(85 days)
Telegraph® Humeral nail with locking screws is intended to be used for proximal and/or diaphyseal fractures of the humerus.
The Telegraph® Humeral nail is designated to be inserted in the proximal extremity of the humerus. It is constructed from stainless steel (ISO 5832/1), length 150 mm for the short humeral nail or 210 to 310 mm length for the long humeral nail, all models are available in three diameters : 7, 8 and 9 mm. It has three proximal and two distal holes for 4.0 mm diameter, fully-threaded screws suitable for cancellous fixation of small bone fragments. The two distal holes can if necessary be used for locking. But its advantages result mainly from the possibilities afforded by the tree proximal screwholes.
Here's an analysis of the provided text regarding the Telegraph® Humeral Nail, focusing on acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Mechanical Performance: | |
| Conformity to ASTM F-1264 | Performance characteristics tested and approved through mechanical tests according to standard ASTM F-1264. |
| Safety and Effectiveness: | |
| General safety and effectiveness (as per predicate device) | Verification, validation, and design control activities demonstrate the safety and effectiveness of the Telegraph® Humeral Nail. |
| Substantial Equivalence to Predicate Device | Concluded to be substantially equivalent to predicate devices in terms of intended use, safety, and effectiveness. |
| Intended Use: Used for proximal and/or diaphyseal fractures of the humerus. | The device is intended to be used for proximal and/or diaphyseal fractures of the humerus. |
| Material: Constructed from stainless steel (ISO 5832/1). | Constructed from stainless steel (ISO 5832/1). |
| Dimensions: Lengths 150 mm (short) or 210-310 mm (long); Diameters 7, 8, 9 mm. | Length 150 mm for short, or 210 to 310 mm for long; all models in three diameters: 7, 8 and 9 mm. |
| Fixation Holes: Three proximal and two distal holes for 4.0 mm screws. | Three proximal and two distal holes for 4.0 mm diameter, fully-threaded screws. |
Study Proving Device Meets Acceptance Criteria:
The study proving the device meets its acceptance criteria is a mechanical testing study performed according to a recognized standard.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the sample size (number of humeral nails) used in the mechanical testing.
- Data Provenance: Not specified, but generally, mechanical testing data for device submissions like this would be generated in a lab setting rather than from patient data. The manufacturer is based in France.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable as the study described is a mechanical performance test against an engineering standard, not a clinical study requiring expert assessment of ground truth.
4. Adjudication Method for the Test Set
This information is not applicable as the study described is a mechanical performance test, not a clinical study requiring adjudication of findings.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not done. The submission focuses on mechanical equivalence and safety/effectiveness based on predicate device comparison and engineering testing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone performance study in the context of an algorithm or AI was not done. This is a physical medical device (intramedullary nail), not a software or AI product.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is adherence to the ASTM F-1264 standard for intramedullary rods. This standard defines the required mechanical properties and test methods.
8. The Sample Size for the Training Set
This information is not applicable. This is a physical medical device, not an AI/machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8.
§ 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.