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The CalcaNail Orthopedic Arthrodesis Nail is intended for subtalar arthrodesis in the treatment of patients with:

• Comminuted fractures of the calcaneus
• Post-traumatic osteoarthritis and/or poor function resulting from calcaneal fracture sequelae
• Osteoarthritis of the posterior subtalar joint, or
• Valgus flatfoot deformities

The CalcaNail is orthopaedic nail for the repair of articular fractures of the calcaneus. The device consists of an orthopedic titanium 12 mm nail available in 3 lengths (65 mm, 75 mm and 85 mm) for subtalar arthrodesis. The system also includes a series of 5 mm cannulated screws for fixation available in 17 lengths (24 mm - 80 mm)

This document is a 510(k) premarket notification for the CalcaNail Orthopedic Arthrodesis Nail, a medical device for subtalar arthrodesis. The information provided outlines the device, its intended use, and its comparison to predicate devices, but it does not contain acceptance criteria for device performance in the typical sense of a clinical trial or performance study on a new AI/software device. Instead, the "study" described is a biomechanical bench test and an engineering simulation comparing the CalcaNail to existing predicate devices for substantial equivalence.

Here's an analysis of the provided text based on your request, with the understanding that this is a hardware device submission, not an AI/software performance study. Therefore, many of your requested points related to AI/software performance metrics, ground truth, and expert evaluation are not directly applicable.

Acceptance Criteria and Device Performance (Based on presented data)

Since this is a hardware device submission and not a software/AI performance study, there aren't "acceptance criteria" in terms of sensitivity, specificity, or AUC. Instead, the acceptance criteria are implicit in demonstrating substantial equivalence to predicate devices through mechanical performance. The "reported device performance" refers to the results of the biomechanical and engineering tests.

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the implicit acceptance criteria for substantial equivalence consists of two parts:

1. Biomechanical Bench Testing: This involved a direct comparison of the CalcaNail to a predicate device in terms of mechanical stability.
2. Engineering Simulation: This involved a comparison of rigidity between the CalcaNail and another predicate device using engineering principles.

Detailed Information for Each Point (as far as extract allows):

1. Sample size used for the test set and the data provenance:

   • Biomechanical Testing: "Seven pairs of (total of 14) enzymatically corroded human calcaneal and talar bones" were used.
   • Data Provenance: The origin of the human bones is not specified (e.g., country of origin). The study appears to be prospective (bench test designed for this submission), not retrospective clinical data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This is not applicable as the "test set" consists of physical bones and engineering models, not data requiring expert interpretation for ground truth in the context of an AI/software device. The integrity of the bones and the setup of the biomechanical test would typically be managed by engineers and biomechanics experts, but these are not "ground truth experts" in the clinical sense.

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

   • Not applicable. This concept pertains to resolving discrepancies among expert readers in clinical data annotation, which is not relevant for a biomechanical bench test or engineering simulation.

4. 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, a multi-reader multi-case comparative effectiveness study was not done. This is a hardware device, not an AI/software diagnostic tool.

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

   • No. This concept is for AI algorithms. The "standalone" performance here relates to the inherent mechanical properties of the nail itself.

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

   • For the biomechanical test, the "ground truth" is the measured mechanical stability of the construct under simulated loading conditions.
   • For the engineering simulation, the "ground truth" is the calculated moment of inertia and derived rigidity based on established engineering principles and material properties.
   • Neither of these involves clinical expert consensus, pathology, or outcomes data.

7. The sample size for the training set:

   • Not applicable. This is a medical device (hardware) submission, not an AI/machine learning model where a "training set" would be used. The design of the nail is based on engineering principles and knowledge, not data training.

8. How the ground truth for the training set was established:

   • Not applicable, as there is no "training set" in the context of an AI/ML model for this hardware device. The device design is based on engineering and anatomical considerations.

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The CalcaNail Orthopedic Nail is intended for fracture fixation in the treatment of patients with displaced articular fractures of the calcaneus.

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)

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

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.

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The OsteoMed Calcaneal Plate and Screw Fixation System Is Intended for fractures and osteotomies of the calcaneus, including, but not limited to extra-articular, intra-articular, ioint depression, tonque type and severely comminuted fractures. Plates and screws are intended for single use only.

The OsteoMed Calcaneal Plate and Screw Fixation System is comprised of various plates and screws. Plates are provided in a variety of arm configurations, in a variety of sizes in lengths of 45mm through 76mm and thickness of 1.0mm through 2.0mm. Screws to be provided in this system are 3.0mm and 3.5mm diameter in lengths of 18mm through 55mm with either standard or locking features. Plates are made of Titanium (ASTM F-67) or Titanium Alloy (ASTM F-136). The Screws are made of Titanium Alloy (ASTM F-136). Drill guides, pilot drills, depth gauge, drivers, bending pliers, plate cutters, guide wires and preparation instruments will also be a part of the system.

This document is a 510(k) Summary for the OsteoMed Calcaneal Plate and Screw Fixation System. It is a medical device submission seeking clearance from the FDA, not a study describing the acceptance criteria and performance of an AI/ML device. Therefore, the requested information regarding acceptance criteria, study data, ground truth establishment, expert qualifications, and AI/ML specific evaluations (like MRMC studies) is not present in this document.

The document discusses substantial equivalence to predicate devices based on similarities in intended use, material, design, and operational principles, rather than performance against specific acceptance criteria.

Information that can be extracted from the provided text:

• Device Proprietary Name: OsteoMed Calcaneal Plate and Screw Fixation System
• Intended Use: Fractures and osteotomies of the calcaneus, including, but not limited to extra-articular, intra-articular, joint depression, tongue type and severely comminuted fractures.
• Predicate Devices: Synthes K991407, New Deal K041786, and Darco K061808.
• Basis for Equivalence: Similarities in intended use, material, design, and operational principle to the predicate devices.
• Conclusion: OsteoMed believes that the OsteoMed Calcaneal Plate and Screw Fixation System does not raise any new safety or effectiveness issues due to the similarity of materials and design to both pre-enactment and post-enactment devices.

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