(22 days)
This subject component, when used together with the components of the Hoffmann® II and/or Monotube® TRIAX™ External Fixation Systems and Apex® Pins, creates an external fixation frame construct. The subject device is intended to be used in the construction of external fixation frames to provide stabilization of open and/or unstable fractures and where soft tissue injury precludes the use of other fracture treatments such as IM rodding or casting.
The Hoffmann® II Hybrid External Fixation System is intended to be used in conjunction with the Apex™ Half Pins of the Hoffmann® External Fixation System and Kirschner Wires of the Monticelli Spinelli™ External Fixation System, and may be used as a Hybrid External Fixation System with the components of the Hoffmann® II External Fixation System and the Monotube® TRIAX™ External Fixation System.
This device is used to provide stabilization of open and/or unstable fractures and where soft tissue injury may preclude the use of other fracture treatments such as IM rods, casts, or other means of internal fixation. The indications for use of metallic external fixation devices include:
- Bone fracture fixation .
- Osteotomy .
- . Arthrodesis
- Correction of deformity .
- Revision procedure where other treatments or devices have been unsuccessful ●
- Bone reconstruction procedures .
The Hoffmann® II Hybrid Clamp is being modified to address issues in manufacturing.
This document is a 510(k) Premarket Notification for a modified medical device, the Hoffmann® II Hybrid Ring Clamp. The core of this submission is to demonstrate substantial equivalence to an already legally marketed predicate device (K000197).
Therefore, this type of submission does not typically contain acceptance criteria or a study proving device performance in the way a novel device might. Instead, the "study" is a technological comparison to the predicate device to show that the modifications do not alter the safety or effectiveness of the device.
Here's how to address your numbered points based on the provided text:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the document. For a 510(k) modification demonstrating substantial equivalence, the "acceptance criteria" are typically that the modified device's performance (e.g., mechanical properties, material properties) is comparable to the predicate device and that the modifications do not raise new questions of safety or effectiveness. The reported "performance" would be the results of the comparison testing.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document does not specify a distinct "test set sample size" in terms of number of patients or clinical cases. The "testing" involved a technological comparison of the modified clamp to the predicate device. This would typically involve in-vitro mechanical testing of components or assemblies. The sample size for such tests (e.g., number of clamps tested for strength) is not stated.
- Data Provenance: Not applicable in the context of clinical data. For mechanical testing, the data would originate from the manufacturer's internal testing facilities, likely in the US (where Howmedica Osteonics Corp is based). The study is essentially a retrospective comparison to the predicate device's established performance and a comparison of the new manufacturing process/design.
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)
This is not applicable as there is no "ground truth" derived from expert consensus on clinical data or images. The "ground truth" in this context is the established performance and safety profile of the predicate device, against which the modified device is compared through engineering analysis and potentially mechanical testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as there is no clinical test set requiring expert adjudication. The comparison is based on engineering principles and potentially laboratory 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
This is not applicable. This device is a mechanical component (a surgical clamp), not an AI-driven diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This device is a mechanical component.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
As explained above, there isn't "ground truth" in the typical clinical sense. The "ground truth" for the comparison is the performance and safety established for the predicate device (K000197), primarily through engineering specifications, material properties, and mechanical testing, which the new device aims to match or exceed.
8. The sample size for the training set
This is not applicable. This is a physical medical device, not an AI/machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
This is not applicable. (See point 8)
Summary of the "Study" from the Document:
The "study" or basis for this 510(k) submission is described as a "Statement of Technological Comparison":
- "Analysis demonstrates comparable properties of the subject to the predicate device."
This indicates that the manufacturer performed an engineering analysis, likely involving:
- Comparison of materials
- Comparison of design specifications (dimensions, geometry)
- Comparison of manufacturing processes (to ensure the modifications did not negatively impact performance)
- Potentially, mechanical testing (e.g., strength, fatigue, corrosion resistance) to verify that the modified clamp's performance characteristics are equivalent to or better than the predicate device.
The acceptance criteria implicitly would be that the modified device maintains the same level of safety and effectiveness as the predicate device, as demonstrated by these comparable properties. The "device performance" reported is simply that this comparability was achieved.
§ 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.