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510(k) Data Aggregation
(63 days)
Arthrex Fracture Plates
The Arthrex Fracture Plates are 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, and fibula.
The Arthrex Low Profile Screws (2.5mm and larger, solid) are intended to be used as stand-alone bone screws, or in a plate-screw system 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. When used with a plate, the screws may be used with the Arthrex Low Profile, Small Fragment Plates, Fracture Plates, Distal Extremity Plates, Humeral Fracture Plates, and Osteotomy Plates.
The Arthrex Fracture Plates are a family of flat and contoured plates and screws. The plates are comprised of stainless steel and come in a variety of configurations. The Arthrex Fracture Plates are intended to be used with solid locking and non-locking Low Profile Screws. The proposed Low Profile Screws, in this submission, are comprised of Stainless Steel and are 2.7mm in diameter and range from 32mm to 60mm in length.
The provided text is a 510(k) premarket notification for the Arthrex Fracture Plates and accompanying screws. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a study proving a device meets specific acceptance criteria in the context of an AI/ML algorithm.
Therefore, many of the requested categories for AI/ML study description (like sample size for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth) are not applicable to this document. The document describes a mechanical performance study to demonstrate substantial equivalence.
Here's the information that can be extracted relevant to acceptance criteria and the "study" conducted for this type of device:
1. A table of acceptance criteria and the reported device performance:
The document describes material and mechanical testing to demonstrate substantial equivalence. It implies that the acceptance criteria for these tests were met by being comparable to the predicate devices. The specific raw data or numerical acceptance limits are not provided in this summary, but the conclusion of meeting them is stated.
| Test Type | Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|---|
| 4-point bend | Performance comparable to predicate devices | Performance is substantially equivalent to predicate devices |
| Section modulus comparison | Performance comparable to predicate devices | Performance is substantially equivalent to predicate devices |
| Torque | Performance comparable to predicate devices | Performance is substantially equivalent to predicate devices |
2. Sample size used for the test set and the data provenance:
- Sample size: Not explicitly stated for the mechanical tests in this summary. Mechanical tests typically involve a small number of samples of the device and predicate.
- Data provenance: The tests were "in-vitro testing" conducted by the manufacturer, Arthrex, Inc., in the USA (Naples, FL).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This pertains to mechanical testing, not expert-based evaluation of medical images.
4. Adjudication method for the test set:
- Not applicable. This pertains to 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:
- No. This is not an AI/ML device, and no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/ML device.
7. The type of ground truth used:
- Mechanical properties comparison to predicate devices. The "ground truth" here is the established mechanical performance of legally marketed predicate devices, against which the new device's performance is compared.
8. The sample size for the training set:
- Not applicable. This is a mechanical device, not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable.
Summary of what the document does say about the "study":
The study conducted was in-vitro mechanical testing (4-point bend, section modulus comparison, torque) to compare the performance of the Arthrex Fracture Plates and screws to their predicate devices. The conclusion was that the "performance of the proposed devices is substantially equivalent to that of the predicate devices" and that "The mechanical data indicate that the Arthrex Fracture Plates are adequate for their intended use." The document explicitly states: "Clinical data and conclusions are not needed for this device."
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(34 days)
ARTHREX FRACTURE PLATES AND SCREWS
The Arthrex Fracture Plates are intended to be used for internal bone froctures, fusions, osteotomies, and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, fibula.
The Arthrex Low Profile Screws (2.0-2.4mm solid) are intended to be used as stand-alone bone screws, or in a plate screw system for internal bone fractures, fusions, osteotomies, and non-unions in the ankle, foot, hand, and wrist. When used with a plate, the screw may be used with the Arthrex Low Profile, Small Fragment Plates, and Distal Extremity Plates.
The Arthrex Low Profile Screws (2.0-3.0mm cannulated) are intended to be used as stand-olone bone screws for internal bone fixation for bone froctures, fusions, ostectomies, and non-unions in the ankle, foot, hand, and wrist.
The Arthrex Low Profile Screws (2.5mm and larger, solid) are intended to be used as stand-alone bone screws, or in a plate-screw system for internal bone fractures, fusions, osteotomies, and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, alecranon, hymerus, radius, ulno, tibig, colconeous, femur, and fibula. When used with a plate, the screws may be used with the Arthrex Low Profile, Smoll Fragment Plates, distal Extremity Plates, Humeral Fracture Plates, and Osteotomy Plates.
The Arthrex Low Profile Screws (3.5mm and larger, cannulated) are intended to be used as stand-alone bone screws for internal bone fractures, fusions, osteotomies, and non-unions in the ankle, foot, hand, wrist, clovicle, scapula, olecranon, humerus, radius, ulna, tibia, calconeous, femur, and fibula.
The Arthrex Fracture Plates and Screws are a family of titanium and stainless steel plates and screws. The plates are flat and contoured, ranging from 50mm to 244mm in length. The accompanying screws are 2.0mm to 6.7mm in diameter.
The provided document is a 510(k) premarket notification for Arthrex Fracture Plates and Screws. It describes a medical device, not a diagnostic AI/ML device. Therefore, the requested information regarding acceptance criteria and study data for an AI/ML device is not applicable to this document. The document focuses on demonstrating substantial equivalence to predicate devices for bone fixation plates and screws, including proposed sterilization methods and line extensions.
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(170 days)
ARTHREX FRACTURE PLATES
The Arthrex Fracture Plates are 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, fibula.
The Arthrex Low Profile Screws (2.0-2.4mm solid) are intended to be used as stand-alone bone screws, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, and wrist. When used with a plate, the screw may be used with the Arthrex Low Profile, Small Fragment Plates, and Distal Extremity Plates.
The Arthrex Low Profile Screws (2.0-3.0mm cannulated) are intended to be used as stand-alone bone screws for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, and wrist.
The Arthrex Low Profile Screws (2.5mm and larger, solid) are intended to be used as stand-alone bone screws, or in a plate-screw system 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. When used with a plate, the screws may be used with the Arthrex Low Profile, Small Fragment Plates, Fracture Plates, Distal Extremity Plates, Humeral Fracture Plates, and Osteotomy Plates.
The Arthrex Low Profile Screws (3.5mm and larger, cannulated) are intended to be used as stand-alone bone screws 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 a family of titanium and stainless steel plates and screws. The plates are flat and contoured, ranging from 50 mm to 244 mm in length. The accompanying screws are 2.5mm to 6.7mm in diameter.
Here's a breakdown of the acceptance criteria and study information for the Arthrex Fracture Plates, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Demonstrates Substantial Equivalence to Predicate Devices) | Reported Device Performance (Arthrex Fracture Plates) |
|---|---|
| Material Composition: Must be composed of materials substantially equivalent to predicate devices. | Composed of Titanium or Stainless Steel, which is substantially equivalent to the predicate devices. |
| Bending Strength: Bending strength must be substantially equivalent to predicate devices. | The mechanical testing data demonstrated that the bending strength of the proposed devices is substantially equivalent to the bending strength of the predicate devices. |
| Pull-out Strength: Pull-out strength must be substantially equivalent to predicate devices. | The mechanical testing data demonstrated that the pull-out strength of the proposed devices is substantially equivalent to the pull-out strength of the predicate devices. |
| Torque Strength: Torque strength must be substantially equivalent to predicate devices. | The mechanical testing data demonstrated that the torque strength of the proposed devices is substantially equivalent to the torque strength of the predicate devices. |
| Indications for Use: Must have equivalent indications for use to predicate devices. | The indications for use are the same as the predicate devices (internal bone fixation for bone fractures, fusions, osteotomies, and non-unions in various specified anatomical locations). |
| Technological Characteristics: Must have technological characteristics comparable to predicate devices. | The technological characteristics are comparable to the predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
This is not applicable as the study described is a benchtop mechanical testing study, not a clinical study involving patients or human data. The "test set" would refer to the physical devices (fracture plates and screws) subjected to mechanical stress tests.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This is not applicable. Ground truth, in the context of this 510(k) submission, is established by objective mechanical testing standards and comparison to predicate device performance, not expert consensus on human data.
4. Adjudication Method for the Test Set
This is not applicable. There is no adjudication method described as it's a mechanical performance study, not involving human interpretation or decision-making.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This submission is for a medical device (fracture plates and screws) and primarily relies on mechanical performance testing for substantial equivalence, not a comparison of human reader performance with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study
No, a standalone performance study (algorithm only) was not done. This device is a physical implant, not an AI algorithm.
7. Type of Ground Truth Used
The "ground truth" used for demonstrating substantial equivalence is objective mechanical performance data (bending, pull-out, and torque strength) and material composition standards, compared against that of legally marketed predicate devices.
8. Sample Size for the Training Set
This is not applicable, as this is a physical medical device submission based on mechanical testing and material equivalence, not an AI/machine learning study. There is no "training set" in this context.
9. How the Ground Truth for the Training Set Was Established
This is not applicable, as there is no "training set" for this type of device submission.
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