(188 days)
The Renovo Life Small Bone IM Nail System is indicated for fixation of fractures where the canal is narrow or flexibility of the implant is paramount, including the fibula, radius, and ulna, upper extremity fractures in all patients and lower extremity fractures in small-stature patients. This system is also intended to treat metaphyseal fractures, such as radial neck fractures and is intended for fixation of small long bones, such as carpal and tarsal bones.
The Renovo Life Small Bone IM Nail System nails are available in diameters ranging from 2.5 mm to 4.5 mm with a length of 150 mm and either solid or cannulated and materials are surgical grade stainless steel or titanium. Renovo Life Screws are 3.5 mm in diameter and are available in lengths from 10mm to 34 mm in materials of surgical grade stainless steel or titanium. The Renovo Life Small Bone IM Nail System is provided non-sterile and are intended for single use only.
The provided text is a 510(k) premarket notification for a medical device called the "Renovo Life Small Bone IM Nail System." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving independent performance or safety through extensive clinical trials for novel devices.
Therefore, the acceptance criteria and study information requested, particularly regarding performance metrics, sample sizes for training/test sets, expert ground truth, and AI-related studies, are not applicable to this document because it describes a traditional medical device demonstrating substantial equivalence, not an AI/ML-driven device with performance metrics.
Here's a breakdown based on the information available in the document:
1. Table of Acceptance Criteria and Reported Device Performance:
This document does not specify quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or provide performance metrics in the way an AI/ML device submission would. Instead, it relies on demonstrating mechanical equivalence to predicate devices.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Conformance to ASTM F136 (Titanium) or ASTM F138 (Stainless Steel) | Device made of surgical grade stainless steel or titanium conforming to these standards. |
| Substantial equivalence in design, materials, and intended use to predicate devices | Demonstrated through comparative testing (ASTM 1264-14, cadaveric implant trial, rotational resistance test) showing substantial equivalence in static and dynamic four-point bend tests, static torsion test, and compliance tests. |
| Meeting general controls provisions of the Act (e.g., registration, labeling, GMP) | Implied by the FDA's substantial equivalence determination, subject to ongoing compliance. |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not applicable. The "test set" here refers to mechanical testing, not a dataset of patient cases. The document mentions "comparative testing" with a predicate device.
- Data Provenance: Not applicable in the context of patient data. The testing involved mechanical tests and a cadaveric implant trial. No information on the provenance of cadaveric material is provided.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. Ground truth in this context refers to the expected mechanical behavior according to standards, not expert interpretations of clinical images or patient outcomes.
4. Adjudication Method for the Test Set:
Not applicable. Adjudication methods like 2+1 or 3+1 are for reconciling expert disagreements in clinical data labeling. Mechanical tests are typically performed according to established protocols with objective measurements.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:
No. This type of study is specifically for evaluating the impact of AI on human reader performance. This device is not an AI/ML device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
No. This device is a physical intramedullary nail system, not an algorithm.
7. The Type of Ground Truth Used:
For the mechanical testing, the "ground truth" would be the established performance characteristics and behavior of the predicate device and the specified ASTM standards.
8. The Sample Size for the Training Set:
Not applicable. No training set is involved as this is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. No training set or associated ground truth for training.
In summary, the provided document is a 510(k) summary for a conventional medical device (intramedullary nail system). It demonstrates substantial equivalence primarily through material specifications and mechanical testing against a predicate device, rather than through clinical performance metrics or AI/ML specific evaluations.
§ 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.