FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The CalcaNail is orthopaedic nail for the repair of articular fractures of the calcaneus. The device consists of an orthopedic titanium 10 mm nail available in 3 lengths (45 mm, 50 mm and 55 mm) for fracture repair. The system also includes a series of 5 mm cannulated screws for fixation available in 17 lengths (24 mm - 80 mm)

AI/ML Overview

This document is a 510(k) Summary for a medical device called the "CalcaNail Orthopedic Nail." The purpose of a 510(k) summary is to demonstrate that a new device is "substantially equivalent" to an existing, legally marketed device (a predicate device). Therefore, the information provided focuses on comparative performance rather than establishing absolute performance criteria for the new device in isolation.

Based on the provided information, the acceptance criteria and study details are as follows:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Primary Stability (biomechanical testing): The CalcaNail Orthopedic Screw should demonstrate at least comparable or better primary stability compared to the predicate Synthes calcaneal locking plate (K991407) in a standardized calcaneal fracture model.	Better Primary Stability: The results of published biomechanical testing showed that the primary stability at the chosen experimental set-up of a standardized calcaneal fracture was better with the CalcaNail than with the standard Synthes calcaneal locking plate.
Rigidity (engineering simulation): The CalcaNail nail should provide at least comparable or greater rigidity than the FHI cannulated screws (K070617) used routinely in rear foot deformity surgery, as demonstrated by moments of inertia of the smallest cross-sections.	Much Greater Rigidity: Engineering simulation demonstrated the CalcaNail provided much greater rigidity than the cannulated screws used routinely in rear foot deformity surgery, based on the moments of inertia of the smallest cross-sections.
Intended Use Equivalence: The CalcaNail must have the same intended use as the predicate devices (fracture fixation in the treatment of patients with displaced articular fractures of the calcaneus).	The CalcaNail has the same intended use: fracture fixation in the treatment of patients with displaced articular fractures of the calcaneus. The predicate devices (Synthes calcaneal locking plate K991407, FHI cannulated screws K070617, NewDeal Panta Nail K091788) are all indicated for use in the foot and ankle, including the calcaneus.
Material Equivalence: The CalcaNail must be manufactured from materials similar to the predicate devices (titanium and/or stainless steel).	The CalcaNail is made of titanium, which is consistent with the materials used in the predicate devices (titanium and/or stainless steel).
Design Equivalence: The CalcaNail's design (orthopedic nail with specific dimensions, cannulated screws) must be comparable to the predicate devices.	The CalcaNail is an orthopedic titanium 10 mm nail with 3 lengths (45, 50, 55 mm) and 5 mm cannulated screws of 17 lengths (24-80 mm). This design is compared to various predicate devices that are also nails, plates, and screws for similar indications.
Principles of Operation Equivalence: The CalcaNail must operate on principles similar to the predicate devices.	The CalcaNail operates on the principle of internal fixation for fracture repair, which is consistent with the predicate devices.
Safety and Effectiveness: No new issues of safety or effectiveness should be raised compared to the predicate devices.	The bench testing and device description confirms that the subject CalcaNail demonstrate no new issues of safety or effectiveness in treating calcaneal fractures.

2. Sample Size Used for the Test Set and Data Provenance

Biomechanical Testing (Primary Stability):
- Sample Size: Seven pairs of (total of 14) enzymatically corroded human calcaneal and talar bones.
- Data Provenance: The document does not explicitly state the country of origin. The test used human calcaneal and talar bones, implying ex vivo or cadaveric testing. The document states it's a "published testing," suggesting it was conducted retrospectively to the 510(k) submission, but the study itself could have involved prospective data collection on the cadaveric specimens.
Engineering Simulation (Rigidity):
- Sample Size: The smallest cross-sections of the CalcaNail nail and the FHI cannulated screws (K070617). The exact number of cross-sections or unique components modeled is not specified.
- Data Provenance: This is an in silico (computer-based) study using engineering principles and likely based on design specifications of the devices. It is therefore retrospective in terms of the submission, but the data is generated via simulation.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

Biomechanics / Engineering: The document does not mention the use of human experts to establish "ground truth" for the biomechanical or engineering studies. These are objective measures (primary stability, moments of inertia) derived from physical testing and computational models, respectively, rather than subjective interpretation requiring expert consensus.

4. Adjudication Method for the Test Set

Not applicable. The studies described are objective measurements (biomechanical forces, rigidity calculations) rather than subjective assessments that would require adjudication.

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

No, an MRMC comparative effectiveness study was not done. This device is an orthopedic intramedullary nail, not an AI-powered diagnostic imaging tool, so such a study would not be relevant.

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

Not applicable. This is a physical, implantable medical device, not a software algorithm.

7. The Type of Ground Truth Used

Biomechanical Testing: The "ground truth" here is the objective, measured mechanical performance (primary stability) obtained from physical testing on human cadaveric bones.
Engineering Simulation: The "ground truth" here is the mathematically calculated and simulated rigidity (moments of inertia) based on the physical properties and geometries of the devices.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable. As above, this device does not involve a training set or ground truth establishment in the context of machine learning.

Summary

Regulation Number and Section

§ 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.