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The Valkyrie Thoracic Fixation System is indicated for use in the stabilization of fractures in the chest wall including sternal reconstructive surgical procedures, trauma, or planned osteotomies. The system is intended for use in patients with normal and/or poor bone quality.

The Valkyrie Thoracic Fixation System consists of a variety of screws and plates intended for use in the stabilization and fixation of fractures in the chest wall including sternal reconstructive surgical procedures, trauma, or planned osteotomies. The system is intended for use in patients with normal and/or poor bone quality.

To accommodate varying patient anatomy and surgeon preference, the Valkyrie Thoracic Fixation System includes screws in diameters from 2.5mm to 3.5mm diameters and lengths from 7-20mm. The system also includes various styles of plates. The Valkyrie Thoracic Fixation System plates are made from PEEK per ASTM F2026, and the screws are made from Ti-6Al-4V per ASTM F136.

The provided text is a 510(k) summary for the Valkyrie Thoracic Fixation System, which is a medical device for stabilizing chest wall fractures. It is not a software-as-a-medical-device (SaMD) or AI product. Therefore, the questions regarding acceptance criteria and studies typical for AI/SaMD are not applicable to this document.

The document discusses the mechanical and material aspects of the device and its substantial equivalence to a predicate device, not the performance of an algorithm.

However, I can extract the acceptance criteria and related information for the device's physical attributes as described in the summary:

1. Table of Acceptance Criteria and Reported Device Performance:

Regarding the other points, as this is a physical medical device and not an AI/SaMD, the following information is not present or applicable in the provided text:

• Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to physical components of the device, and the testing is laboratory-based mechanical and MR compatibility testing, not data-driven performance evaluation.
• 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. "Ground truth" in this context would refer to established engineering standards (ASTM standards in this case), not expert interpretation of data.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication is not a concept used for mechanical and material testing of a physical device.
• 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 an AI-assisted diagnostic tool, which this device is not.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the physical tests, the "ground truth" is defined by the requirements of the ASTM standards (F2052, F2213, F2119, F2182, F543). The ultimate "ground truth" for regulatory approval is demonstrating substantial equivalence to a legally marketed predicate device.
• The sample size for the training set: Not applicable. There is no training set for a physical device.
• How the ground truth for the training set was established: Not applicable.

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The Valkyrie Thoracic Fixation System is intended for use in the stabilization of fractures in the chest wall including sternal reconstructive surgical procedures, trauma, or planned osteotomies. The system is intended for use in patients with normal and/or poor bone quality.

The Valkyrie Thoracic Fixation System consists of a variety of screws and plates intended for use in the stabilization and fixation of fractures in the chest wall including sternal reconstructive surgical procedures, trauma, or planned osteotomies. The system is intended for use in patients with normal and/or poor bone quality. To accommodate varying patient anatomy and surgeon preference, the Valkyrie Thoracic Fixation System includes screws in 3.0mm and 3.5mm diameters and lengths from 7-20mm. The system also includes various styles of plates. The Valkyrie Thoracic Fixation System plates are made from PEEK-Optima™ per ASTM F2026, and the screws are made from Ti-6Al-4V per ASTM F136.

Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on what is available within the document. It's important to note that this 510(k) summary is for a modification (addition of an instrument) to an already cleared device, so extensive clinical studies with AI components are not expected or detailed here.

This document describes a submission for a medical device (Valkyrie Thoracic Fixation System) which is a physical bone fixation system, not an AI/ML powered device. Therefore, many of the questions related to AI/ML specific criteria (such as AI assistance, standalone algorithm performance, training/test set data, expert ground truth for AI, etc.) are not applicable to this submission. The "acceptance criteria" and "study" described herein refer to non-clinical testing for the physical device components and their materials.

Acceptance Criteria and Device Performance (for the physical device, not AI)

This submission is for the addition of a "Caddy Guide Instrument" to an existing Thoracic Fixation System. The acceptance criteria primarily revolve around the safety and performance of the device materials and the new instrument.

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

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

• Not explicitly stated in the provided text. The document mentions "nonclinical tests" and "Design Control Activities Summary," which would involve material testing and instrument functionality tests. The sample sizes for these tests (e.g., number of material samples tested, number of instrument prototypes tested) are not specified.
• Data Provenance: Not specified. Standard medical device testing is typically conducted in controlled laboratory environments.

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 / Not explicitly stated. For material and instrument testing, "ground truth" is typically established by engineering specifications, recognized standards (like ISO and ASTM), and validated test methodologies rather than expert human interpretation in the way it would be for an AI diagnostic device. Experts involved would be engineers and material scientists specialized in medical device testing.

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 primarily used for clinical studies involving subjective human interpretation (e.g., radiologists reviewing images) to establish a consensus ground truth. This is not relevant for non-clinical material and 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 a physical thoracic fixation system and associated instrument. It is not an AI-powered device, so an MRMC study related to AI assistance is not applicable.

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

• No. This is not an AI algorithm.

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

• For biocompatibility: The ground truth is established by the pass/fail criteria defined in the specific ISO standards (e.g., ISO 10993-5 for cytotoxicity).
• For instrument performance: The ground truth is established by engineering specifications and performance criteria derived from risk analysis and intended use of the instrument, verified through nonclinical functional testing.

8. The sample size for the training set

• Not applicable. This device does not involve a "training set" in the context of AI/machine learning.

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

• Not applicable. See point 8.

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