(123 days)
The Ellipse PRECICE Trauma Nail System is indicated for open and closed fracture fixation, pseudoarthrosis, or mal-unions and non-unions of long bones.
The Ellipse PRECICE Trauma Nail System is composed of the PRECICE Trauma Nail (supplied sterile), locking screws, surgical instruments and an external remote controller (ERC). The Nail is available in various diameters, lengths 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 Trauma Nail is supplied sterile by gamma radiation while the locking screws and 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 Nail is supplied pre-distracted by 10 mm to allow for compression fracture reduction techniques.
The provided document is a 510(k) premarket notification for the "PRECICE Trauma Nail System". The document states that the device is substantially equivalent to a previously cleared device (K141447) and relies on the testing and data from that predicate device. Therefore, a direct study proving the device meets new acceptance criteria is not presented, as the submission is based on demonstrating equivalence.
Here's an analysis of the provided text, addressing your questions where information is available:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding performance results for this specific 510(k) submission (K142599). Instead, it states that "all testing that was performed on the predicate PRECICE Trauma Nail System is applicable" because there are "no changes to the design of the PRECICE Trauma Nail being made as a result of this submission."
However, the document lists the types of tests performed on the predicate device, which can be inferred as satisfying the acceptance criteria for those tests:
| Acceptance Criteria Type (Inferred from Predicate Testing) | Reported Device Performance (from Predicate) |
|---|---|
| Mechanical Testing (ASTM F1264-03) | Satisfied (implied "applicable" and "conclusions can be drawn") |
| Gamma Radiation Sterilization (ANSI/AAMI/ISO 11137-2) | Provides a sterility assurance level of 10^-6 |
| Design Verification and Validation | Satisfied (implied "applicable" and "conclusions can be drawn") |
| Shelf Life Testing (packaging after accelerated aging) | Satisfied (implied "applicable" and "conclusions can be drawn") |
| O-ring Seal Performance Testing | Satisfied (implied "applicable" and "conclusions can be drawn") |
| Biocompatibility (ISO 10993-1) | Satisfied for the intended use (implied "applicable" and "conclusions can be drawn") |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify sample sizes for individual tests. It refers to "mechanical testing according to the methods outlined in the standard ASTM F1264-03." These standards typically define sample size requirements.
- Data Provenance: The data comes from tests performed on the predicate device (K141447). The document doesn't specify the country of origin of this data or if it was retrospective or prospective, but it's implied to be data collected during the development and clearance process of the predicate device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This type of information (experts for ground truth) is typically relevant for studies involving subjective human assessment (e.g., image interpretation for AI algorithms). For physical medical devices undergoing mechanical, sterilization, or biocompatibility testing, ground truth is established by the specified test standards and methodologies themselves (e.g., ASTM, ISO standards), not by human expert consensus in the same way. Therefore, this information is not applicable in this context and is not provided in the document.
4. Adjudication Method for the Test Set
As explained above, for physical device testing against established standards, adjudication methods like 2+1 or 3+1 (common in clinical trials or diagnostic studies) are not applicable. The "ground truth" and "adjudication" are inherent in the test method's specifications and the objective measurements obtained.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC study was not done. This type of study is specifically for evaluating the effectiveness of a diagnostic tool, often an AI algorithm, by comparing human reader performance with and without its assistance. The PRECICE Trauma Nail System is an intramedullary fixation rod, a physical implant, and therefore, an MRMC study is not applicable to its evaluation.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. This is also specific to AI/software as a medical device. The PRECICE Trauma Nail System is a physical device, and therefore this type of study is not applicable.
7. The Type of Ground Truth Used
The "ground truth" for the predicate device's evaluation (and by extension, for this submission's substantial equivalence claim) is based on:
- Compliance with recognized industry standards: ASTM F1264-03 for mechanical testing, ANSI/AAMI/ISO 11137-2 for sterilization, and ISO 10993-1 for biocompatibility.
- Objective measurements and criteria: As defined within these standards for various performance parameters (e.g., strength, sterility assurance level, material compatibility).
8. The Sample Size for the Training Set
Not Applicable. The device is a physical medical implant, not an AI algorithm. Therefore, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set was Established
Not Applicable. As there is no training set for an AI algorithm, there is no ground truth to establish for it.
§ 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.