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IRENE Cannulated Screw System is intended for fracture fixation, fusion and osteotomies of bones appropriate for the size of the device. For specific screw indications please see below.

Acutec Headless Compression Screw:

Used for fusion, fractures, or osteotomies of the clavicle, humerus, radius, ulna, ilium, femur, patella, fibula, tibia, talus, malleolus, calcaneus and other small bones.

Cannulated Screw:

Intended for bone fracture fixation and bone fragment fixation. Washers may be used with the Cannulated Screw in cases where the patient has poor bone quality.

IRENE Cannulated Screw System includes two kinds of screws, Acutec Headless Compression Screw and Cannulated Screw. Acutec Headless Compression Screw has six different diameters in various lengths and is manufactured from Titanium Alloy (ASTM F 136 and ISO 5832-3). Cannulated Screw has four different diameters in various lengths and contains two optional washers. Cannulated Screw and washers are manufactured from Titanium Alloy (ISO 5832-3).

This is a 510(k) premarket notification for a medical device, which focuses on demonstrating substantial equivalence to a predicate device rather than on clinical safety and effectiveness studies with acceptance criteria as typically understood for AI/ML devices. Therefore, much of the requested information regarding acceptance criteria, study types, ground truth, and expert involvement is not applicable in this context.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: The primary "acceptance criteria" here are established through mechanical testing to demonstrate that the new device (IRENE Cannulated Screw System) is at least as safe and effective as the predicate devices. The standard used is ASTM F543-13, Standard Specification and Test Methods for Metallic Medical Bone Screws.
• Reported Device Performance: The document states: "Results of testing indicates no difference between the level of performance of proposed device and the predicate device, through which the differences are deemed not relevant to device performance and has been justified, and the conclusion of Substantial Equivalence is reached." Specific numerical performance metrics (e.g., specific torque values, pullout strengths) are not provided in this summary document. The summary indicates that the tests conducted were:
  • Torsional properties
  • Driving torque test
  • Axial pullout test

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

• This is not applicable as there is no "test set" in the context of an AI/ML device for diagnostic or prognostic performance. The "test set" here refers to physical samples of the screws used for mechanical testing. The specific number of screws tested is not mentioned in this summary.
• Data provenance: The mechanical tests were performed on the proposed device (IRENE Cannulated Screw System) and the predicate devices. The manufacturing location for the proposed device is Tianjin, P.R. China.

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

• This is not applicable. Ground truth establishment by experts (e.g., radiologists) is relevant for AI/ML diagnostic studies, not for mechanical testing of bone screws. The "ground truth" for mechanical properties is determined by physical measurement instruments according to established engineering standards.

4. Adjudication Method for the Test Set:

• This is not applicable. Adjudication methods are specific to subjective human assessment in diagnostic or clinical studies. Mechanical tests have objective measurement outcomes.

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 is not applicable. This is a 510(k) for a physical medical device (bone screws), not an AI/ML diagnostic or assistive device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• This is not applicable. This is not an algorithm.

7. The Type of Ground Truth Used:

• For the mechanical tests, the "ground truth" is the physical measurement taken by calibrated instruments in accordance with the specified standard (ASTM F543-13). This is an objective, quantitative ground truth.

8. The Sample Size for the Training Set:

• This is not applicable. There is no "training set" as this is a physical device, not an AI/ML model that is trained on data.

9. How the Ground Truth for the Training Set Was Established:

• This is not applicable for the same reason as point 8.

In summary, the provided document is a 510(k) summary for a conventional medical device (bone screws). The "study" referenced is a series of mechanical tests comparing the proposed device to predicate devices to demonstrate substantial equivalence, rather than a clinical trial or AI/ML performance study with traditional acceptance criteria for diagnostic accuracy.

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The IRENE Locking Compression Plate System is indicated for patients with age above 21 for fixation of fractures. Indicated facture areas include ulna, radius, humerus, femur, and tibia.

The IRENE Locking Compression Plate System is designed for internal fixation of bones that subject to fracture. The system includes bone plates and screws that can be used with the plate. Various sizes of plate are available for different fracture areas or clinical conditions. Bone screws are incorporated in the system and are intended to fix with plate with appropriate size. The plate has a limited-contact design. The plate system is provided unsterile. And the system is intended for single-use.

This document is a 510(k) Summary for the IRENE Locking Compression Plate System, which is a medical device for orthopedic fixation. It's a regulatory filing, not a research study. Therefore, most of the information requested about acceptance criteria and study details (like sample sizes, expert adjudication, MRMC studies, ground truth) is not applicable or present in this type of document because it describes a submission for regulatory clearance, not the results of a clinical effectiveness study.

Here's an analysis of the provided text based on your request, highlighting what's available and what's explicitly stated as not applicable:

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

The document does not provide a table of acceptance criteria with specific numerical performance targets. Instead, it states that the device's performance was evaluated against predicate devices using recognized ASTM standards. The acceptance criterion implicitly is that the proposed device performs comparably to the predicate devices and meets the requirements of these standards.

The document states:

• "Results of testing indicates no gap between the level of performance of proposed device and the predicate device" (Page 6)

The performance data mentioned are:

• Plate: Static and dynamic testing conducted as per ASTM F382-13.
• Screw: Torsional properties, driving torque, and pull-out strength conducted as per ASTM F543-13.

No specific numerical results for these tests are provided, only the general conclusion of "no gap" in performance compared to predicate devices.

2. Sample size used for the test set and the data provenance

• Sample size: Not specified. The document refers to "mechanical testing" and "testing the mechanical properties of the proposed and predicate device" (Page 5, 6) but does not provide the number of units/samples tested for either the proposed or predicate device.
• Data provenance: The mechanical testing was conducted by Tianjin ZhengTian Medical Instrument Co., Ltd. in China, as indicated by the submitter's address (Page 3). It is preclinical (bench) testing, not clinical data from patients.

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

Not applicable. This was preclinical mechanical testing, not a study requiring expert clinical opinion for ground truth.

4. Adjudication method for the test set

Not applicable. This was preclinical mechanical testing.

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

Not applicable. This device is a bone fixation plate system, not an AI diagnostic or assistive tool. No MRMC study was conducted.

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

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

7. The type of ground truth used

Not applicable in the conventional sense of clinical ground truth (e.g., pathology, outcomes). The "ground truth" for this submission's performance evaluation lies in the established mechanical testing standards (ASTM F382-13 and ASTM F543-13) and the performance of legally marketed predicate devices. The goal was to show the proposed device met these standards and was comparable to predicates.

8. The sample size for the training set

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

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

Not applicable. This device is a physical product, not an AI/ML algorithm.

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