(59 days)
The Hoffmann® II Micro™ External Fixation System is intended for use to provide stabilization of open and/or unstable fractures in children and adults where soft tissue injury precludes the use of other fracture treatments such as IM rodding or casting or other means of internal fixation and for use in reconstruction procedures in conjunction with commercially available Fixation Pins and/or Kirschner Wires. Specific indications include, but are not limited to:
- Bone fracture fixation .
- . Osteotomy
- Arthrodesis .
- . Correction of deformity
- Revision procedure where other treatments or devices have been unsuccessful .
- Non-unions and delayed unions .
The new components are additions to the Hoffmann® II Micro™ External Fixation System. They are external fixation frame components intended to be used with the components in other Howmedica Osteonics' external fixation systems such as the Hoffmann® External Fixation System, Hoffmann® II External Fixation System, Hoffmann® II Compact™ External Fixation System, Hoffmann® II Hybrid Frame System, Monotube Triax™ External Fixation System.
This document is a 510(k) premarket notification for modifications to the Hoffmann® II Micro™ External Fixation System. It focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria or reporting device performance from a study with specific metrics like sensitivity, specificity, or accuracy.
Therefore, most of the requested information regarding acceptance criteria, study design, ground truth, and sample sizes for testing and training cannot be extracted from this document, as it describes a different type of regulatory submission.
Here's what can be inferred from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
Not applicable. This document is a 510(k) premarket notification for modifications to an existing device. It does not contain pre-defined performance metrics or reported performance data in the typical sense of a diagnostic or predictive device study. The "acceptance criteria" for a 510(k) submission revolve around demonstrating substantial equivalence to predicate devices. The reported "performance" is that the modifications meet this equivalence.
| Metric | Acceptance Criteria (Implicit for 510(k)) | Reported Device Performance |
|---|---|---|
| Substantial Equivalence | Similarities in intended use, materials, and design to predicate devices, with testing demonstrating equivalence. | "Testing has been conducted on the Hoffmann® II Micro™ new components demonstrating substantial equivalence to the predicate devices." (from Section {0}) |
2. Sample size used for the test set and the data provenance:
Not applicable. This document refers to "testing" conducted to demonstrate substantial equivalence but does not specify a test set sample size or data provenance in the context of a clinical performance study. The testing would likely involve mechanical or biocompatibility tests, not a clinical data set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This type of information is pertinent to studies involving human interpretation or clinical outcomes, which is not the focus of this 510(k) submission for an external fixation system.
4. Adjudication method for the test set:
Not applicable. See point 3.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
No. This is a 510(k) for modifications to a mechanical device. MRMC studies are typically for evaluating the performance of diagnostic imaging solutions with human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No. This device is an external fixation system, not an algorithm or AI-driven system.
7. The type of ground truth used:
Not applicable for a clinical performance study. For a 510(k) of a mechanical device, "ground truth" would relate to engineering specifications, material properties, and mechanical performance standards, established through recognized test methods.
8. The sample size for the training set:
Not applicable. There is no concept of a "training set" in the context of this 510(k) submission for an external fixation system.
9. How the ground truth for the training set was established:
Not applicable. See point 8.
In summary:
This 510(k) notification for the Hoffmann® II Micro™ External Fixation System focuses on demonstrating substantial equivalence to predicate devices for its modified components. The "study" mentioned is the "testing" conducted to prove this equivalence, likely involving mechanical and material characterization rather than clinical performance studies with metrics like sensitivity or specificity. Therefore, many of the typical questions asked for AI or diagnostic device studies are not applicable to this document.
§ 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.