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The titanium Telegraph humeral nail is indicated for proximal and/or diaphyseal fractures of the humerus

The Titanium Telegraph® Humeral Nail is designed to be inserted in the proximal extremity of the humerus. It is made of titanium (according to ASTM 136) and is available in two models: the short humeral nail (150mm) and the long humeral nail (from 210 to 310mm). All models are available in three diameters (7, 8, 9 and 10mm). These two Humeral Nail are intended to be used with cancellous screws and selfthreating cortical cotter screws, supplied by FH Industrie.

This special 510(k) is being submitted to propose clearance of the titanium selfthreating cortical cotter screws intended to be used with the Titanium Telegraph® Humeral Nail cleared in K042332. FH Industrie will manufacture and commercialize these screws.

These screws are made of titanium (according to ISO 5832 and ASTM F-136) and are available in 4 lengths (24, 28, 30, 32mm) and with a 4mm diameter

This document is a 510(k) summary for a medical device, the Titanium TELEGRAPH® HUMERAL NAIL. It is not a study report or clinical trial. Therefore, it does not contain the detailed information needed to answer many of your questions about acceptance criteria and study methodologies.

This 510(k) submission is for a modification to an already cleared device, specifically changing the material of certain screws and also making them sterile and supplied with the device. The core of this submission is to demonstrate "substantial equivalence" to predicate devices, not to present novel performance data from a new clinical study.

Here's an attempt to answer your questions based on the provided text, with clear indications where the information is not available in the document:

1. A table of acceptance criteria and the reported device performance

   This information is not available in the provided 510(k) summary. The document does not describe specific acceptance criteria in terms of quantitative performance metrics (e.g., tensile strength, fatigue life) or clinical outcomes. Instead, it relies on demonstrating substantial equivalence to predicate devices. The "reported device performance" is implicitly that it performs equivalently to the predicate devices due to shared design and materials for the nail itself, and the new screws also being made of medical-grade titanium with similar design, diameters, and lengths as existing screws.

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   This information is not available. No specific test sets or clinical data are presented as part of this 510(k) summary. The "performance data" section only states: "Risk to health have been addressed through the specified materials, Processing controls, quality assurance and compliance to the Medical Device Good Manufacturing Practices Regulations." This indicates that the safety and effectiveness are established through adherence to manufacturing standards and material specifications, rather than through a dedicated clinical or non-clinical study with a defined sample size.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

   This information is not available. No test set requiring expert ground truth establishment is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   This information is not available. No test set requiring adjudication is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

   This information is not available. This device is a surgical implant (humeral nail) and not an AI-powered diagnostic tool. Therefore, an MRMC study with AI assistance is not relevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

   This information is not available. This device is a surgical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

   This information is not available. As explained in point 2, no specific performance study generating ground truth data is described. The "ground truth" for demonstrating safety and effectiveness in this 510(k) relies on the established safety and effectiveness of the predicate devices and the material and design specifications of the new components.

8. The sample size for the training set

   This information is not available. There is no mention of a "training set" as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

   This information is not available. There is no mention of a "training set" or its ground truth.

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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:

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."

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