(74 days)
Indications For Use:
Triple arthrodesis
Isolated rearfoot arthrodesis
Midfoot arthrodesis
Comminuted trauma
Diabetic Charcot reconstruction
Most foot pathology not requiring fixation above the ankle
The E-Z Frame Surgical Boot is manufactured of light weight stable materials to allow the surgeon to stabilize the foot at or below the ankle for post surgical conditions. Presently liizarov or Sheppard Rings are used for this purpose and require multiple avenues of surgical intervention in the tibia to stabilize the distal support ring. With the E-Z Frame system a boot is stabilized on the distal leg (tibia) and further stabilized to the distal ring about the foot with carbon fiber rods that are attached to the boot and ring respectfully. Light weight materials are employed using 6061 Aluminum, ABS plastic, carbon fiber rods, FR10/11 laminate and small ASTM F 17-4 Stainless Steel Fixtures. The foot is stabilized to the distal ring using Kirshner Wires (K-Wire) purchased from PROMEX of Indianapolis, IN under 510 K: K960023. The boot utilized to stabilize the device on the tibia is purchased and modified from Darco International of Virginia.
This document is a 510(k) premarket notification for a medical device called the "E-Z Frame Surgical Boot," submitted to the FDA in 2005. It is a traditional submission for a physical medical device, not a software or AI-driven diagnostic device. Therefore, the questions related to AI/software performance, such as acceptance criteria, study design for performance, ground truth establishment, expert adjudication, MRMC studies, and standalone performance, are not applicable here.
The document primarily describes the device's components, its intended use, and its substantial equivalence to a predicate device. The FDA's letter confirms the clearance based on substantial equivalence to pre-amendment devices or previously cleared devices.
Here's an attempt to address the questions based on the provided text, indicating where information is not applicable:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as quantifiable performance metrics for this type of device. For a traditional medical device like a surgical boot, acceptance is typically based on mechanical integrity, biocompatibility of materials, and successful comparison to a predicate device's intended use and safety profile.
- Reported Device Performance:
- Manufactured of light weight stable materials to allow the surgeon to stabilize the foot at or below the ankle for post-surgical conditions.
- Stabilized on the distal leg (tibia) and further stabilized to the distal ring about the foot with carbon fiber rods that are attached to the boot and ring respectfully.
- Employs lightweight materials: 6061 Aluminum, ABS plastic, carbon fiber rods, FR10/11 laminate, and small ASTM F 17-4 Stainless Steel Fixtures.
- Foot stabilized to the distal ring using Kirshner Wires (K-Wire) (predicate K960023).
- Boot utilized to stabilize the device on the tibia is purchased and modified from Darco International of Virginia.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. This is a physical device submission, not a study of algorithm performance on a test set of data. The "test" in this context refers to general mechanical and material quality and safety validations, not data-driven performance.
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. Ground truth for a dataset is not relevant to this type of device submission. The "ground truth" for the device itself would be its ability to physically stabilize the foot as intended and its safety through material and design evaluation, usually performed by engineers and regulatory bodies.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No adjudication method for a test set of data.
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 not an AI/software device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable for an AI data-driven context. For this device, the "ground truth" for its performance is its physical stability, material compatibility, and engineering design meeting specified standards for orthopaedic devices, which is evaluated through engineering tests and comparison to predicate devices, not data-based ground truth.
8. The sample size for the training set
- Not applicable. There is no training set for an AI/software model.
9. How the ground truth for the training set was established
- Not applicable. There is no training set for an AI/software model.
§ 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.