(21 days)
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
| Acceptance Criteria Category | Acceptance Criteria Met (Reported Device Performance) |
|---|---|
| Biocompatibility - Cytotoxicity | Met acceptance criteria per ISO 10993-5:2009 |
| Biocompatibility - Sensitization | Met acceptance criteria per ISO 10993-10:2010 |
| Biocompatibility - Irritation or Intracutaneous Reactivity | Met acceptance criteria per ISO 10993-10:2010 |
| Biocompatibility - Acute Systemic Toxicity | Met acceptance criteria per ISO 10993-11:2017 |
| Biocompatibility - Material-Mediated Pyrogenicity | Met acceptance criteria per ISO 10993-11:2017 |
| Design Control Activities Summary | All criteria met |
| Performance of Caddy Guide instrument | Supported by nonclinical testing |
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.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.