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The Arthrex Fracture System is intended to be used for internal bone fixation for bone fractures, fusions, osteotomies, and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, femur, and fibula. The Arthrex Fracture Plates are to be used with the 2.7mm-4.0mm Arthrex Low Profile Screws.

The Clavicle Plate Button is intended for use with the clavicle plates for clavicle indications such as for the treatment of syndesmotic trauma, such as fixation of acromioclavicular separations due to coracoclavicular ligament disruption, and this button may not be used alone. The button is intended to be used with #5 FiberWire or FiberTape.

The Arthrex Fracture System is a family of stainless steel plates, screws, and buttons that will be offered as sterile or non-sterile devices. The plates may be contoured or straight and may be available in left and right configurations. The screw family ranges from 2.7mm to 4.0mm in diameter and from 8mm to 80mm in length. The screws are solid and fully threaded and may be locking or non-locking. The button is stainless steel and designed to fit securely in the holes of the fracture plates. The button is intended to be used with the previously cleared suture, which is provided separately.

This document is a 510(k) premarket notification for the Arthrex Fracture System, focusing on the sterilization methods of Gamma Irradiation and Ethylene Oxide (EO). The purpose of the submission is to obtain clearance for sterile versions of a device previously cleared as non-sterile (K112437).

Based on the provided information, it's essential to understand that this submission is for a medical device (bone fixation plates, screws, and buttons), not an AI-powered diagnostic or assistive tool. Therefore, many of the requested criteria related to AI performance, ground truth, expert adjudication, and comparative effectiveness studies are not applicable to this type of device submission.

Here's a breakdown of the requested information, addressing what is present and what is not applicable:

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

The document does not specify quantitative acceptance criteria in terms of accuracy, sensitivity, or specificity, as these are typically associated with diagnostic or AI performance. The "acceptance criteria" for a medical device like this are generally related to its physical and mechanical properties, biocompatibility, and sterility, ensuring it performs its intended function safely and effectively.

The "reported device performance" is essentially the determination of substantial equivalence to a predicate device. The claim is that the Arthrex Fracture System, with the addition of sterilization, is substantially equivalent to the predicate device (K112437). This equivalence is based on:

• Identical intended use: Internal bone fixation for fractures, fusions, osteotomies, and non-unions in various anatomical locations.
• Similar material: Stainless steel.
• Fundamental technological characteristics: Plates, screws, and buttons for bone fixation.
• Sterilization validation: The critical new aspect for this submission is the validation of Gamma Irradiation and Ethylene Oxide (EO) sterilization processes, ensuring the device remains safe and effective after these treatments. This is implied to have met relevant standards, though details are not provided in this summary.

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

This information is not applicable and not provided in the document. This is a submission for a physical medical device, not an AI/software product requiring a "test set" in the computational sense. The "test set" would be related to mechanical testing, biocompatibility, and sterilization validation, which are typically performed according to established ISO standards and are not described in terms of "samples" in this summary.

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 applicable and not provided. "Ground truth" and "experts" in this context would refer to material scientists, engineers, and microbiologists conducting various tests to validate the device's properties and the effectiveness of the sterilization processes. This document is a summary and does not contain that level of detail.

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

This information is not applicable and not provided. Adjudication methods are relevant for subjective interpretations, especially in diagnostic imaging or clinical trials, which is not the nature of this device's evaluation.

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 applicable and not provided. MRMC studies and the concept of "human readers" improving with AI assistance are specific to AI/CAD (Computer-Aided Detection/Diagnosis) systems, which this device is not.

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

This information is not applicable and not provided. This is for a physical orthopedic implant system, not an algorithm.

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

This information is not applicable and not provided in the context of AI. For a physical device, the "ground truth" would be established by scientific and engineering principles, material specifications, and validated test methods (e.g., mechanical strength testing, biocompatibility testing, sterility assurance level (SAL) validation for sterilization). These details are not part of the 510(k) summary.

8. The sample size for the training set

This information is not applicable and not provided. There is no "training set" for this type of medical device submission.

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

This information is not applicable and not provided. There is no "training set" or "ground truth" establishment in the AI sense for this device.

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The Arthrex Fracture System is intended to be used for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, femur and fibula. The Arthrex Fracture Plates are to be used with the 2.7mm-4.0mm Arthrex Low Profile Screws.

The Clavicle Plate Button is intended for use with the clavicle plates for clavicle indications such as for the treatment of syndesmotic trauma, such as fixation of acromioclavicular separations due to coracoclavicular ligament disruption, and this button may not be used alone. The button is intended to be used with #5 Fiber Wire or FiberTape.

The Arthrex Fracture System is a family of stainless steel plates, screws, and buttons. The plates may be contoured or straight and may be available in left and right configurations. The plates are to be used with the 2.7mm-4.0mm Low Profile Screws. The screws are solid and fully threaded and may be locking or non-locking. The button is stainless steel and designed to fit securely in the holes of the fracture plates. The button is intended to be used with the previously cleared suture, which is provided separately.

This document describes the Arthrex Fracture System, a device for internal bone fixation. Given the provided text, there is no information available regarding specific acceptance criteria, a study proving the device meets these criteria, or details about artificial intelligence (AI) in this context.

The document is a 510(k) summary for a medical device, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting performance data against specific, defined acceptance criteria. It primarily addresses the device's description, intended use, and a comparison to existing devices.

Therefore, many of the requested sections regarding acceptance criteria, study details, ground truth, and AI performance cannot be extracted from this text.

Here's a breakdown of what can be inferred or stated based on the provided information, and what cannot:

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

• Acceptance Criteria: Not explicitly stated as pass/fail criteria with numerical thresholds. The "acceptance" for this 510(k) submission is based on demonstrating substantial equivalence to predicate devices.
• Reported Device Performance:
  "The submitted mechanical testing data demonstrated that the bending and pull-out strength of the proposed devices are substantially equivalent to the bending and pull-out strength of the predicate devices."
  • Comment: The document doesn't provide specific numerical values for bending and pull-out strength or detailed comparison data. It only states that the data demonstrated "substantial equivalence."

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

• Sample Size: Not specified.
• Data Provenance: Not specified, but the context implies laboratory mechanical testing rather than clinical data from a specific country. This would be prospective testing on manufactured devices to compare against predicates.

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)

• Not applicable. This device is a bone fixation system, and the "ground truth" in this context would be physical/mechanical properties, not expert-interpreted diagnostic images or outcomes. The review of the 510(k) submission itself would involve regulatory experts (FDA staff).

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

• Not applicable. This is a physical device being evaluated for mechanical equivalence, not a diagnostic algorithm or image interpretation task requiring adjudication of expert opinions.

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 study was NOT done. This document is for a physical medical device (fracture system) and does not involve AI or human readers for diagnostic interpretation.

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

• No, a standalone algorithm performance study was NOT done. This document is for a physical medical device and does not involve any algorithm or AI component.

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

• Mechanical properties of predicate devices. The "ground truth" for demonstrating substantial equivalence appears to be the established mechanical performance (bending and pull-out strength) of the predicate devices. The new device's performance is compared against these benchmarks.

8. The sample size for the training set

• Not applicable. This document describes a physical medical device. There is no mention of a "training set" in the context of an algorithm. If referring to the manufacturing process, quality control samples would be used, but not a "training set" as understood in AI/ML.

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

• Not applicable. As above, there is no "training set" in the AI/ML sense for this device.

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