(52 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, ERC2P). 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.
This document is a 510(k) summary for the PRECICE® Intramedullary Limb Lengthening System. It describes the device and claims substantial equivalence to previously cleared devices. However, it does not contain the detailed acceptance criteria and study data typically found in a clinical study report or a more comprehensive premarket submission.
Based on the provided text, here's what can be extracted and what information is not available:
1. A table of acceptance criteria and the reported device performance
The document presents in vitro mechanical testing for the device modifications. It doesn't explicitly state "acceptance criteria" as numerical thresholds that were met, but rather implies that the modifications were found substantially equivalent through these tests.
| Test Description | Applicable Test Standard | Reported Device Performance |
|---|---|---|
| Static Torsion Testing | ASTM F1264 | Conclusions can be drawn from the tests that the modifications to the PRECICE System are substantially equivalent and meet the performance specifications. |
| Tensile Strength Testing | N/A | Conclusions can be drawn from the tests that the modifications to the PRECICE System are substantially equivalent and meet the performance specifications. |
Missing Information: Specific numerical acceptance criteria and the actual numerical results from these tests are not provided in this summary. The statement "meet the performance specifications" is a general conclusion without supporting data.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document describes in vitro mechanical testing, not a clinical study involving human subjects. Therefore, traditional "sample size," "test set," and "data provenance" as applied to clinical data are not directly applicable.
Missing Information: The number of devices or components tested for Static Torsion and Tensile Strength is not specified.
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)
This document details in vitro mechanical testing. The concept of "ground truth" established by human experts is not relevant to this type of testing. Engineering standards (ASTM F1264) are used for evaluation.
Missing Information: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable to in vitro mechanical testing.
Missing Information: Not applicable.
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
This document describes a medical device, an intramedullary limb lengthening system, not an AI or imaging diagnostic tool. Therefore, an MRMC study is not relevant.
Missing Information: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable to an intramedullary limb lengthening system.
Missing Information: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the in vitro testing, the "ground truth" would be the established engineering principles and standards (e.g., ASTM F1264) for evaluating the mechanical properties of a medical device.
Missing Information: While the standard is mentioned, specific numerical "ground truth" values for performance are not.
8. The sample size for the training set
This document describes in vitro mechanical testing for a physical medical device, not a machine learning model. Therefore, the concept of a "training set" is not applicable.
Missing Information: Not applicable.
9. How the ground truth for the training set was established
Not applicable, as it's not a machine learning model.
Missing Information: Not applicable.
In summary: The provided text is a 510(k) summary focused on demonstrating substantial equivalence for modifications to an intramedullary limb lengthening system through in vitro mechanical testing. It does not contain the detailed clinical study data, ground truth establishment, or expert involvement typically associated with AI/diagnostic device evaluations. The reported "performance" is a general statement of meeting specifications rather than specific numerical results against defined acceptance criteria.
§ 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.