(123 days)
The Ellipse PRECICE System is indicated for limb lengthening of the tibia and femur.
The Ellipse PRECICE System is composed of the modified 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 modified 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 appears to be a 510(k) premarket notification for a medical device, specifically the Ellipse PRECICE® System, which is an intramedullary nail for limb lengthening. This type of regulatory submission typically focuses on demonstrating substantial equivalence to a predicate device through engineering and performance testing, rather than clinical studies involving human patients as one might find for a new drug or complex diagnostic AI.
Therefore, many of the requested categories related to clinical studies, such as "Sample size used for the test set," "Number of experts," "Adjudication method," "MRMC comparative effectiveness study," and "Standalone (i.e. algorithm only without human-in-the loop performance)" are not applicable to this type of device submission as described in the provided text.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Description | Applicable Test Standard | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|---|
| PRECICE, Static Four Point Bend | ASTM F1264 | Meet or exceed predicate device performance; demonstrate structural integrity under static load. | The modified PRECICE System includes these tests. |
| PRECICE, Dynamic Four Point Bend | ASTM F1264 | Meet or exceed predicate device performance; demonstrate fatigue resistance under dynamic load. | The modified PRECICE System includes these tests. |
| PRECICE, Static Torque to Failure | ASTM F1264 | Meet or exceed predicate device performance; demonstrate rotational stability. | The modified PRECICE System includes these tests. |
| 6 Month Shelf Life Packaging Validation | ISO 11607-1 | Maintain sterility and integrity of the device package for at least 6 months. | Testing performed to meet this standard. |
| Sterilization (Gamma Radiation) | ANSI/AAMI/ISO 11137-2 | Achieve a Sterility Assurance Level (SAL) of 10⁻⁶. | Validation performed to verify SAL of 10⁻⁶. |
| Biocompatibility | ISO 10993-1 | Device materials must not cause adverse biological reactions. | Testing performed and deemed biocompatible. |
| Device functionality and verification | none | Demonstrate proper functioning of the nail's lengthening mechanism and ERC. | "Functional testing" performed. |
Study Proving Device Meets Acceptance Criteria:
The study proving the device meets the acceptance criteria is a series of in vitro (benchtop) engineering and performance tests as outlined in the provided text. These tests are conducted according to recognized industry standards (ASTM F1264, ISO 11607-1, ISO 11137-2, ISO 10993-1) and internal functional verification protocols. The purpose of these tests is to demonstrate that the modified Ellipse PRECICE System performs equivalently or superiorly to its predicate device and meets established safety and performance specifications.
2. Sample Size for the Test Set and Data Provenance:
- Sample Size for Test Set: Not explicitly stated in terms of a "test set" as one would find in a clinical trial. For in vitro engineering tests, the sample size typically refers to the number of devices or components tested per condition. This information is not provided in the summary but would be detailed in the full test reports submitted to the FDA.
- Data Provenance: The data provenance is derived from in vitro laboratory testing conducted by Ellipse Technologies, Inc. There is no information regarding country of origin of data as it's not patient data. This is typically considered retrospective in the sense that the testing is performed on manufactured devices, not in a live patient setting.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- Not Applicable. For mechanical/functional testing of a medical device, "ground truth" is established by the specifications of the design, the chosen ASTM/ISO standards, and the capabilities of the testing equipment. There is no mention of human expert interpretation for establishing ground truth in these types of tests.
4. Adjudication Method for the Test Set:
- Not Applicable. Adjudication methods are relevant for subjective human interpretations, especially in clinical or image-based studies. This submission focuses on objective, quantifiable engineering test results.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:
- No. An MRMC study is relevant for diagnostic imaging devices where multiple readers evaluate cases. This is a limb lengthening implant, and its performance is evaluated through engineering tests, not human reader interpretation of clinical cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a mechanical implant with an external remote controller, not an algorithm-driven diagnostic or therapeutic device. "Standalone performance" in this context refers to the device's ability to lengthen, and its mechanical integrity, which is assessed through the engineering tests.
7. The Type of Ground Truth Used:
- The "ground truth" for this device, in the context of the provided information, is based on:
- Validated engineering standards (ASTM F1264, ISO 11607-1, ISO 11137-2, ISO 10993-1): These standards define performance expectations and testing methodologies.
- Predicate device performance: The modified device must demonstrate substantial equivalence or improvement compared to the previously cleared predicate device.
- Device design specifications: Internal specifications for strength, functionality, and biocompatibility.
8. The Sample Size for the Training Set:
- Not Applicable. This device does not use machine learning or AI, so there is no "training set." The development of the device is based on engineering design principles and material science, then validated through the specified in vitro tests.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. As there is no training set for an AI algorithm, this question is not relevant.
§ 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.