(84 days)
The EVOS Small Fragment Plating System is indicated for adult and pediatric patients, as well as patients with osteopenic bone. It is indicated for fixation of small and long bone fractures, including, but not limited to, those of the tibia, fibula, femur, humerus, ulna, radius, pelvis, acetabulum, metacarpals, metatarsals, and clavicle.
Subject of this premarket notification is an extension of the EVOS Small Fragment Plating System, the EVOS Small Fragment Upper Extremity Plates. The subject plates feature similarities to existing Smith & Nephew small fragment plating systems (TC-100 Small Bone Plating System, PERI-LOC/PERI-LOC VLP Plating Systems) and also share some instruments and compatible implants from the existing EVOS MINI Plating System and EVOS Small Fragment Plating System. When compared against EVOS Small Fragment Plates already cleared for market, the subject plates use the same hole features and are designed to work with the same bone screws. The EVOS Small Fragment Upper Extremity Plates are available in a variety of plate designs for specific anatomical areas. These plate designs include plates with 2.7mm holes or 3.5mm holes only, or with a combination of 2.7mm and 3.5mm holes. Plate designs may include threaded holes, non-threaded holes, and variable-angle locking holes.
The context provided is for a 510(k) premarket notification for a medical device called the "EVOS Small Fragment Upper Extremity Plates." This document describes the device, its indications for use, and a summary of pre-clinical testing conducted to demonstrate its substantial equivalence to predicate devices. It is not a study demonstrating device performance against specific acceptance criteria for an AI or diagnostic device.
Therefore, many of the requested sections regarding AI/algorithm performance, ground truth, expert adjudication, multi-reader multi-case studies, and training/test set sample sizes cannot be answered from the provided text.
However, I can extract information related to the device's pre-clinical testing and the general concept of acceptance criteria in the context of mechanical performance and sterility.
Here's an attempt to answer based on the provided text, indicating when information is not available:
Acceptance Criteria and Study Details (Based on K173293 Summary)
This document describes the pre-market notification (K173293) for the EVOS Small Fragment Upper Extremity Plates, a Class II medical device (metallic bone fixation appliances and accessories) manufactured by Smith & Nephew, Inc. The submission aims to demonstrate substantial equivalence to legally marketed predicate devices, not to prove performance against specific AI-related acceptance criteria.
The "studies" described are pre-clinical tests to assess the mechanical robustness and packaging integrity of the bone plates.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria / Metric (Implicit) | Reported Device Performance |
|---|---|---|
| Mechanical Performance (Bending Fatigue/Structural Strength) | Equivalent or superior structural strength and fatigue performance to predicate devices under similar conditions. (Implied: Resist fracture, maintain structural integrity) | - Finite Element Analysis (FEA): Conducted to identify worst-case plates for mechanical testing. |
- Bending Fatigue Testing: Worst-case plates were tested. Results showed "the subject EVOS plates performed similar or superior to the predicate plates tested, when evaluated under the same conditions."
- Engineering Rationales: Leveraged for some plates based on previous FEA, mechanical testing, and hand calculations. |
| Packaging Integrity | Product not damaged during shipment; sterility maintained post-shipment. | "Packaging verification testing was conducted for the proposed packaging configurations and the results of this testing demonstrated that the product will not be damaged during shipment and will adequately maintain sterility post shipment." |
| Bacterial Endotoxin Limits | Meet acceptable endotoxin limits as per FDA Guidance and ANSI/AAMI ST72. | "Bacterial endotoxin testing was completed and met the acceptable endotoxin limits as stated in the FDA Guidance..." |
2. Sample size used for the test set and the data provenance:
- Mechanical Testing (FEA & Fatigue): The text mentions "worst case plates" were identified through FEA for further mechanical testing. It does not specify the exact number of plates or samples tested in the bending fatigue analysis.
- Data Provenance: The tests are pre-clinical, conducted by the manufacturer, Smith & Nephew, Inc. The data is prospective, generated specifically for this submission. The country of origin for the data generation is not explicitly stated but is implicitly tied to Smith & Nephew's testing facilities (likely in the US based on the company's address).
- Packaging and Endotoxin Testing: No specific sample sizes are mentioned for these tests, only that they were conducted and met criteria.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is a medical device (bone plate) pre-market notification, not an AI or diagnostic device. There is no concept of "ground truth" established by experts in the context of these mechanical and sterility tests. The "truth" is determined by objective physical and chemical measurements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. No adjudication method is described as there is no subjective interpretation of results by experts involved in establishing a "ground truth" for these pre-clinical tests.
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 device is a bone plate, not an AI-assisted diagnostic tool. No MRMC studies were conducted or are relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical device. No algorithm or standalone performance study was conducted.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Applicable (in the context of AI/diagnostic "ground truth"). For the mechanical tests, the "ground truth" corresponds to the objective physical properties and performance measured against established engineering standards and predicate device performance. For packaging and endotoxin tests, it's objective adherence to recognized standards and guidance.
8. The sample size for the training set:
- Not Applicable. There is no "training set" as this is not an AI/machine learning device. The "training" in manufacturing refers to process validation and quality control, not a data set for model development.
9. How the ground truth for the training set was established:
- Not Applicable. No training set or associated ground truth.
§ 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.