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The AOS Small Fragment Plating System Lite is intended to be used for fixations of fractures, and nonunions of the clavicle, scapula, olecranon, humerus, radius, ulna, and or fibula, including osteopenic bone.

The AOS Small Fragment Plating System Lite consists of titanium plates in various configurations and sizes. The system is compatible with the AOS Small Fragment Plating System Instruments and non-locking and variable angle locking screws in diameters of 2.4mm, 2.7mm, 3.5mm, and 4.0mm. The plate system also includes 3.5mm headless compression screws.

The provided text describes a medical device, the "AOS Small Fragment Plating System Lite," and its clearance process (K181035) by the FDA. However, this document does not contain information about acceptance criteria or a study proving that an AI device meets acceptance criteria. Instead, it details a traditional 510(k) submission for a physical medical device (bone plating system) where substantial equivalence is demonstrated through preclinical testing (mechanical strength, material properties) and comparison to predicate devices, rather than AI performance metrics.

Therefore, I cannot fulfill your request for all the specified information as it pertains to an AI device's acceptance criteria and study.

What can be extracted from the document related to "acceptance criteria" (understood as performance standards for this physical device) and "studies" (preclinical testing):

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

2. Sample sized used for the test set and the data provenance: Not applicable. This is preclinical physical testing, not a clinical study involving a test set of data. The devices themselves are the "samples" for mechanical testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device's mechanical properties is established through standardized testing protocols (e.g., ASTM standards) and engineering analysis, not expert medical consensus.

4. Adjudication method for the test set: Not applicable.

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 is for a physical orthopedic implant, not an AI diagnostic or assistance device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.

7. The type of ground truth used: For the mechanical properties, the "ground truth" is defined by the physical laws and material science principles measured by validated test methods (ASTM standards) and engineering calculations.

8. The sample size for the training set: Not applicable. This is not an AI/machine learning model.

9. How the ground truth for the training set was established: Not applicable.

Summary of Preclinical Testing Mentioned:

• Type of Study: Preclinical mechanical testing and engineering analysis.
• Purpose: To demonstrate substantial equivalence of the AOS Small Fragment Plating System Lite to predicate devices in terms of mechanical performance.
• Methods:
  • ASTM F382 Static and dynamic four-point bend testing for plates (bending strength and stiffness).
  • Engineering analysis for screws (torsional strength, bending strength, and axial pullout strength).
  • Comparison to predicate devices (Synthes One Third Tubular Plate K011335, Small Fragment Dynamic Compression Locking (DCL) System K000684, AOS Small Fragment Plating System K161913).
• Conclusion: The device was found to have substantially equivalent bending strength and bending stiffness for plates, and substantially equivalent performance in torsional strength, bending strength, and axial pullout strength for screws through engineering analysis. This demonstrated that the device "does not raise any different questions of safety or effectiveness" compared to the predicates.
• Clinical Data: "There is no clinical data referenced in this 510(k)."

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The AOS Anterolateral Proximal Humeral Plate is indicated for fractures, fracture dislocations, osteotomies, and non- unions of the proximal humerus

The AOS Anterolateral Proximal Humeral plates are open reduction internal fixation devices for the temporary fixation of various types of fractures of the humerus and are intended as load sharing devices which may be removed once the fracture has healed. The AOS Anterolateral Proximal Humeral System consists of titanium plates, and proximal and distal locking and non-locking screws. 16 and 18 hole plates are being added to the system. The 16 hole plates are 9.4 inches long. The 18 hole plates are 10.4 inches long.

The provided text describes a medical device, the "AOS Anterolateral Proximal Humeral Plate," which is a metallic bone fixation appliance. The document is a 510(k) premarket notification for modifications being added to the existing system. Crucially, the document explicitly states under the "CLINICAL DATA" section: "There is no clinical data referenced in this special 510(k)."

This means that no clinical study was conducted as part of this specific 510(k) submission to prove the device meets acceptance criteria. The claim of substantial equivalence for the modifications (adding 16 and 18-hole plates) is based on similarities to predicate devices and preclinical testing (though the document states mechanical testing was not necessary due to no anticipated decrease in strength or increase in risk).

Therefore, I cannot provide information on acceptance criteria, device performance, sample sizes, ground truth, expert qualifications, adjudication methods, or MRMC studies for this specific submission because the document explicitly states no clinical data was referenced.

The relevant information is:

• Acceptance Criteria and Reported Device Performance: Not applicable, as no clinical study was referenced for this submission. The submission relies on substantial equivalence to predicate devices and the absence of a need for new mechanical testing for the additions.
• Sample size for test set and data provenance: Not applicable, as no clinical study was referenced.
• Number of experts used to establish ground truth and qualifications: Not applicable.
• Adjudication method for the test set: Not applicable.
• Multi-reader multi-case (MRMC) comparative effectiveness study: No, not applicable.
• Standalone (algorithm only) performance: Not applicable, as this is a physical medical device, not an AI algorithm.
• Type of ground truth used: Not applicable.
• Sample size for the training set: Not applicable, as no clinical study was referenced.
• How the ground truth for the training set was established: Not applicable.

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The AOS Small Bone Nail System is intended for fixation of fractures and osteotomies of the fibula, radius and ulna, including fractures where the medullary canal is narrow or flexibility of the implant is paramount.

The AOS Small Bone Nail is a titanium alloy (Ti-6Al-4V) intramedullary nail available in various lengths (110mm to 260mm) and diameters (2.5mm to 5.0mm). The nail is compatible with use of 3.5mm and 2.7mm cortical locking screws that allow for additional fracture fixation and locking capabilities.

The provided text describes a 510(k) premarket notification for the "AOS Small Bone Nailing System." A 510(k) submission generally aims to demonstrate substantial equivalence to a legally marketed predicate device rather than strictly proving a device meets predefined acceptance criteria through a study with outcome measures. Therefore, much of the requested information regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in terms of clinical performance metrics (like sensitivity, specificity, etc.) is not directly applicable or provided in this type of regulatory document.

However, based on the information provided, I can construct a table and address the other points within the context of a 510(k) substantial equivalence submission.

1. Table of Acceptance Criteria and Reported Device Performance

In the context of a 510(k) for a medical device like an intramedullary nail, "acceptance criteria" and "device performance" primarily relate to demonstrating mechanical equivalence to a predicate device and fulfilling the same indications for use.

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

• Sample Size for Test Set: The document mentions "comparative mechanical testing per a four point bend test based on ASTM F1264-14." However, it does not specify the exact sample size (number of nails tested) for this mechanical test.
• Data Provenance: The data is from preclinical testing performed by the manufacturer, Advanced Orthopaedic Solutions, Inc. (AOS). This is not clinical data from patients. The country of origin for the data is not explicitly stated beyond being conducted by AOS, which is based in Torrance, California, USA. It is inherently prospective data, as it was generated specifically for this regulatory submission.

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

This information is not applicable and not provided in the document. The device in question is a medical implant (intramedullary nail), and the "ground truth" for its mechanical performance is established through standardized engineering tests, not expert human assessment of images or clinical outcomes.

4. Adjudication Method for the Test Set

This is not applicable and not provided. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or studies involving human readers to resolve discrepancies in expert opinions or diagnoses. Mechanical testing does not involve such 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

This is not applicable. The device is an intramedullary nail, not an AI or imaging device that would involve human readers or AI assistance. No MRMC study was conducted or referenced.

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

This is not applicable. The device is a surgical implant, not an algorithm or AI system. Its performance is assessed through mechanical properties and clinical outcomes (which are not presented here, as the submission states "No clinical data referenced").

7. The Type of Ground Truth Used

The "ground truth" for the device's performance in this context is the results of standardized mechanical testing (four-point bend test based on ASTM F1264-14), which assesses physical properties like strength and flexibility. The intended use and material composition also serve as "ground truths" in the demonstration of substantial equivalence to predicate devices.

8. The Sample Size for the Training Set

This is not applicable and not provided. The device is not an AI/ML algorithm that requires a training set.

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.

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The AOS Small Fragment Plating System is intended to be used for fixations of fractures, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, particularly in osteopenic bone.

The AOS Small Fragment Plating System consists of titanium plates, screws, and washers in various configurations and sizes. The system includes Kirschner wires, non-locking screws in diameters of 2.7mm, 3.5mm, and 4.0mm. The system includes variable angle locking screws in diameters of 2.7mm, and 3.5mm. The plate system includes 3.5mm headless compression screws, 4.0mm cannulated screws, and 4.0mm partially threaded cannulated screws.

This document describes a Special 510(k) premarket notification for the AOS Small Fragment Plating System, which is a metallic bone fixation appliance. The purpose of this submission is to demonstrate substantial equivalence to a previously cleared predicate device, K152732. This submission does not involve an AI/ML powered device, therefore the information requested is not present.

Here's a breakdown of the relevant information from the provided text:

• Device Name: AOS Small Fragment Plating System
• Regulation Number & Name: 21 CFR 888.3030, Single/multiple component metallic bone fixation appliances and accessories. Also 21 CFR 888.3040, Smooth/threaded metallic bone fixation fastener.
• Regulatory Class: Class II
• Product Code: HRS, HWC, HTN
• Indications for Use: Fixations of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, particularly in osteopenic bone.
• Predicate Device: AOS Small Fragment Plating System (510k): K152732
• Modifications in K161913 (this submission): Longer and shorter plates, shorter screws, and screw cannulation.
• Basis for Substantial Equivalence: The modified device has the same intended use, indications for use, raw material, method of manufacture, design, type of interface, shelf life, biocompatibility, sterilization, packing methods, and physical limitations as the predicate. It also has similar sizes and dimensions.

Information related to acceptance criteria and study for an AI/ML device (which this is not):

The provided document details a mechanical testing study for a medical device (bone plating system), not an AI/ML powered device. Therefore, the specific criteria requested for AI/ML device performance (such as sensitivity, specificity, AUC, etc.) and studies like MRMC comparative effectiveness studies are not applicable and not present in this document.

The "study" described in this document is a pre-clinical mechanical test:

• Preclinical Testing: "The AOS Small Fragment Plating System was subjected to comparative mechanical testing per a four point bend test based on ASTM F382-14. The results demonstrate that the AOS Small Fragment Plating System and accessories are substantially equivalent to the predicate."
• Acceptance Criteria & Reported Performance: The document states that the results of the comparative mechanical testing "demonstrate that the AOS Small Fragment Plating System and accessories are substantially equivalent to the predicate." It implies that the acceptance criteria were met if the mechanical performance of the modified device was comparable to the predicate device per ASTM F382-14. The specific numerical values for performance are not included in this summary, but the conclusion of substantial equivalence implies they were acceptable.
• Clinical Data: The document explicitly states: "There is no clinical data referenced in this special 510(k)".

Therefore, the requested information for an AI/ML device is not applicable to this submission. This document pertains to a physical medical device (bone plates and screws) and its mechanical performance.

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