Search Results

Double Engine Intramedullary Nail System is intended to be implanted into the medullary canal of tibia for alignment, stabilization, fixation of fractures caused by trauma or disease.

Double Engine Intramedullary Nail System is composed of intramedullary nails, interlocking screws, and end caps. Intramedullary nails are provided in variety of lengths and anatomical deigns to accommodate the medullary canal of long bones (tibia). Interlocking screws are used for axial compression and preventing rotation. End caps on intramedullary nails are intended to facilitate removal and to allow length adjustment of the nail.

The provided text does not contain information about acceptance criteria for a device's performance, a study proving device performance against such criteria, expert evaluations, or AI/software-related details.

The document is a 510(k) summary for the Double Engine Intramedullary Nail System, which is a physical orthopedic implant. It focuses on demonstrating substantial equivalence to a predicate device through bench tests of material properties and mechanical strength, rather than clinical performance or AI algorithm assessment.

Therefore, I cannot provide the requested information. The text describes a regulatory submission for a medical device based on physical and mechanical properties, not an AI or software device with specific performance metrics against clinical outcomes or expert ground truth.

Ask a specific question about this device

Double Engine Bone Plate and Screw Systems are provided non-sterile. Double Engine Bone Plate and Screw Systems are intended for fixation of various bone fracture, including large bone (clavicle, scapula, pelvis, humerus, ulna, radius, femur, tibia, and fibula), and small bone (metacarpals, metatarsals, and phalanges).

Double Engine Bone Plate System consists of plates in various designs and size. Plates are provided in straight designs and various geometric configurations that are commonly used in traumatic and reconstructive surgery (Table 3.5.1). Plates are provided with screw holes to accommodate non-locking and locking screws. They are named according to both anatomical positions and biomechanical functions of the plates. The sets in size of Double Engine Bone Plate System are divided into four sets: large, small, mini, and reconstruction. The thickness of plates varies from 1.0 to 5.6mm, width from 3.8 to 43.6mm, length from 15.4 to 361mm, and hole number from 2 to 27 holes.

Double Engine Bone Screw System is used either to fasten plates or similar devices onto bones, or, as lag screws, to hold bone fragments together. The screws are differentiated by the manner in which they are inserted into bone, their size, and the type of bone they are intended for. There are three sets of style: cortex, cancellous, and cannulated sets. The screw recess is hexagon or star shaped to allow screw removal and insertion. The thread diameter of screw varies from 1.5 to 7.3mm, total length from 6 to 150mm.

The proposed devices are not provided sterile. It is required to be sterilized via autoclave method to reach a SAL of 10th by the hospital prior to surgery. The sterilization method is presented in the user manual, which was validated per ISO 17665-1: 2006 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices.

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text.

Note: This document describes a traditional medical device (bone plates and screws), not an AI/ML-based device. Therefore, many of the typical questions for AI/ML validation (like expert adjudication, MRMC studies, training set details, etc.) are not applicable here. The evaluation focuses on physical characteristics and mechanical performance compared to predicate devices.

Acceptance Criteria and Device Performance for Double Engine Bone Plate and Bone Screw Systems

This submission evaluates the Double Engine Bone Plate and Screw Systems against predicate devices based on their mechanical and physical properties to demonstrate substantial equivalence, rather than using typical AI/ML performance metrics.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Mechanical Testing:
  • Bone Plates: Four representative types of bone plates were selected for testing: one from each of the large, small, mini, and reconstruction sets. These were chosen based on finite-element analyses indicating they had "poor mechanical properties" (implying they were the weakest and thus represented a critical test case).
  • Bone Screws: Three representative types of bone screws were selected: cortex, cancellous, and cannulated. The size and type of the predicate screws were identical to the proposed screws.
• Data Provenance: Not explicitly stated as retrospective or prospective in the context of clinical data. This is a non-clinical, laboratory-based study. The finite-element analyses and mechanical tests were presumably conducted internally or by a contracted lab. There is no mention of country of origin for test data, as it's not patient-related.

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

• Not Applicable: For this type of medical device submission (bone plates and screws), "ground truth" typically refers to established engineering standards, material specifications (e.g., ASTM), and the mechanical performance of legally marketed predicate devices. It does not involve expert consensus on image interpretation or clinical outcomes in the way an AI/ML study would. The experts involved would be engineers, material scientists, and regulatory specialists.

4. Adjudication Method for the Test Set

• Not Applicable: Adjudication methods like 2+1 or 3+1 are used for human expert disagreement on ground truth labeling in AI/ML studies. This submission relies on objective mechanical testing and finite-element analysis results, compared against engineering standards and predicate device performance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

• Not Applicable: This device is a physical implant, not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study and evaluation of human reader improvement with AI assistance are irrelevant.

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

• Not Applicable: As a physical medical device, the concept of "standalone algorithm performance" does not apply.

7. The type of ground truth used

• Engineering Standards and Predicate Device Performance:
  • Material Ground Truth: Adherence to ASTM F67-06, F1472-08e1, and F163-02a standards for titanium and titanium alloys.
  • Mechanical Performance Ground Truth: The established mechanical properties and performance of legally marketed predicate devices (Synthes, Syntec Scientific). The acceptance criterion was that the proposed devices perform "equivalent to or better than" these predicates.
  • Sterilization Ground Truth: Compliance with ISO 17665-1:2006 for sterilization validation.

8. The Sample Size for the Training Set

• Not Applicable: There is no "training set" in the context of traditional medical device mechanical testing. Finite-element analyses (FEA) were likely used for design and optimization, which could be considered an initial "simulation phase," but this doesn't equate to a data-driven training set for an algorithm.

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

• Not Applicable: As there is no training set for this type of device validation, this question is not relevant. The "ground truth" in the design and development phase (e.g., for FEA) would be based on engineering principles, material properties, and clinical requirements for bone fixation.

Ask a specific question about this device