performing as well as or better than predicate devices, and uses well-researched materials. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set or the data provenance for the non-clinical performance data. It mentions that "All models that are covered by this 510(k) premarket notification have been on the market in Europe for many years with no device failures," suggesting real-world data from Europe, but this is not a formal "test set" in the context of a controlled study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided in the document. The data presented is primarily non-clinical "performance data" such as testing against industry standards, biocompatibility, and mechanical properties, rather than data requiring expert-established ground truth for a clinical test set.
4. Adjudication Method for the Test Set
This information is not applicable as the studies described are non-clinical performance data (e.g., mechanical testing against standards).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The document focuses on non-clinical performance data and a comparison of technological characteristics to predicate devices.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable as the device is a medical implant (plates, screws, and pins), not an algorithm or AI system.
7. The Type of Ground Truth Used
For the non-clinical performance data, the "ground truth" is established by:
- Industry Standards: Compliance with established international and national standards (ISO 5838, ASTM F366-04, ASTM F0543-07, ASTM F 382-99).
- Predicate Device Performance: Direct comparison of functional and mechanical properties against legally marketed predicate devices.
- Biocompatibility Testing: Results of established biocompatibility tests.
There is no mention of clinical ground truth (e.g., pathology, outcomes data, expert consensus) in the context of a clinical study for this 510(k) summary.
8. The Sample Size for the Training Set
This is not applicable as the device is a medical implant, not an AI or algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as the device is a medical implant, not an AI or algorithm that requires a training set.
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