(45 days)
The Ellipse PRECICE System is indicated for limb lengthening of the tibia and femur.
The Ellipse PRECICE System is composed of the PRECICE nail (supplied sterile), locking screws, surgical instruments and an external remote controller (ERC). The nail is available in tibia or femur models with various diameters, lengths and screw hole configurations to accommodate a variety of patient anatomies. The locking screws are also available in a variety of diameters and lengths. The PRECICE nail is supplied sterile by gamma radiation while the locking screws and PRECICE specific accessories are supplied non-sterile and must be sterilized prior to use. The nail contains an enclosed rare earth magnet, telescoping lead screw/nut assembly, and planetary gearing.
The Ellipse PRECICE® System, specifically the 8.5 mm PRECICE Nail and its associated 3.5 mm diameter locking screw, obtained 510(k) clearance (K133289) based on its substantial equivalence to a previously cleared device, the Ellipse Intramedullary Limb Lengthening System (K131677). This clearance was supported by non-clinical testing.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Description | Applicable Test Standard | Acceptance Criteria (Implied by Equivalence) | Reported Device Performance |
|---|---|---|---|
| PRECICE Nail, Static Four Point Bend | ASTM F1264-03 | Equivalent to predicate (K131677) | Met equivalence criteria |
| PRECICE Nail, Dynamic Four Point Bend | ASTM F1264-03 | Equivalent to predicate (K131677) | Met equivalence criteria |
| PRECICE Nail, Static Torque to Failure | ASTM F1264-03 | Equivalent to predicate (K131677) | Met equivalence criteria |
| PRECICE Locking Screw, Static Three Point Bend | ASTM F1264-03 | Equivalent to predicate (K131677) | Met equivalence criteria |
| PRECICE Locking Screw, Dynamic Three Point Bend | ASTM F1264-03 | Equivalent to predicate (K131677) | Met equivalence criteria |
| PRECICE Locking Screw, Axial Pullout Strength | ASTM F543-07 | Equivalent to predicate (K131677) | Met equivalence criteria |
| PRECICE Locking Screw, Torque to Failure | ASTM F543-07 | Equivalent to predicate (K131677) | Met equivalence criteria |
| Device functionality and verification | None | Functionally equivalent to predicate | Met equivalence criteria |
- Note: The document explicitly states that "Substantial equivalence is based on similar indications for use, designs, and on in vitro testing performed. Where specific dimensional differences exist, bench testing has shown that these differences do not present new risks." This implies that the acceptance criteria for these tests were to demonstrate performance at least equivalent to, or not presenting new risks compared to, the predicate device (K131677). The reported performance is that the tests were performed and the device was found to be "as safe, effective, and performs as well as the predicate device (K131677)."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a distinct "test set" in terms of patient data. The evaluation was primarily based on mechanical testing and design functionality/performance testing of the device components (nail and screws). Therefore, the "sample size" would refer to the number of devices or components tested in these benchtop studies. This information is not provided in the given text.
- Data Provenance: The data provenance is non-clinical bench testing. The country of origin of the data is not explicitly stated, but the company is U.S.-based (Irvine, CA), and the submission is to the U.S. FDA, suggesting the testing was likely conducted in the U.S. or at a facility that meets U.S. standards. The data is retrospective in the sense that it's laboratory testing, not prospective patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This question is not applicable to this submission. The "ground truth" for this medical device clearance was established through objective engineering standards and mechanical testing, not expert consensus on patient data. No human experts were used to establish ground truth for a "test set" in the context of clinical performance.
4. Adjudication Method for the Test Set
This question is not applicable as there was no "test set" requiring human adjudication as would be found in a clinical study for diagnostic devices. The acceptance was based on direct comparison of mechanical properties and design features to a predicate device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This device is a mechanical implant, not a diagnostic imaging device that would typically undergo such a study. The evaluation focused on mechanical and functional equivalence.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
No, a standalone algorithm performance study was not done. This device is a mechanical implant, not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this submission was based on objective performance metrics from mechanical testing conducted according to ASTM standards (F1264-03, F543-07) and a comparison to the known performance and design of a legally marketed predicate device (K131677). Essentially, the ground truth was "does this new device perform at least as well as the predicate device on established engineering tests, and does it introduce any new risks?"
8. The Sample Size for the Training Set
This question is not applicable. There was no "training set" in the context of machine learning or AI algorithms. The submission is for a medical device (intramedullary nail).
9. How the Ground Truth for the Training Set was Established
This question is not applicable for the same reason as #8.
§ 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.