(322 days)
- Indication for Use: Multi Angle Tibial Nail is intended to stabilize fracture of the proximal & distal tibia and the tibial shaft, open and closed tibial shaft fractures, certain pre and post isthmic fractures and tibial malunions & nonunions.
- Indications for Use: Ga-mma Nail is indicated for use in stabilizing various types of intertrochanteric fractures of proximal femur.
The GPC Intramedullary Nailing Systems include intramedullary nails and corresponding screws/end caps/locking bolts for fastening these intramedullary nails to the fractured bones.
The provided text describes a 510(k) premarket notification for "GPC Intramedullary Nailing Systems". This submission demonstrates substantial equivalence to predicate devices based on non-clinical testing and comparison of characteristics, rather than a clinical effectiveness study involving human subjects or an AI standalone or AI-assisted performance evaluation.
Therefore, many of the requested categories regarding acceptance criteria for AI performance, clinical study details, and expert involvement are not applicable to this document.
Here's a breakdown of the information that is available and the information that is not.
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are implicitly defined by compliance with the given material and performance standards, and comparison to the predicate devices. The "reported device performance" is framed as demonstrating equivalence to the predicate devices in these areas rather than specific quantitative performance metrics against a defined threshold.
| Acceptance Criteria Category | Device Performance (vs. Predicate Device) | Remarks |
|---|---|---|
| Multi Angle Tibial Nail | ||
| Indications for Use | Same intended use | Equivalent |
| Material | Same material (also available in Stainless Steel type) | Equivalent |
| Performance Standards | Same performance standards | Equivalent |
| Sterilization | Same method of sterilization | Equivalent |
| Dimensional Verification | Differences in geometry do not affect safety; performance test results indicate equivalence | Equivalent |
| ASTM F 136 Material Standard | Complied | |
| ASTM F 138 Material Standard | Complied | |
| ASTM F 1264 Performance | Complied; relevant test results comparing subject devices with predicate devices in Executive Summary (not provided here) | |
| Ga-mma Nail | ||
| Indications for Use | Same intended use | Equivalent |
| Material | Same material | Equivalent |
| Performance Standards | Same performance standards | Equivalent |
| Sterilization | Same method of sterilization | Equivalent |
| Dimensional Verification | End cap with collar prevents sharp edges, adds strength and safety; does not lead to safety concerns related to device performance | Equivalent |
| ASTM F 136 Material Standard | Complied | |
| ASTM F 138 Material Standard | Complied | |
| ASTM F 384 Performance | Complied; relevant test results comparing subject devices with predicate devices in Executive Summary (not provided here) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This submission relies on non-clinical (bench) testing and comparison to predicate devices, not a test set of patient data, retrospective or prospective.
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. This submission does not involve ground truth assessment by experts in the context of a test set for clinical performance. The "ground truth" for equivalence is established by compliance with engineering and material standards and direct comparison of specifications and bench testing results to the predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no test set for clinical performance or adjudication process described.
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 and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device (intramedullary nailing systems), not an algorithm or software. Its performance is assessed through material and bench testing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is established by:
- Compliance with material standards (ASTM F 136, ASTM F 138).
- Compliance with performance standards (ASTM F 1264 for Tibial Nail, ASTM F 384 for Ga-mma Nail).
- Demonstration of equivalence in physical characteristics (dimensions, materials) and intended use compared to legally marketed predicate devices.
- The results of non-clinical (bench) testing showing comparable performance to the predicate devices (as detailed in the "executive summary" which is not fully provided here, but referenced).
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/machine learning device.
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.