(38 days)
The TELEGRAPH® Humeral Nail is indicated for fractures of the upper extremity and/or the diaphysis of the humerus.
The titanium Telegraph® humeral nails are made of titanium and are available in two models: a short humeral nail (150mm length) and a long humeral nail (from 210 to 310mm). These two models are available in four diameters: 7, 8, 9 and 10mm. These titanium humeral nails are intended to be used with titanium cancellous screws, available in 15 lengths (from 24 to 50mm) and with a 4mm diameter. The titanium Telegraph® humeral nail and the screws are supplied sterile.
"The document describes the acceptance criteria and a study conducted for the ""Titanium TELEGRAPH® Humeral Nail.""
1. Table of Acceptance Criteria and Reported Device Performance:
| Feature | Acceptance Criteria (Predicate Device: Telegraph® Humeral Nail) | Reported Device Performance (Titanium Telegraph® Humeral Nail) |
|---|---|---|
| Intended Use | Intended for use for proximal and/or diaphyseal fractures of the humerus. | Intended for fractures of the upper extremity and/or the diaphysis of the humerus. |
| Material | Stainless steel | Titanium alloy (according to ISO 5832/3 and ASTM F-136) |
| Cylindrical | Yes | Yes |
| Diameters | Ø 7, 8, and 9 mm | Ø 7, 8, 9, and 10 mm |
| Lengths (Short nail) | 150 mm | 150 mm |
| Lengths (Long nail) | 210, 230, 250, 270, 290, 310 mm | 210, 230, 250, 270, 290, 310 mm |
| Interlocking screws | Proximal: 3 self-stable screws; Distal: 2 screws in the frontal plane | Proximal: 3 self-stable screws; Distal: 2 screws in the frontal plane |
| Performance Tests | Flexion tests and Torsion tests (according to ASTM F 1264-00) | Flexion tests and Torsion tests (according to ASTM F 1264-00) |
| Sterility | Yes (Gamma) | Yes (Gamma) |
The document states that ""All results demonstrate that the proposed device is in accordance with the mechanical resistances required by the ASTM F 1264-00 standard.""
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size:
- Flexion tests: 6 Titanium nail Ø7 and 310mm length.
- Torsion tests: 6 Titanium nail Ø7 and 310mm length.
- Data Provenance: Not explicitly stated, but the tests were performed by ""F.H.I"" (Fournitures Hospitalières Industrie) which is a French company. The study appears to be prospective as it was conducted specifically to support the 510(k) submission for the new titanium device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. The study involved mechanical performance testing against a recognized standard (ASTM F 1264-00), not expert-based ground truth for clinical interpretation.
4. Adjudication Method for the Test Set:
Not applicable. The study involved mechanical performance testing, not human readers or adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done:
No, an MRMC comparative effectiveness study was not done. The study focused on the mechanical equivalence of the device, not the effectiveness with human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
Not applicable. This is a medical device (intramedullary rod), not an algorithm or AI system. The study was a standalone mechanical performance evaluation of the device itself.
7. The Type of Ground Truth Used:
The ground truth used for performance evaluation was the mechanical resistance requirements defined by the ASTM F 1264-00 standard for intramedullary rods.
8. The Sample Size for the Training Set:
Not applicable. There is no training set mentioned, as this is not an AI/ML algorithm.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set."
§ 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.