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

The AOS Small Fragment Plating System consists of titanium plates in various configurations and sizes. The system includes 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.

This document describes a 510(k) premarket notification for the "AOS Small Fragment Plating System."
It indicates that the device is substantially equivalent to legally marketed predicate devices based on indications for use, similar shape and design, and fundamental technology.

Here's the breakdown of the information requested based on the provided text:

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

• Four-point bend strength (based on ASTM F382-14)
• Variable Angle Locking Mechanism strength (screw-plate interface) | Substantially Equivalent to Predicate Devices:
• The AOS Small Fragment Plating System met the mechanical performance requirements tested, demonstrating substantial equivalence to the predicate devices in terms of four-point bend strength and variable angle locking mechanism strength. |

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 explicitly stated. The document mentions "comparative mechanical testing" but does not detail the number of samples tested for each device or test.
• Data Provenance: Not specified. The testing was reported by Advanced Orthopaedic Solutions, Inc., located in Torrance, CA, USA, but the origin of the data itself (e.g., specific lab, country) is not mentioned. The testing is likely prospective, as it was performed specifically for this 510(k) submission.

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 device is a physical implant (plating system), not a diagnostic or AI-driven device that requires expert review for ground truth establishment. The "ground truth" for this device's performance is established through mechanical testing against industry standards (ASTM F382-14) and comparison to predicate devices, rather than expert medical interpretation of data. Therefore, this question is not applicable in the typical sense for this type of device.

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

• Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for expert consensus in diagnostic studies. For mechanical testing, the results are objectively measured per a defined protocol.

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 a physical orthopedic implant system, not a diagnostic imaging or AI-assisted device. Therefore, MRMC studies involving human readers and AI assistance are not relevant.

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

• Not applicable. This is a physical orthopedic implant.

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

• The "ground truth" for this device's performance is established through mechanical testing data demonstrating that it meets predefined physical and mechanical properties and performs comparably to the predicate devices. The ASTM F382-14 standard provides the benchmark for performance, and the predicate devices serve as the comparative ground truth.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device that requires a training set. The "training" for such devices involves adherence to engineering design principles and manufacturing quality control.

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

• Not applicable. (See #8)

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