(29 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. Iengths and screwhole 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 describes the Ellipse PRECICE Intramedullary Limb Lengthening System and its substantial equivalence to a previously cleared device. The focus of the provided text is on demonstrating the device's safety and effectiveness through mechanical and functional testing, rather than clinical study results involving human readers or comparative effectiveness studies with AI.
Here's an analysis based on the provided text, addressing the requested points where information is available:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria with corresponding performance values for the modified device in a table format. Instead, it describes tests performed to establish equivalence to predicate devices, implying that the modified device met the performance of those predicates. The "Conclusions can be drawn from the tests that the modifications to the PRECICE System are safe and effective and meet the performance specifications" suggests that the device passed these tests according to predefined specifications, which are not detailed in the text.
| Test Description | Applicable Test Standard | Implied Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Static Four Point Bend | ASTM F1264-03 | Performance equivalent to predicate device as per ASTM F1264-03 | Met specifications |
| Dynamic Four Point Bend | ASTM F1264-03 | Performance equivalent to predicate device as per ASTM F1264-03 | Met specifications |
| Static Torque to Failure | ASTM F1264-03 | Performance equivalent to predicate device as per ASTM F1264-03 | Met specifications |
| Magnet Holding Torque | None | Functionality equivalent to predicate device | Met specifications |
| Device functionality and verification | None | Functionality equivalent to predicate device, safe and effective | Met specifications |
Note: "Met specifications" in the "Reported Device Performance" column is inferred from the statement "Conclusions can be drawn from the tests that the modifications to the PRECICE System are safe and effective and meet the performance specifications." The specific numerical results or detailed performance metrics are not provided in this submission summary.
2. Sample Size Used for the Test Set and Data Provenance
The provided text details mechanical and functionality testing for a medical device (an intramedullary nail), not a medical imaging or diagnostic device that would typically use human test sets or patient data with a "sample size" in the context of clinical studies. Therefore, this question is not applicable to the type of safety and efficacy evidence presented. The "test set" here refers to the device prototypes or components undergoing mechanical stress tests. The data provenance is laboratory testing conducted by Ellipse Technologies, Inc. No information on country of origin of the data or retrospective/prospective nature is relevant for these in vitro tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable. The "ground truth" for mechanical and functional testing of a medical device like an intramedullary nail is established by engineering specifications, international standards (e.g., ASTM F1264-03), and comparison to predicate devices, not by medical experts interpreting results from a test set in a diagnostic context.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
This question is not applicable. Adjudication methods like "2+1" or "3+1" are used in clinical trials or diagnostic studies to resolve discrepant expert opinions on patient data. The current document describes in vitro engineering tests.
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 question is not applicable. The device described is a physical implant (intramedullary nail) for limb lengthening, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study involving AI assistance is mentioned or relevant to this type of device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable. The device is a physical medical implant, not an algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the mechanical and functional testing, the "ground truth" is based on:
- Established engineering standards: ASTM F1264-03 for Static/Dynamic Four Point Bend and Static Torque to Failure.
- Performance of predicate devices: The modified device's performance is compared to that of previously cleared Ellipse PRECICE Systems (K131677 and K133289) to demonstrate "substantial equivalence." This implies that the predicate devices' established safety and performance serve as the "ground truth" for the modified device.
- Internal design specifications: For tests like "Magnet Holding Torque" and "Device functionality and verification" where no external standard is cited, the ground truth would be the device's own design specifications, validated through testing.
8. The Sample Size for the Training Set
This question is not applicable. The context is not machine learning or AI, so there is no "training set." The testing involved physical prototypes or samples of the device.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable, as there is no "training set" in this context.
§ 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.